Tuesday, 29 April, 2008

Atorvastatin: USPTO Refuses Again To Reissue 995' Patent

USPTO Refuses Again To Reissue Lipitor PatentThe USPTO has again rejected (second time) Pfizer ’s request to reissue US5273995 (995’), which covers enantiomer of Atorvatatin as product. The verdict gives Ranbaxy who has 180 days first to file Para IV exclusivity hope to launch the cholesterol-lowering drug Lipitor as early as March 2010. (link to financial express news).

The basic patent which covers Atorvastatin racemate 893' is also under reexamination by USPTO on the opposition filed by a lawfirm representing Ranbaxy.

Monday, 28 April, 2008

clopidogrel bisulfate: Apotex sue USFDA to Recover 180-Day Exclusivity

Apotex filed an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification in early 2001 and was subsequently sued by innovator Sanofi-Synthelabo and Bristol-Myers Squibb (BMS) for infringement of following product patent listed in Orange book, US4847265 (Expiring on Nov 17, 2011)-which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts
The 30 month stay on Apotex ANDA approval expired in 2005 and its ANDA was subsequently approved in 2006. Apotex launched its product at risk with 180 days exclusivity but was enjoined after 23 days by preliminary injunction by District court on appeal from innovator. Apotex now wants that FDA should not allow Dr. Reddy to market its product before Apotex enjoy remaining exclusivity period of 157 days

It is pertinent to mention that Apotex failed to invalidate 265' patent in district court. The CAFC opinion is due in May 2008. (For complete review of this case link to orangebookblog )

Risperidone: Teva faces opposition for 180 days First to file exclusivity from Apotex

As reported earlier on first to file exclusivity litigation between Teva and FDA over relisting of US5158952 (Teva won recently as per district court decision). Apotex filed a motion to intervene in the Rieperidone generic case to safeguard its substantial interests in the outcome of Teva V/S FDA litigation. Apotex’s ANDA is not yet tentatively approved. (Only Mylan and Pliva have tentative ANDA approvals.) If Judge grants Apotex’s motion, then the company “intends to file a notice of appeal and immediately pursue the appropriate appellate remedies to obtain a stay of the District Court’s ruling pending appeal, and/or review of the ruling on an emergency or expedited basis prior to the June 29, 2008 launch date.” It is pertinent to mention that Teva has opposed the motion from Apotex (For complete review of this case Link to FDAlawblog here)

Drug approvals: Cefixime tablets,Certolizumab, Lisdexamfetamine

Lupin launches Cefixime tablets
Lupin Pharmaceuticals Inc, a wholly owned US subsidiary of Mumbai-based pharma major Lupin Limited, launched Suprax 400 mg tablets (Cefixime USP) in US. With this line extension, Lupin has tightened its grip on the brand franchise of its flagship anti-infective Suprax (Cefixime for oral suspension 100 mg/ 5 ml and 200 mg/ 5ml).
USFDA approves UCB's Certolizumab
UCB announced that USFDA has approved Cimzia (certolizumab pegol), the first and only PEGylated anti-TNF (Tumour Necrosis Factor alpha) antibody indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.
USFDA approves Lisdexamfetamine Dimesylate
Shire has received approval from the USFDA for Vyvanse (Lisdexamfetamine Dimesylate), for the treatment of Attention Deficit Hyperactivity Disorder in adults.

Saturday, 26 April, 2008

News from Watson Pharma

Watson to sell authorized generic of Pravastatin
Watson Pharma announced that under a distribution agreement with Bristol-Myers Squibb (BMS) the Company has initiated shipments of Pravastatin sodium tablets in the 10, 20 and 40 mg. strengths.
Pravastatin sodium distributed by Watson is the authorized generic version of BMS 's Pravachol(R) product and is cholesterol lowering agent.
Watson is also marketing an authorized generic form of Alendronate in agreement with Merck.

Watson filed Para IV on Fentanyl buccal tablet
Cephalon announced its receipt of a Para IV Certification Notice Letter relating to an ANDA submitted to the USFDA by Watson, requesting approval to market and sell a generic version of Fentora (R) (Fentanyl buccal tablet).
In its Notice Letter, Watson alleges that the US6200604 and US 6974590 covering Fentora are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.
Cephlon has 45 days time to bring infrigement action against Watson

Thursday, 24 April, 2008

Drug Approvals

*Akorn-Strides announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials

*Taro Pharma reported today that it has received final approval from the USFDA for its ANDA for cetirizine hydrochloride oral solution, 1 mg / 1 ml

*Mylan announced that it has received final approval from the USFDA for its ANDA for Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg.

Divalproex Sodium: Again setback to Nupharm

Nu-Pharm Inc.’s efforts to get USFDA to approve the company’s ANDA for the generic version of Abbott Laboratories’ Depakote (divalproex sodium) Delayed-Release Tablets 500 mg were earlier rejected by District court of Columbia earlier in Jan 2008. On April 17, 2008, a 3-judge panel from the U.S. Court of Appeals for the District of Columbia Circuit issued an order granting FDA’s Motion for Summary Affirmance. The court decision here

Tuesday, 22 April, 2008

Ranbaxy and Orchid entered into a business alliance

Ranbaxy and Orchid Chemicals & Pharmaceuticals have entered into a business alliance agreement involving multiple geographies and therapies for both finished dosage formulations and active pharmaceutical ingredients (API). Additionally, this agreement would establish a synergestic association between the two companies.

Pharma News

Mylan got Final Approval for Felodipine Extended-Release Tablets, USP
Mylan got final approval from the USFDA to market Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg which is generic version of AstraZeneca 's Plendil Extended-release tablets.
APP Pharma got USFDA Approval for Colistimethate For Injection
APP Pharma announced that it has received approval from the USFDA to market Colistimethate for Injection, USP, 150 mg, the generic equivalent of JHP Pharmaceutical ‘s ColyMycin injection.
Bayer filed lawsuit against Sandoz and Watson
Bayer filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York against Watson and Sandoz for the infringement of US5569652 (which covers Yasmin). Bayer has earlier lost it patent battle against Barr.
Heritage launched Nimodipine Soft Gel Capsules
Heritage Pharma announced the immediate availability of Nimodipine Soft Gelatin Capsules in 30 mg strength. Heritage's earlier received final approval of its ANDA on Nimotop on January 17, 2008

Azelastine: Meda settled patent dispute with Apotex

Meda has settled the patent infringement case against Apotex on Azelastine (4-[(4-chlorophenyl)methyl]-2- (1-methylazepan-4-yl)-phthalazin-1-one). Azelastine is an antihistamine and mast cell stabilizer available as a nasal spray (Astelin®) for hay fever and as eye drops (Optivar®) for allergic conjunctivitis. The following patent is listed in orange book for Optivar (azelastine opthalmic solution) and Astelin (azelastine Nasal spray)
US5164594 (Expiry: May 1, 2011) which covers a method for the treatment of irritation or disorders of the nose and eye which comprises applying directly to nasal tissues or to the conjunctival sac of the eyes a medicament which contains a member selected from the group consisting of azelastine and its physiologically acceptable salts.

