Monday, 31 March, 2008

Drug approvals

Bethanechol Chloride Tablets
Lannett announced that it has received approval from the USFDA on its Abbreviated New Drug Application for Bethanechol Chloride Tablets in 5 mg, 10 mg, 25 mg, and 50 mg, the generic equivalent of Urecholine(R) Tablets marketed by Odyssey Pharma. Bethanechol Chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
Bupropion Hydrochloride extended-release tablets

Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the USFDA to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR(R) and are indicated for the treatment of major depressive disorder.

Pharma firms bet big on new B'desh law

The business standard reported an article by Joe C Mathew on Domestic drug firms, which lost the opportunity to sell cheap generic versions of patented medicines after changes in the Indian patent law three years ago, may find favorable market in Bangladesh. Chances of technical partnerships in Bangladesh have brightened after it changed its patent law in an attempt to become a hub for manufacturing cheap copies of patent-protected medicines. The World Trade Organisation allows such medicines to be produced in least developed countries till 2016. ( Link to full article business-standard.)

Eisai Got Favorable Preliminary Injunction Ruling in Donepezil product Patent Infringement Lawsuit Against Teva

Eisai announced that the United States District Court of NewJersey has ruled in Eisai's favor with respect to Eisai's motion for a preliminary injunction in its patent infringement lawsuit against TevaPharmaceuticals and its division Gate Pharmaceuticals concerning Aricept tablets (Donepezil ). Eisai filed the infringement actions in December 2005 contesting Teva's submission of an abbreviated new drug application (ANDA) to the USFDA for Aricept(R). Teva received tentative approval from the FDA in January, and could receive final approval April 26, following a delay required under federal drug law because of the patent litigation.
Following patents are listed In the Orange book for 5 and 10 mg tablets of Donepezil
US4895841 (Expiry: NOV 25,2010)- Product patent
US5985864 (Expiry: DEC 30,2016)- Polymorph (Form-II, III, IV and V)
US6140321 (Expiry: DEC 30,2016)-polymorph
US6245911 (Expiry: DEC 01,2018)-Polymorph A, B and C
US6372760 (Expiry: MAR 31,2019)- Formulation
Teva alleged earlier that 841’ patent is unenforceable due to inequitable conduct (based on materiality and intent) as Esai had not disclosed to the patent examiner its co pending application (now US4849431 patent) at the time of prosecution of 841’ patent. Teva also said that an article by Dr. Kenley published in Journal of Medicinal Chemistry (JMC) in 1984 further suggest that 841’ invention is obvious and if patent examiner would have known about this patent (431') and JMC article he would have not granted the 841’ patent. Esai produced the testimony by Dr. Kenley who sided with Esai.
The U.S. District Judge Harold Ackerman concluded in his opinion that There is no doubt that Teva has infringed Eisai's valid patent, and Eisai will likely prevail at trial in demonstrating the enforceability of that patent over Teva's inequitable conduct defense
The other para IV filer against this product are Ranbaxy, Par and Roxane
Donepezil (2-[(1-benzyl-4-piperidyl)methyl]- 5,6-dimethoxy-2,3-dihydroinden-1-one), marketed under the trade name Aricept (Eisai), is a centrally acting reversible acetylcholinesterase inhibitor. Its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. The USFDA first approved Aricept tablets in 1996. The drug is Tokyo-based Eisai's biggest product, with $2.16 billion in worldwide sales in the year ended in March 2007. (orangebookblog) (Eisai press release)

Teva Press Release

Teva Pharma that the U.S. District Court for the District of New Jersey has granted Eisai's motion for a preliminary injunction related to Teva's tentatively approved Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept(R) (Donepezil Hydrochloride) Tablets, 5 mg and 10 mg. The injunction is based on Eisai's enforcement of US4,895,841 that Teva has asserted is unenforceable. A trial date has not been set.

Friday, 28 March, 2008

Regulatory News

Voclosporin: New immunosuppressive
Isotechnika Inc. announced today that the International Nonproprietary Name (INN) expert committee has accepted the proposed generic name of its lead immunosuppressive drug, ISA247. ISA247 will now be referred to as voclosporin. The name will serve to identify the active pharmaceutical substance during the drugs' life-timeworldwide.Voclosporin is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidneyrejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LX211 by Lux) for the treatment of uveitis
Novel oral anticoagulant Pradaxa® (dabigatran etexilate) approved by the European Commission
Boehringer Ingelheim announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa® (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa® will be launched in Germany and the United Kingdom in the coming weeks.
Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
The standard recommended dosage of Pradaxa® is a fixed oral dose of 220 mg given once daily. A single capsule of 110 mg (half-dose) is administered orally between 1 and 4 hours following surgery, continuing with 2 capsules once daily thereafter for a total of 10 days in total knee replacement patients and 28-35 days in total hip replacement patients. A second approved dosage of 150 mg taken as two capsules of 75 mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.
Pradaxa® prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme that enables the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore prevents the development of a thrombus
FDA Looking Into Montelukast sodium Suicide Risk
The USFDA is investigating a possible connection between the use of Merck’s Singulair and changes in behavior and mood involving suicidal thoughts and suicide. The agency said in an Early Communication Thursday that it is considering, but has not reached a decision on, possible regulatory action. Singulair (Montelukast sodium), Merck’s top-selling product, had worldwide sales of $4.3 billion last year. Singulair is a leukotriene receptor antagonist indicated for treating asthma, and the symptoms of allergic rhinitis and for preventing exercise-induced asthma.

Graceway Pharmaceuticals Files False Advertising and Unfair Competition Litigation Against River's Edge Pharmaceuticals

Graceway Pharma has filed a lawsuit against River's Edge Pharma in the US District Court for the Northern District of Georgia based on River's Edge's improper sales and marketing practices.
The lawsuit alleges that River's Edge unlawfully promotes its benzoyl peroxide gel and wash products as generically equivalent to - or otherwise substitutable for - Graceway's Benziq(TM) family of products: Benziq LS Gel (benzoyl peroxide 2.75%); Benziq Gel 50 g Tube (benzoyl peroxide 5.25%); and Benziq Wash (benzoyl peroxide 5.25%).
Benzoyl peroxide is used as a radical initiator. Homolytic cleavage of the weak oxygen-oxygen bond forms benzoyl free radicals which trigger further reactions.
Jack Breitbart of Revlon laboratories first developed benzoyl peroxide's use for treating acne in the 1920s. It is typically placed over the affected areas in gel or cream form, in concentrations of 2.5% increasing through the usually effective 5% to up to 10%. Research suggests that 5 and 10% concentrations are not significantly more effective than 2.5% and 2.5% is usually better tolerated
The lawsuit sets forth claims for False Advertising and Unfair Competition in violation of the federal Lanham Act, as well as claims for common law Unfair Competition and Misappropriation.

Patent news

USPTO upheld the validity of Osteotech patent on radiolucent material
Osteotech, Inc. , a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the United States Patent and Trademark Office has confirmed the validity of its US5,676,146. The '146 patent covers mixtures of a radiolucent material, such as demineralized bone, with a radiopaque material, such as nondemineralized or partially demineralized bone, that is provided in sufficient quantity to be used as a radiographic marker. The Patent Office's reexamination certificate also includes four new claims.
Neptune got patent on Natural Marine Source Phospholipids
Neptune Technologies & Bioressources Inc. announces that the European Patent Office (EPO) granted on May 31st 2007 Neptune's composition of matter patent EP01417211 entitled "Natural Marine Source Phospholipids comprising flavonoids, polyunsaturated fatty acids and their applications" and that this patent has now been issued and validated in twenty-four European countries.
Epeius Biotechnologies got patent on Targeted gene delivery
Epeius Biotechnologies announced today the issue of US7,347,998 for Targeted Gene Delivery in vivo. This patent provides additional intellectual property protection for the platform of highly advanced biotechnologies embodied in the company's leading anti-cancer agent, Rexin-G. Administered clinically by simple intravenous infusion, the Epeius tumor-targeted gene delivery system enables Rexin-G to seek out and accumulate selectively in cancerous tissues and remote metastatic tumor nodules that have spread throughout the body. Rexin-G delivers it tumor-killing payload precisely where it is needed most, by targeting cancer from the inside.
Human Genome Hits Genentech With Patent Suit
A patent dispute between two biotechnology companies over a type of protein that can be used to detect tumors has landed in federal court, after Human Genome Sciences appealed the USPTO decision in an interference proceeding.
Invitrogen Sues GE for Enzyme Kit Patent infringement
Invitrogen sue GE health care subsidiary with two lawsuits alleging that GE is willfully infringing several patents related to reverse transcriptase enzyme kits and DNA amplification kits.

