Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • FDA Announces New “First Generics” Policy for Review of ANDAs

    Dr. Steven Galson, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, recently announced a new "First Generics" policy for review of ANDAs.  Under the agency’s current "First-In, First-Reviewed" policy, CDER reviews ANDAs in the order in which they are received.  Under the new policy, FDA will make exceptions to the first-come, first-served approach in the following circumstances:

    • an ANDA is received for a first generic (one that has never been approved, and that is not affected by blocking petitions or exclusivities);
    • a public health emergency exists;
    • a nationwide shortage of a drug exists;
    • the ANDA is for a drug that falls under a special program, such as the President’s Emergency Plan for AIDS relief.

    In these circumstances, CDER will endeavor to complete the ANDA review process within 6 months.

    RELATED READING:

    NOTE:  thanks to Kurt Karst for passing along this news.

  • Mylan Wins Motion to Dismiss One of Two Patents-in-Suit in Norvasc Case Against Pfizer

    Mylan Laboratories announced today that the U.S. District Court for the Western District of Pennsylvania has granted its motion to dismiss U.S. Patent No. 4,572,909 from its case against Pfizer concerning Mylan’s ANDA for generic Norvasc (amlodipine besylate).  Pfizer’s U.S. Patent No. 4,879,303 is still in the case.  According to Mylan’s press release, the court decision has "far-reaching implications for the generic drug industry."

    The district court granted Mylan’s motion to dismiss simply because the ‘909 patent had expired, and therefore the court lacked subject matter jurisdiction to decide whether the ‘909 patent was valid and infringed.  Pfizer wanted the court to keep the ‘909 patent in the case as a sort of insurance policy in case the ‘303 patent, which does not expire until March, 2007, is held invalid or unenforceable at trial.  A bench trial in the case is scheduled to begin on November 28th.

    How an expired patent could be valuable to Pfizer is a bit complicated.  Although the ‘909 expired on July 31, 2006, Pfizer is entitled to 6 mos. of pediatric exclusivity on the patent, essentially extending the life of the patent to January 31, 2007.  Mylan has received final approval to market its generic version of Norvasc (Pfizer’s 30-month stay has expired), but Mylan has not yet launched its product.  Pfizer believed that if the court were to find the ‘909 patent valid and infringed, then the FDA would revoke Mylan’s final approval, changing Mylan’s ANDA status back to tentative approval until the pediatric exclusivity on the ‘909 patent ran out at the end of next January.

    Based on its two previous victories on the ‘303 patent (which we reported in this post last month), Pfizer still appears to be in a good position.  If Pfizer wins the upcoming trial, it would hold onto its exclusive rights to market Norvasc through September, 2007, when Pfizer’s pediatric exclusivity on the ‘303 patent will expire.  It would be another big win for Pfizer, since Norvasc has annual sales of $2.7 billion in the U.S.

    RELATED READING:

  • S.D.N.Y. Dismisses Oxycontin Patent Case Between Purdue Pharma and Teva

    The U.S. District Court for the Southern District of New York issued an Order earlier this week dismissing the patent case Purdue Pharma brought against Teva to protect Oxycontin from generic competition.  Oxycontin, a controlled-release formulation of oxycodone, is a widely-prescribed pain killer with annual sales of $2 billion.  The court dismissed the case because of a settlement agreement reached by the parties in August.  Under the terms of the settlement, Teva will stop selling generic oxycodone no later than March 31, 2007 and Purdue will not pursue damages against Teva for past infringement.

    Last February, in a related case that Purdue brought against Endo Pharmaceuticals, the Court of Appeals for the Federal Circuit reversed a district court finding that Purdue's patents were procured through inequitable conduct, and remanded the case.  In an August 28th post, we reported that Purdue and Endo settled that litigation, with Endo agreeing to stop selling generic oxycontin by the end of this year and Purdue agreeing not to pursue damages for Endo's past infringement.

    Purdue is still fighting Impax Labs over generic oxycodone sold by Impax's Global Pharmaceuticals division.  That litigation is pending in the S.D.N.Y.  The patents-in-suit are U.S. Patent Nos. 5,656,295; 5,266,331; and 5,508,042.  The last of these patents will not expire until 2013.

    Meanwhile, Watson Pharmaceuticals is continuing to sell an authorized generic version of oxycodone.

    RELATED READING:

  • Janssen Wins Trial Verdict in Risperdal Case Against Mylan and Dr. Reddy’s

    Janssen Pharmaceutica, a division of Johnson & Johnson, won its patent infringement case against Mylan and Dr. Reddy’s over generic Risperdal (risperidone), an antipsychotic medication with worldwide sales of $3 billion annually.  Judge John C. Liflind of the U.S. District Court for the District of New Jersey held a four-day bench trial in June, and decided the case last week.

