By Donald Zuhn --
Reflecting upon the events of the past twelve months, Patent Docs presents its second annual list of top biotech/pharma stories. For 2008, we identified a baker's dozen of top stories covered on Patent Docs. Today we will count down stories #13 to #10. On Sunday, we will present stories #9 to #6, and on Monday, we will count down the top five stories. As with last year's list, links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.
#13 -- Pharma Patent Injunctions in View of Amgen v. F. Hoffmann-La Roche
In the fall of 2007, a jury returned verdicts in Amgen Inc. v. F. Hoffmann-La Roche Ltd., finding five of Amgen's patents not invalid and three of these patents infringed by Roche's Mircera®, a form of recombinant EPO that has been covalently linked to polyethylene glycol. The District Court for the District of Massachusetts entered a preliminary injunction in February preventing Roche from putting Mircera® on the market. In granting the injunction, the Court found that Amgen had satisfied all but the public interest prong of the classic four-factor test discussed in eBay Inc. v. MercExchange, L.L.C. The District Court struggled with the public interest prong of the test, in view of Roche's argument that the public interest was served, at least in part, by the presumed reduced price that would ensue from competition between Mircera® and Amgen's Epogen® and Aranesp® products. The Court, expressly refraining from entering any findings on the fourth prong, left open the possibility that the injunction could be modified under a handful of conditions. Roche agreed to the Court's conditions, but Amgen did not, and the Court subsequently appointed a special master to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared. Roche responded to the Court's appointment of the special master by filing a Notice of Appeal. On October 2nd, the Court issued a 150-page opinion in the case, handing victory to Amgen, and eight days later, the Federal Circuit affirmed the preliminary injunction without opinion.
For information regarding this and other related topics, please see:
• "Amgen v. Hoffmann-LaRoche: Remaining Issues," October 13, 2008
• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision - Part III," October 9, 2008
• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "How to Avoid a Permanent Injunction: The Lessons of Amgen v. Hoffmann-LaRoche," April 28, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
#12 -- International Enforcement of Drug Patents
Last year, drug pricing and compulsory licensing in the developing world took the #10 spot on our list of top stories. The fact that this story dropped two places on this year's list should not, however, be taken to mean that developing countries and the pharmaceutical industry have reached accord regarding this issue. For example, in February, Novartis responded to Thailand's threats to issue a compulsory license by agreeing to supply its cancer drug Gleevac® (imatinib mesylate) at no cost to Thai patients -- provided that the Thai gvernment did not issue any compulsory licenses. One month later, Thailand instead announced that it would maintain its compulsory licensing policy for Gleevac® as well as three other anti-cancer drugs (Novartis' Letrozole®, Sanofi-Aventis' Docetaxel®, and Roche's Erlotinib®). The use by developing countries of tools provided in international agreements such as GATT, TRIPS, and the Doha Declaration (e.g., compulsory licensing and parallel importing) will no doubt continue to be a hotly debated in 2009.
For information regarding this and other related topics, please see:
• "Recent Developments in Pharmaceutical Patenting and Compulsory Licensing of Pharmaceutical Patents in Developing Countries," July 8, 2008
• "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008
• "Thailand Continues Its Compulsory Licensing Practices," March 11, 2008
• "Indian Generic Drug Maker Seeks to Invalidate Cancer Drug Patent," February 29, 2008
• "Novartis to Supply Cancer Drug to Thai Patients," February 5, 2008
#11 -- Greater Cooperation between Patent Offices
When your backlog of unexamined applications rises from 760,924 to 771,529, as it did for the USPTO in 2008, you should be searching for all reasonable ways to reduce that backlog. Last year, the USPTO attempted to address its application backlog by focusing on the development of a number of worksharing programs with foreign patent offices. In particular, the USPTO expanded its Patent Prosecution Highway (PPH) program to include pilots with the Canadian Intellectual Property Office (CIPO), Korean Intellectual Property Office (KIPO), IP Australia (IPAU), European Patent Office (EP), and Danish Patent and Trademark Office (DKPTO); extended its PPH pilot program with the CIPO; entered into an agreement with IPAU, in which the IPAU will act as an International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) for certain International applications filed with the USPTO Receiving Office; added the KIPO as a participating foreign patent office in the Priority Document Exchange (PDX) system; initiated the "Triway" worksharing program between the USPTO, EPO, and JPO; initiated the "New Route" worksharing program with the JPO; announced a new worksharing initiative with the KIPO, EPO, JPO, and State Intellectual Property Office of the People's Republic of China (SIPO); and released information about a Common Application Format (CAF) that arose out of an agreement between the USPTO, EPO, and JPO at the 25th Annual Trilateral Conference.
For information regarding this topic, please see:
• "Patent Prosecution Highway Pilot with CIPO Is Extended," December 23, 2008
• "Additional Application Types Eligible for Participation in PPH Between USPTO and EPO," December 11, 2008
• "'Blueprint' Announced for Work Sharing Initiative Between Five IP Offices," November 6, 2008
• "IP Australia Now Competent ISA for PCT Applications Received by USPTO," November 3, 2008
• "Patent Prosecution Highway Pilot Program Between U.S. and Danish Patent Offices," October 29, 2008
• "KIPO Becomes Participating Foreign Office in PDX Program," October 21, 2008
• "Online Priority Document Exchange Service Between USPTO and KIPO," October 9, 2008
• "USPTO and JPO Sign Statement of Enhanced Mutual Cooperation," September 29, 2008
• "IP Australia to Provide International Search and Examination Services for Certain PCT Applications," September 29, 2008
• "Patent Prosecution Highway Expands to Europe," September 25, 2008
• "USPTO and KIPO Sign Memoradum on Cooperative Patent Examination," September 24, 2008
• "USPTO and UKIPO Extend Patent Prosecution Highway Pilot Program," September 3, 2008
• "PTO Announces 'Triway' Pilot Program," July 15, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "USPTO and EPO to Implement Pilot Patent Prosecution Highway Program," April 29, 2008
• "Patent Office Announces Common Application Format," April 28, 2008
• "Patent Prosecution Highway Extended to IP Australia," April 2, 2008
• "Patent Prosecution Highway Network Expands to Canada & Korea," January 29, 2008
• "'New Route' Created between USPTO and JPO," January 25, 2008
• "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program," January 17, 2008
#10 -- USPTO's PTA Calculations Called into Question
On September 30th, the District Court for the District of Columbia issued a decision in Wyeth v. Dudas that could eventually impact the manner in which Patent Term Adjustment (PTA) determinations are made. In particular, the Court granted summary judgment in favor of Wyeth, determining that the USPTO had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled. Less than a month later, USPTO Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia, appealing the Court's decision in Wyeth to the United States Court of Appeals for the District of Columbia Circuit, thus indicating how the Office would rule on requests for reconsideration being filed by patentees that had been similarly deprived of patent term. Having no other recourse under 35 U.S.C. § 154(b)(4)(A), which requires patentees to file actions seeking corrected PTA determinations within 180 days of a patent's issuance, Napo Pharmaceuticals, Inc.; Ironwood Pharmaceuticals, Inc.; Solvay Pharmaceuticals GmbH; Biogen Idec Inc.; Purac Biochem B.V.; and Molecular Insight Pharmaceuticals, Inc. all followed Wyeth's lead by filing lawsuits against Director Dudas this fall.
For information regarding this topic, please see:
• "More Patentees Follow Wyeth's Lead in Seeking Additional PTA," December 3, 2008
• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
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