As reported earlier by ippharmdoc that litigation is another way for negotiating licensing fees with innovator, this settlement is on similar grounds. The settlement treaty allows Apotex to launch a generic version of Astelin, under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5% of their net sales of this product to Meda until 1 February 2011. The agreement also allows Apotex to launch a generic version of Optivar, under license from Meda, on 1 December 2009, without further payments to Meda.
The innovator Meda is in litigation with Sun pharma on Optivar and with Cobalt on Astelin

Perrigo Files ANDA For Generic Miconazole vaginal suppository

Perrigo confirmed its filing of an ANDA for a generic version of Monistat 1 combination pack (Miconazole formulation). Johnson & Johnson's the innovator for this formulation had filed an infringement lawsuit against various generic players. Miconazole is an imidazole antifungal agent, is commonly applied topically or mucus membranes to cure fungal infections. It acts by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes.

Monday, 21 April, 2008

Caraco Won Summary Judgment on Generic Ultracet (Tramadol and Acetaminophen)

Caraco announced that the United States District Court of New Jersey has granted Caraco's motion for summary judgment and held that the claims of Ortho-McNeil ‘s reissue patent USRE39221- which covers a pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio from about 1:1 to about 1:1600 are invalid as obvious.
Caraco's Tramadol with Acetaminophen product is a generic version of Ortho-McNeil's Ultracet.
The District court concluded that Caraco has demonstrated by clear and convincing evidence that the combination of Tramadol with Acetaminophen in a weight ratio of 1:5 and 1: 1600 are obvious to person having ordinary skill in the art. The judge also observed that the patent application of USRE39221 was initially rejected by the USPTO in 1991 on the grounds of obviousness w.r.t prior patent application by Frankus et al. However, some claims were granted in 1994 and in reissue patent in 2006. The Company commenced shipment of Tramadol with Acetaminophen following the USFDA's approval on December 19, 2005, and it has remained on the market since that time.

Pharma News in Brief

Akorn got UDSFDA Approval on Diclofenac Sodium Ophthalmic Solution 0.1%
Akorn announced that the USFDA has granted approval to market Diclofenac Sodium Ophthalmic Solution, 0.1%. Diclofenac Sodium Ophthalmic Solution is a non-steroidal anti-inflammatory agent used to treat cataract and refractive surgery patients. Annual sales for Diclofenac Sodium Ophthalmic Solution were approximately $14 million in 2007, according to IMS sales data.
Alcon's olopatadine nasal spray gets USFDA approval
Alcon announced that USFDA has approved Patanase (Olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. This product will be in the market from May onwards.
Dabur sold majority stake to Fresenius
Indian based Dabur announced that its founders and other shareholders have agreed to sell 73.27% in the company to Fresenius Kabi (Singapore) which is a unit of European firm Fresenius SE. Earlier, Dabur had sold its non-oncology drugs business to Vadodra based pharma firm Alembic to focus on cancer treatment drugs.

Friday, 18 April, 2008

Amlodipine (Norvsac): Pfizer 's patent upheld by Canadian court

The Canadian federal circuit court has upheld the validity of a innovator Pfizer ‘s patent CA1321393 (Expiry: August, 2010)- which covers a process for preparing the besylate salt of amlodipine characterised by the steps of reacting amlodipine base with a solution of benzenesulphonic acid or its ammonium salt in an inert solvent and recovering the besylate salt of amlodipine.

Pharmascience may appeal the decision to the Federal Court of Appeal of Canada. In a ruling Judge Roger T. Hughes of the Canadian Federal Court stopped Canada’s Minister of Health from approving Pharmascience s generic copy of Norvasc (Amlodipine) until Pfizer’s patent expires The invalidity challenges to this patent in Canada by other generic manufacturers are still pending. The decision by Canadian Federal Court prevents Pharmascience from launching a generic version of the drug until the Canadian patent expires in 2010. Norvasc sales plunged 52 per cent to $513 million in the quarter.
Amlodipine (3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate) is a long-acting calcium channel blocker (dihydropyridine) used as an anti-hypertensive and in the treatment of angina. As other calcium channel blockers, amlodipine acts by relaxing the smooth muscle in the arterial wall, decreasing peripheral resistance and hence reducing blood pressure; in angina it increases blood flow to the heart muscle.
Amlodipine is marketed as Norvasc® in North America and as Istin® in the United Kingdom by Pfize. The patent on Amlodipine has alredy expired in USA in 2007 and number of generic version of this drug are availabe in U.S market

Sepracor and UCB sue Synthon for infringement of method of use patent of Levocetirizine

Belgian healthcare group UCB S.A. and Sepracor has filed a legal action against Synthon for allegedly infringing the following Orange book patent on its antihistamine drug levocetirizine (Xyzal) in the federal court of Delaware.

US5698558 (Expiry: September 24, 2012)- This patent covers a method of treating the symptoms of seasonal and perennial allergic rhinitis in a human which comprises administering to a human in need of such symptomatic relief therapy an amount of (-) cetirizine, or a pharmaceutically acceptable salt thereof, substantially free of its (+) stereoisomer, said amount being sufficient to alleviate or palliate said allergic rhinitis.

Sepracor said the company has filed a lawsuit in the U.S., together with UCB, claiming Synthon used the levocetirizine in the treatment of allergic rhinitis.UCB said the move is a response to Synthon's statement at the end of March that it believes itself to be the only first Para IV filer' of an ANDA for the Xyzal drug product.As a result (of the filing) Synthon expects to be eligible for 180 days exclusivity upon the first commercial marketing of the generic drug product.Xyzal is the successor to blockbuster drug Zyrtec, whose patent has expired.

Teva got Tentative approval for Raloxifene tablets

Teva Pharma announced today that the USFDA has granted tentative approval to the Company's ANDA to market its generic version of Lilly's osteoporosis treatment Evista(R) (Raloxifene Hydrochloride) Tablets, 60 mg.
Raloxifene ([6-hydroxy-2-(4-hydroxyphenyl)- benzothiophen-3-yl]- [4-[2-(1-piperidyl)ethoxy]phenyl] –methanone) is an oral selective estrogen receptor modulator (SERM) that has oestrogenic actions on bone and anti-oestrogenic actions on the uterus and breast. It is used in the prevention of osteoporosis in postmenopausal women. On September 14, 2007, the USFDA announced approval of Raloxifene for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer
The brand product had annual sales of approximately $691 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data. Teva and Barr are involved in patent litigation concerning this product with ELI LILLY in the Indiana Southern District Court on following Orange book listed patents
US6458811 (Expiry 2017)
US5478847 (Expiry 2014)
US5457117 (Expiry 2012)
US5393763 (Expiry 2012)
US5641790 (Expiry 2014)
US5747510 (Expiry 2014)
US5731342 (Expiry 2017)
US6,797,719 (Expiry 2017)
US6894064 (Expiry 2017)
US6906086 (Expiry 2012)
USRE38968 (Expiry 2012)
USRE39049(Expiry2012) USRE39050 (Expiry 2014)

Pharma News

HIV test faces patent battle
Inverness Medical Innovations has filed a lawsuit accusing OraSure of patent infringement for the manufacture and sale of the OraQuick rapid HIV test. (link)
The Long Wait For Pfizer
Pfizer Inc.'s first-quarter profit tumbled 18% on stiffer competition and signs of weakness in blockbuster drug Lipitor (Atorvaststin), falling short of estimates and adding to long-term downward pressure on the company's stock. (Link)

Teva got tentative approval from USFDA for Rizatriptan Benzoate

Teva announced that the USFDA has granted tentative approval for the Company's ANDA to market its generic version of Merck's migraine pain treatment Maxalt(R) (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base. Final approval of this product is anticipated upon expiration of patent protection for the brand product in June 2012.
Rizatriptan (N,N-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethanamine, Maxalt®) is a triptan was developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).
Maxalt obtained approval by the USFDA on June 29, 1998. It is a second-generation triptan.
The brand product had annual sales of approximately $193 million in the United States for the twelve months that ended December 30, 2007, based on IMS sales data.