Thursday, 27 March, 2008

Lilly Settles Alaska Suit Over Olanzapine

Eli Lilly and Alaska announced a $15 million settlement on Wednesday in the state's lawsuit over the use of the drug Zyprexa in its Medicaid program. Olanzapine (Zyprexa, Zyprexa Zydis, or in combination with fluoxetine Symbyax) is an atypical antipsychotic, approved by the FDA for the treatment of: schizophrenia. The deal ensures that Alaska will be treated as well as any other state that may settle with Lilly over similar claims involving the drug, which is used to treat schizophrenia and bipolar disorder.The agreement included no admission of wrongdoing by Lilly.The state sued for hundreds of millions of dollars to cover costs to Medicaid for treating what it says are Zyprexa-related health problems, including weight gain, high blood sugar and diabetes.The settlement ended a case in which jurors began hearing testimony on March 6. Lilly attorneys got a sense of the challenges they faced earlier this month.Anchorage Superior Court Judge Mark Rindner said on the bench, without jurors present, that without lawsuits like the one the state of Alaska brought, claims that drugs cause health problems "might well go unaddressed."Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is up to the federal Food and Drug Administration, not any state. He argued that Alaska's Unfair Trade Practices and Consumer Protection Act shouldn't apply to drugs.But Rindner said evidence presented by the state had established that the FDA "isn't capable of policing this matter."

Wednesday, 26 March, 2008

Lipitor and Caudet: Pfizer sued Ranbaxy for process patents infringement

Pfizer sued Ranbaxy for the infringement of two process patents (process patents are not listed in Orange book) on Lipitor (Atorvastatin) and Caduet (Atorvastatin and Amlodipine combination). The suit filed by Pfizer in the U. S District Court of Wilmington, Delaware claims that Ranbaxy's generic version of Lipitor would infringe two patents covering the process for making amorphous Atorvastatin, the active ingredient in the cholesterol lowering drug. Following are the process patents
US6087511- which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin
US6274740- which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof
The two patents will expire in July 2016. Pfizer has asked for a court order that would ban Ranbaxy from making, selling or importing generic Lipitor until that time. Separately, Pfizer filed a suit against Ranbaxy citing the same patents in order to extend the exclusivity of Caduet by a similar amount of time. Lipitor is the world's best-selling medicine and Pfizer's top seller. It clocked sales of US$12.7 bn in 2007, about 26% of Pfizer's total revenues, but faces generic competition in March 2010. Caduet had 2007 sales of US$568mn. Ranbaxy already is banned from selling generic versions of Lipitor and Caduet until product patent 893’ expires in 2010. The new lawsuits seek to extend that ban another six years. The innovator has many process, derivative and intermediate patents covering Atorvastatin which innovator can use to block generic entry.
Earlier On March 23, Pfizer announced that a Canadian court has ruled in its favour upholding a patent for Atorvastatin, a molecule for making Lipitor, thereby preventing Ranbaxy from launching a generic version until 2010. The Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy from obtaining approval for a cheaper copy of Lipitor. In canada it was also found that Ranbaxy's Amorphous API will infringe Pfizers crystalline polymorphic forms patent as Ranbaxy was using crystalline form in their process of manufacturing amorphous Atorvastatin (Link to bloomberg news) (Link to economictimes)

Tuesday, 25 March, 2008

Calcipotriol ointment for UK market (Leo pharm V/S Sandoz): Advantage Leo pharm

In a significant decision on Calcipotriol ointment (Leo Pharma v Sandoz), a decision of Justice Mann in the Chancery Division, England and Wales, on 17-3-2008 favored innovator Leo pharm.
Leo held a patent for Calcipotriol Monohydrate (EP0679154), a new crystalline form of Calcipotriol which was used in the treatment of the skin disease psoriaris. The patent claimed that the monohydrate form had technical and stability properties better than those of the existing anhydrate form and claims monohydrate form as product. On April 2007 Sandoz obtained market authorisation for a calcipotriol ointment, launching the product shortly thereafter. On 18 June, it obtained market authorisation for a cream.
Calcipotriol ((1R,3S)-5-[2-[(1R,3aR,7aS)-1-[(2S)-5-cyclopropyl-5-hydroxy-pent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexane-1,3-diol ) or calcipotriene is a synthetic derivative of calcitriol or Vitamin D. It is used in the treatment of psoriasis, marketed under the trade name Dovonex or Daivonex. Available as a cream, ointment or scalp solution (50mcg/mL), Calcipotriol is applied twice daily to plaque psoriasis on the body or scalp, but not the face. Improvement is usually detectable within 2 weeks. Most patients show some improvement, slightly more so than is seen with the use of corticosteroids alone.
Leo procured a sample of the ointment and, on testing it, found that it contained the monohydrate version of the calcipotriol molecule. In August Leo'informed Sandoz that the ointment infringed its patent EP0679154. When Leo requested for the samples, Sandoz refused the request for a sample on confidentiality grounds and challenged the reliability of Leo's testing procedures. Sandoz continued to refuse the request, which was repeated on several occasions, and failed to disabuse Leo of their mistaken belief as to the date of the cream's launch, which actually occurred on 31 October. Following a further request for a sample made in December, Sandoz told Leo that the cream had been on the market for some time, meaning they could obtain a sample from a third party. Having experienced difficulties in getting hold of a sample, Leo repeated the request and later told Sandoz that it would be bringing infringement proceedings. At this point Sandoz made samples available, the testing of which revealed the presence of the monohydrate molecule, which constituted 15% of the crystalline forms detected.At this point Leo applied for an interim injunction to stop Sandoz distributing the cream. Sandoz argued that there was no serious issue of infringement to be tried since, according to Leo's own tests, the presence of monohydrate crystals was so small that, as a matter of common sense, the beneficial effects referred to in the patent were not present. Questions also arose as to whether damages would be an adequate remedy for Leo if Sandoz were allowed to market the cream until trial, and as to the adequacy of any cross-undertaking in damages that Leo (whose own financial position was in doubt) would have to make in favour of Sandoz in the event that interim relief should not have been granted. Judge Mann J allowed Leo's application for interim relief. The judge concluded that It would be dangerous for a judge in an interim application to use common sense to determine what is ultimately likely to be a technical question that might require expert evidence. The balance of convenience and what could be taken to have been the status quo also pointed in favour of granting an injunction. So all parameters pointed towards granting injunction.

Monday, 24 March, 2008

Sun got approval of Benzonatate capsules

Sun announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, Benzonatate capsules. Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP. Benzonatate has annual sales of approximately USD 40 million in the US. Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections.

Canadian court block Ranbaxy's generic Atorvastatin approval

After a series of unfavorable rulings for Pfizer a Canadian Court of appeals has upheld the Pfizer's patent for Lipitor, delivering a setback to Ranbaxy Lab in its quest to market a generic version of the blockbuster cholesterol drug Pfizer announced that the Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy Lab from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy's product in Canada until Pfizer's enantiomer (calcium salt) patent--Canadian Patent No. 2,021,546--expires in July 2010. This is a second setback to Ranbaxy in Canada, earlier it was found that Ranbaxy’s amorphous API infringe Pfizers crystalline patent

Thursday, 20 March, 2008

Sagent Pharmaceuticals and Teva Launched Ciprofloxacin injection

Sagent and Teva announced that they have launched Ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous (I.V.) administration used to treat bacterial infections. Sagent's and Teva's ciprofloxacin injection will be available immediately in 200mg and 400mg premix bags. According to IMS data, sales of injectable ciprofloxacin in the United States in 2006 were approximately $60 million. Ciprofloxacin is the third product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product, adenosine injection, USP, in December 2007.

