Atorvastatin + Ramipril (Atocor-R): Dr. Reddy launch new combination in India

Dr Reddy's has launched Atocor-R (Atorvastatin + Ramipril) in India. It is the first such combination to be approved by DCGI and has completed a multi-centre clinical trial data on Indian patients.It is a one of its kind combination that has two blockbuster molecules, atorvastatin and ramipril combined together for the first time as a fixed dose combination. Atocor-R is used in the treatment of patients with both essential hypertension and hypercholesterolemia. It is available in two fixed dose combinations of Atocor-R 2.5 (atorvastatin 10mg + ramipril 2.5 mg) and Atocor-R 5 (atorvastatin 10mg + ramipril 5 mg) and comes is packs of 10. According to ORG IMS March 2008, Atorvastatin market is currently valued at Rs 300 crore growing at over 34 per cent annually and Ramipril market is about Rs 145 crore growing at over 15 per cent annually. (Source: Pharmabiz)

Drug approval/Launch: Topiramate (Lupin), Bupropion Hydrochloride (Teva), Cetirizine Hydrochloride Syrup (Teva)

Lupin got tentative Approval for Topiramate Tablets
Lupin announced that it has received tentative approval for the Company's ANDA for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA). Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures.
Teva Announces Launch of Generic Wellbutrin XL Tablets, 150 mg
Teva Pharma announced that it has begun commercially shipping Bupropion Hydrochloride Extended-Release Tablets, 150 mg, the generic version of Biovail Corporation's antidepressant Wellbutrin XL(R) Tablets, pursuant to its March 2007 agreement with Anchen Pharmaceuticals, Inc. Wellbutrin XL(R) Tablets, 150 mg, marketed by GlaxoSmithKline, had U.S. sales of approximately $930 million for the 12 months ended March 2008, according to IMS data.
Teva Launch Cetirizine Hydrochloride Syrup
Teva Pharmaceuticals announced the introduction and availability of Cetirizine Hydrochloride Syrup. This product is AA rated and bioequivalent to Zyrtec®* Syrup. Cetirizine Hydrochloride Syrup is available in a 5 mg/5 mL strength, in bottle sizes of 120 mL and 473 mL.

Levocetrizine (Xyzal): Innovator File second Suit To Thwart Generic challenge

Belgian drugmaker UCB SA and its U.S. partner, Sepracor Inc., have filed their second lawsuit in two months in an effort to stave off a generic challenge to their antihistamine drug Xyzal.
The lawsuit was filed on wednesday on US district court for the Eastern District of North Carolina. UCB alleged that Sun pharma infringed the company's patent US5698558 (Expiry: September 24, 2012, which covers method of use of levocetrizine) for levocetirizine hydrochloride 5mg by filing an ANDA with USFDA.Eralier innovator has sued first para IV filer Synthon for infringement of said patent as reported earlier by this blog

Clopidogrel: Generic players filed Marketing Authorization Application (MAA) with Besylate salt in Germany

Sanofi-aventis has become aware of the registrations of Clopidogrel besylate in Germany, as reflected in the AMIS-database of the BfArM (The German Federal Drug Regulatory Authority) on May 28, 2008. These registrations refer to a different salt of clopidogrel than the one of Plavix® (clopidogrel bisulfate), and the products are labelled only for a limited number of indications when compared to Plavix®.
IP pharma doc has earlier speculated the same in its earlier post

Tibolone (Arrow V/S Akzo): Scottish patent revocation decision

In a patent dispute between innovator Akzo and generic manufacturer Arrow (in Scottish court), the generic player seeks revocation of claims 1 to 3 and 5 of EP0389 035. The patent covers various crystalline forms of tibolone. That compound has been known since the 1960s and, since about 1988, has in one composition been marketed as Livial. It has combined oestrogenic, progestagenic and androgenic characteristics. In tablet form, it is used for treating menopausal complaints, for modulating the immune system and for combating osteoporosis. The patent is concerned with tibolone in a high degree of crystalline purity, that is, with a high degree of one form as against any other form of the crystals of that compound. The priority date of the patent is 18 March 1989. Following are the claims
"1. A pharmaceutical composition which contains a pharmaceutically suitable solid carrier and the compound having the structure (7ά, 17ά) - 17 - hydroxy-7-methyl-19-nor-17-pregn-5(10)-en-20-yn-3-one, characterized in that the compound is crystalline pure, which purity is greater than 90%.
2. The pharmaceutical composition of claim 1, characterized in that the crystalline purity is greater than 95%.
3. The pharmaceutical composition according to claim 1, characterized in that the crystalline pure compound has the monoclinic P21 form.
4. The pharmaceutical composition according to claim 1, characterized in that the crystalline pure compound has the triclinic P1 form.
5. A method for the preparation of a crystalline pure compound for use in a pharmaceutical composition accordingly to claim 3, characterized in that the polymorphous compound is crystallized from mixtures of water and acetone or ethanol, or from ethyl acetate, acetonitrile, or acetone-hexane mixtures.
Claims 4 and 6 are not challenged in these proceedings. Of the challenged claims, claims 1, 2 and 3 are claims to a product; claim 5 is a claim to a process (for the preparation of the monoclinic crystalline form).
6. A method for the preparation of a crystalline pure compound for use in a pharmaceutical composition according to claim 4, characterized in that the polymorphous compound is crystallized from an apolar solvent."
During trial only claims 1-3 and 5 were in dispute. Arrow challenges the validity of the patent on grounds both of anticipation and of obviousness. The Lord Ordinary upheld that challenge on the basis of anticipation but rejected it on the ground of obviousness. Akzo has reclaimed against the Lord Ordinary's interlocutor. It contends that, properly construed, the patent was not anticipated by any relevant prior art. Arrow resists that contention and further cross-appeals, contending that the Lord Ordinary erred in holding that the invention was not obvious.
The prior art upon which Arrow primarily, but not exclusively, relies is an article published in May 1984 in the Annual of the Royal Netherlands Chemical Society. The title of the article is in the following terms:"Conformational analysis of 3-oxo 5(10)-unsaturated steroids. Single-crystal X-ray structure analysis of 17-hydroxy-7ά-methyl-19-nor-17ά-pregn-5(10)-en-20-yn-3-one (Org OD 14)". Its authors were J.-P. Declercq and M. Van Meerssche