Thursday, 17 April, 2008

Akorn got USFDA Approval of Ofloxacin Ophthalmic Solution USP, 0.3%

Akorn announced that the USFDA has granted approval to ANDA for Ofloxacin Ophthalmic Solution USP, 0.3%.
Ofloxacin ((+/-)-9-fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)- 7-oxo-7H-pyrido [1,2,3-de]-1, 4-benzoxazine-6-carboxylic acid) Ophthalmic Solution (generic form of Allergen pharma 's OCUFLOX, which was approved on July 30, 1993) is an anti-infective used to treat infections caused by bacteria in conjunctivitis and corneal ulcers. Annual sales for Ofloxacin were approximately $7.5 million in 2007, according to IMS sales data. There following are generic players in US market for this formulation:

Aventis Defends Clopidogrel Patent in Canada

Sanofi-Aventis requested Canada's Supreme court to upheld existing Canadian patent laws and protect its blood-thinner Plavix (Clopidogrel) from generic competition from Apotex.
Clopidogrel (+)-(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It is marketed by Bristol-Myers Squibb and Sanofi-Aventis under the trade name Plavix. It acts by blocking a receptor called P2Y12. Clopidogrel is marketed as clopidogrel bisulfate (clopidogrel hydrogen sulfate), most commonly under the trade names Plavix, as 75 mg oral tablets. In 2006, generic clopidogrel was briefly marketed by Apotex, a Canadian generic pharmaceutical company before a court order halted further production until resolution of a patent infringement case brought by Bristol-Myers Squibb.The court ruled that Bristol-Myers Squibb's patent was valid and has patent protection until November 2011. In 2007, the production was halted to many retail pharmacies and will be changing back to Plavix. In 2005 it was reported that Plavix was the world's second highest selling pharmaceutical with sales of US$5.9 billion
Sanofi Aventis attorney stressed that it took lot of effort to develop New chemical moiety like Clopidogrel. Sanofi spent millions of dollars and even abandoned the project before discovering the compound that led to the development of Plavix, he said.
However, Apotex claims that Sanofi's following patent
CA1336777(equivalent to US4847265) (Expiry:2012) - Which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts.
Is obvious as per earlier expired patent, which covers Clopidogrel genrically . Apotex attorney said Sanofi scientists used known research methods on a large group of compounds the company had patented earlier to come up with the key ingredient in Clopidogrel as per doctrine of selection.
Apotex argued that the doctrine of selection is contradictory to established principles of patent law and urged the court to abolish the practice that allows innovator companies to patent a large group of generic structures and then obtain new patents with enhanced life on individual components that prove useful.
Plavix last year regained its title as the world's second best-selling drug, behind Pfizer Inc.'s Lipitor, with $8.1 billion in global sales.
Apotex claims that clopidogrel bisulfate, the active ingredient, was covered by a US4529596 (Expired in 2003). Innovator Sanofi maintains that the earlier patent covered a whole class of generic compounds (Genus) and the discovery of clopidogrel bisulfate was serendipity.
Researchers separated the racemic compound into individual enatiomenrs. Sanofi further stressed that resolution of enatiomer resulted into therapeutically active enatiomer.
The expert during testimony stressed that abolishing the principle of the doctrine of selection would stifle research and innovation. Supreme court panel announced it would reserve a decision.
The European and U.S. laws make it more difficult to patent specific compounds taken from a larger group of genus, however Canadian laws are not strict on this aspect. The U.S. Supreme Court gives companies challenging patents more latitude to argue that something is simply an obvious variation of earlier inventions.

Wednesday, 16 April, 2008

Federal Circuit Affirms Pepcid (Famotidine and antacid combination)Patent's Invalidity

A federal appellate court has affirmed a lower court ruling finding a patent for Johnson & Johnson and Merck & Co.’s popular over-the-counter heartburn drug Pepcid Complete invalid. The following patent was at issue
US5817340 (Expiry: June 1, 2013)- which covers A solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of impermeably coated famotidine granules for the treatment of gastric disorders and pharmacologically acceptable salts thereof; and a therapeutically effective amount of aluminum hydroxide or magnesium hydroxide wherein the oral dosage form has said coated famotidine granules and the aluminum hydroxide or magnesium hydroxide in contact with each other, but separated by said impermeable coating on the famotidine granules which is impermeable to the aluminum hydroxide or magnesium hydroxide
On June 5, 2007, the Court of southern district of New York issued its opinion, concluding the'340 patent is invalid due to obviousness. The court noted that the patent was obvious which was evident from office actions and patent office repeatedly rejected original claims as evident in prosecution history of 340’ patent. However, innovator got patent in 1998 with amended claims. This decision was based on KSR V/S Teleflex decision. Pepcid has annual sale approximately $90 millions in 2007.

Famotidine (2-[4-[2-(amino-sulfamoyliminomethyl)ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine) was developed by Merck and is marketed by a joint venture between Merck and Johnson & Johnson. The imidazole-ring of cimetidine was replaced with a 2-guanidinothiazole ring. Famotidine proved to be 30 times more active than cimetidine.
It was first marketed in 1985. Pepcid RPD orally-disintegrating tablets (that are not swallowed) was released in 1999. Generic preparations became available in 2001, e.g. Fluxid (Schwarz) or Quamatel (Gedeon Richter Ltd.). In the United States, Pepcid Complete is available that combines famotidine with an antacid in a chewable tablet to ameliorate the relatively slow onset of effects.