18 states sue Abbott Laboratories for blocking generic versions of Fenofibrate

Eighteen states have filed suit in federal court against Abbott, alleging the drug maker blocked generic competition for a popular cholesterol medication. The antitrust lawsuit charges that Abbott and a French drug company tried to block competition for a cheaper, generic version of the prescription drug TriCor (Fenofibrate), a cholesterol drug. Fenofibrate is a drug of the fibrate class. The development of Fenofibrate was discovered by Groupe Fournier SA, before it was acquired by Solvay Pharmaceutical in 2005. It is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease. The pharmaceutical form and the strength may change from one country from another, and from one brand to another. In the United States, Tricor was reformulated in 2005 and is available in tablets of 48 and 145 mg. This reformulation is controversial and is the subject of antitrust litigation by generic drug manufacturer Teva The medicine accounted for more than $1 billion (€0.63 billion) of Abbott's sales last year. The states allege that the companies continuously made minor changes in the formulations of TriCor to prevent generic versions from entering the market

Sun and Strides got approval to market Fosphenytoin sodium injection

Sun pharma and strides got approval to market generic version of Fosphenytoin. Fosphenytoin (Cerebyx®, Parke-Davis; Prodilantin®, Pfizer Holding France) is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. Fosphenytoin was approved by the USFDA on August 5, 1996 for use in epilepsy
Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised, such as endotracheal intubation, status epilepticus or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.
Sun Pharma news
Sun Pharma announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection which is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents). Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US. Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery.
Strides Arcolab news
Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials. The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc and Strides Arcolab Limited Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.

Cipla get green signal from Delhi high court for marketing Tarceva

Delhi High Court today declined to restrain Cipla Ltd from manufacturing and selling the generic version of Hoffman-La Roche's lung cancer drug Tarceva.The Swiss pharmaceutical company had approached the court after it found that Cipla was planning to launch a generic version of Tarceva in India and export the same to various countries. While the generic version will cost about Rs 1,600 per tablet, the price of Roche’s patented version is around Rs 4,800. After considering the huge difference in prices of the two products, Delhi High Court said the drug should be available in the market for the benefit of patients.The court was of the view that the balance had to be tilted in favour of the people. Passing the interim order, Justice S. Ravinder Bhatt, however, directed Cipla to maintain accounts of sales figures for the calculation of damages to be awarded if Hoffmann finally wins the case. Roche was granted a patent for Tarceva in India in February 2007. Patent experts, however, said this may not serve the purpose, as the damages to Roche following the ruling will be far more than what Cipla earns by selling the drug. Cipla is selling the drug at one-third Roche’s tab. Now when Cipla is allowed to sell it, Roche will be compelled to reduce match Cipla’s price if it has to keep selling Tarceva. It is believed that the Swiss drug maker could even approach the Supreme Court. For more details on this new please check sify Telegraph

Wednesday, 19 March, 2008

FDA issue approvable letter to J&J on Ceftobiprole

Johnson & Johnson announced that it received an approvable letter from the USFDA regarding its New Drug Application (NDA) for Ceftobiprole (6R,7R)-7-[ [(2Z)-2-(5-amino-1,2,4-thiadiazol-3-ylidene)-2-nitroso-1-oxoethyl]amino]-8-oxo-3-[(E)-[2-oxo-1-[(3R)-3-pyrrolidinyl]-3-pyrrolidinylidene]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid) for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
Ceftobiprole is a fifth generation cephalosporin antibiotic with activity against methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae and Enterococci. It was discovered by Basilea Pharmaceutica and was developed by Johnson & Johnson Pharmaceutical Research and Development. The drug is under regulatory review in Europe, Australia and Canada

Hi-Tech got Final Approval for Ofloxacin Otic Solution

Hi-Tech Pharma announced today that the USFDA has granted final approval to the Company's Abbreviated New Drug Application for Ofloxacin otic solution, 0.3%. Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin(R) otic solution, 0.3% indicated for the treatment of bacterial infections of the ear.

FDA news

FDA Setting Up Shop in China
The FDA is establishing three permanent offices in China to monitor drug safety, which will be staffed by eight FDA employees along with five Chinese nationals to assist them.
The State Department has approved the plan, but the Chinese government has yet to do so. The posts are to be established by September 2009 at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou as part of the agency’s Beyond our Borders initiative.
This region is the first of at least five where the FDA intends to establish an overseas presence, FDA Commissioner Andrew von Eschenbach said. India, Europe, South America and the Middle East also are on the list. FDA spokeswoman Stephanie Kwisnek said the regions are listed in no particular order. The new FDA offices in China will give the agency greater access to local manufacturing facilities for inspections and improve its interactions with Chinese manufacturers, helping ensure that food and drug products shipped to the U.S. meet its standards for safety and manufacturing quality. (source: FDA newsletter)

Schering-Plough Files Application for OTC Heartburn Drug
Schering-Plough has submitted a new drug application for 20-mg Zegerid as an OTC product to treat frequent heartburn.
The company acquired exclusive U.S. and Canadian rights to market OTC proton pump inhibitor products using proprietary technology under a 2006 license agreement with Santarus.
Under the agreement, Santarus received a $15 million upfront license fee and is entitled to an additional $65 million in milestone payments. Santarus continues to manufacture and sell Zegerid (omeprazole/sodium bicarbonate) prescription products in both 20- and 40-mg strengths in the U.S. The U.S. OTC heartburn market generated an estimated $1.6 billion sales in 2007, based on data from market research firm A.C. Nielsen and Santarus’ calculations. (source: FDA newsletter)

Tuesday, 18 March, 2008

Sanofi Aventis Sues Wockhardt Over Alfuzosin Patent

Sanofi-Aventis has filed suit against Wockhardt alleging that the Indian generics maker has infringed the Orange book listed patents for Sanofi prostate treatment Uroxatral (Alfuzosin) Extended release 10 mg tablets.
Alfuzosin hydrochloride is an alpha-adrenergic blocker used to treat benign prostatic hyperplasia (BPH). It works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. Alfuzosin was approved by the FDA for treatment of BPH in June 2003. The following are Orange book listed patents for (Alfuzosin) Extended release 10 mg tablets.
US4661491 (Expiry: JAN 18, 2011)- Method of use for the treatment of dysuria
US6149940 (Expiry: AUG 22, 2017)- Controlled release Tablet
Sanofi-Aventis has earlier sued 10 generic players like Actavis, Aurobindo, Barr Laboratories, Mylan, Par, Ranbaxy, Sun, Teva, Torrent and Apotexfor filing Para IV against orange book listed patents.

1st para IV filer Sun got final approval on Amifostine injection

Sun Pharma. announced that USFDA has granted final approval to market a generic version of MedImmune’s Ethyol®, Amifostine for injection 500mg. This generic amifostine for injection is therapeutically equivalent to MedImmune’s Ethyol® Amifostine for injection 500mg. S-2-(3-Aminopropylamino) ethyl dihydrogen phosphorothioate (Amifostine) Ethyol® has annual sales of approximately USD 80 million in the US. Sun Pharma, being the first-to-file an ANDA for generic Ethyol® with a para IV certification, has a 180-day marketing exclusivity.Ethyol® is covered under 3 patents –
US5424471 (Expiry: July 31, 2012)-Covers crystalline Amifostine composition
US5591731 (Expiry: July 31, 2012)- Covers crystalline Amifostine composition with improved stability
US5994409 (Expiry: Dec 8, 2017)- Method of use
This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation. Amifostine is used as an adjuvant in cancer treatment. Sun Pharma’s amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.

