By Donald Zuhn --
Reflecting upon the events of the past twelve months, Patent Docs presents its fourth annual list of top biotech/pharma patent stories. For 2010, we identified a dozen stories that we covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. Yesterday, we counted down stories #12 to #9, and today we cover stories #8 to #5. Later this week, we will present our top four stories of 2010. As with our other lists (2009, 2008, and 2007), 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 anything we included, please let us know.
#8 -- Change Comes to Europe Patent Practice
For longtime patent practitioners, October 1, 2010 may have recalled June 7, 1995; the latter date marked the deadline for filing US applications that could secure a patent term of 17 years from grant under the Uruguay Round Agreements Act, and the former constituted the deadline for filing EP divisional applications in which a first communication or unity of invention objection had been issued more than two years prior to the October 1 deadline. While the EPO announced this major rule change in 2009 (see "Changes Coming to Divisional Application Practice in Europe"), the impact of the rule was obviously felt in 2010. Other important changes in Europe included the prohibition of Swiss-style claiming ("the use of compound X for the manufacture of a medicament for treating of disease Y"), and the modification of the requirements for supplying search results on priority applications. Aside from the above rules changes, Europe also continued to move toward some type of unified patent system that would create a single EU patent.
For information regarding this and other related topics, please see:
• "Several EU Members Push for Unified Patent System," December 30, 2010
• "EPO Prepares to Roll out New Prior Art Search Disclosure Rules," November 1, 2010
• "Swiss-type Claims Are No Longer Acceptable at the EPO," March 3, 2010
• "Europe Takes Step Closer to Single EU Patent and Patent Court," February 24, 2010
#7 -- Federal Circuit Finds Separate Written Description Requirement
In March, the Federal Circuit sitting en banc in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. determined that there is a separate written description requirement in 35 U.S.C. § 112, first paragraph. The opinion of the en banc Court was written by Judge Lourie, who authored the Federal Circuit's landmark decision in Regents of the University of California v. Eli Lilly & Co. While current Chief Judge Rader and Judge Linn each wrote dissenting-in-part opinions, then Chief Judge Michel and Judges Newman, Mayer, Bryson, Gajarsa, Dyk, Prost, and Moore joined Judge Lourie in finding a separate written description requirement.
For information regarding this topic, please see:
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (Fed. Cir. 2010) (en banc)," March 22, 2010
#6 -- Federal Circuit Reviews Inequitable Conduct Case En Banc
Having dispatched with written description in Ariad v. Lilly, the Federal Circuit turned its attention to the issue of inequitable conduct, deciding that the appeal in Therasense, Inc. v. Becton, Dickinson & Co. warranted en banc consideration. The Court asked the parties to address ten questions involving the materiality and intent standards and materiality-intent-balancing framework for resolving inequitable conduct claims. As with Ariad v. Lilly, Patent Docs provided extensive coverage of the briefs filed by the parties and various amici in Therasense (see links below). Oral argument in the case took place on November 9, and practitioners now await the Court's decision.
For information regarding this and other related topics, please see:
• "Abbott Files Reply Brief in Therasense Case," November 8, 2010
• "Appellees File Reply Brief in Therasense v. Becton Dickinson," October 27, 2010
• "Bayer Submits Brief in Therasense v. Becton Dickinson," October 20, 2010
• "PhRMA Files Amicus Brief in Therasense Case," August 22, 2010
• "PTO Files Amicus Brief in Therasense Case," August 19, 2010
• "American Bar Association Files Amicus Brief in Therasense Case," August 17, 2010
• "Therasense, Inc. v. Becton, Dickinson & Co. -- Briefing Schedule Update," August 8, 2010
• "BIO Files Amicus Brief in Therasense Case," August 8, 2010
• "Pharma and Software Companies File Joint Amicus Brief in Therasense Case," August 3, 2010
• "IPO Files Amicus Brief in Therasense Case," August 2, 2010
• "Abbott Files Brief in Therasense Case," July 28, 2010
• "CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal," June 9, 2010
• "Therasense, Inc. v. Becton, Dickinson & Co. -- Briefing Schedule Update," May 16, 2010
• "Therasense, Inc. v. Becton, Dickinson & Co. Briefing," May 13, 2010
• "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010
#5 -- Federal Circuit Affirms District Court in Wyeth PTA Case
Coming on the heels of the Federal Circuit's March 2009 decision in Tafas v. Doll, the Federal Circuit's decision ten months later in Wyeth v. Kappos was somewhat unexpected. In contrast with Tafas, the Federal Circuit in Wyeth affirmed a determination by the District Court that the U.S. Patent and Trademark Office had misconstrued a portion of the Patent Act (35 U.S.C. § 154(b)(2)(A)), and as a result, had denied Wyeth a portion of the patent term to which it was entitled. In response to the Federal Circuit's decision, the USPTO announced that it was changing the manner in which it calculates Patent Term Adjustment (PTA) to conform with the Federal Circuit's decision (i.e., applicants would no longer receive only the greater of an application's A-delay or B-delay, but rather would receive the sum of A-delay and B-delay less any overlapping A- and B-delay). Less than two weeks after the Federal Circuit's decision, the USPTO and Department of Justice announced that they would not be seeking further review of the case. The USPTO subsequently implemented an interim procedure by which patentees could request PTA recalculations while the Office revised its procedures to comply with Wyeth. Unfortunately, the interim procedure only applied to patents issued after August 1, 2009 and before March 2, 2010 (when the Office expected to complete the software modification necessary to comply with the decision). However, as Wyeth led the way with its challenge to the Office's original interpretation of § 154(b)(2)(A), Novartis has since challenged the Office's PTA calculations for ten patents that issued prior to the August 1, 2009 deadline specified in the Office's interim procedure.
For information regarding this and other related topics, please see:
• "Novartis Challenges USPTO's Interim Procedure for Requesting PTA Recalculations," July 12, 2010
• "USPTO Continues to Modify System for Calculating PTA," May 25, 2010
• "USPTO Announces Interim Procedure for Requesting PTA Recalculations," January 28, 2010
• "USPTO and DOJ Will Not Seek Review of Wyeth v. Kappos," January 21, 2010
• "USPTO Posts Notice Regarding Wyeth Decision," January 11, 2010
• "The Federal Circuit's Wyeth v. Kappos Decision," January 10, 2010
• "Wyeth v. Kappos (Fed. Cir. 2010)," January 7, 2010
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