- Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity. This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA. FDA Law Blog posted a nice summary of FDA’s response.
- FDA Law Blog also posted on a very interesting case recently filed by Nu-Pharm against FDA, in which Nu-Pharm seeks to force FDA to grant it final approval to market generic Depakote (divalproex sodium).
- The Wall St. Journal had an interesting article yesterday on health plans that pay doctors $100 each time they switch a patient to a generic drug. The WSJ Health Blog posted this summary of the article.
- A district court in New York recently held that three Purdue Pharma patents on Oxycontin are not unenforceable for inequitable conduct.
- Cypress Pharmaceutical announced today that it has settled patent litigation with GSK concerning its generic version of Zantac (ranitidine) syrup.
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IQPC will be holding its 3rd annual "Pharmaceutical Patent Litigation Strategies" conference in London, March 31 to April 1.
The conference is split into two days–one focusing on European law, the other focusing on U.S. law–and includes an optional third day, with workshops.
The European Focus Day will emphasize proposals for supranational patent litigation; EPLA; and the community patent and how to push it forward. The U.S. Focus Day will analyze the trends and developments in the pharmaceutical and biotech law sector; the Patent Reform Act 2007; parallel US and European patent litigation strategies; and key rulings.Margot Fröhlinger, Director, European Commission, will be speaking during the European Focus Day on "How to Achieve Consistency Across European Courts in the Future." Dr. Fröhlinger leads an exceptional speaker panel that will discuss successful litigation practices and a changing regulatory framework in order to provide superior practical intelligence.
IQPC’s 3rd annual "Pharmaceutical Patent Litigation Strategies" conference is sharply focused on improving in-house patent litigation for pharmaceutical companies. The event will feature the latest updates from both in-house experts and outside counsel. Key issues to be covered include the link between regulations and actual litigation practices; international litigation processes; patent life extension; and new industry developments.
For more information or to register, please visit the conference website.
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A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva’s right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for risperidone tablets until Teva’s exclusivity expires. Risperdal is Johnson & Johnson’s blockbuster treatment for schizophrenia and other neurological disorders.
Teva filed its ANDA for risperidone tablets on August 28, 2001, with a paragraph III certification to U.S. Patent No. 4,804,663 and a paragraph IV certification to the ‘952 patent. At the time, both patents were listed in the Orange Book for Risperdal. On October 12, 2001, FDA notified Teva that it had delisted the ‘952 patent from the Orange Book and informed Teva that it would not accept Teva’s ANDA for filing unless Teva amended its paragraph IV certification to reflect the fact that the ‘952 patent had been delisted. Teva complied by amending its ANDA.
Five years later, in Ranbaxy v. Leavitt, the D.C. Circuit ruled that FDA had improperly delisted two patents on Zocor because the effect of delisting would be to deny the first ANDA filer of 180-day exclusivity on simvastatin tablets. According to Teva’s citizen petition, following that decision "Teva began reviewing its portfolio of pending ANDAs to determine whether FDA’s unlawful delisting practices had deprived Teva of its entitlement to 180-day exclusivity for any other generic product."
In its risperidone petition, Teva contends that because the ‘952 patent was listed in the Orange Book when it filed its ANDA for risperidone tablets, it had no choice but to certify as to the ‘952 patent. "Teva thus did precisely what it was obligated to do under the plain text of the governing statute and Agency regulations, and it therefore earned its exclusivity as the first applicant to file a paragraph IV certification to a patent listed as claiming the reference listed drug." Teva argues that the Ranbaxy decision compels FDA to relist the ‘952 patent and restore Teva’s right to 180-day exclusivity. Teva further argues that "the fact that FDA never accepted Teva’s paragraph IV ANDA for filing has no bearing on the fact that FDA must relist the ‘952 patent."
The ‘663 patent (whose validity was affirmed in a Federal Circuit decision last year) expired on December 29, 2007. Pediatric exclusivity on Risperdal extends to June 29, 2008. Thus, FDA must decide the issues presented in Teva’s citizen petition before then. FDA will post its decision in the docket established for Teva’s petition.
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- Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials). Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva’s citizen petition–namely, whether Teva’s failure to market its generic product within 30 months of ANDA submission caused forfeiture of its exclusivity. FDA is expected to release a formal response to Teva’s petition in the near future.
- King Pharma and CorePharma settled their patent litigation over generic Skelaxin (metaxalone). According to this AP story, however, analysts disagreed over the impact of the settlement.
- Taro Pharma and Breckenridge Pharma announced settlements with Novartis of their patent cases concerning generic Trileptal (oxcarbazepine). According to their press releases, Taro and Breckenridge are sharing 180-day exclusivity for the product.
- Bloomberg published an interesting article earlier this week about the faltering biotechnology industry in China.
- Both Pharmalot and the WSJ Health Blog had posts this week about a Bloomberg story that reported the FDA approved only 19 new drugs last year, the fewest since 1983.