Monday, 17 March, 2008

Panacea Biotech invalidated Novartis patent on emulsion preconcentartes of cyclosporine or a macrolide

European Patent Office in Munich has revoked Novartis Patent EP1059913 on opposition filed by Panacea Biotec.EP1059913 assigned to Novartis AG, entitled “Emulsion preconcentrates containing cyclosporine or a macrolide” has total 20 claims out of which claim 1 is independent claim, which covers a composition in form of an emulsion pre-concentrate or a microemulsion pre-concentrate suitable for oral administration comprising: 1) a cyclosporine or macrolide, and a carrier medium comprising 2) a second component selected from the group consisting of (i) glyceryl di C6-C16 fatty acid ester, (ii) glyceryl mono C6-C14 fatty acid ester, (iii) a mixture of mono-, diglycerides of C6-C16 fatty acids, (iv) propylene glycol mono C6-C12 fatty acid ester, (v) fatty alcohols, and3) a lipophilic component, and 4) a surfactant, with the proviso that when component 2) consists of a mixture of mono-, diglycerides of C8-C10 fatty acids, said composition is free of a C6-C12 fatty acid triglyceride.Panacea Biotec had filed an opposition in 2005 on EP1059913 on the grounds of Lack of Novelty and Inventive-step. Novartis filed two auxiliary requests in order to protect their granted patent. In August 2007, summons for ‘Oral hearing’ were issued to both the parties. Subsequently on Oral hearing the EP1059913 was revoked on account of being taken of the amendments made by the Novartis during opposition proceedings because the patent and the invention to which it relates were found not to meet the requirements of the EPC (Art. 101(3) (b) EPC) (Source: Amit)

Saturday, 15 March, 2008

PTO Sidesteps Patent Term Extension “Regulatory Review Period” Issue in Petition Response

Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” For a medical device subject to an approved Premarket Approval Application (“PMA”), the Patent Term Extension (“PTE”) statute at 35 U.S.C. § 156(g)(3)(B) states that the “testing phase” begins on “the date a clinical investigation on humans involving the device was begun and [ends] on the date [a PMA] was initially submitted with respect to the device.” The “review phase” is the period between PMA submission and approval. A patent term may be extended for a period of time that is the sum of one-half of the time in the “testing phase,” plus all the time in the “review phase.” The “regulatory review period” must be reduced by any time that the applicant “did not act with due diligence.” (For complete news click on FDAlawblog)

Wisconsin Court Adds to Precedent Holding that the FDC Act Cannot Be Privately Enforced

On February 29, 2008, Judge Stadtmueller of the United States District Court for the Eastern District of Wisconsin dismissed a lawsuit brought by Schering-Plough Healthcare Products, Inc. (“Schering”) against three manufacturers of prescription polyethylene glycol 3350 (“PEG”), a laxative drug product. In its lawsuit, Schering sought to use the Lanham Act, 15 U.S.C. § 1125, (along with state law claims) to privately enforce the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The court, following the reasoning of many other courts, held that Schering could not do so and dismissed the case. Hyman, Phelps & McNamara, P.C., represented one of the defendants in the case. For complete story please click on Link (Source:FDAlawblog)

Drug filing/approvals

Watson Files ANDA for Generic Lybrel (Levonorgestrel and Ethinyl Estradiol)
Watson Pharma confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the USFDA seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets, which is indicated for the prevention of pregnancy.
Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of US6500814.
Hawthorn Receives FDA Approval on Granisol Oral Solution
Hawthorn Pharmaceuticals, Inc. announced today the US Food and Drug Administration (FDA) approval of the company's Granisol(TM) (granisetron HCl) Oral Solution. Granisol(TM) is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol(TM) is the AA-rated equivalent of Roche's Kytril(R) Oral Solution. Granisol(TM) Oral Solution is available through all the national drug wholesalers as well as multiple other distribution channels and will begin shipping immediately. Granisol(TM) Oral Solution is available by prescription only in the United States.

First time generics (Feb 2008)


Thursday, 13 March, 2008

Sanofi-Aventis filed lawsuit against Sandoz to block Zolpidem Tartrate CR generic

Sanofi-Aventis filed a lawsuit on Friday against Sandoz on Ambien (Zolpidem Tartrate) CR. Sandoz recently filed an ANDA with the USFDA to market a generic extended-release tablet containing zolpidem tartrate, the active ingredient in Ambien, before Aventis patent on the Zolpidem, US6514531, expires, Sanofi says in a complaint filed in the U.S. District Court for the District of New Jersey.The '531 patent, issued to Sanofi in 2003, describes a “controlled-release dosage forms of zolpidem or salts thereof adapted to release zolpidem over a predetermined time period.” Sandoz certified in its ANDA that the '531 patent is invalid, according to Sanofi's complaint. Sanofi has requested the court to enjoin Sandoz from selling a generic version of Ambien until the '531 patent expires and to award monetary damages for any other acts of infringement it might find.Last June, the company sued Mutual Pharma, United Research Lab and their parent company Pharmaceutical Holdings Corp., which had also filed an ANDA to make generic versions of Ambien. Those suits are still pending in the District of New Jersey. In addition, Sanofi filed suit in February 2007 against Dutch pharmaceutical company Synthon Holding BV over an ANDA Synthon submitted in a bid for FDA approval to market generic Ambien in the U.S. As in the suits against Sandoz and Mutual, Sanofi asserted the '531 patent in its suit against Synthon. Ambien, which was approved for sale in the United States in the early 1990s, is one of Sanofi's biggest sellers, generating $1.9 billion in sales during the first nine months of 2006.

New Para IV filings

Exforge®(amlodipine and valsartan) Tablets 5/320mg on Nov 26, 2007
Epivir®(lamivudine) Tablets 150mg and 300mg on October 16, 2007
Sular®(nisoldipine) ER Tablets 20 and 30mg on Nov 7, 2007
Tarka®(trandolapril and verapamil) ER Tablets 2/180mg and 2/240mg on Nov 9, 2007
Fosamax Plus D®(alendronate and cholecalciferol) Tablets 70 mg/2800 IU and 70 mg/5600 IU on Nov 20, 2007
Metadate CD®(methylphenidate) ER Tablets 50 and 60mg on Nov 13, 2007
Abilify®(aripiprazole) Oral Solution 1 mg/mL on Dec 20, 2007
Xyzal®(levocetirizine) Tablets 5mg on Dec 17, 2007
Monistat 1 Combination Pack®(miconazole nitrate) Vaginal Cream and Suppository 2% and 1.2 g on Dec 5, 2007
Actonel with Calcium®(risedronate with calcium carbonate) Tablets 35 mg; 500 mg on Dec 18, 2007
Soctreotide Acetate Injection®(octreotide acetate) Injection 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free) on Jan 17, 2008

Pharma news in brief

Barr receive FDA approval for Paclitaxel injection
Barr Pharma announced that its subsidiary, Plivia has received final approval from the USFDA for its generic version of Bristol-Myers Squibb Company's Taxol(R) (Paclitaxel) Injection USP, 6mg/mL, packaged in 100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials. The Company plans to launch its product shortly.
Trail Date set for Quetiapine litigation
AstraZeneca announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharma. and Sandoz alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (ANDAs). The ANDAs seek approval to market generic versions of Seroquel® (quetiapine fumarate tablets) in the US before Seroquel’s patent expires in 2011. The Court has set a date for trial beginning on 11 August 2008.
Connecticut AG Blumenthal Sue Eli Lilly For Illegal Marketing of Olanzapine for unapproved Uses
Attorney General Richard Blumenthal sued Eli Lilly for illegally marketing its antipsychotic drug Zyprexa (Olanzapine) for unapproved uses, and concealing the drug's serious side effects, for more than a decade. Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children. The deceptive marketing campaign dangerously concealed risks associated with Zyprexa, including diabetes, cardiovascular problems, and significant weight gain. In a lawsuit filed today, Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa. "The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems," Blumenthal said. "This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects. "Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa. "Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes." Blumenthal sued pursuant to the Connecticut Unfair Trade Practices Act (CUTPA) and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) on behalf of Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr. and Department of Social Services (DSS) Commissioner Michael Starkowski.

