Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • Alza Loses Appeal of Ditropan XL Case to Mylan

    The Court of Appeals for the Federal Circuit recently affirmed a lower court’s determination that Alza’s patent on Ditropan XL, a controlled-release formulation of oxybutinin, is invalid due to obviousness.  Ditropan XL is a treatment for incontinence, with annual sales of $380 million.

    In the opinion, written by Judge Gajarsa, a unanimous panel of the Federal Circuit concluded that the controlled-release formulation of oxybutinin claimed in Alza’s U.S. Patent No. 6,124,355 would have been obvious.  Alza argued that one of ordinary skill in the art would not have believed that oxybutinin could be absorbed in the colon, and therefore would not have believed that a controlled-release formulation would have been effective, and therefore there was no motivation to make the claimed oxybutinin formulation.  The court rejected Alza’s argument based on Mylan’s expert testimony.

    The Federal Circuit used this case, like it has used other recent cases, to defend its "teaching, suggestion, motivation" test of obviousness, which is under assault in the KSR v. Teleflex case currently pending before the Supreme Court.  The Federal Circuit stated:

    As an initial matter, it is essential to recognize that, as we have explained above, under our non-rigid "motivation-suggesting-teaching" test, a suggestion to combine need not be found in the prior art.  . . .  Accordingly, where the testimony of an expert witness is relevant to determining the knowledge that a person of ordinary skill in the art would have possessed at a given time, this is one kind of evidence that is pertinent to our evaluation of a prima facie case of obviousness.

    The district court decision, written by Judge Irene M. Keeley of the U.S. District Court for the Northern District of West Virginia, found that Alza’s patent was both invalid and not infringed by Mylan.  Because the Federal Circuit affirmed the obviousness finding, it did not address the infringement issue.

    RELATED READING:

  • Pfizer’s Patent on Norvasc Survives Challenge by Synthon

    The U.S. District Court for the Middle District of North Carolina recently found Pfizer’s patent on the active ingredient of Norvasc, amlodipine besylate, valid and infringed by Synthon’s generic equivalent.  Norvasc, a treatment for hypertension, has annual sales of nearly $5 billion.

    In the opinion, Judge James A. Beaty, Jr. concluded that Pfizer’s U.S. Patent No. 4,879,303 was not invalid for obviousness, lack of written description, or double patenting.  According to Pfizer’s press release announcing the court decision, in January the U.S. District Court for the Northern District of Illinois found the same patent valid and infringed by Apotex.

    As reported in Orange Book Blog last month, the U.S. District Court for the Eastern District of Virginia recently found that Pfizer did not infringe Synthon’s patent on a process for making amlipodine.

  • ABA Section of Antitrust Law Presents Discussion of Authorized Generics

    The ABA Section of Antitrust Law presented a short, but very informative and interesting, teleconference on authorized generics today.  The speakers were Seth Silbert of Wilson Sonsini, Tim Gilbert of Gilbert’s LLP, and Jerry Swindell of Johnson & Johnson.  Mr. Silbert presented an introduction to the topic, Mr. Gilbert presented the generic drug industry’s perspective, and Mr. Swindell presented the perspective of the brand drug industry.  In case you missed it, the ABA should be making an audio file of the teleconference available here.  Additionally, links to the PowerPoint presentations are provided below.

    LINKS:

  • Astra Zeneca Lists Device Patents In Orange Book

    AstraZeneca recently filed a Request for Advisory Opinion with the FDA, asking for a determination "whether patents on drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formation," should be listed in the Orange Book.  GlaxoSmithKline submitted a request to the FDA in January, 2005, asking the very same question, which AstraZeneca attached to its filing.

    Interestingly, AstraZeneca reveals toward the end of its request, "Because AstraZeneca believes that such patents should be listed, AstraZeneca will continue to list them unless it receives guidance from  FDA that such listings are improper."  Of course, Orange Book listing is a predicate to a 30-month stay of FDA approval of any generic equivalents, as well as to 6-month marketing exclusivity after any successful generic patent challenge.

    NOTE:  Thanks very much to Kurt Karst for bringing this FDA filing to my attention.

  • Authorized Generics Brown Bag Lunch, Sept. 14

    Via the Antitrust Review, three ABA committees will be presenting a lunch seminar entitled "Who’s Drug is it Anyway?  Authorized Generics, Their Role in the Pharmaceutical Marketplace, and the FTC Study" on Thursday, September 14 from noon to 1:30 pm EST.  You may attend the seminar in person at Drinker Biddle & Reath’s Washington D.C. office, or you may call in by phone.  Additionally, an .mp3 audio recording of the program will be posted at http://www.abanet.org/anitrust/at-bb/bb-audio.shtml.  More details are here.

  • Lipitor Worldwide Patent Infrinement Litigation Update

    Ranbaxy announced in a press release yesterday that it won a court decision in Norway that Ranbaxy does not infringe two of Pfizer’s Norwegian patents on Lipitor.  Pfizer responded with its own press release, announcing that the ruling "has no practical effect on Pfizer’s ability to protect Lipitor" from generic competition in Norway because a different Norwegian Lipitor patent was held valid and infringed last year.  Lipitor is the world’s best-selling drug, with $12.2 billion in sales last year.