The question was whether the Lord Ordinary at the first instance had been correct in determining that the claims were not obvious in light of one particular prior art document disclosing tibolone in a crystalline form. The prior art document did not disclose that tibolone occurred in more than one crystalline form, as the discovery that tibolone was in fact polymorphic was made only later on. The Lord President, in judgment, considered that this did not make the claimed invention obvious:
The circumstance that following the experimental parameters described by Declercq et al. the skilled person would ordinarily obtain crystals, some at least of which were monoclinic, does not entail that 'the invention' would thereby be performed. The invention, properly understood, was constituted by a pharmaceutical composition having a high degree of crystalline purity in the active ingredient. While the skilled person, following Declercq, might be expected to obtain a mixture of crystalline forms (including some monoclinic), from which a particular crystal might by some process under the laboratory microscope have been isolated, Declercq did not teach how to obtain a product of high crystalline purity for pharmaceutical use - even if the skilled person for some reason was alert to the need to isolate a particular form, notwithstanding his ignorance of polymorphism in tibolone.In these circumstances, while Declercq enabled the skilled person to take certain steps, it did not enable him 'to perform the invention
Lord President Opinion : The Lord President considered that the use of tibolone to a high degree of crystalline purity as the active ingredient in a pharmaceutical composition was not obvious. Preliminary to that inventive step was the discovery by Akzo (not itself an invention, according to the Lord President) that tibolone was in fact polymorphous, i.e. with at least two crystalline forms. That discovery led in turn to the practical identification of the product, involving use in a pharmaceutical composition of crystalline pure tibolone having distinct advantages over a general mixture of forms, these advantages being stability and reproducibility. The skilled but unimaginative man would not have taken these steps or any of them.That was effectively the end of the story, as far as the patent was concerned, since Lord Kingarth agreed with the Lord President's conclusions. Lord Clarke, however, did not agree entirely and considered that claims 1-3 were not inventive:
Lord Clarke opinion: On discovery of the polymorphous character of tibolone, the patentee, no doubt, sought to address the consequences of that discovery. In my judgment, however, they did so by virtue of what is addressed in claims 4, 5 and 6. In claims 1-3, however, as they are worded, what was being claimed was the incorporation of monoclinic P21 form tibolone, up to a level of purity greater than 90%, which would include 100%. Claims 1-3 do not address the means (whether robust or otherwise) whereby a purity of more than 90% of monoclinic P2 tibolone is to be produced. They are, as previously noted, product claims, not process claims. They seek a monopoly in the product so described. My acceptance, shared by all members of this court, of Arrow's submission that these claims required to be read as embracing single crystal pharmaceutical compositions has to be kept in mind. The composition, tibolone, had been known since the 1960s. I accept that the skilled man would, at the priority date, have known that it was being developed by a drug company and was of particular interest in relation to the treatment of menopausal complaints. After Declercq, he knew also that the crystalline structure had been discovered as monoclinic form. Prior to the priority date tibolone had been put on the market in pill form. The question then comes to be, whether it would have been an inventive step to do what claims 1-3 embrace. [...] I repeat that the knowledge, or otherwise, of the discovery of the polymorphous character of tibolone seems to me to have bedevilled the discussion of this question and certainly led, in my view, the Lord Ordinary to misdirect himself when dealing with the matter. On this branch of the case, it seems to me that the question is, can it be said to be inventive to place a single crystal of monoclinic form 1 tibolone in a pill, tablet or capsule? Judging matters from the viewpoint of the skilled man who was aware of only Form 1 monoclinic tibolone as at the priority date, I agree with Arrow that, on the evidence, it cannot
Opinion of court

Atorvastatin (Lipitor): Australian court upheld Pfizer's basic patent

The Australian Federal Court in Victoria has upheld the basic patent AU601981 covering Atorvastatin racemic form, the active ingredient in the cholesterol-lowering drug Lipitor, preserving the product's patent coverage in Australia through May 2012, informed Pfizer Inc. The court, however, ruled a second patent AU 628198 covering the hemicalcium salt of atorvastatin, which expires in September 2012, as invalid. The Federal court had ruled that one of Pfizer's patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of the second Australian patent, said Ranbaxy. The court found that a proposed Ranbaxy generic product would infringe Pfizer's basic Lipitor patent ‘981. A second patent covering the calcium salt of atorvastatin ‘198, which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal that ruling. The ruling, the culmination of a lawsuit filed in 2005 by generic drug manufacturer Ranbaxy. Ranbaxy can appeal the decision of upholding the basic patent of Lipitor, even as Pfizer can appeal against the court's decision on its patent covering the calcium salt of atorvastatin.By this ruling Ranbaxy will get advantage of 4 months early launch in Australian market.

News analysis:India set for starting Pharm.D courses

After years of dilly-allying on the issue, the Union health ministry has at last given the green signal for the introduction of Pharm.D course in the pharmacy colleges in the country. Introduction of the advanced Pharm.D course will go a long way in bringing the pharmacists of the country on par with international standards. A notification in this regard has been issued by the health ministry setting criterions for starting this course in the pharmacy colleges. Major prerequisites for starting the Pharm.D course included proper teaching and building infrastructure, tie-up with any 300-bedded hospital or own hospital and prior permission from the Pharmacy Council of India (PCI).The PCI, a statutory body under the ministry of health to regulate the pharmacy education in the country, has been making all efforts to introduce this advanced course in the country. The PCI had sent draft regulations for Pharm.D course to the health ministry for its final approval before introducing the course. Plus 2 students with science as main subject are eligible to join this course which will open up new vistas for the students as the course will have validity all over the world including advanced countries like US, UK, etc. For the students who have already completed B Pharm course can join the Pharm.D (post baccalaureate) course. The duration of the Pharm.D course will be for 6 academic years (5 years of study and 1 year internship/residency). In the one year internship, a student is exposed to actual pharmacy practice/clinical pharmacy services and acquires skill under supervision so that he/she may become capable of functioning independently.Minimum qualifications for admission to Pharm.D course: (1) should be a pass in 10+2 examination with physics and chemistry as compulsory subjects along with one of the following subjects: mathematics/biology/bio-technology/computer science; (2) A pass in D.Pharm course from an institution approved by the PCI u/s 12 of the Pharmacy Act, 1948; and (3) any other qualification approved by the Pharmacy Council of India as equivalent to any of the above examination. For Pharm.D (post baccalaureate) course one should be B.Pharm from an institution approved by the PCI u/s 12 of the Pharmacy Act. Institutions running B.Pharm programme approved under section 12 of the Pharmacy Act, 1948 will only be permitted to run Pharm.D programme. Pharm.D (Post Baccalaureate) programme will be permitted only in those Institutions which are running Pharm.D programme. (source: Pharmabiz)