Wednesday, 12 March, 2008

Wisconsin Alumni Research Foundation (WARF) won patent battle on key embryonic stem cell patents

The Wisconsin Alumni Research Foundation announced that USPTO has rejected challenges to its two key embryonic stem cell patents.
The decision marks a complete victory for the foundation, known as WARF, and makes Wisconsin a critical stop for anyone aiming to commercialize products that rely on embryonic stem cells.
The patent office in late February rejected a challenge to a third embryonic stem cell patent held by WARF.
All of the patents are based on discoveries made by James Thomson, the first person to isolate human embryonic stem cells, from which virtually all organs, cells and other body tissues arise.
The victory will not cause WARF to raise fees on its commercial licenses, Gulbrandsen said.
WARF is seeing a small amount of commercial royalties coming in from stem cell licenses that involve research products. Two companies - Menlo Park, Calif.-based Geron Inc. and Los Angeles-based Advanced Cell Technology - have said they hope to enter clinical trials this year with therapeutic products based on embryonic stem cells. The patent office decision might spur some companies that haven't yet negotiated stem cell licenses with WARF.
The challenges had been brought by the Foundation for Taxpayer and Consumer Rights in Santa Monica, Calif., and the Public Patent Foundation in New York City. The groups had argued that the pioneering work done in the mid-1990s by Thomson, a University of Wisconsin-Madison scientist, could have been done by any good scientist with access to embryos and funding.
The patent office decisions said the challengers failed to prove that.
The foundations had pulled in four stem cell scientists to file declarations in support of overturning the patents: Douglas Melton and Chad Cowan of Harvard University; Alan Trounson, who recently left Monash University in Australia to run California's stem cell agency; and Jeanne Loring of the Scripps Research Institute.
The patent office said their declarations didn't put a dent in WARF's claims. For example, Loring's declaration relied on "opinion on the ultimate legal issue without providing sufficient underlying factual support," the patent office decision said.
The foundations still claimed a victory, saying they had pushed WARF to loosen its licensing requirements during the challenge. John Simpson, stem cell project manager for the Santa Monica group, said the two groups intend to appeal the patent office's February decision on one of the patents - the only one it can appeal based on patent office procedures.
During the re-examinations, WARF saw no downturn in its stem cell licensing, Gulbrandsen said.
The three key stem cell patents expire in 2015, but it's likely that "improvements" WARF has made to them will generate royalties for WARF after 2015, Frenchick said. Improvements are subsequent patent filings made by WARF that represent material changes to the original ones.
One such improvement has likely been filed on the work announced by Thomson and a team of scientists in November. By genetically manipulating human skin cells, they said they were able to reprogram them to act like embryonic stem cells without using human embryos.

Pharma news (drug approvals/filings/litigation)

Perrigo got Final Approval on Clobetasol Propionate Foam
Perrigo announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.
The product is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008. As the first filer, Perrigo will be eligible for 180 days of generic marketing exclusivity once it launches the product.
In late 2005, Connetics Corporation, which sells the brand drug, filed a patent infringement suit against Perrigo in the United States District Court for the District of New Jersey following Perrigo's paragraph IV patent certification in its ANDA stating that the Connetics' patent is invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In response to a motion filed by Connetics last Thursday, the Court temporarily restrained Perrigo, as of March 7, 2008, from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19, 2008. On that date, the Court will hear arguments on Perrigo's pending Summary Judgment Motion as well as Connetics' Motion for a Preliminary Injunction.
Akorn-Strides Got approval for Tobramycin injection
Akorn-Strides today announced the approval of an ANDA for Tobramycin Injection USP, 80 mg/2mL and 1.2 grams/30mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn and Strides Arcolab Limited. The primary mission for the Joint Venture is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines. Tobramycin Injection is an antibiotic and is indicated for the use in treating or preventing infections that are proven or strongly suspected to be caused by susceptible bacteria. Recent IMS data estimates an annual marketsize of approximately $19 million.
Sigma-Aldrich settle patent dispute on Lentivector technology
Sigma-Aldrich , Oxford BioMedica and Open Biosystems have jointly announced a confidential settlement of their patent litigation. Sigma-Aldrich and Oxford BioMedica agreed to dismiss the lawsuit brought against Open Biosystems. Open Biosystems agreed to dismiss its counterclaims in the lawsuit. As part of the settlement Open Biosystems will acquire certain license rights under the Oxford BioMedica patents for use of the LentiVector technology in research activities.
Spectrum got approval of Levoleucovorin
Spectrum Pharma announced that it has received marketing approval from the USFDA for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. Levoleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.Levoleucovorin was reviewed under a full NDA, and included an Oncologic Drug Advisory Committee (ODAC) review. Spectrum anticipates that the drug will be listed without any therapeutically equivalent product in the FDA Orange Book. Drugs without therapeutic equivalents are considered 'single source drugs' which under section 1847A of the Social Security Act generally qualify for a separate reimbursement code with CMS.
Schering-Plough files new drug application with FDA for over-the-counter Zegerid (Omeprazole/sodium bicarbonate)
Schering-Plough announced that it has submitted a NDA to the USFDA for Zegerid (Omeprazole/Sodium bicarbonate) , the company's branded over-the-counter product to treat frequent heartburn.The NDA was submitted under the terms of a license agreement with Santarus Inc. for the exclusive U.S./Canadian rights to market Zegerid proton pump inhibitor products using Santarus' patented technology.
In June 2004 the FDA approved an immediate release preparation of omeprazole/sodium bicarbonate that does not require an enteric coating. This preparation employs sodium bicarbonate as a buffer to protect omeprazole from gastric acid degradation. This allows for the production of chewable tablets. This combination preparation is marketed in the United States by Santarus under the trade name Zegerid. Zegerid is marketed as capsules, chewable tablets, and powder for oral suspension. Zegerid is most useful for those patients who suffer from nocturnal acid breakthrough or those patients who desire immediate relief.
Dabur got approval for Irinotecan hydrochloride injection in Italy and Denmark
Dabur Pharma Ltd has received approvals for Irinotecan hydrochloride injection, generic version of Pfizer's Camptosar, in Italy and Denmark. The company had successfully launched the generic version of the drug in the US recently. It has also received approval for the drug in the UK. Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. It is also indicated for patients with metastatic carcinoma of the colon or rectum where disease has recurred or progressed following initial fluorouracil based therapy.