    Earlier this month, the U.S. Court of Appeals for the Federal Circuit partially reversed a district court decision that held two Pfizer patents on Lipitor valid and infringed.  The CAFC upheld the ruling as to one of Pfizer’s patents, but reversed as to the other, finding a dependent claim of the second patent invalid due to incorrect claim structure.  Pfizer has indicated that it is seeking a reissue of that second patent to correct the claim defect.  If the CAFC’s ruling holds up and Pfizer fails in its bid for a reissue patent, generic Lipitor could be launched on the U.S. market in March 2010 rather than June 2011.

    MarketWatch.com has a nice article summarizing the state of the Lipitor patent infringement cases between Pfizer and Ranbaxy worldwide.

    UPDATE:

    • Pfizer announced on Sept. 13 that a court in the Netherlands upheld Pfizer’s basic patent on atorvastatin (the active ingredient in Lipitor) and ruled that it would be infringed by Ranbaxy’s generic atorvastatin.  According to Pfizer, the patent will not expire until November, 2011.

  • Purdue and Endo Settle Oxycontin Patent Case

    Endo Pharmaceuticals announced today that it has reached an agreement with The Purdue Frederick Company settling a long-standing patent infringement case concerning Endo's generic equivalent to Oxycontin, sold by Purdue.

    The case was on remand to the district court after the Federal Circuit ruled in February that further fact finding was required to balance the evidence of materiality and intent in determining whether Purdue engaged in inequitable conduct in procuring its Oxycontin patents.  The Federal Circuit's February ruling came on a petition for rehearing filed by Purdue, and vacated the court's June 2005 ruling, which upheld the district court's finding of inequitable conduct.

    According to Endo's press release, Endo will continue selling its generic Oxycontin until December 31, 2006.  Endo did not state whether any sales after that date would be permitted.  Endo had launched its generic version in June 2005 in light of the CAFC's decision that month.

    The settlement agreement has been submitted for review to the Federal Trade Commission and the Antitrust Division of the Department of Justice, as required by statute.

  • Biovail Sues FDA to Force Decision on Wellbutrin XL Citizen Petition

    Biovail Corporation (Canada) filed suit yesterday in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration.  Biovail's complaint and motion for a temporary restraining order and preliminary injunction request the court to compel FDA action on Biovail's citizen petition submitted in December 2005 relating to the criteria used in evaluating generic applications for Wellbutrin XL.  Biovail further requested that the court order the FDA to rule on its citizen petition at least one week prior to any FDA approval of generic Wellbutrin XL.

    Wellbutrin XL is an extended release version of the popular Wellbutrin (bupropion hydrochloride) antidepressant that is manufactured by Biovail Corporation for GlaxoSmithKline.  GSK faces suit for alleged antitrust violations related to Wellbutrin SR, a different sustained release version of bupropion hydrochloride, as previously reported in Orange Book Blog.

    Biovail's complaint alleges that the FDA has failed to rule on generic bioequivalence issues raised in its citizen petition within the required 180 day period, and that those issues are of critical importance given bupropion's association with dose-related risk of seizures that can be life-threatening.  Biovail further alleges that FDA routinely refuses to decide citizen petitions within the required 180 days when the petitions relate to specific criteria for reviewing proposed generic versions of prescription drugs, and instead withholds its decisions on such petitions until after it approves the generic version.  Biovail argues that this FDA practice deprives the courts of the opportunity to timely review FDA decisions on citizen petitions, potentially leading to consumer exposure to unsafe generic drugs.

    In a related action, Biovail filed suit in December 2004 in the U.S. District Court for the Central District of California against Anchen Pharmaceuticals (Irvine, CA), the first Paragraph IV generic filer for Wellbutrin XL.  The district court in that case ruled in favor of Anchen on summary judgment on August 2, 2006, holding that Anchen did not infringe Biovail's patents.  Since Anchen received tentative FDA approval for generic Wellbutrin XL on November 14, 2005, Biovail and GSK are concerned that Anchen may soon launch a generic version of Wellbutrin XL.

    RELATED READING:

  • Pfizer Victorious in Norvasc Case Against Synthon IP

    Pfizer announced in a recent press release that a jury in the Eastern District of Virginia has found that Pfizer does not infringe Synthon IP’s patent on a process for making amlodipine, the active ingredient in Norvasc.  The jury also found Synthon’s patent invalid.  Norvasc, a treatment for hypertension, is Pfizer’s second largest selling product after Lipitor, with $4.7 billion in annual sales.

    The patents-in-suit were U.S. Patent Nos. 6,653,481 (process patent) and 6,858,738 (compound patent; a divisional of the ‘481).  The court construed the claims of these patents in a June 30 Markman ruling.

    According to Pfizer’s press release, Pfizer not only published its process for making amlodipine, but Pfizer has been using that process for the last 15 years.

  • New Paper on Authorized Generics by Prof. Jay Thomas

    Prof. Jay Thomas recently wrote a new paper entitled "Authorized Generic Pharmaceuticals: Effects on Innovation".  The paper was publised by Congressional Research Service, of the Library of Congress.

    Prof. Thomas’s new paper provides a very nice, concise summary of the authorized generics issue.  After going through the basics of Hatch Waxman and how the practice of authorized generics was born, the paper discusses two recent working papers that offered differing views of the effects of authorized generics.  Finally, the paper addresses where the practice of authorized generics may be heading in the future.

    Thanks to a helpful reader for sending me a copy of the new paper!