IP pharma doc believe that this decision will create confusion in students on whether to go for B.Pharm or Pharm.D.? Further, the said decision will lower the education standards in private colleges where facilities and staff are lacking. In our opinion if Govt. wants to go ahead on this issue then the said course should be started in the reputed institutes like NIPER, Hamdard, BHU, College of Pharmacy (Delhi), Manipal Pharmacy College, MS univesity Vadodra, UDCD Mumbai, UIPS Panjab University (Chandigarh) etc.

Osmotica Pharma got final approval for venlafaxine XR

Osmotica Pharma has got notice of final approval for its venlafaxine hydrochloride extended-release 37.5 mg, 75 mg, 150 mg and 225 mg tablets NDA from USFDA for major depressive disorder. The Osmotica formulation provides a controlled release tablet form of venlafaxine HCl including a previously unavailable 225 mg dosage strength. Equal doses of venlafaxine HCl Extended-release tablets are bioequivalent to Effexor XR capsules, a leading product marketed by Wyeth, when administered under fed conditions. Osmotica expects to launch the new product line for the two FDA-approved indications in the near future.
Osmotica Pharmaceutical is specializing in neurology based drug therapies and delivery technologies. The Osmotica Group has a portfolio of products in various stages of development focused in the treatment of Parkinson's disease.

Precose (Acarbose): Cobalt Drops Suit Against USFDA

Cobalt has voluntarily dismissed a lawsuit in which it had asked a court to restore its 180 days marketing exclusivity for a generic version of Bayer Pharma’s antidiabetic drug Precose (Acarbose).
Cobalt said that it was dismissing the case against the USFDA without prejudice. Cobalt had brought the suit May 8 in the U.S. District Court of Columbia, alleging the USFDA had unlawfully forfeited the company’s 180-day marketing exclusivity for a generic version of Precose (acarbose).
Cobalt had maintained that it was the first company to file an ANDA with a Paragraph IV certification on the drug’s ’769 patent, which has been delisted from the Orange Book. However, the FDA informed Cobalt May 7 that it had forfeited its right to generic exclusivity.
Cobalt said in court documents the FDA acknowledged its actions had delayed the company’s ability to market the product, but the agency said Cobalt had forfeited its exclusivity because it failed to obtain final approval and launch within 30 months of its 2005 ANDA submission.
Cobalt asked the court to enjoin the agency from approving all other ANDAs for the drug “until natural expiration of Cobalt’s statutory right to exclusivity for its acarbose ANDA.” It also requested that the FDA stay or withdraw approval for other acarbose ANDAs, including one from Boehringer Ingelheim’s subsidiary Roxane, which the agency approved May 7. Finally, it asked the court to order the FDA to recall any acarbose product made by Roxane on the market.
The court declined to issue a temporary restraining order against Roxane, finding that under the language of the Food, Drug and Cosmetic Act, Cobalt was unlikely to prevail in the case and Roxane would suffer “significant competitive injury,” Zuckerman Spaeder, the law firm representing Roxane, said.
(Source: FDA news)

GVK Biosciences And Wyeth Pharma In New Drug Discovery Pact

GVK Biosciences Pvt. Ltd. announced that it has entered into a research agreement with U.S.-based Wyeth Pharmaceuticals to discover drug candidates. Under the agreement, GVK Biosciences will receive an initial upfront payment, as well as payments based on the achievement of certain research milestones, the Indian pharmaceutical research services company said in a statement. The statement didn't elaborate on the amount of the payments.
GVK Biosciences will be responsible for identifying drug candidates, which will be transferred to Wyeth to advance towards clinical studies, the statement added.

Contrave (Bupropion and Naltrexone): Orexigen wins patent covering lead obesity drug

Obesity drug developer Orexigen Therapeutics Inc. said Tuesday the U.S. Patent and Trademark Office issued a patent US7375111 with broad claims covering sustained release (SR) compositions of Bupropion and Naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave, the company's lead obesity product candidate, now in Phase III clinical trials.
Orexigen anticipates results from the first Contrave late-stage trial late this year or early next year, with USFDA filing in late 2009.
The company has another obesity candidate, Empatic, currently in mid-stage trials. It is a combination of bupropion and zonisamide, which is used to treat seizures

Patent reexamination: an augmentation of litigation strategy rather than an alternative

Considered as an "alternative to litigation," recent research strongly suggests that Inter Partes Reexamination has become "an augmentation of litigation strategy rather than an alternative" (more than half (52%) of patents in inter partes re-exams are known to be in litigation during that time). People from the recently formed Institute for Progress (IFP) have published a study titled "Reexamining Inter partes Reexam". The study was published by iam-magazine.
The study highlights that it takes more than 3 ½ years for the average case to proceed through the basic reexam process to a final conclusion – this assumes that the case is not appealed to the Board of Patent Appeals and Interferences (BPAI) or beyond. A range of between 34 and 53 months for average pendency for an un-appealed inter partes reexamination average pendency (assuming no “rework” by the patent office and no secondary appeals to the BPAI, the Federal Circuit, or the Supreme Court) is 78.4 months – slightly longer than 6.5 years. A 95% confidence interval suggests an average pendency for appealed cases (again, assuming no rework) is between 5 -8 years. Given that the only three inter partes reexam cases that have received a BPAI decision all require further “rework” and are subject to further appeal, these estimates may be highly conservative
The inter partes reexam process requires special attention by the U.S. Patent Office. At present, the time to complete these cases far exceeds the expectation of “special dispatch” embodied in the patent statute. Federal judges, administrative law judges, and litigants should take special note of these facts as they can significantly impact the progress of patent litigation.

