Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories.  For 2013, we identified fourteen stories that were 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.  On Tuesday and Wednesday, we counted down stories #14 to #7, and today we count down stories #6 to #4 as we work our way towards the top three stories of 2013.  As with our other lists (2012, 2011, 2010, 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.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

6.  Rules of Practice Revised to Implement Patent Law Treaty

Setting aside the significant rules changes that were introduced to implement the final provisions of the Leahy-Smith America Invents Act, there were other important changes to the rules of practice that did not have their basis in the AIA.  For example, in April, the U.S. Patent and Trademark Office issued new USPTO Rules of Professional Conduct, which conform the ethical obligations for representing others before the USPTO to the ABA Model Rules of Professional Conduct, which have been adopted in some form by every state (except California) and the District of Columbia.  Also, in October, the USPTO issued a final rule revising the rules of practice pursuant to title II of the Patent Law Treaties Implementation Act of 2012 (PLTIA), which amends U.S. Patent Law to implement the provisions of the Patent Law Treaty (PLT).  Those rules took effect on December 18.  As a result of U.S. ratification of the PLT and enactment of the PLTIA, the rules of practice were revised to (1) change the filing date requirements for a patent application, (2) allow for the restoration of patent rights via the revival of abandoned applications and acceptance of delayed maintenance fee payments, and (3) permit the restoration of the right of priority to a foreign application or the benefit of a provisional application in a subsequent application filed within two months of the expiration of the twelve-month period for filing the subsequent application.  In response to the changes resulting from the PLT and PLTIA, the Office also revised the patent term adjustment provisions to provide for a reduction of any patent term adjustment if an application is not in condition for examination within eight months of its filing date or date of commencement of national stage in an international application.

For information regarding this and other related topics, please see:

• " USPTO Issues Memo on Changes Pertaining to Patent Law Treaty," December 26, 2013
• " USPTO Issues Final Rule to Implement Patent Law Treaty -- Changes Take Effect December 18," December 16, 2013
• "IPO White Paper Calls for Update to Patent Examination System," September 25, 2013
• "USPTO Proposes Rules Changes to Implement Patent Law Treaty," June 5, 2013
• "USPTO Publishes Final Rule Adopting New Rules of Professional Conduct," April 4, 2013
• "USPTO Extends Comments Deadline, Will Hold Roundtables on RCE Practice," February 11, 2013
• "USPTO News Briefs," February 6, 2013

5.  Supreme Court Decides FTC v. Actavis -- Rule of Reason Analysis Should Be Applied in Reverse Payment Settlement Cases

In June, the Supreme Court ruled in favor of the Federal Trade Commission in FTC v. Actavis, reversing the decision of the Eleventh Circuit Court of Appeals dismissing the FTC's complaint that a "reverse payment" settlement agreement between an innovator drug maker and generic challengers in ANDA litigation was anticompetitive and violated the antitrust laws.  The Court, however, refused to accept the FTC's position that such agreements are presumptively unlawful, holding instead that lower courts should apply an antitrust "rule of reason" analysis when evaluating such agreements.  Shortly after the Supreme Court's decision, the Generic Pharmaceutical Association (GPhA) released a study on the effects of reverse payment settlement agreements in ANDA litigation.  The study indicated that settlements of ANDA litigation for 33 different drug molecules resulted in a savings to consumers of $25.5 billion from 2005-2012, and were projected to provide an additional $61.7 billion through patent expiry for patents listed in the Orange Book for these drugs.  Not satisfied with its victory in Actavis, the FTC filed an amicus curiae brief in August in In re Effexot XR Antitrust Litigation, where the agreement the FTC objected to involves Wyeth committing not to launch a so-called "authorized generic" form of its branded Effexor XR extended-release product and Teva not entering the market with its generic product for two years (but nevertheless entering the market several years before it would otherwise be able to do so).

For information regarding this and other related topics, please see:

• "The FTC Is at It Again," August 22, 2013
• "IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation," July 18, 2013
• "Federal Trade Commission v. Actavis, Inc. (2013)," June 17, 2013
• "Supreme Court Oral Argument in FTC v. Actavis," April 1, 2013
• "Academic White Paper Rebuts FTC and S. 214," March 28, 2013
• "Case Brief: Federal Trade Commission v. Watson Pharmaceuticals," March 25, 2013
• "Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements," March 14, 2013
• "Par/Paddock Answers FTC Before Supreme Court," February 27, 2013
• "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation," January 17, 2013

4.  Federal Circuit Confronts Patent Eligibility of Computer-Implemented Inventions

We stretched a little on our criteria with respect to story #4, which is obviously not a biotech/pharma patent story.  However, the Federal Circuit's difficulty in dealing with the Supreme Court's § 101 jurisprudence in CLS Bank Int'l v. Alice Corp., Ultramercial, Inc. v. Hulu, LLC, and Accenture Global Services, GmbH v. Guidewire Software, Inc. could impact how the Federal Circuit decides future § 101 cases on the biotech/pharma side of the fence.  As we noted in May, the per curiam opinion issued in CLS Bank Int'l may be the most important § 101 jurisprudence since the Supreme Court's Bilski v. Kappos and Mayo v. Prometheus decisions, with a plurality of judges setting forth procedures for determining whether claims that recite an abstract idea or a law of nature meet the requirements of this section.  In December, the Supreme Court granted certiorari in Alice Corp. v. CLS Bank Intl., opening the door once again for the Justices to further carve out the landscape of patent-eligible software and business method claims, and making this a story to watch in 2014.

For information regarding this and other related topics, please see:

• " Supreme Court Grants Cert. in Alice Corp. v. CLS Bank Intl.," December 6, 2013
• "Accenture Global Services, GmbH v. Guidewire Software, Inc. (Fed. Cir. 2013)," September 6, 2013
• "Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2013)," June 27, 2013
• "SAP America, Inc. v. Versata Development Group, Inc. (PTAB 2013)," June 18, 2013
• "The Broader Meanings of the CLS Bank Decision," May 27, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Opinions by Judge Moore, Judge Newman, and Judges Linn and O'Malley," May 21, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Chief Judge Rader's Concurrence-in-part and Dissent-in-part," May 20, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Judge Lourie's Concurrence," May 15, 2013