Esomeprazole (Nexium):Ranbaxy settled lawsuit with innovator

AstraZeneca announced that it has settled a lawsuit against Indian pharma giant Ranbaxy Lab in an agreement that will keep Ranbaxy's generic version of the blockbuster heartburn drug Nexium off the U.S. market until 2014.
AstraZeneca also awarded Ranbaxy some valuable contracts, which are separate from the litigation settlement. These contracts could trigger questions from the U.S. Federal Trade Commission, which still must review the agreements. The commission has objected to some deals where it believed that a patent holder was giving a generic company something of value in exchange for staying off the market, arguing that this process decrease competition and hurt consumers.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the USFDA an ANDA for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US5877192 and US6875872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.Nexium had U.S. sales of $5.5 billion last year, making it the second-biggest-selling drug, behind Pfizer Inc.'s cholesterol pill Lipitor, according to IMS Health.
In contracts AstraZeneca said were separate from the settlement, the company is allowing Ranbaxy to start making a portion of AstraZeneca's Nexium supply in May 2010. Ranbaxy will also start supplying AstraZeneca with the active pharmaceutical ingredient used to make Nexium in May 2009.
AstraZeneca is also giving Ranbaxy the right to distribute generic versions of two older AstraZeneca drugs -- Plendil for hypertension and Prilosec for heartburn -- in the U.S.
AstraZeneca still faces battles with other makers of generic drugs that are attempting to sell copies of Nexium as well as the company's drug to treat schizophrenia, Seroquel, in the U.S.
As per FDA guidelines Ranbaxy could have started selling generic Nexium this week, when a 30-month stay barring Ranbaxy from the market expired. But if Ranbaxy had started selling generic Nexium but lost the litigation, it would have to pay willful infringement damages to Astra.

Tuesday, 15 April, 2008

Patent on Alendronate revoked in Belgium

Teva Pharma announced that the Court of First Instance in Brussels, Belgium, decided to revoke the Belgium part of Merck Sharp & Dohme's ("MSD") EP1175904 (which covers A method for inhibiting bone resorption in a mammal, said method comprising orally administering to said mammal a pharmaceutically effective amount of a bisphosphonate as a unit dosage according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing), due to lack of inventive step. This patent relates to Fosamax® Once Weekly (Alendronate 70mg Once Weekly). This favorable decision follows a similar judgment rendered by the Hague District Court in the Netherlands regarding the same patent two months ago. The decision may be appealed. Teva's Alendronate products are subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. This patent is currently being litigated by Teva in France, Italy, Sweden and Spain as well as in the European Patent Office. Teva is already marketing Alendronate 10mg and 70mg in various European countries and may market Alendronate 70 mg in Belgium starting April 15, 2008. Earlier the same patent was invalidted by courts in Netherlands and France.

Lundbeck Won Supreme court ruling on Cipralex (Escitalopram) Patent in UK

The British Supreme court has overturned a ruling that found claims in H. Lundbeck A/S’ patent EP0347066 for its antidepressant drug Cipralex or Escitalopram (S-(+)-1-[3-(dimethylamino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrileoxalate) insufficient, scoring a win for the innovator in an ongoing patent challenge brought by three generics makers Generics (UK) Ltd, Arrow Generics Ltd, and Teva.

In a sweeping victory for Lundbeck, a three-judge panel in the Supreme Court of Judicature, Court of Appeal in England and Wales overturned part of the lower court’s ruling that deemed Lundbeck’s patent insufficient and obvious.
EP0347066 is entitled "New enantiomers and their isolation". Three claims were mainly at issue
Claim 1 which covers (+) -1-(3-dimenthylaminopropyl)-1-(4´-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile… and non-toxic addition salts thereof
Claim 3 which covers "pharmaceutical composition in unit dosage form comprising, an active ingredient, a compound as defined in claim 1."
Claim 6 which covers process for the preparation of a compound as defined in claim 1".
The high court judge Justice Kitchin held claim 1 and 3 invalid in his decision here That decision was based on the so-called ‘Biogen insufficiency’ principles, set down by Lord Hoffmann in Biogen v Medeva decision here. Judge Justice Kitchin reasoning was that claim 1, being a claim to the (+) enantiomer as a product, was a claim to a monopoly of that product however made: as per section 60(1)(a) of the 1977 Act. But Lundbeck's inventive idea was not to discover that the enantiomer existed and had a medicinal effect. Everyone knew that the two enantiomers existed and that one or other or both had a medicinal effect. What innovator Lundbeck discovered was one way of making it. But that did not entitle them to a monopoly of every way of making it.
Three judge panel LORD HOFFMANN, LADY JUSTICE SMITH and LORD JUSTICE JACOB reversed the Justice Kitchin judgement and held that patent can not be invalidated on insufficiency as per section 72(1)(c). Section 72(1)(c) explains revoking a patent [on the ground that] the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art The judge Justice Kitchin founded his decision entirely upon the decision of the House of Lords in Biogen v Medeva. Supreme court panel held that decision in Biogen is limited to the form of claim which the House of Lords was there considering and cannot be extended to an ordinary product claim in which the product is not defined by a class of processes of manufacture. Supreme court panel further elaborated that Justice Kitchin in his judgement stick to “extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported or justified” notion. In holding claim 1 insufficient, Justice Kitchin was applying this principle. But then he treated the relevant "technical contribution to the art" as being the inventive step, namely a way of making the enantiomer, which was a wrong interpretation by Justice Kitchin. When a product claim satisfies the requirements of section 1 of the 1977 Act, the technical contribution to the art is the product and not the process by which it was made, even if that process was the only inventive step.
As for obviousness The panel held that generic companies argument was that the skilled man could have come by the invention by doing a short and simple experiment. But one could say that, with hindsight, of many an invention. It is not enough that an experiment revealing an invention would have been short and simple. There has to be a reason why the skilled man would have carried it out. Normally that would require at least an expectation that something might come out of it. Otherwise, short and simple though it would have been, doing the experiment would have been pointless. Court decision here
Escitalopram history
Escitalopram (Lexapro by Forest Laboratories in the United States and elsewhere by Lundbeck as Cipralex, Sipralexa and Seroplex) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is approved for the treatment of major depressive disorder and generalized anxiety disorder; other indications include social anxiety disorder, panic disorder and obsessive-compulsive disorder. Escitalopram is the S-stereoisomer (enantiomer) of the earlier Lundbeck drug citalopram (Celexa), hence the name escitalopram. Escitalopram is noted for its high selectivity of serotonin reuptake inhibition and, as a result has fewer side effects not related to its serotonergic activity.
Escitalopram was developed in a close cooperation between Lundbeck and Forest Laboratories. Its development was initiated in the summer of 1997, and the resulting new drug application was submitted to the FDA in March 2001. The short time (3.5 years) it took to develop escitalopram can be attributed to the previous extensive experience of Lundbeck and Forest with citalopram, which has similar pharmacology. FDA issued the approval of escitalopram for major depression in August 2002 and for generalized anxiety disorder in December 2003. Escitalopram can be considered an example of "lifecycle management" - the strategy pharmaceutical companies use in order to extend the lifetime of a drug, in this case of the citalopram franchise. Escitalopram is an enantiomer of citalopram, used for the same indication, and for that reason it required less investment and less time to develop. Two years after escitalopram's launch, when the patent on citalopram expired, the escitalopram sales successfully made up for the loss. On May 23, 2006, the FDA approved a generic version of escitalopram by Teva.However, on July 14 of that year, the U.S. District Court of Delaware decided in favor of Lundbeck regarding the patent infringement dispute and ruled the patent on escitalopram valid.

