Orange Book Blog

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:

• 24 August 06 Biovail press release regarding its lawsuit against the FDA
• 02 August 06 BioSpace story on Biovail's lawsuit against Anchen Pharma

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!

Strategic Planning for Growth in the Competitive Generics Marketplace: September 27-29, 2006: Washington, DC

The Institute for International Research (IIR) has announced that its 7th Annual Generic Drugs Summit will be taking place September 27-29 in Washington, D.C.  Orange Book Blog is a media partner of this conference.

According to IIR, the generics industry is currently faced with several unfavorable trends hindering the marketplace and margins are under pressure from the increased competition, cutthroat pricing, growth of brand-name companies' generic subsidiaries and M&A consolidation.  It’s been tough times for generics and the industry has had much to contend with as it prepares for an expected ramp-up in the coming years when an increasing number of brand name drugs are set to lose patents.

With this in mind, IIR's 7th Annual Generic Drugs Summit provides generic drug manufacturers with information about legislative and regulatory updates, recent court decisions and IP and business development strategies, preparing them for the changing market dynamics of the generic drug industry.  In addition to keynote and featured sessions with Congressman Henry Waxman, Wall Street, FTC, two individual tracks on Business Development & Intellectual Property/Legal Issues, the program has expanded this year to offer generic industry professionals three pre-conference workshops with information to equip their teams with ideas and strategies on:

• Strategic API Sourcing in Generic Pharmaceuticals
• Understanding How to Submit Quality ANDAs to Reduce Approval Time
• Strategies for Filing Successful Paragraph IV Certifications

The Generic Drugs Summit is attended annually by over 200+ senior-level professionals representing government, regulatory and legal affairs as well as marketing, sales and business development--making it the leading independent forum for addressing business and legal concerns impacting the generics marketplace.

View the program agenda for event details and speaker line-up.

Maximizing Pharmaceutical Patent Life Cycles Conference October 23-25 in New York City

American Conference Institute has announced that its seventh annual conference on Maximizing Pharmaceutical Patent Life Cycles will be taking place October 23-25, 2006, in New York.

According to ACI, the conference is designed specifically for pharmaceutical patent attorneys, and allows patent practitioners for brand name and generic drug makers to benchmark their companies’ current patent strategies and tactics against competitors in both camps.  ACI has assembled a distinguished faculty of leading in-house pharmaceutical counsel and expert attorneys for both brand names and generics, as well as government representatives who will share their knowledge and give critical insight on such topics as the CAFC’s findings on inequitable conduct, the link between patent life cycle management and patent portfolio management, Orange Book listing and delisting strategies, market exclusivities, the safe harbor, brand-name and generic settlements, and Supreme Court cases affecting pharmaceutical patents.

Other highlights include keynote addresses by the FDA and FTC.  There also will be Master Classes for brand names and generics on:

• New Strategies for Obtaining Pharmaceutical Patent Extensions; and
• Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters

According to ACI, demand for this conference is high and another sell-out is expected; early registrations are recommended.  For more information, visit the conference website.  Orange Book Blog is a media sponsor of this conference.

Apotex Launches Generic Plavix At Risk

Apotex announced today that it has launched its generic version of Plavix.  Earlier this morning, MarketWatch reported that Bristol-Myers Squibb expected Apotex to launch its generic Plavix shortly.  Plavix, a blood thinner, is the second best selling pharmaceutical in the world, with $5.9 billion in annual sales.

Apotex is currently in patent litigation with Bristol-Myers Squibb and sanofi-aventis over its generic Plavix.  By launching its product before that litigation has been decided, Apotex is taking a huge risk that it will win the case.  If it loses, Apotex may be on the hook for billions of dollars in patent infringement damages.

Thanks to David Fischer of The Antitrust Review for alerting me to this news!

RELATED READING:

• Wall Street Journal Online story about Apotex's launch
• related Apotex press releases
• 08-Aug-06 sanofi-aventis press release

Abbott and Teva Settle Patent Litigation Over Biaxin XL

Abbott Laboratories and Teva Pharmaceuticals have settled their Biaxin XL patent infringement litigation in the U.S. District Court for the Northern District of Illinois.  Biaxin XL is an extended release formulation of clarithromycin used to treat bacterial respiratory infections, with over $1 billion in annual sales.

The parties filed a stipulation of dismissal with the District Court on July 31.  Terms of the settlement were not available in published court documents.  However, a spokeman for Teva reportedly stated that pursuant to the settlement agreement, Teva would not sell its generic version of Biaxin XL "at this time," suggesting that Teva plans to do so in the future.

In June, the Federal Circuit vacated the district court's preliminary injunction order and soon after, Teva began selling generic Biaxin XL.  Then, the district court ruled that its preliminary injunction order would remain binding on Teva unless and until a mandate issued from the Federal Circuit vacating the preliminary injunction.  Teva then announced that it would voluntarily pull all of its generic Biaxin XL off the market.  Later, Abbott filed a motion to compel the recall of all of Teva's generic Biaxin XL that Teva had already sold to its customers.

The settlement agreement does not end all disputes over generic Biaxin XL, as litigation against Andrx Pharmaceuticals and Roxane Laboratories remains pending.