Tuesday, 11 March, 2008

Unprecedented Number of International Patent Filings in 2007

In a year that saw a record number of filings under the World Intellectual Property Organization (WIPO) Patent Cooperation Treaty (PCT), the cornerstone of the international patent system, inventors from the Republic of Korea (4th place) and China (7th) consolidated their top ten position in 2007, along with the United States of America (1st) , Japan (2nd), Germany (3rd), France (5th), United Kingdom (6th), Netherlands (8th), Switzerland (9th) and Sweden (10th). In total, a record 156,100 applications were filed in 2007, representing a 4.7% rate of growth over the previous year. For the fourth year running, the most notable growth rates came from countries in north east Asia which accounted for over a quarter (25.8%) of all international applications under the PCT.
“The growth in patent filings by a number of countries in north east Asia and their share of overall patenting activity is impressive and confirms shifting patterns of innovation around the world,” said Dr. Kamil Idris, Director General of WIPO. “It is most encouraging to see clear evidence that countries in the region are embracing the tools of the international patent system to stimulate commercial activity and economic growth,” he added, noting “The PCT remains an attractive option for businesses as it makes it easier for companies and inventors to obtain patent rights in multiple countries.” The Director General further noted that “Strategic use of the patent system is a business imperative in today’s knowledge-driven economy. The success of the PCT is largely due to the sustained use of the system by some of the world’s foremost innovation-based companies.”
The Republic of Korea, which experienced 18.8% growth in 2007 as compared to 2006, overtook France to become the 4th biggest country of origin of PCT filings, and applicants from China, whose use grew by 38.1%, dislodged the Netherlands to take the position of 7th largest country of origin.
With more than 52,000 PCT applications, inventors and industry from the United States of America represented 33.5% (a 2.6% increase over 2006) of all applications in 2007. Applicants from Japan, who unseated their German counterparts in 2003 for the number two spot, maintained their second place position with 17.8% of the total number of applications, representing a 2.6% increase over 2006. Inventors and industry from Germany held third position with 11.6% of all applications in 2007, representing an 8.4% increase, followed by users in the Republic of Korea (4.5% of all applications and an 18.8% increase) and France (4.1% of all applications and a 2.1% increase). Of the fifteen top filing countries, China achieved double-digit growth (7th highest filer, with a growth rate of 38.1% in 2007). Among other countries to register double-digit growth in 2007 were Brazil (15.3%), Malaysia (71.7%), Singapore (13.9%) and Turkey (10%).
Mr. Francis Gurry, Deputy Director General who oversees the work of the PCT, said “WIPO is continuing to enhance the PCT and its operations to ensure that applicants benefit from access to ever-more efficient, cost-effective quality services of the highest caliber”, and pointed out that WIPO receives on average over 400 PCT applications every day. Mr. Gurry said “We have seen tremendous efficiency gains in the delivery of PCT services over the last four years. WIPO is handling an unprecedented volume of applications with lower staff numbers and is effectively responding to increased demands resulting from changing patterns of innovation. We are clearly seeing a maturing of the system as the PCT celebrates 30 years of operations and currently enjoys a membership of 138 countries.”
Top Applicants
The year 2007 saw some changes in the list of top users of the PCT system. Matsushita of Japan moved into 1st place (2,100 applications published in 2007), overtaking the Dutch multinational Philips Electronics N.V. (2,041 applications published in 2007). Siemens (Germany) (1,644) retained 3rd place. Huawei Technologies of China moved up 9 places to become the 4th largest applicant with 1,365 applications published in 2007. These were followed by Bosch (Germany) (1,146), Toyota (Japan) (997), Qualcomm (USA) (974), Microsoft, which jumped 38 places to 8th place (USA) (845), Motorola (USA) (824) and Nokia (Finland) (822). Among the 20 top filing companies, six were from the USA, six from Japan and three from Germany.
Fields of Technology
The largest proportion of PCT applications published in 2007 related to the telecommunications (10.5%), information technology (10.1%) and pharmaceuticals (9.3%) sectors. The fastest growing technology areas are nuclear engineering (24.5% increase) and telecommunications (15.5%).
The main fields of technology in which PCT applications were published in 2007 are broken down according to the International Patent Classification (IPC) - a classification system designed to facilitate the retrieval of technical information found in patent documents.

Developing Countries
WIPO continued to receive international patent applications from developing countries in 2007. The largest number of applications received came from the Republic of Korea (7,061) and China (5,456) followed by India (686), South Africa (390), Brazil (384), Mexico (173), Malaysia (103), Egypt (41), Saudi Arabia (35) and Colombia (31). Developing countries make up 78% of the membership of the PCT, representing 108 of the 138 countries that have signed up to the treaty to date.
Other Developments
Applicants are increasingly submitting their international applications electronically. In 2007, more than half (53%) of the applications received were filed electronically. A further 15% were filed using PCT-EASY software (electronic bibliographic data with the patent specification on paper). The remaining 32% were filed entirely on paper.
Approximately 5.6% - some 8,700 international applications - of all PCT applications in 2007 were filed directly with the WIPO PCT Receiving Office. Applicants, who so wish, may file their international applications directly with the WIPO PCT receiving office in Geneva rather than through the intermediary of a national or regional IP office.
Through the application of information technologies and the outsourcing of certain functions, for example, in the field of translation, WIPO has augmented productivity levels in PCT operations. All PCT applications are now scanned on receipt at WIPO and processed electronically. Mr. Gurry said “With these changes, WIPO is able to contain costs and process the increased volume of PCT applications while keeping staff levels relatively constant.”
The PCT offers inventors and industry an advantageous route for obtaining patent protection internationally. By filing one “international” patent application under the PCT, protection of an invention can be sought simultaneously in each of a large number of countries. Both applicants and patent offices of PCT member states benefit from the uniform formality requirements, the international search and preliminary examination reports, and the centralized international publication provided by the PCT system. The national patent granting procedure and the related expenses are postponed, in the majority of cases, by up to 18 months (or even longer in the case of some offices) as compared with the traditional patent system. By this time, the applicant will have received important value-added information concerning the likelihood of obtaining patent protection as well as potential commercial interest in that invention.
Growth rates in the filing of PCT applications have been particularly dynamic over the last nine years. It took 18 years from the beginning of PCT operations in 1978 to reach 250,000 total applications, but only four years to double that figure (500,000), and another four to double it again (1,000,000).

(Source: WIPO report Link)

Monday, 10 March, 2008

USV got patent on Donepezil Oxalate

USV Ltd. got a major success in a legal appeal, winning exclusive US rights to a new drug salt of Donepezil oxalate which is effective in treating Alzheimer's disease. USV applied to patent this compound in 2004. USV's patent application described its invention as a "Composition of matter," the legal term used in the US patent statute. Surprisingly, the US Patent Office then refused to issue USV's patent application, arguing that the phrase "composition of matter," which appears in the patent statute itself, is too vague to support proper patent rights. An appeals board in Washington disagreed. Rather, The Board of Patent Appeals and Interferences noted that a 1980 Supreme Court ruling involving another Indian inventor, Sidney A. Diamond v. Ananda Mohan Chakrabarty, concluded that the phrase "composition of matter" is perfectly acceptable. The appeals board thus concluded, in Ex parte Venkatasubraminarian Radhakrishnan Tarur et al., Appeal No. 2007-4478, that USV is entitled to its patent. The development is significant, since an important intermediate, Donepezil base is covered by several patents by the innovator company. USV’s patent on a novel salt, Donepezil Oxalate helps the company make Donepezil Hydrochloride (the active ingredient in Alzheimer drug Aricpet) without violating the innovator company’s patents on the intermediate, a company official explained.
Donepezil Hydrochloride it the active ingredient in Aricept, an over $ 2 billion Alzheimer’s drug from Japanese drug-maker Eisai Co Ltd . The US patent on Aricept, which is co-marketed with Pfizer Inc., expires in November 2010.
The patent-related development comes even as the Mumbai-based USV sets about its strategy of getting a process patent on a drug that is set to expire in the short term. This helps USV get some elbow-room for itself in a competitive generic drugs market.
The US Patent office though refused USV’s patent application, arguing that the said phrase was too vague, the note said. The company appealed to the Board of Patent Appeals and Interferences, which disagreed with the patent office’s view, the note added.