Monday, 14 April, 2008

Teva got exclusivity for Risperidone tablets

Teva Pharma announced today that the U.S. District Court of Columbia has ordered that the USFDA relist in the Orange Book US5158952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal (Risperidone) Tablets. Teva expects final approval with exclusivity on June 29, 2008. The brand product had annual sales of approximately $2.5 billion in the United States. (Link to fdalawblog)

Friday, 11 April, 2008

Hi-Tech Pharmacal got tentative approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution

Hi-Tech announced that the USFDA has granted tentative approval to the Company's Abbreviated New Drug Application for Dorzolamide hydrochloride with Timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Cosopt. Cosopt is indicated for lowering pressure in the eye to normal levels, and a treatment for glaucoma. It got USFDA approval in April 1998, and is supplied by Merck. According to IMS, Merck's Cosopt had sales of $334 million in 2007. The Company believes that it has 180 days of marketing exclusivity for generic version, and will begin marketing the product upon the completion of Merck's pediatric exclusivity period in October 2008.

Thursday, 10 April, 2008

Ranbaxy got approval to market Amlodipine tablets in Japan

Indian Pharma giant Ranbaxy Lab has received authorization from Ministry of Health and Labour Welfare of Japan for marketing the generic version of Amlodipine tablets 2.5mg & 5mg. Amlodipine tablet is the first independent product approval received by Ranbaxy in Japan. It has the unique distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by MHLW (Japan). Amlodipine tablets has a market size of around US $2 billion (Jan-Dec' 2007 - IMS - Japan). The product is currently the largest molecule which has gone off patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market. The Government of Japan is encouraging generic substitution which is reflected in the growing genericization of medicines from 17 per cent by volume in 2007 to 30 per cent by volume in 2012.

Novel Lab challenged Moviprep Orange book listed patent US7169381

Drug developer Salix Pharma announced that Novel Laboratories is challenging the patent (US7169381) on the company's bowel cleansing drug Moviprep. The following patent is listed in Orange book for Moviprep
US7169381 (Expiry: Sep 1, 2024)- Which covers a dry composition for admixture with water wherein the dry composition comprises, per liter of aqueous solution to be made, the following components, the components of the composition being selected such that an aqueous solution made up to 1 liter has an osmolarity within the range of from 300 to 700 mOsmol/kg: a) 80 to 350 g polyethylene glycol; b) 3 to 20 g a mixture of ascorbic acid and one or more salts of ascorbic acid; c) 1 to 15 g of an alkali metal or alkaline earth metal sulphate or a mixture of alkali metal or alkaline earth metal sulphates; and d) optionally one or more electrolytes selected from sodium chloride, potassium chloride and sodium hydrogen carbonate.
FDA approved in August 2006, MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), provides the efficacy of a 4 liter polyethylene glycol (PEG) lavage in a tolerable lower volume. MoviPrep is the only PEG lavage with ascorbic acid and sodium ascorbate to increase stool volume and enhance taste. MoviPrep is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep offers a tolerable dosing regimen that does not require the use of bisacodyl tablets, thereby avoiding bisacodyl-associated abdominal cramping in patients. The drug is licensed to Salix by Netherlands-based Norgine B.V., which is privately held. The company said privately held Novel asked the Food and Drug Administration to approve a generic version of the drug, alleging that the current patent is invalid and unenforceable. Salix now has 45 days to file a patent infringement lawsuit against Novel to bar the USFDA from approving a generic version of Moviprep for up to 30 months or until court decision.

Repligen Corporation settle patent dispute on Abatacept (Orencia)

Repligen Corporation announced that it has reached a settlement with Bristol-Myers Squibb (BMS) in its lawsuit alleging infringement of US6685941 (claims a method of treating a patient having multiple sclerosis comprising administering to the patient CTLA-4Ig in an amount effective to suppress the patient's immune response) , based on BMS's sale of Abatacept (Orencia) for the treatment of rheumatoid arthritis.
Abatacept (marketed as Orencia) is a fusion protein composed of an immunoglobulin fused to the extracellular domain of CTLA-4, a molecule capable of binding B7. Abatacept is a selective costimulation modulator as it inhibits the costimulation of T cells. It was developed by BMS and is licensed in the United States for the treatment of rheumatoid arthritis in the case of inadequate response to anti-TNF╬▒ therapy.The settlement provides for Bristol-Myers Squibb to make an initial payment of $5,000,000 and to pay royalties on the U.S. net sales of Orencia for any clinical indication at a rate of 1.8% for the first $500,000,000 of annual sales, 2.0% for the next $500,000,000 of annual sales and 4% of U.S. annual sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The settlement also provides for the grant by Repligen and co-plaintiff the to Bristol-Myers Squibb of an exclusive worldwide license under certain patent rights of Repligen and the . The settlement serves as the basis for Repligen and co-plaintiff the to dismiss the lawsuit against Bristol-Myers Squibb. In January 2006, Repligen and the filed a complaint in the United States District Court for the Eastern District of Texas against Bristol-Myers Squibb alleging infringement of the '941 patent based on its sale of Orencia(R).

Astellas loses patent on key drug Tacrolimus

Japan's Astellas Pharma loses U.S. patent protection on its product patent US4894366 on Tacrolimus (Prograf), a major transplant drug, on 8th april 2008, amid worries that its market share may erode more quickly than expected despite only mild generic competition for such drugs in the past.
Tacrolimus (also FK-506 or Fujimycin) is an immunosuppressive drug whose main use is after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis ("eczema"), severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo. It is a 23-membered macrolide lactone discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. The stakes are high for Astellas. Transplant drugs are often be taken for life, making them stable earners for drug companies and Prograf's $2 billion in annual sales is around one fifth of the firm's overall revenues. The U.S. market accounts for around half of Prograf's sales.
Tacrolimus was discovered in 1987 by a Japanese team headed by T. Goto, T. Kino and H. Hatanaka; it was among the first macrolide immunosuppressants discovered, preceded by the discovery of rapamycin (sirolimus) on Rapa Nui (Easter Island) in 1975. Like ciclosporin, it was found in a soil fungus, although it is produced by a type of bacteria, Streptomyces tsukubaensis. The name tacrolimus is reportedly derived from 'Tsukuba macrolide immunosuppressant'.
The drug is owned by Astellas Pharma Inc. (Merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. as of April 1, 2005) and is sold under the tradenames Prograf®, Advagraf, and Protopic®. It is sometimes referred to as FK-506, an early name relating to its action. It was first approved by the USFDA in 1994 for use in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.
Astellas has also suffered delays in the approval of a successor drug it has developed, further clouding the outlook its transplant drug business. But a risk of organ rejection from transplants will work in Astellas' favour. While other drugs can easily lose up to half their sales after a patent ends, doctors and patients dealing with the potential of organ rejection are expected to be reluctant to switch to a generic transplant drug. Basing their assumptions on slow generic inroads into Novartis' immunosuppressant cyclosporine when it went off patent, most analysts say they are forecasting annual sales declines of only around 10-15 percent for Prograf. In a market dominated by Prograf and Novartis' cyclosporine, Prograf commands about 60 percent of the immunosuppressant market for a class drugs known as calcineurin inhibitors. In new transplants, its holds market share of around 84 percent for kidney transplants, 90 percent for liver transplants and 63 percent for heart transplants.
Generic threat
It's not known how many or which generic firms are planning to launch their versions of Prograf, or when. It depends on whether big generic firms like Sandoz or Teva enter the market. If Novartis' unit Sandoz enters, then that's a major threat. Novartis has the experience with immunosuppressants and it could shift sales staff with that experience to Sandoz. A key turning point for Astellas could be late April when the USFDA is expected to send a letter indicating whether it is ready to approve Prograf's successor drug, Advagraf, for liver transplants. Advagraf, a modified release version of Prograf taken once a day by patients, has been approved in Europe but has had less success with U.S. health authorities. Prograf is taken twice a day. The FDA declined in January 2007 to approve Advagraf for heart transplants and requested data on kidney and liver transplants. Last month, it requested further information on Advagraf for kidney transplants, meaning that Advagraf will face delays of at least six months before receiving approval for that indication. Prograf's patent expires in Europe in June 2009 and in Japan in December 2010.