Reexamination Process
Reexamination is a process whereby a third party or inventor can have a patent reexamined by a patent examiner to verify that the subject matter it claims is patentable. In order to have a patent reexamined, the party of interest must submit prior art that raises a "substantial new question of patentability".
request for a reexamination can be filed by anyone at anytime during the period of enforceability of a patent. In order to request a reexamination, one needs to submit a “request for reexamination”, pay a fee, and provide an explanation of the new reasons why the patent is invalid. These reasons must be based on prior art. Copies of the prior art must be provided and the requester has to let the patent owner know that a request has been filed. The USPTO will then review the request. If the request does raise a substantial new question of patentability, the USPTO will order a reexamination. Most requests for reexamination are filed by third parties. A substantial fraction of these parties are already involved in a patent infringement lawsuit. By filing a reexam, they can hopefully invalidate the patent while at the same time keeping their legal fees low. If the judge in the lawsuit agrees, then the trial proceedings may be delayed pending the outcome of the reexamination.
Ex parte reexaminations are initiated by members of the public, but once said members submit their request, they no longer actively participate in the proceedings. The correspondence is strictly between the examiner and the patent owner.
Inter partes reexaminations are initiated by member of the public, but said members of the public continue to participate in the proceedings.
Link to report
Link to presentation

Palivizumab: MedImmune and Genentech settled lawsuit

Biotechnology firms MedImmune and Genentech settled a lawsuit over a patented component of Synagis, MedImmune's best-selling drug, which is aimed at preventing respiratory infections in infants.
Palivizumab (brand name Synagis) is a monoclonal antibody produced by recombinant DNA technology. It is used in the prevention of Respiratory Syncytial Virus (RSV) infections. It is recommended for certain infants that are high-risk (because of prematurity or other medical problems).
Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of the Respiratory Syncytial Virus (RSV). In two Phase III clinical trials in the pediatric population, Palivizumab reduced the risk of hospitalization due to RSV infection by 55% and 45%. Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season. Palivizumab targets the fusion protein of RSV, inhibiting its entry into the cell and thereby preventing infection.
The settlement follows a Supreme Court decision last year that allowed MedImmune to sue in an attempt to overturn a Genentech patent while MedImmune continued to pay royalties to use it. The patent covers a technology that uses cell cultures to manufacture human antibodies. MedImmune, a Gaithersburg-based unit of the drug giant AstraZeneca, said Genentech had illegally obtained the patent by conspiring with a British biotech company to monopolize the technology.

FTC’s Bureau of Competition Issues FY 2007 Summary of Pharmaceutical Company Settlement Agreements

The Federal Trade Commission’s Bureau of Competition today issued (In a press release) a summary of agreements filed with the agency in fiscal year 2007 (ending September 30, 2007) by generic and branded drug manufacturers.
The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 requires drug companies to file certain agreements with the FTC and the U.S. Department of Justice. The summary provides information regarding the agreements filed with the FTC in FY 2007. It also compares FY 2007 data with data received in FY 2006, FY 2005, and FY 2004.
In fiscal year 2007, there were 33 final settlements, nearly half of which (14, or 42%) included both compensation to the generic company and a restriction on the generic’s ability to market its product. Of those 14 settlements, seventy-nine percent involved agreements with first-filer generic companies. Unlike FY 2006, however, most of the FY 2007 agreements involving restrictions on generic entry did not include a side deal involving elements not directly related to the resolution of the patent dispute. Instead, the majority involved compensation to the generic firm through an agreement by the branded firm not to sponsor or compete with an authorized generic product for some period of time.
“This report confirms that settlements with potentially anticompetitive arrangements continue to be prevalent,” FTC Chairman William E. Kovacic said. “The Commission remains committed to ensuring that brand and generic companies do not use such settlements as a way to deny consumers the benefits of competition.”
Commissioner Jon Leibowitz added, “As our report today sadly demonstrates, pay-for-delay settlements continue to proliferate. That’s good news for the pharmaceutical industry, which will make windfall profits on these deals. But it’s bad news for consumers, who will be left footing the bill. These agreements inflict special pain on the working poor and the elderly, who need effective drugs at affordable prices.”
In the 14 final settlement agreements received in FY 2007 that involved both a restriction on generic entry and compensation to the generic, the compensation took two forms: 1) In 11 of the final settlements, the branded company agreed not to launch or sponsor an authorized generic drug for some period of time after the entry of the generic drug company’s product; and 2) In three of the final settlements, the compensation flowed to the generic firm in the form of a side deal.
In six of the 14 agreements, both the brand and generic firm received compensation. In three of these six agreements, the branded company received a royalty in exchange for granting the generic firm a license to the patent at issue in three cases. In one case, the brand received a royalty payment on the generic firm’s sales of an authorized generic product. In another case, the brand received a royalty on the generic company’s sales of a particular dosage of the drug at issue in the litigation. And in the final case, the branded company could receive a percentage of the generic company’s sales of the drugs at issue in the litigation, as well as of some unrelated products.
The report also states that 11 of the settlements reported included a restriction on the generic drug’s ability to enter the market, with no compensation to the generic firm. In six of these cases, the generic withdrew its patent challenge, agreeing not to enter the market until the patent expired.
Eight settlements included no explicit restriction on the generic’s ability to market its product. In five of these cases, the generic was already on the market. Six of the eight settlements included no compensation to either firm; the two remaining settlements involved the generic paying the branded company a fixed sum.
In 16 of the 33 final settlements reported, the generic manufacturer was the first-filer with the FDA. Eleven of those agreements resulted in both a restriction on generic entry and compensation to the generic manufacturer. In addition, in FY 2007, nine interim agreements between branded and generic firms were reported. Seven of these involved either: 1) an agreement to stay the litigation and be bound by the results of litigation involving the same patents; 2) an agreement by the generic firm to provide the branded firm with advance notice of an “at risk” generic launch, to provide the branded firm with the opportunity to seek a preliminary injunction; or 3) an agreement by the generic firm not to introduce its generic product until the court ruled on a preliminary injunction motion.
Finally, the report states that in FY 2007, only one agreement was reported between generic drug manufacturers. Under the terms of the agreement, the first filer agreed to give up its 180-day marketing exclusivity period, thereby allowing the subsequent filer to receive FDA approval for its product. (Link to full Report)