- Pharmalot also posted this week on a new report from Cutting Edge Information entitled "Combating Generics 2008," which found that 66 percent of brand name drug companies do not begin strategizing against generics until at least two years after product launch.
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- Eisai announced yesterday that the district court in New Jersey recently dismissed its lawsuit against Mutual Pharma concerning Aricept ODT. The case was dismissed on jurisdictional grounds because Mutual has not challenged Eisai’s patent.
- The Wall St. Journal had an interesting article Wednesday about Sun Pharma’s generic version of Wyeth’s blockbuster antidepressant Effexor XR. AP published this related story last week.
- On Monday, Teva announced that it launched generic Protonix (pantoprazole). In response, Wyeth announced that it will pursue monetary damages from Teva. For more, see Pharmalot and the WSJ Health Blog. As we previously reported, in September a district court denied Wyeth’s motion for a
preliminary injunction against Teva. - FDA Law Blog reported last week that the district court in Washington, D.C. enjoined the federal government’s Average Manufacturer Price (AMP) rule for pharmaceutical reimbursement.
- Pharmalot had an interesting post last week about a recent report on the various types of pharmaceuticals in Phase I studies.
- Depomed announced on December 13 that a district court in California granted summary judgment of infringement in its patent case against IVAX concerning generic Glumetza.
- AstraZeneca announced on December 12 that it filed patent infringement suits against seven generic drug makers who filed ANDAs for generic versions of Crestor (rasuvastatin calcium). See also this Reuters article.
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American Conference Institute will hold its fifth annual “Pharma/Biotech IP Due Diligence” conference January 30-31 in New York. ACI describes this conference as the “complete guide for M&As, licensing and other collaborations.”
The agenda includes several talks that sound especially interesting, including:
- “Factoring Patent Reform, PTO Rulemaking and New Case Law Into Your Due Diligence Analysis”
- “Managing Due Diligence When Dealing with Industry/University Collaborations and Licenses”
- “Evaluating the Scope, Validity, and Enforceability of the Target’s Patents”
- “Freedom to Operate: Ensuring the Purchaser/Licensee Has the Right to Commercialize the IP at Issue”
- “FDA Regulation of Small Molecule Drugs and Biologics: Understanding How This Affects the Diligence Review”
In addition, ACI is offering an optional master class on February 1, entitled “Drafting an Effective Due Diligence Report.”
For more information or to register, please visit the conference website.
Orange Book Blog is a media partner of this conference.
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Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007)
Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The ‘893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the ‘574 patent claims combinations of atorvastatin sodium and amlodipine besylate. Ranbaxy filed counterclaims seeking declaratory judgments that (1) the ‘893 patent is invalid; (2) the ‘574 patent is invalid and not infringed; and (3) a third patent, U.S. Patent No. 5,273,995, is invalid, unenforceable and not infringed. In an opinion filed November 29, the district court granted Pfizer’s motions to dismiss Ranbaxy’s counterclaims on the ‘893 and ‘995 patents, leaving only the ‘574 patent in the case.
On August 2, 2006, the Federal Circuit affirmed the validity of the ‘893 patent in Pfizer’s case against Ranbaxy concerning Ranbaxy’s ANDA for a generic version of Lipitor. Ranbaxy appealed to the Supreme Court, and in April, the Court denied Ranbaxy’s cert petition. Accordingly, in the Caduet litigation, Pfizer moved to dismiss Ranbaxy’s counterclaims of invalidity of the ‘893 patent on grounds of res judicata. In addition, Pfizer moved for partial summary judgment on the pleadings, asking for a judgment of infringement of the ‘893 patent on grounds of collateral estoppel.
In opposition to Pfizer’s motion, Ranbaxy argued that res judicata principles should be narrowly applied because the issue of obviousness was not presented at trial or adjudicated in the Lipitor litigation, and “significant factual and legal changes have occurred since the Lipitor litigation that fundamentally alter the obviousness analysis of the ‘893 patent.” Specifically, Ranbaxy argued that the Supreme Court’s decision in KSR v. Teleflex “dramatically lowered the bar of 35 USC 103.” The district court, however, was unconvinced, stating that Ranbaxy challenged the validity of the ‘893 patent in the Lipitor litigation, and therefore, absent fraud or a momentous legal change in constitutional rights, “Ranbaxy was required to raise all of its invalidity defenses at that time.” Thus, the court granted Pfizer’s motion to dismiss. In addition, because Ranbaxy did not contest infringement of the ‘893 patent, the court granted Pfizer’s motion for a judgment of infringement of the ‘893 patent on the pleadings.