Tuesday, 8 April, 2008

Metformin hydrochloride extended release tablets: Ivax settle patent dispute with innovator Depomed after licensing agreement

Depomed will receive about $10 million in payment and royalties to settle patent infringement claims aginst Ivax. Depomed announced today that it has reached a settlement with IVAX (Now Teva Pharma), w.r.t the patent infringement lawsuit filed by Depomed against IVAX in January 2006, in which Depomed alleged infringement of Depomed's following patents which covers Extending the duration of drug release within the stomach during the fed mode.
US6340475 (Expiry: Sep 19, 2016)- which covers a controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising a solid polymeric matrix with said drug dispersed therein at a weight ratio of drug to polymer of from about 15:85 to about 80:20, said polymeric matrix being one that swells upon imbibition of water thereby attaining a size large enough to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug within about eight hours after such immersion, and that remains substantially intact until all of said drug is released.
US6635280- which covers a controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising one or more polymers forming a solid polymeric matrix with said drug incorporated therein at a weight ratio of drug to polymer of from 15:85 to 80:20, said dosage form being one that when swollen in a dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug after such immersion, and that remains substantially intact until substantially all of said drug is released.
The parties have entered into a settlement and license agreement that provides for a one-time payment to Depomed of $7.5 million, and a non-exclusive license to the asserted patents in favor of IVAX and Teva to continue to market their generic Glucophage (metformin hydrochloride extended release tablets) product in the United States under Depomed's patents. Depomed will also receive ongoing royalty payments from Teva on sales by IVAX and Teva of generic Glucophage XR. The royalty is subject to a $2.5 million aggregate cap.
The agreement also provides for the parties to dismiss their pending patent litigation and for a release of all claims associated with the litigation. Michael Plimack of Heller Ehrman LLP represented Depomed.
If innovator has a very strong patent on a particular technology then generic player should device strategy to get license on particular technology. If innovator demands high licensing fees then generic player can face a trial and during the trial in court generic player can settle with innovator with comparatively low licensing fees. Ivax adopted the same strategy on this dispute.
Other generic players on this product

Monday, 7 April, 2008

Depakote(Divalproex sodium) :Nu Pharm appeal district court against FDA decision

Nu-Pharm sought both a judicial declaration that FDA’s decision not to approve its ANDA violated the Administrative Procedure Act (“APA”), and preliminary and permanent injunctive relief requiring FDA to approve ANDA. The district court dismissed the complaint, declining to exercise jurisdiction for “prudential reasons,” reportedly on the ground that the injunctive relief sought by Nu-Pharm would “conflict irreconcilably” with a previous order entered in a contempt proceeding. On January 29, 2008, Nu-Pharm appealed the decision to the U.S. Court of Appeals for the District of Columbia Circuit. exercise jurisdiction for “prudential reasons,” reportedly on the ground that the injunctive relief sought by Nu-Pharm would “conflict irreconcilably” with a previous order entered in a contempt proceeding (see below). As we anticipated, on January 29, 2008, Nu-Pharm appealed the decision to the U.S. Court of Appeals for the District of Columbia Circuit. (Link for complete article fdalawblog)

Saturday, 5 April, 2008

Takeda Wins Patent Infringement Litigation on Pioglitazone hydrochloride

Takeda Pharm announced that the U.S. Supreme Court denied the Petition for a Writ of Certiorari by Alphapharm
The Supreme Court decision finally affirms the Appeals Court decision upholding the validity of Takeda’s US4687777 (Expiry: JAN 17,2011) which covers novel thiazolidinedione derivatives, a method of preparing them and antidiabetic agents containing same, which are utilized in the field of medicines including Pioglitazone hydrochloride, the active ingredient in ACTOS® as product. The decision arises from a lawsuit brought by Takeda and TPNA in March 2004 in order to oppose an Abbreviated New Drug Application (ANDA) filed by Alphapharm
Based on this final decision, the FDA will not approve and Alpharpharm Pty Ltd. may not launch a generic version of pioglitazone until the 777’ patent expires in 2011.
Takeda has other 10 patents listed in Orange book covering methods of treatment use and compositions of Pioglitazone hydrochloride.

Friday, 4 April, 2008

Teva Sued For Seeking Approval For Aripiprazole

Japanese drugmaker Otsuka Pharma has filed a patent infringement suit against Teva Pharma over the anti-psychotic drug Abilify. The patent in dispute is US5006528 (Expiry: Apr 20, 2015) which covers carbostyril derivatives like Aripiprazole as product.
Aripiprazole (sold as Abilify) was approved by the USFDA on November 15, 2002 for the treatment of schizophrenia. Recently it received USFDA approval for the treatment of acute manic and mixed episodes associated with bipolar disorder, as well as treatment of depression. Aripiprazole was developed by Otsuka in Japan; in the U.S., Otsuka America markets the drug jointly with Bristol-Myers Squibb.
The other generic companies in litigation with innovator are Sandoz, Barr, Apotex, Synthon and Sun Pharma.

Sandoz Faces Another Suit Over Generic Desloratadine

Sepracor and the University of Massachusetts have filed suit against Sandoz Inc., claiming the generic-drug maker’s proposed version of allergy treatment Clarinex infringes two of their patents. The patent in complaint are
US7214683- which covers descarboethoxyloratadine (DCL), a metabolic derivative of Loratadine, for the treatment of allergic rhinitis, and other disorders, while avoiding the concomitant liability of adverse side-effects associated with other non-sedating antihistamines.
US7214684- which covers A method of treating allergic rhinitis in a human comprising orally administering to a human a therapeutically effective amount of descarboethoxyloratadine, or a pharmaceutically acceptable salt thereof, wherein the amount of the descarboethoxyloratadine administered is 0.1 mg to 5 mg per day.
Sepracor has earlier initiated infringement action against various generic players (for filing para IV against Orange Book listed patents for Clarinex Tablets 5 mg) like Zydus, Sandoz, Mylan, Orchid/Orgenus, Perrigo, Glenmark, GeoPharma/Belcher, Lupin, Ranbaxy, Sun, Watson, Dr. Reddy's
Desloratadine is a drug used to treat allergies. It is marketed under several trade names such as NeoClarityn, Claramax, Clarinex and Aerius. It is an active metabolite of loratadine, which is also on the market.