Protonix I.V. (Pantoprazole) :Wyeth, Nycomed Sue Sandoz For Patent Infringement

Wyeth and Nycomed filed infringement lawsuit against Sandoz in U.S. District Court of Illinois in Chicago. The suit seeks a court order that Sandoz has infringed the Protonix (Pantoprazole) I.V. patent and a permanent injunction barring Sandoz from selling a generic version until the patent expires.
Protonix was previously one of Wyeth's top-selling drugs, racking up $1.9 billion in sales in 2007. But late last year, Teva began selling generic copies of the tablet formulation in the U.S. despite the existence of a patent for Protonix that doesn't expire until 2010. Teva soon halted shipments amid talks with Wyeth to settle patent-infringement litigation, but no settlement was reached.
Wyeth itself began selling an authorized generic Protonix in partnership with Prasco Laboratories, while Caraco Pharma, owned by Sun Pharma, has jumped in with a rival generic, too.
Wyeth has insisted that the Protonix patent is valid and is being infringed. The company plans to seek lost profits and other damages from Teva and Sun. Wyeth expects the case against those companies to go to trial in federal court by mid-2009.

USPTO upheld one Viread (Tenofovir Disoproxil Fumarate) patent

Gilead Sciences announced that the USPTO has upheld one of the four patents on its AIDS medicine Viread that has come under challenge.
The USPTO has not announced its ruling on the remaining three Viread patents under review, the company said.
The nonprofit Public Patent Foundation had challenged the Viread patents last year. The group said it submitted evidence that patent on Viread are obvious as per prior art.
Tenofovir disoproxil fumarate ( 1-(6-aminopurin-9-yl) propan-2-yloxymethylphosphonic acid ), belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people.
Tenofovir is also available in a fixed-dose combination with emtricitabine in a product with the brand name Truvada for once-a-day dosing. (Emtricitabine is marketed as a single-compound product called Emtriva, also by Gilead.) Atripla, a fixed-dose triple combination of tenofovir, emtricitabine and efavirenz, was approved by the FDA on 12 July 2006 and is now available, providing a single daily dose for the treatment of HIV.

FDA law blog:FDA Sued After Denying Citizen Petition and Approving Generic EFUDEX Cream ANDA; Agency Will Reconsider ANDA Approval

Valeant Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved in July 1970 for the topical treatment of multiple actinic or solar keratoses (“AK”). In 1976, FDA approved the drug for a second indication - for the topical treatment of superficial basal cell carcinomas (“sBCC”) when conventional methods are impractical. In December 2004, Valeant submitted a citizen petition to FDA requesting that the Agency not approve any Abbreviated New Drug Application (“ANDA”) for a generic version of EFUDEX Cream unless the application contains data from an adequately designed comparative clinical study conducted in sBCC subjects. Specifically, Valeant argues in the company’s petition that: Link to FDA law blog for full article

U.S. District Court of Minnesota upheld NMT patent

NMT announced that a $2.25 million judgment for damages has been entered by the U.S. District Court of Minnesota against Cardia of Burnsville, Minnesota. The judgment is required to be paid to NMT in increments over the next several months.
The patent infringement lawsuit, originally filed in September 2004, alleged that Cardia’s Intrasept device infringes US5451235 (‘235). The ‘235 Patent is owned by the Children’s Medical Center Corporation and is licensed exclusively by NMT. In November 2007, the U.S. District Court of Minnesota issued a summary judgment ruling confirming the validity of the ‘235 Patent and holding that Cardia had infringed upon it.
As part of the settlement, Cardia will pay $2.25 million and agreed immediately to cease further production, marketing and sales of its Intrasept device. The cash payments will be divided equally between NMT and CMCC, following reimbursement of NMT’s legal fees and expenses. All parties have agreed to have the matter dismissed with prejudice.

Biopure patent upheld by EPO

Biopure has successfully defended European challenge to a patent governing purification of its artificial blood substitute. Biopure said on Monday that it defended the challenge filed in the EPO involving a way it removes bad proteins from its main product. The ruling gives Biopure patent protection in France, Germany, the United Kingdom, Ireland, Italy, Spain and Switzerland. Switzerland's Octapharma AG had challenged the patent process.

AstraZeneca jumps on hope for Quetiapine patent win

A U.S. court hearing over patents on AstraZeneca's blockbuster schizophrenia drug Seroquel (Quetiapine) has been brought forward to Tuesday from June 4, boosting hopes the Anglo-Swedish group may prevail in the case. (Link)

Moviprep: Salix Pharma sue Novel Lab

Salix Pharma announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Lab, for infringement of Norgine's patent US7169381, which covers Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) formulation. Norgine licensed Moviprep to Salix for commercialization in the United States. The lawsuit is in response to ANDA filed by Novel with the USFDA regarding Novel's intent to market a generic version of Mviprep in the United States prior to the expiration of US 7169381 (September 1, 2024).

Mylan launched Paroxetine Hydrochloride

Mylan Pharma has launched Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR(R). As the first company to successfully file ANDA containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. Mylan has supply and distribution agreement with GSK. Mylan further has the right to market the 37.5 mg strength.