    Judge Lifland’s 79-page Opinion (part 1; part 2) held that Janssen’s U.S. Patent No. 4,804,663 is not invalid as obvious.  Mylan and Dr. Reddy’s argued that the invention in the ‘663 patent, the claims of which cover both risperidone and "compound 11" (in Markush group form), would have been obvious.  More specifically, the defendants argued that the claimed invention would have been obvious because compound 11 (though not risperidone) would have been obvious in view of the drug pirenperone, which is covered by U.S. Patent No. 4,342,870.  The compounds are structurally similar:  where risperidone has a ketone group, pirenperone has a benzisoxazole group.

    Judge Lifland summarized the defendants’ obviousness argument as follows:

    First, Defendants claim that pirenperone would have been chosen as a lead compound by one looking for an antipsychotic with minimal side effects, including EPS, because it possessed indicators of those properties.  Second, Defendants claim that once pirenperone was chosen, it would have been obvious to the person of ordinary skill in 1985 that its only problem was that it had a short half-life, and thus had to be administered to patients three times per day, which was a problem for schizophrenics.  Third, given the prior art, Mylan and DRL believe it then would have been obvious that pirenperone’s ketone group was responsible for this durational problem.  Fourth, it then would have been obvious, Defendants assert, to the person of ordinary skill that the solution to this problem was to convert the ketone group to benzisoxazole, and that this change would permit the compound to retain its desired antipsychotic activity with low side effects.

    The court found that the defendants failed to prove that any one of those steps would have been obvious.  In particular, Judge Lifland found that one of ordinary skill in the art would not have chosen pirenperone as the lead compound because there was no teaching, suggestion, or motivation to do so.  In fact, the court found evidence that defendants’ experts admitted to using hindsight when they testified that pirenperone would have been selected as the lead compound.

    Mylan (but not Dr. Reddy’s) also argued that the ‘663 patent is unenforceable due to inequitable conduct, but that argument failed as well.  The court found that Mylan failed to prove both materiality and intent to deceive.

    Judge Lifland’s Order enjoins Mylan and Dr. Reddy’s from marketing their generic versions of Risperdal until the ‘663 patent expires, on December 29, 2007.

    RELATED READING:

  • Pharmaceutical Patent Litigation News In Brief

    There’s been a lot of news lately in pharmaceutical patent cases.  Summaries are below.  I’ve updated the Hatch-Waxman Tracker to include the new lawsuits.

    New lawsuits filed:

    • Biovail Laboratories filed a new lawsuit against Andrx Pharmaceuticals over Andrx’s attempt to market generic Cardizem.
    • Novartis sued Par Pharmaceuticals, the third and most recent company to file an ANDA for generic Lotrel.
    • Schering-Plough sued over a dozen companies who filed ANDA’s to market generic versions of Clarinex.

    New settlements reached:

    • Alza Corp., a subsidiary of Johnson & Johnson, dropped its lawsuit against Impax relating to Impax’s ANDA to market a generic version of Concerta.  Concerta, a treatment for Attention Deficit Disorder (ADD), had sales of $846 million last year.  Alza had also sued Andrx over its own ANDA, but the Stipulated Order dismissing the suit did not mention the case against Andrx.  Source:  Impax press release.
    • Solvay Pharmaceuticals settled patent litigation with generic drug makers Par Pharmaceutical Cos. and Watson Pharmaceuticals Inc. over Solvay’s AndroGel drug product.  AndroGel, a treatment for testosterone deficiency, had sales of $225 million in 2002.  Watson, the first ANDA filer, will be allowed to begin marketing its generic product no later than August 31, 2015, which is five years before Solvay’s patent on AndroGel expires.  Par will co-promote AndroGel for $10 million a year beginning in 2006 and will.be allowed to launch its generic product no later than February 28, 2016.  Source:  Solvay press release.
    • GlaxoSmithKline and Dr. Reddy’s settled their litigation over generic Imitrex, with the parties agreeing that Dr. Reddy’s will sell an authorized generic version of Imitrex in late 2008, before GSK’s patents on Imitrex expire in February, 2009.  Imitrex, a medication to treat headaches, had sales of $890 million last year.  Source:  MarketWatch article.

    New court decisions:

    • Eisai won summary judgment of patent validity in its lawsuit against Teva and Dr. Reddy’s over generic Aciphex (rabeprazole).  Aciphex is a proton-pump inhibitor indicated for the treatment of ulcers, and had sales of $1.2 billion last year.  The opinion by Judge Gerard E. Lynch of the Southern District of New York states that the claims of Eisai’s U.S. Patent No. 5,045,552, would not have been obvious because there was no teaching, suggestion, or motivation to combine three prior art references.  Some observers believe the “suggestion test” will be discarded by the Supreme Court in KSR v. Teleflex, currently pending before it, which would affect this case.  Source:  Eisai press release.

    As always, please e-mail me with any new information to add to the Hatch-Waxman Tracker.

  • Reminder: Maximizing Pharmaceutical Patent Life Cycles Conference, Oct. 23-24 in NYC

    ACI’s 7th annual Maximizing Pharmaceutical Patent Life Cycles conference will take place October 23-24, 2006, at the Helmsley Park Lane hotel in New York City.