Nabi Biopharmaceuticals Announce Settlement of Litigation

Nabi Biopharma announced that they have settled the patent infringement case against Roxane Lab w.r.t PhosLo® GelCaps. PhosLo® consists of the mineral calcium acetate. It is an orally given phosphate binder used in patients with End Stage Renal Disease (ESRD). PhosLo® was owned by Nabi Biopharmaceuticals until late 2006 when it and its related assests was sold to the US subsidiary of Fresenius Medical Care. From November 14, 2006 Nabi stopped distributing PhosLo®.
The settlement between Fresenius Medical Care Holdings, Roxane Lab and Nabi was made to the mutual satisfaction of all parties and was reviewed and accepted by the U.S. District Court of the Southern District of Ohio.
Nabi filed this lawsuit on September 27, 2005 under the Hatch-Waxman Act in response to a Paragraph IV Certification letter submitted by Roxane to the Company concerning Roxane's filing of an Abbreviated New Drug Application (ANDA) with the USFDA to market a generic version of the Company's PhosLo GelCaps. Nabi filed the lawsuit on the basis that Roxane Laboratories' submission of its ANDA and its proposed generic product infringed a patent held by the Company. On November 12, 2006, Nabi completed the sale of PhosLo and related intellectual property to Fresenius USA Manufacturing, Inc. While Fresenius assumed primary responsibility for the intellectual property dispute, Nabi remained subject to a counterclaim by Roxane that alleged violations of antitrust law and, therefore, responsible for defense costs and for any liability arising from the counterclaim. As a result of this settlement, Nabi is not required to pay any sums to the other parties

Taro Receives Tentative USFDA Approval for Lamotrigine Tablets

Taro Pharma reported today that it has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg.Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal(R) Tablets. According to industry sources, Lamictal(R) Tablets had annual U.S. sales of approximately $2.6 billion. This product has one orange book listed patent US4602017 which will expire on JAN 22,2009.On February 17, 2005, Teva issued a press release regarding settlement with innovator GSK. As per settlement Teva was granted the exclusive right to manufacture and sell its own generic version of Lamotrigine tablets (25mg, 100 mg, 150 mg, and 200 mg) in the United States with an expected launch date in 2008. As per FDA records TEVA is marketing this drug in USA. Following firms have received tentative approval

Wednesday, 2 April, 2008

Federal Circuit Revives Escitalopram Patent Suit

An appeals court has revived Caraco Pharmaceutical Laboratories Ltd.'s declaratory judgment suit against Forest Laboratories Inc. over a patent for depression drug Lexapro despite a covenant by Forest not to sue its generics-making rival over the patent. The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court for the Eastern District of Michigan, which had dismissed Caraco's request for a declaratory judgment of noninfringement. The appeals court said there was no record the lower court considered two cases establishing the legal precedents to be taken into account in such a patent dispute. Following patents are listed in Orange Book
USRE34712 (Expiry: MAR 14, 2012)- which covers compound selected from substantially pure (+)-1-(3-Dimethylaminopropyl)-1-(4'- fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof.
US6916941(Expiry: FEB 12, 2023)- which covers crystalline particles of escitalopram oxalate having a median particle size of at least 40 .mu.m.
Ivax (Now part of Teva) was the first Para IV applicant on this product. Accordingly, Ivax is entitled to 180 days of market exclusivity, which will begin either on the day it begins marketing its drug or on the day a court determines that both the '712 and '941 patents are invalid or not infringed, whichever comes first. However Forest sue Ivax on 712 patent infringement, which was found valid and infringed by the district court.
Caraco (Sun Pharma) filed para IV against both O.B listed patents. Innovator sued Caraco for the infringement of 712’ patent. Caraco then filed a complaint seeking a declaratory judgment that its generic version of Lexapro does not infringe the '941 patent. Forest granted Caraco an irrevocable covenant not to sue for infringement of the '941 patent. Due to the covenant not to sue, the district court dismissed Caraco's complaint for lack of jurisdiction.
The Federal Circuit decided (opinion) that an ANDA applicant's declaratory judgment action for noninfringement meets Article III's "case or controversy" requirement notwithstanding that the patentee has granted the applicant a covenant not to sue. The Federal Circuit further determined that the issues are ripe and the case is not moot. Accordingly, the court held that Caraco's action presents an ongoing Article III case and controversy, reversed the district court's decision dismissing the case, and remanded the case for a decision on the merits.
more details on orangebookblog

Tuesday, 1 April, 2008

Amgen's Patent Rights to Recombinant Human Erythropoietin: An Article by Patent Docs team

Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin? The Patent docs team has reviewed this case. I am providing link to this interesting article patentdocs

Court Upholds Ortho-McNeil's Topiramate Patent

Mylan Lab suffered another setback in its battle to sell a generic version of the epilepsy drug Topamax (Topiramate), after a federal appeals court on Monday upheld a summary judgment ruling that Ortho-McNeil Pharma's patents for the blockbuster pharmaceutical were valid.
The patent in dispute is US4513006 (Expiry: Sep 26, 2008), which covers Topiramate as product. The District Court in New Jersey had concluded that the 006’ patent should be construed to contain two subsets of compounds, and the District Court issued summary judgments in favor of Ortho-McNeil on the Mylan defenses that the patent was invalid due to obviousness and enablement or was otherwise unenforceable due to inequitable conduct. The Court of Appeals affirmed this ruling, concluding the claims construction proper, that Mylan infringed, and that the patent was valid and enforceable. The Court entered final judgment in favor of Ortho McNeil and prohibiting Mylan from marketing its product until the expiry of 006’ patent.
The following orange book listed patents were not litigated
US5998380 (Expiry: Oct 13, 2015)
US6503884 (Expiry: Oct 13, 2015)
US7018983 (Expiry: Oct 13, 2015)
Topiramate (2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. Generic versions are available in Canada and were FDA approved in September 2006 .It was discovered in 1979 by Drs. Bruce E. Maryanoff and Joseph F. Gardocki during their research work in McNeil Pharmaceutical.This drug is used to treat epilepsy in both children and adults. In children it is also indicated for treatment of Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delay). It is also USFDA approved for, and now most frequently prescribed for, the prevention of migraines. It has been used by psychiatrists to treat bipolar disorder. (Court Opinion)

link to orangebookblog analysis on this case

Carbatrol (Carbamazepine ) Litigation: Claim construction

A federal judge delivered a mixed ruling in Shire Lab's patent infringement lawsuit against generics maker Corepharma over Shire's anti-seizure drug Carbatrol (Carbamazepine ), accepting Corepharma's proposed construction of one disputed term and rejecting its constructions of three others. Carbamazepine ((Z)-5H-dibenzo[b,f]azepine-5-carboxamide) is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat ADD, ADHD, schizophrenia and trigeminal neuralgia.
Shire Lab and Defendant Corepharma, have filed an application for claim construction to resolve disputes over the construction of four claim terms in US5326570. Court Ordered that the term “unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman v. Westview Instruments, as a single thing or entity that is a constituent or isolable member of a more inclusive whole, being the least part of the whole to have a clearly definable existence separate or different from other parts of the whole; and the term “immediate release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman , as a unit, as defined above, which begins to release the carbamazepine upon ingestion; and the term “sustained release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, as a unit, as defined above, which provides for a gradual release of carbamazepine over time in the gastro-intestinal tract; and the term “enteric release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, as unit, as defined above, which provides for a delayed release of carbamazepine in the lower gastro-intestinal tract. (Source: inputs from AMIT)