Enoxaparin: US court affirms inequitable coduct against Sanofi

A U.S. federal court affirmed a ruling that Sanofi-Aventis intended to deceive the patent office in its dispute over generic versions of its blockbuster drug Lovenox.
Sanofi, the world's third-biggest drugmaker, has sued Teva Pharmaand Amphastar Pharma over their bid to sell a generic version of Sanofi's Lovenox, a blood-thinning drug that had sales of about $1.1 billion in the first quarter of 2008.
Enoxaparin (6-[5-acetylamino-4,6-dihydroxy-2- (sulfooxymethyl)tetrahydropyran-3-yl] oxy-3- [5-(6-carboxy-4,5-dihydroxy-3- sulfooxy-tetrahydropyran-2-yl)oxy-6-(hydroxymethyl)- 3-sulfoamino-4-sulfooxy-tetrahydropyran-2-yl] oxy-4-hydroxy-5-sulfooxy-tetrahydropyran-2- carboxylicacid ) is a low molecular weight heparin manufactured by Sanofi-Aventis. It is marketed as Lovenox or Clexane. Enoxaparin injections are derived from the intestinal mucosa of pigs. Enoxaparin is used to prevent and treat deep vein thrombosis or pulmonary embolism, and is given as a subcutaneous injection (by a health care provider or the patient). Its use is evolving in acute coronary syndromes (ACS).
Following patents are listed in Orange book for this product
US5389618 (Expiry: Feb 14, 2012)
USRE38743 (Expiry: Feb 14, 2012)
Earlier Amphastar and Teva ‘s Motion for Summary Judgment was granted on June 15, 2005, which held '618 patent invalid due to inequitable conduct. The USPTO reissued the disputed patent in June 2005 as USRE38743. Subsequently Aventis filed a Motion to substitute '618 for '743. On July 2005, the district Court granted the substitution of the patents and also entered final judgment on inequitable conduct grounds.
The U.S. Court of Appeals for the Federal Circuit ruled that pharma giant Sanofi-Aventis had committed "inequitable conduct" for failing to inform the U.S. patent office of information relevant to patentability.
The inequitable conduct was alleged w.r.t EP40144, which was granted in Europe as patent in 1980 (Which got revoked in 1990). The said patent covers the same invention as disclosed in ‘723. Aventis got ‘618 patent after overcoming 3 rejections by USPTO. Finally, Aventis demonstrated that pharmacokinetic profile with respect to t1/2 is better in ‘618 patent in comparison to ‘144 patent.
The federal court affirmed the ruling by a district court in California that there was an intent to deceive by Sanofi-Aventis in its failing to disclose dosages of the drug in pharmacokinetic studies.
The judge Radar dissented the ruling, arguing that inequitable conduct should be reserved for only the most extreme cases of fraud and deception, which he said did not apply in this case. In his dissenting note judge said that Aventis may have been careless, but hardly culpable
The USFDA has not cleared any generic form of Lovenox. (opinion of Court)

perindopril tert-butylamine: UK Supreme court slammed patent ever greening attempt of innovator

In a significant decision by The Lord Chief Justice of England & Wales in a patent dispute between Apotex (generic) V/S Servier (innovator) w.r.t Perindopril, the court sided with Apotex and slammed patent ever greening attempts by innovator Servier. Innovator Servier had a patent EP1296947, which covers a new crystalline polymorphic form α of perindopril tert-butylamine salt, and a process for its preparation and pharmaceutical compositions containing it. This patent claimed priority from a French application published in 2000, but the original perindopril compound was patented as EP0049658 in the early 1980s and another earlier patent for the compound patent EP0380341 for the industrial synthesis of perindopril

from 1988.

The patent was lucrative: Servier's turnover in the UK alone was £70 million and generics manufacturer Apotex had sold £4 million worth of perindopril in the short period before Servier, alleging infringement, secured interim injunctive relief.
Apotex challenged the validity of the patent, while Servier sought permission to amend it. HIGH COURT OF JUSTICE CHANCERY DIVISION (PATENTS COURT) The Hon Mr Justice Pumfrey, held that Servier's EP1296 947 was invalid for lack of novelty and obviousness. He gave permission to appeal applying the Pozzoli test. But he also refused to continue an interim injunction pending appeal on the grounds that he considered there was no real prospect of success. An application to this court for continuation of the injunction was refused on the same basis.
The upshot of all this is that were the patent valid, Servier's monopoly in practice would last until 2020. But the judge held the patent invalid. In our view, The EPO did not properly check the patent. This decision firmly prohibits patent ever greening by innovator companies (court opinion here)

Aurbindo got MCC approval

Hyderabad based Aurobindo Pharma has received approvals from the Medicines Control Council (MCC) to manufacture and market nine products in South Africa. These products are estimated to have a generic market size of ZAR 165 million in the local market The following products received approval from MCC:
1) Auro-Lisinopril Co (CVS)
2) Auro-Amlodipine (CVS)
3) Auro-Finasterid (BPH)
4) Zinoxime (anti-infective)
5) Zolid (CNS)
6) Yomax (anti-infective)
7) Lazivir (ARV)
8) Lisinozide (CVS)
9) Profina (BPH)

Phentolamine mesylate: Novalar Pharma got approval from USFDA

Novalar Pharma a dental specialty pharmaceutical company, announced that the USFDA has granted marketing approval for OraVerse (Phentolamine mesylate). OraVerse is the pharmaceutical agent indicated for the reversal of softtissue anaesthesia and the associated functional deficits resulting from a local dental aesthetic. Novalar is establishing a specialty direct sales force to launch OraVerse in late 2008.

ZIOPHARM Receives Notices of Allowance for Two U.S. Patent Applications Covering anticancer drug Darinaparsin

ZIOPHARM announced that it has received Notices of Allowance from the USPTO for patent applications which covers claims for various organic arsenic compounds, including purified crystalline Darinaparsin, glycolic arsenicals, and the oral pharmaceutical composition of an organic arsenic compound, and their use in the treatment of cancer. A notice of allowance signifies that the applicant is entitled to a patent under the U.S law.