Pfizer won by 2-1 against Teva on Celecoxcib litigation

Pfizer announced that the Court of Appeals for the Federal Circuit (CAFC) has upheld the two main US patents covering Celebrex (Celecoxcib), the company's Cox-1 enzyme selective non-steroidal anti-inflammatory (NSAID) drug. Generic manufacturer Teva Pharma challenged the Orange book listed patents. The panel ruled that the patents (US5466823 and US5563165) covering the active pharmaceutical ingredient (API) and a pharmaceutical composition thereof are valid, enforceable and infringed by the generic manufacturer's product. In the same decision, the court ruled that a third patent (US 5760068) covering the use in the treatment of inflammation was invalid. The decision prohibits Teva from launching a competitor drug in the US until May 2014. Either party may request a rehearing by the court of appeals or a review by the US Supreme Court.
35 U.S.C 121 blocks the use of a parent application “as a reference … against a divisional application” if the divisional was the result of a restriction requirement.
One of the Pfizer patents (the ‘068) is a continuation-in-part (CIP) filed after a restriction requirement. On appeal, the CAFC confirmed that Section 121 does not apply to CIPs: “a divisional application contains an identical disclosure to its parent application, but a CIP introduces new matter. . . . [T] he protection afforded by section 121 . . . is limited to divisional applications.”
Thus, the parent application of a CIP will potentially be used for an obviousness-type double patenting rejection. Here, the CAFC held that the CIP claims were indeed obvious when compared to the parent application.
A patent is invalid when the applicant fails to satisfy the best mode requirement of Section 112. The requirement can be broken down into two elements:
Whether the applicant subjectively “possessed” a best mode for practicing the invention at the time the application was filed; and, if so, Whether the disclosure would objectively enable a PHOSITA to practise the best mode. Like other invalidity issues, best mode is determined on a claim-by-claim basis. There was no real question here that the COX-specific claims did satisfy the best mode requirement. The appellate panel refused to speculate further on the moot issue of how the best mode requirement is met for claims covering a larger class of compounds. (As reported earlier by patently-O)
Celecoxib was developed by G. D. Searle & Company and co-promoted by Monsanto (parent company of Searle) and Pfizer under the brand name Celebrex. Monsanto merged with Pharmacia, from which the Medical Research Division was acquired by Pfizer, giving Pfizer ownership of Celebrex. The drug was at the core of a major patent dispute that was resolved in Searle's favor (later Pfizer) in 2004. In University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), the University of Rochester claimed that United States Pat. No. 6,048,850 (which claimed a method of inhibiting COX-2 in humans using a compound, without actually disclosing what that compound might be) covered drugs such as celecoxib. The court ruled in favor of Searle, holding in essence that the University had claimed a method requiring, yet provided no written description of, a compound that could inhibit COX-2 and therefore the patent was invalid.After the withdrawal of rofecoxib (Vioxx) from the market in September 2004, Celebrex enjoyed a robust increase in sales. However, the results of the APC trial in December of that year raised concerns that Celebrex might carry risks similar to those of Vioxx, and Pfizer announced a moratorium on direct-to-consumer advertising of Celebrex soon afterwards. After a significant drop, sales of Celebrex have recovered, and reached $2 billion in 2006. Pfizer resumed advertising Celebrex in magazines in 2006Celebrex was approved by the FDA in 1998. Its sales totaled $1.7 billion the US in 2007.

Orange book blog ( Link) and Patentdoc (link) have come up with interesting review on Celebrex litigation

Friday, 7 March, 2008

Pfizer sue Impax for filing Para IV on Tolterodine capsules

Impax confirmed that Pfizer have filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging patent infringement related to Impax's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Detrol LA(Tolterodine) 2mg and 4mg capsules. Impax's ANDA submission includes a Paragraph IV certification stating the Company believes its product does not infringe Pfizer's listed patents or that the listed patents are invalid or unenforceable.
following are the orange book patents listed for Tolterodine ER capsules

US5382600 (Expiry:SEP 25,2012)- Product patent
US6630162 (Expiry:MAY 11,2020)-Formulation
US6770295 (Expiry:FEB 26,2020)-Method of use and controlled release Formulation

US6911217 (Expiry:FEB 26,2020)- Controlled release formulation

Tolterodine (2-[3-[bis(1-methylethyl)amino]- 1-phenyl-propyl]-4-methyl-phenol) is an antimuscarinic drug that is used to treat urinary incontinence.

Barr filed lawsuit to block Seasonique (Levonorgestrol/Ethinylestradiol) generic

Barr Pharma announced that it has filed suit against Watson Pharma for infringement of the patent protecting Duramed's Seasonique extended-cycle oral contraceptive product. The Company's Seasonique (Levonorgestrol/Ethinylestradiol combination) US7320969 is due to expire on January 30, 2024. In addition to the patent, the Company also has 3-year New Product Exclusivity for its Seasonique product until May 25, 2009. On January 22, 2008, the U.S. Patent and Trademark Office issued the patent for the Company's Seasonique extended-cycle oral contraceptive. The Company immediately submitted the patent to the USFDA for listing in the Orange Book. On January 22, 2008, Watson notified the Company pursuant to the Hatch-Waxman Act that Watson had filed an Abbreviated New Drug Application (ANDA) with the FDA for Seasonique and that Watson had amended its application to include a paragraph IV certification asserting that the Seasonique patent is invalid, unenforceable or not infringed by Watson's ANDA product. Barr has filed to enforce the patent and prevent Watson from marketing a competing product prior to patent expiry in 2024. If Barr is unsuccessful in this litigation, the Company may face generic competition for Seasonique as early as May 25, 2009.

Drug approvals

EMEA issued positive opinion on clopidogrel bisulfate tablets (300 mg)
Sanofi-Aventis and Bristol-Myers Squibb Company announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix(R) (clopidogrel bisulfate). This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.The new 300mg tablet will facilitate the use of the approved loading dose of Plavix(R) and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS), including those with unstable angina / non-ST segment elevation myocardial infarction (managed with percutaneous intervention (PCI) with or without stent or medically managed) and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).
Sun got tentative approval for Gemcitabine injection
Sun Pharma announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co’s Gemzar, Gemcitabine injection.These generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co’s Gemzar® injections availablein two strengths: 200 mg and 1 g single use vial. These strengths of gemcitabine injections have annual sales ofapproximately USD 680 million in the US.Gemcitabine is an anticancer, used singly or in combination with other anticancer agents.
Teva got final approval for Cetrizine, Pseudoephedrine extended release tablets
Perrigo Company announced that its partner, Teva Pharma has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.

Wednesday, 5 March, 2008

Watson filed ANDA on Levonorgestrel and Ethinyl estradiol combination (Seasonique)

Watson Pharma confirmed that it has filed an ANDA with the USFDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharma, a subsidiary of Barr. Watson's Levonorgestrel and Ethinyl estradiol product is a generic version of Barr's Seasonique. On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified Barr that it had filed an ANDA with a paragraph IV certification with the FDA for a generic version of Seasonique (R) asserting that the Seasonique (R) patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for Seasonique (R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