CryoCor Patent Fight Goes to Trade commision

The U.S. International Trade Commission will evaluate a request by CryoCor to bar imports of catheters and other medical equipment made by a Canadian rival.
CryoCo requested the ITC last month to investigate CryoCath Technologies and decide whether the company is infringing patents that CryoCor licensed from AMS Research Corp. AMS, which is based in Minnetonka, Minn., joined CryoCor in the request.
The patents at issue are for catheters, consoles and other equipment used to treat cardiac arrhythmias, or irregular heartbeats, the ITC said Thursday.
The ITC, an independent federal agency, investigates unfair trade practices and has the authority to bar imports that infringe U.S. patents and trademarks.
In a lawsuit filed in January, CryoCor said patents for its Cryoablation system, which is used to treat irregular heartbeats, were infringed by CryoCath's products. Cryotherapy generally involves the use of freezing temperature to treat diseased tissue. CryoCor said in that suit that it is the exclusive licensee for the patents and is seeking monetary damages and sales injunctions against CryoCath. CryoCath filed its own patent infringement suit against CryoCor in October. The company said last month that CryoCor and AMS Research illegally extended "at least one patent beyond it scope."(Source: Viney)

Oxymorphone hydrochloride extended-release tablets: Endo filed lawsuit against Actavis

Endo Pharma announced that they have filed a lawsuit against Actavis in the US District Court of New Jersey in connection with Actavis's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets. The lawsuit is in response to Actavis's notice to Endo and Penwest, send on February 15, 2008, regarding the filing by Actavis an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release. Actavis's Paragraph IV certification notice refers to four Penwest patents listed in the FDA's Orange Book, which patents cover the formulation of OPANA ER. The complaint filed today alleges infringement of US5958456. OPANA ER has been granted new dosage form regulatory exclusivity that prevents the FDA from approving any ANDA for a generic version of OPANA ER for launch prior to June 22, 2009, the date such regulatory exclusivity

Sun Pharma launches generic Amifostine for injection 500mg

Sun Pharma has commercially launched generic Amifostine for injection 500mg, which is therapeutically equivalent to MedImmune's Ethyol. Sun Pharma's product is being sold in the USA by its marketing partner Caraco Pharma. Sun Pharma had received a USFDA approval for Amifostine in March 2008. 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. The ANDA was filed with para IV certification against following Orange book listed patents
US5424471 (Expiry: 7/31/12)
US5591731 (Expiry: 7/31/12)
US5994409 (Expiry: 12/08/17) Medimmune filed a suit in the District Court of Maryland and the case is under litigation. earlier in january 2007 district court has delivered summary judgement opinion in this case.

Actavis receives approval for Bupropion Hydrochloride tablets

Actavis has received two separate approvals from the USFDA to market Bupropion Hydrochloride extended-release tablets. Distribution of the products will commence immediately. Bupropion Hydrochloride extended-release tablets, available in 150mg strength, are the generic equivalent of Wellbutrin and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin were US $498 million for the 12 months ending December 2007 according to IMS Health data.

Teva to appeal against decision On generic Lansoprazole

Teva Pharma announced that the U.S. District Court for the District of Delaware has delivered its decision in the case related to the its Abbreviated New Drug Application (ANDA) for marketing the generic version of the Prevacid (Lansoprazole) Delayed Release Capsules 15 mg and 30 mg, saying that the patent is valid and enforceable. The company said it intends to appeal against the court decision

Bayer appeals ruling against Yasmin patent

Bayer AG announced (in a press release) that it would appeal against an unfavorable U.S. court ruling in a patent dispute over one of its major products, the oral contraceptive Yasmin. Bayer said it filed a notice of appeal with the U.S. District Court in New Jersey against the March 3 opinion and order. In a statement, Bayer said that a district judge found that certain claims of Bayer Schering's U.S. patent were invalid. Bayer said the decision came after it sued Barr Laboratories for patent infringement in connection with its application for U.S. approval to market a generic version of Yasmin. The German company said the Federal Circuit would hear its appeal. The ip pharm doc has earlier reported on Yasmin litigation here

Atorvastatin: Favorable ruling for Pfizer in Spain on enantiomer patent

Pfizer Inc said today (In a press release) that the Court of Appeal of Barcelona has upheld the company's enantiomer patent (ES2153332) covering the calcium salt of atorvastatin, the active ingredient in Lipitor, reversing the lower court decision. The enantiomer patent expires in July 2010.
The patent was challenged jointly by generic companies Laboratorios Cinfa S.A., Kern Pharma S.L., Laboratorios Alter S.A. and Laboratorios Belmac S.A., and is one of four separate challenges to the enantiomer patent by generic companies in Spain. Lipitor is sold in Spain under the brand names Zarator and Cardyl. "This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those discoveries," said Pfizer Senior Vice President and Associate General Counsel Peter C. Richardson. Cinfa, Kern, Alter and Belmac can seek to appeal the decision to the Supreme Court of Spain.
Earlier Pfizer has asserted that it intends to litigate aggressively in order to defend its products. ( pfizer press release)

Earlier Decision in Spain
1) In December 2005 Madrid Court of First Instance finds enantiomer patent valid and enforceable.
2) In September 2006 Barcelona Mercantile Court finds some claims of the Basic patent invalid in two separate decisions against generic companies like Lek and Laboratorios Cinfa

3) In October 2006 Madrid Court of Appeal rejects appeal in relation to enantiomer patent. however At the request of Barcelona Mercantile Court, the European Patent Office (EPO) provides an advisory opinion (news-medical) holding the Basic patent valid. Ranbaxy issues statement to investors referring to the earlier Barcelona Mercantile Court decisions and announced that the EPO opinion is not legally enforceable.

4) On 25 July 2007 The Commercial Court of First Instance in Barcelona, has upheld the enantiomer patent covering the calcium salt of atorvastatin. However Stabilized formulation patent ES2133158 (Expiry: December 2013) for Atorvastatin was held invalid and unenforceable.

5) on 23 October 2007 Court of Appeal of Barcelona upheld Pfizer's Enantiomer patent covering the calcium salt of atorvastatin reversing the lower court decision. The calcium salt patent expires in July 2010. Generic manufacturer Lek Pharmaceuticals challenged the patent

web page statistics
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)
eXTReMe Tracker