Ranbaxy & Merck to jointly discover novel antibiotic molecule

After collaborating with Advinus therapeutics ( Tata group company) to discover and work on drugs for metabolic disorders and Nicholas Piramal (Anticancer drugs), The pharma giant Merck has now collaborated with Ranbaxy for novel antibiotic research. Ranbaxy Ltd. and Merck & Co., Inc have signed a strategic Product Development Agreement for a drug discovery and clinical development collaboration for new products, in the anti-infective field. Ranbaxy and Merck will work together to develop clinically effective anti-bacterial and anti-fungal drug candidates. Ranbaxy will carry-out drug discovery and clinical development through phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates thereafter.
India is a good outsourcing destination for innovator companies. In recent times, some pharma companies have outsourced their work to Indian pharmaceutical companies.

Court concern on baseless Para IV filings: Do your home work before challenging patent

The act of filing ANDA is not willfull infringement (Glaxo v/s Apotex, 2004: decision of court that act of filing ANDA on Cefuroxime Aexitil by Apotex is not a willfull infringement), but court in certain cases can grant attorney fees to winning party on baseless ANDA filing (21 U.S.C. 285) The US courts in the recent times have seen many ANDA filings with baseless para IV grounds, which are not strong cases to invalidate or design around the para IV certified patent. Now a generic company should be careful while filing Para IV, as a baseless ANDA filing can result in punishmnet from court. Orange book blog has concluded the above fact in a recent article : Link to orange book blog

Sanofi, BMS hit by generic Plavix (Clopidogrel) threat in Europe

Sanofi-Aventis and Bristol-Myers Squibb are facing generic threat on Plavix or Iscover (Clopidogrel) in Europe from Schweizerhall (Swiss company). Schweizerhall announced that its close to winning approval for a generic version of the blood-thinning product in Germany and Luxembourg. The company furter added that it will launch the generic version before the end of June.
Sandoz, Hexal and Ratiopharm will be the marketing partner of Schweizerhall.
The EP281459 claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. But Schweizerhall said it was close to launching a generic version despite this.The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form.
Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries.
The Basel-based company expects approval shortly from German regulators for its version of clopidogrel, as Plavix is known generically, and it plans to launch the drug throughout the European Union in cooperation with marketing partners.
The Ippharmadoc believes that Schweizerhall may have design around EP281459 by developing a different salt form of clopidogrel.
Plavix suffered a major decrease in sales after Apotex launched a generic form of the medicine in August 2006. Although a New York federal judge blocked the sale of the generic weeks later, the huge supplies already on the market undermined sales of Plavix through early 2007. Recently, BMS and Sanofi were succcessful in blocking generic version in USA as reported earlier by this blog.

Phrama News: Drug approvals

Roxane Lab Announced the Launch of Acarbose Tablets
Roxane Lab. announced the approval of their ANDA for Acarbose Tablets, 25mg, 50mg, and 100mg. The product is available in bottles of 100 tablets for all strengths as well as Unit Dose Blisters for the 50mg strength and is available for immediate shipment to wholesalers and pharmacies nationwide
Mylan and Teva Introduces Ropinirole Hydrochloride Tablets
Mylan and Teva Pharma announced the introduction and availability of Ropinirole Hydrochloride Tablets. This product is AB rated and bioequivalent to Requip Tablets. Ropinirole HCl Tablets are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths, in bottle sizes of 100
Amneal got USFDA Approval for Three Generic Prescription Drugs

Amneal Pharma announced that it has received USFDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks. Two of these products were filed during 2007 using the FDA's evolutionary electronic dossier submission 9e-CTD) format that enabled approvals in less than twelve months
Sepracor Announces Final Settlement of Xopenex Inhalation Solution Patent Infringement Litigation
Sepracor announced that it has entered into a Settlement and License Agreement with Breath Limited (Breath), an Arrow Group subsidiary, to resolve the patent litigation involving Sepracor's Xopenex brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL). The agreement permits Breath to launch generic versions of these Xopenex Inhalation Solution dosages under terms of an exclusive license commencing on August 20, 2012.
Teva Introduces Epoprostenol Sodium for Injection
Teva Pharma announced that the USFDA has granted approval to its ANDA to market Epoprostenol, a generic version of GlaxoSmithKline’s Flolan® for Injection
Mylan Announces Final FDA Approval for Trandolapril Tablets
Mylan got final approval from the USFDA for its ANDA for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.
Ohm Lab (Ranbaxy subsidry) got Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
Ohm Lab (Ranbaxy subsidry) announced that it has received final approval from the USFDA to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC).

Barr got final approval to market Yasmin (Drospirenone and Ethinyl estradiol)

Barr Pharma announced that USFDA has approved the ANDA for generic version of the oral contraceptive Yasmin.
Barr challenged the Yasmin patent held by Bayer AG and in March, a U.S. district court found that the patent held by Bayer was invalid because it was obvious (as reported earlier by this blog). The German drugmaker has appealed the ruling.
Yasmin, known generically as Drospirenone and Ethinyl estradiol, had branded annual sales of about $575 million, Barr said.
The generic drugmaker said it planned to start selling its version of Yasmin in mid 2008. It expects, as the first to file for approval, to have 180 days of exclusivity before any other generic companies can start selling the contraceptive (news link to Reuters & Forbes)

Merck gets Indian patent for upcoming drugs

Pharma giant Merck & Co Inc has received patent approval from the Indian Patent Office for two of its upcoming drugs for dyslipidemia and obesity. The two new-patented drugs are in final stages of trial and are yet to receive the Drug Controller General of India’s (DCGI) (Link)

Phillippines patent law amendment:Draft law affirms patent rights of drug firms

Phillippines goverment in a bid to provide cheaper generics to its people will amend patent law, which will favour genrics.