    This should be an excellent meeting, with the following presentations:

    • Striking a Balance: Reconciling the Needs and Interests of Brand Name and Generic Pharmaceutical Companies With Public Policy
    • From Product Development to Patent Portfolio Management to Patent Life Cycles: Strategies for a Post-MMA World
    • Legislative and Regulatory Update: Of Patents and Politics
    • Pharmaceutical Patent Extensions and Hatch-Waxman Reform: Observations and Considerations Relative to Patent Term Adjustment and Patent Term Restoration
    • ANDA/Paragraph IV Litigation: New Challenges and New Findings
    • Update on FDA Activities Relative to Pharmaceutical Patent Life Cycles (Keynote Address)
    • Re-exploring Orange Book Listing and De-listing Strategies
    • Exclusivity: Patent and Non-Patent–Traditional Modes
    • Present Controversies and Uncertainties in Market Exclusivity
    • Brand Name/Generic Pharmaceutical Patent Settlements Revisited
    • FTC Initiatives to Promote Competition in the Pharmaceutical Industry (Keynote Address)
    • The Safe Harbor: Post-Integra
    • Eye on the Supreme Court: Key Patent Cases before the Supreme Court and Their Impact on Pharmaceutical Patent Life Cycles
    • Pharmaceutical Patent Developments in the EU, India and China: Implications for Pharmaceutical Patent Life Cycles in the US

    Keynote addresses will be given by Elizabeth Dickinson, Assoc. Chief Counsel for Drugs at the FDA, and Suzanne T. Michel, Chief Counsel for Intellectual Property at the FTC.  In addition, an optional third day, on October 25th, includes workshops on new strategies for obtaining pharmaceutical patent extensions and updated drafting guidelines for paragraph IV certifications and notice letters.

    For more information, visit the conference website.  I’ll be attending the meeting; if you’ll be there too, please introduce yourself!

  • Supreme Court Denies Review of Apotex v. Pfizer

    Via SCOTUSblog, the Supreme Court today denied review of Apotex v. Pfizer, in which Apotex had asked the Court to consider whether listing patents in the Orange Book creates a justiciable controversy, thereby allowing a generic drug company to file a declaratory judgment action for noninfringement or invalidity.

    Last May, the Court asked the Solicitor General for his views on whether the Court should grant certiorari in the case, just as the Court has often done in recent patent cases.  However, the Solicitor General’s office had not yet filed its brief when the Court denied review of the case today.

    Moreover, the Court denied Apotex’s cert petition without ruling on Pfizer’s recent motion arguing that the case had become moot.  Pfizer argued that the case was moot because Teva had begun selling a generic version of Zoloft, the drug involved in the dispute.

    Because the Court denied Apotex’s petition, the Federal Circuit ruling stands:  merely listing patent information in the Orange Book does not create a justiciable controversy.

    RELATED READING:

  • Sens. Kohl and Leahy Introduce Bill to Prevent Abuse of Citizen Petition Process

    Continuing their collaboration on new laws relating to pharmaceuticals, Senators Herbert Kohl (D-WI) and Patrick Leahy (D-VT) recently introduced legislation to stop perceived abuses of the FDA’s citizen petition procedure that result in delaying approval of generic drugs.  The bill is entitled the Citizen Petition Fairness & Accuracy Act of 2006.

    According to Sen. Leahy’s press release announcing the new bill:

    Of the 21 citizen petitions reviewed and ruled upon by the FDA since 2003, 20 have been found to be without merit.  Of these, ten were identified as “eleventh hour petitions” — those filed less than 6 months prior to the estimated entry date of the generic drug – and none were found to have merit.

    If enacted, the new law would allow the Dept. of Health and Human Services (HHS) to sanction companies "who file citizen petitions simply to keep competition off the market."  Possible sanctions include a fine, a suspension or revocation of the right to file future citizen petitions, and a dismissal of the petition.  The bill also requires HHS to review citizen petitions within six months of filing.

    Click here to read the complete text of the proposed bill.

    NOTE:  thanks to Kurt Karst for alerting me to this proposal.

  • FDA Announces Improvements to ANDA Review Process

    The FDA announced last Friday that it recently began using the Division File System (DFS) for reviewing and archiving Abbreviated New Drug Applications electronically.  According to the FDA’s press release:

    This system will now allow electronic archiving of ANDA documents for better tracking and search capabilities.  It will also enable reviews to become part of the official electronic record for a specific generic drug application.  DFS is also a mechanism for OGD and OND to have access to reviews completed in either Office, thus allowing full access to all available information on approved drug products.

    FDA has been using DFS for New Drug Applications since October, 2000.

  • Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill

    Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday.  If enacted, the legislation would establish an abbreviated application process for biological products.

    According to the proposed bill, a generic biological product is “comparable,” and therefore approvable in an abbreviated application “if there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product, based on non-clinical studies and clinical studies, as necessary.”

    This page on Rep. Waxman’s website includes a press release, background on biologics, a quick summary, a bill summary, the text of the bill, and letters of support.

    RELATED READING:

    NOTE:  thanks to Kurt Karst for sending me the link to this material.