Patent issues

Teva filed lawsuit against USFDA on Risperidone exclusivity
Teva Pharma announced (as reported earlier by this blog) today that its U.S. subsidiary has filed a lawsuit against the USFDA seeking an order requiring the FDA to relist in the Orange Book US5158952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal (Risperidone) Tablets.Teva argues that the FDA's denial of Teva's Citizen's Petition, seeking the relisting of US5158952 and restoration of Teva's 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to Teva's submission of a Paragraph IV certification to that patent.
Solvay Filed lawsuit against Teva on Fenofibrate patent infringemnet
Solvay SA said its pharmaceutical business' units Laboratoires Fournier SA and Fournier Laboratories Ireland Ltd have filed a patent lawsuit against Teva Pharmaceutical Industries over fenofibrate drug TriCor.Fenofibrate is a drug of the fibrate class. The development of Fenofibrate was discovered by Groupe Fournier SA, before it was acquired by Solvay Pharmaceutical in 2005. It is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease. Like other fibrates, it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density liporotein (HDL) levels and reducing tryglycerides level. It also appears to have a beneficial effect on the insulin resistance featured by the metabolic syndrome. It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia. Fenofibrate is sold under the brand name Tricor by Abbott Labs and Lipanthyl by Solvay Pharmaceutical.
Teva filed an abbreviated new drug application at the end of January seeking approval for a generic version of the fenofibrate 145 mg form tablets in the US.'Solvay Pharmaceuticals is fully committed to its fenofibrate franchise and will vigorously protect the intellectual property for this product against any infringement,' the group said in a statement.
US Court Splits Evenly In Warner-Lambert Troglitazone Suit
The U.S. Supreme Court Monday deadlocked in a Michigan lawsuit against Pfizer Warner-Lambert unit, an outcome that allows a product liability case over Troglitazone (Rezulin) to proceed. The high court heard oral arguments in the appeal just last week where the justices appeared sharply-divided on whether earlier Supreme Court precedent restricts state product liability lawsuits alleging fraud in the Food and Drug Administration drug-review process.
Troglitazone (Rezulin, Resulin or Romozin) is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was introduced in the late 1990s but turned out to be associated with an idiosyncratic reaction leading to drug-induced hepatitis. It was withdrawn from the USA market on 21 March 2000, and from other markets soon afterwards
The court was split 4-4, it announced in a brief order. Chief Justice John Roberts Jr. was recused from the case, presumably because he owns less than $15, 000 in Pfizer stock, his most recent financial disclosure shows.
The outcome provides no new legal precedent, but it is a blow for Warner- Lambert because a lower-court ruling that revived the lawsuit now stands.
Pfizer, which acquired Warner-Lambert in 2000, has already announced a fourth- quarter charge against earnings in 2003 to cover all the costs associated with Rezulin litigation.
The case was over injuries from Troglitazone (Rezulin), a diabetes drug that was removed from the market in 2000 after less than four years on the market. The lawsuit is proceeding under a unique Michigan state drug products liability law that favors pharmaceutical companies by generally barring lawsuits over drugs approved for sale by the FDA. But the law has an exemption that allows injured patients to sue if they allege a drug company committed fraud during the FDA drug-review process.
The issue of federal preemption of state lawsuits over drugs is one the Supreme Court is scheduled to hear in a separate case next fall when it takes up Wyeth's challenge to a $6.8 million judgment awarded to a Vermont woman over complications from an anti-nausea drug.The Michigan claims were thrown out by a federal trial judge in 2005 prior to the Second Circuit ruling that revived the claims on appeal.

District court invalidates patent covering micronization of Drospirenone and Ethinyl estradiol combination

Barr Pharmaceuticals, Inc. today announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious.Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $572 million for the twelve months ended December 2007, based on IMS sales data.Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Yasmin product with the U.S. Food & Drug Administration (FDA) in January 2005, and received notification of the application's acceptance for filing in February 2005. Following receipt of the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA) holder, and Schering AG, the patent owner. In April 2005, Schering AG and Berlex filed a patent infringement suit against Barr in the U.S. District for the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In November 2007, the patent infringement case was heard in front of Judge Sheridan. There are 3 orange book listed patents for Yasmin.
US5569652 (Expiry: OCT 29, 2013) – Covers Dihydrospirorenone method of use
US6787531 (Expiry: AUG 31, 2020)- Combination of Drospirenone and Ethinyl estradiol (Micronization technique)
US6933395 (Expiry: AUG 11, 2017)- Formulation and drospirenone intermediates as product
The patent in suit is micronization technique patent 531’. Barr argued that micronization technique is obvious as it increases dissolution of Drospirenone. Bayer argued that micronization without coating to reduce acid degradation in stomach is not obvious. Court decided in the light of KSR V/S Teleflex decision and concluded that person having ordinary skilled in the art would have known to test bioavailability of Drospirenone, and when choosing from finite number of methods for delivering oral contraceptive, micronized tablets without enteric coated would have been obvious to try.
Yasmin is part of a group of contraceptives that became the single biggest contributor to Bayer's pharmaceutical revenue last year, with 1.04 billion euros ($1.58 billion) in sales. The ruling may threaten the newer Yaz birth control pill, which is also protected by the patent. Bayer, which bought German rival Schering AG in 2006 to boost growth from pharmaceuticals, reduced the 2008 profitability goal for its health unit as a result of the Yasmin decision. Yasmin had sales of about $572 million in 2007.
The ruling increases the possibility that Barr will introduce a generic version sometime in the second half of the year. There are three patents on Yasmin, with the one invalidated yesterday considered among the strongest, he said.

Monday, 3 March, 2008

Pharma news in brief

Teva to appeal against Risedronate infringement decision
Teva Pharma announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter & Gamble's Actonel® (Risedronate Sodium) Tablets, 5mg, 30mg and 35 mg. The Court found Procter & Gamble's US5,538,122 (Covers formulation) to be valid. Teva intends to appeal this decision.
Glenmark to hive off API, generic business
The Mumbai-based leading research oriented pharmaceutical company Glenmark is all set to start its new company- Glenmark Generics Ltd (GGL) from April 1, 2008. The company is transferring its domestic active pharmaceutical ingredients (APIs) business and generics formulations business to GGL. The new company is planning to enter in the capital market during first quarter of 2008-09. Glenmark is transferring its entire assets related to APIs and generic business, including brands, trademarks and employees, located at Goa, Ankleshwar, Kurkumbh and Mohol to GGL as a going concern. The new company will handle the development, manufacture and marketing of generic formulation and API businesses. Glenmark will continue to directly manage the novel R&D and branded formulation businesses of the Glenmark group including India, Brazil, Rest of Latin America (excluding Argentina), Russia/CIS, Africa and Asia.

Eisai's Rabeprazole gets US priority review
USFDA have granted priority (With in six months) review for a new application of Eisai Aciphex acid reflux drug, Japan's fourth-largest drug maker said.
Aciphex, known chemically as Rabeprazole sodium, belongs to a class of drugs known as proton pump inhibitors designed to suppress production of stomach acid that can burn and damage the esophagus, a condition known as gastroesophageal reflux disease.
Eisai announced that the USFDA had accepted a supplemental New Drug Application (NDA) for Aciphex for the short-term treatment of gastroesophageal reflux disease in patients of age 12-16.
It said the FDA has indicated it would grant the new application priority review status.Eisai derives nearly half of its U.S. drug sales from Aciphex and it is its second-biggest selling drug after Aricept, which is used to treat Alzheimer's disease.

Saturday, 1 March, 2008

Procter & Gamble Wins Patent Infringement Lawsuit On Risedronate Sodium tablets

Today the United States District Court of Delaware ruled in favor of The Procter & Gamble (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharma. The positive ruling protects P&G's rights in the U.S. to exclusively market the osteoporosis therapy Actonel(R) (risedronate sodium tablets).
On August 13, 2004 P&G filed a patent infringement lawsuit against Teva to enforce P&G's U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. Today's Court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.
"We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G President, Global Health Care. "We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures." Following patents are listed in orange book w.r.t Risedronate tablets
US5583122 (Expiry: DEC 10,2013)- Covers Formulation
US6096342 (Expiry: NOV 22,2011)- Covers Formulation
US6165513 (Expiry: JUN 10,2018)- covers Formulation
Innovator has earlier also sued Teva on infringement of US5994329 (Expiry: Jul 7, 2018)- which covers pharmaceutical kit. The court has decided on 122’ patent infringement. Teva has approved ANDA for Residronate tablets.The Actonel patent life extends through the end of 2013, excluding any potential extensions. The U.S. Food and Drug Administration approved Actonel in 2000 for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures with in a year

USFDA Approves Aripiprazole for the Acute Treatment of Manic and Mixed Episodes in Pediatric Patients (10 to 17 Years of Age)

Otsuka Pharma and Bristol-Myers Squibb Company (BMS ) announced today that the USFDA approved the supplemental New Drug Application for ABILIFY® (Aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). Aripiprazole has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.
The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score."We are pleased that the FDA has approved ABILIFY to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population."
"We are committed to developing innovative new medicines to their fullest potential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease."
US 5006528 is listed in orange book for Aripiprazole tablets. The patent will expire on 20 april 2015. This product has also got Pediatric exclusivity which will expire in September 2008. There is one adjunctive treatment exclusivity which will expire in 16 November 2010.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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