IP provisions included in the final draft of the bicameral bill are formidable. These include:

o adopting the principle of international exhaustion of intellectual property rights (IPR) for drugs and medicines to improve access to cheaply priced drugs anywhere in the world without risk of patent infringement;

o narrowing the definition of what medicines can be patented by disallowing the practice of evergreening ¯ patent coverage for "new uses" of existing, already patented substances;

o providing for a broad parallel importation provision to allow the government to procure quality, affordable patented drugs and medicines from other countries;

o providing additional means to issue compulsory licenses so that the government can easily set aside patent restrictions in response to public health threats; and

o adopting an "early working" or Bolar provision, which ensures that affordable versions of patented medicines can be introduced into the Philippines market immediately upon patent expiration.The bicameral version also adopted Section 93-A that was introduced in the House bill, which provides an alternative procedure for the issuance of a special compulsory license under the framework of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.The IPO itself has declared that these amendments are a legitimate exercise of the flexibilities accorded to developing countries like the Philippines in the Doha Declaration on the TRIPS and Public Health.The World Trade Organization (WTO) had adopted the TRIPS Agreement in November 2001. More than six years later, however, such flexibilities have yet to be incorporated in Philippine intellectual property law that would have made it more responsive to the problem of inaccessible medicines and expensive drug prices. (For complete article link to manilatimes)

Suven secures European patent on SUVN-502

Suven Life Sciences, a biopharmaceutical company based here, has secured a product patent EP 1581492 from the European Patent Office (EPO) for its clinical candidate SUVN-502, valid until June 2023. The product is being developed for central nervous system (CNS) disorders. It can be used in the treatment of cognitive impairments associated with neuro-degenerative disorders such as Alzheimer's disease and attention-deficit hyperactivity disorder or memory loss associated with aging and schizophrenia.

Generics slam proposed drug patent rules in Canada

New patent rules just proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, costing consumers and taxpayers tens of millions of dollars annually, generic companies are warning.
(Link to full text news nationalpost)

Oxaliplatin (Eloxatin): Innovator Sanofi-Aventis Sues Heraeus

Sanofi-Aventis has filed suit against W.C. Heraeus GmbH for infringement of US5338874 which covers oxaliplatin as product. Eloxatin is covered by following patents

US5338874 (Expiry Apr 07,2013)

US5420319 (Expiry Aug 08,2016)

US5716988 (Expiry Aug 07,2015)

US5290961 (Expiry Jan 12, 2013)
Sanofi-Aventis alleged Infringement of US5338874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994) based on Heraeus' filing of a DMF (drug master file) with the FDA for the manufacture of Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer).
Oxaliplatin is a platinum-based chemotherapy drug in the same family as cisplatin and carboplatin. It is typically administered in combination with fluorouracil and leucovorin in a combination known as FOLFOX for the treatment of colorectal cancer. Compared to cisplatin the two ammine groups are replaced by cyclohexyldiamine for improved antitumour activity. The chlorine ligands are replaced by the oxalato bidentate derived from oxalic acid in order to improve water solubility.
Oxaliplatin was discovered in 1976 at Nagoya City University in Japan by Professor Yoshinori Kidani, who was granted U.S. Patent 4,169,846 over the drug in 1979. Oxaliplatin was subsequently in-licensed by Debiopharm, a Swiss drug company headquartered in Lausanne and developed as an advanced colorectal cancer treatment. Debio licensed the drug to Sanofi-Aventis in 1994. Eloxatin gained European approval in 1999 and USFDA approval in 2004.

Atorvastatin: Relief to Pfizer on 893' reexamination

Pfizer announced that it had received a Notice of Intent to Issue an Ex Parte Reexamination Certificate for US4681893 from the U.S. Patent and Trademark Office. The '893 patent, which expires in March 2010, is product patent of Atorvastatin Hemicalcium. This patent covers racemic Atorvastatin.
The reexamination request was filed by a lawfirm representing Ranbaxy in July 2007. In the Notice of Intent's Statement of Reasons for Patentability and/or Confirmation, the Examiner indicated that Pfizer had overcome obviousness rejections based on EP0179 559 and US4647576. (Pfizer press release) (Patent doc article link )

P&G sues J&J over tooth-whitening strip patent

Procter & Gamble filed a lawsuit in the U.S. District Court for the Western District of Wisconsin, The plaintiff alleges that the Listerine strips infringe P&G patents related to the tooth whitening active ingredient and delivery systems.
P&G has asked the court to stop J&J and its subsidiries, from making, selling, and importing allegedly infringing products. P&G also is seeking recovery of damages.

Nabi Biopharmaceuticals patent upheld

Nabi Biopharmaceuticals has prevailed in a challenge of its European patent for the process that covers its NicVAX® vaccine. In a recent ruling, the European Patent Office (EPO) upheld the firm’s European Patent EP1135166. In July 2005, Cytos Biotechnology AG filed a Notice of Opposition against Nabi's European patent and the Company filed its response in December 2005. The EPO notified Nabi in September 2007 that the opposition filing was admissible and held a hearing on April 23, 2008. The EPO cancelled some claims in the patent that do not affect the primary claim protecting Nabi Biopharmaceuticals' exclusive use of NicVAX for its intended purpose of treating and preventing nicotine addiction. Nabi plans to appeal these ancillary claim cancellations.
NicVAX is a nicotine conjugate vaccine intended to reduce or eliminate physical addiction to nicotine. According to the National Institute on Drug Abuse, NicVAX can potentially be used to inoculate against addiction. This proprietary vaccine is being developed by Nabi Biopharmaceuticals with the aid of the University of Houston-Clear Lake and University of Minnesota. NicVAX consists of the hapten 3'-aminomethylnicotine which has been conjugated (attached) to Pseudomonas aeruginosa exoprotein A.

Atorvastatin: Pfizer sued Teva in the District Court of Delaware

Pfizer sued Teva in the District Court of Delaware for the Infringement of US 5273995 ("[R-(R*R*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl-3-phenyl-4-[(phenylamino) carbonyl]- 1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof," issued December 28, 1993) based on Teva's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (Atorvastatin hemicalcium). This is second time Pfizer has sued Teva for the same patent for different strength. The CAFC on complaint from Ranbaxy has invalidated the claim 6 of this patent. Pfizer is trying to reissue the said patent and USPTO has twice rejected Pfizer request as reported earlier by this blog

Drug companies oppose bid to link marketing, patents

The drug controller general of India (DCGI), Surinder Singh, had said in a conference last week that he intended to reject applications to sell copycat versions of a patented drug from other drug makers in India. This could avoid ticklish situations where a generics manufacturer gets the marketing go-ahead from DCGI for a drug patented by another. (link to full text article)