In the same August 2, 2006 decision, the Federal Circuit held that Claim 6 of the ‘995 patent is invalid. The ‘995 patent covers pharmaceutical compositions containing atorvastatin calcium. Pfizer is currently seeking a reissue of the ‘995 patent to correct the defect in Claim 6 and to correct defects in other claims. In the Caduet litigation, Pfizer moved to dismiss Ranbaxy’s counterclaims on the ‘995 patent on grounds that it has provided Ranbaxy a covenant not sue Ranbaxy on all remaining claims of the original ‘995 patent.
In response to this motion, Ranbaxy argued that its declaratory judgment counterclaims of unenforceability of the ‘995 patent should not be dismissed, notwithstanding Pfizer’s covenant not to sue, because “Pfizer has not agreed to provide Ranbaxy with a covenant not to sue related to any reissue of the ‘995 patent.” Here too, however, the district court was unconvinced by Ranbaxy’s arguments. The court stated: “the question of whether a new patent will ever be reissued is speculative, purely hypothetical and unripe for judicial determination. Accordingly, the Court concludes that these circumstances do not support jurisdiction under the MedImmune standard.”
As a result of the district court’s decision, Ranbaxy will not be able to launch its generic version of Caduet until at least 2010, when the ‘893 patent expires. Pfizer will now proceed with the case, aiming to keep Ranbaxy off the market until 2018, when the ‘574 patent expires.
RELATED READING:
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- Prof. Chris Holman, who has contributed to this blog in the past, recently started his own blog: Holman’s Biotech IP Blog. Formerly in-house counsel at a biotech company, Chris offers valuable insights on biotech IP law.
- “Big Pharma Faces Grim Prognosis” was the top story on the front page of the Wall Street Journal Thursday. It proclaims: “Over the next few years, the pharmaceutical business will hit a wall.” Summaries of the article appear on the WSJ Health Blog and Pharmalot.
- Watson Pharmaceuticals announced Thursday that it settled patent litigation with Novartis concerning its generic version of Novartis’s Exelon.
- Sun Pharma also announced a settlement with Novartis on Thursday, concerning its own generic version of Exelon. On October 23, Sun announced that the FDA granted final approval to its ANDA for generic Exelon.
- On Tuesday, Watson announced that it settled litigation with Biovail over its generic version of Cardizem LA. Biovail also put out its own press release.
- King Pharmaceuticals announced Monday that the Federal Circuit denied its petition for rehearing and rehearing en banc of the Federal Circuit’s September 11 decision invalidating the patent on Altace.
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District Court Upholds Validity of Pfizer’s Accupril Patent, Rejecting Teva’s Nonenablement Argument
Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007)
Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva’s ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva’s 2002 approval letter, Teva also filed its ANDA with a paragraph III certification to U.S. Patent No. 4,344,949, which expired on October 3, 2002, and section viii statements to U.S. Patent Nos. 5,684,016 and 5,747,504.
The ‘450 patent broadly claims pharmaceutical compositions containing an ACE inhibitor, "an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration," and "a saccharide to inhibit hydrolysis." The ‘450 patent did not expire until February 24, 2007, with pediatric exclusivity extending until August 24, 2007.
In October 2003, the district court granted Warner-Lambert’s motion for summary judgment of infringement of claims 1, 4-10 and 12 of the ‘450 patent. The court also granted Warner-Lambert’s motion for summary judgment of validity of the same claims. Following a trial in May 2004, the district court ruled that claims 16 and 17 are valid, and that the ‘450 patent is not unenforceable due to inequitable conduct. Teva appealed the findings of infringement, no invalidity for lack of enablement, and no inequitable conduct, and in August 2005, the Federal Circuit reversed the district court’s rulings on infringement and enablement and remanded the case for further proceedings. In January 2006, the district court granted Warner-Lambert’s motion for summary judgment of infringement, leaving the issue of enablement for trial.
The district court held a trial on the question of enablement on May 2 and 3, 2007, and released an opinion last week finding the claims enabled. The court applied the standard test: whether the specification provides "sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation." Teva argued that the claims of the ‘450 patent are extremely broad and the specification provides insufficient guidance to develop the full range of pharmaceutical formulations encompassed by the claims. In addition, Teva argued that numerous failures to arrive at operative embodiments of the claims proved nonenablement. The court, however, found the testimony of Warner-Lambert’s expert witness (who "wrote the book on stability of pharmaceutical formulations") to be more persuasive than the testimony of Teva’s expert. The court was convinced by Warner-Lambert’s expert that one skilled in the art could readily practice the full scope of the claimed invention through routine experimentation. In addition, the court found that none of the purported "failures" proffered by Teva were evidence of lack of enablement.
Last week’s court decision could impact other cases in which the ‘450 patent has been asserted. For instance, Warner-Lambert filed suit against Teva and Ranbaxy in January 2005, after Teva announced that it began shipping generic quinapril HCl tablets in partnership with Ranbaxy. In addition, Schwarz Pharma AG, an exclusive licensee of the ‘450 patent, has asserted the patent against in litigation concerning generic versions of Univasc (moexipril).
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