By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories.  For 2011, we identified a dozen 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 Monday and Tuesday, we counted down stories #12 to #10 and #9 to #7, and yesterday, we covered stories #6 to #4.  Today, we present the top three stories for 2011.  As with our other lists (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.

3.  Federal Circuit Issues Standards for Establishing Inequitable Conduct Defense

In May, the Federal Circuit delivered its en banc opinion on inequitable conduct in Therasense, Inc. v. Becton, Dickinson & Co.  The majority determined that (a) an omitted reference is a material reference only if "but for" its exclusion, the claim or patent would not have issued; (b) a finding of inequitable conduct requires clear and convincing evidence of a specific intent to deceive by the applicant; (c) a court cannot use a "sliding scale" to find inequitable conduct, i.e., it cannot use a strong showing of materiality to overcome a weak showing of intent; (d) both materiality and intent to deceive must be supported by clear and convincing evidence; and (f) courts should apply equity to ensure that the remedy of unenforceability is not imposed for misconduct that was "immaterial to the issuance of the patent."  The opinion was authored by Chief Judge Rader and joined in full by Judges Newman, Lourie, Linn, Moore, and Reyna.  Judge O'Malley joined in part, and Judge Bryson authored a dissenting opinion and was joined by Judges Gajarsa, Dyk, and Prost.  The dissent differed from the majority with regard to the standard for assessing materiality, arguing that the best measure of a material reference is the one used by the U.S. Patent and Trademark Office and codified as PTO Rule 56 (37 C.F.R. § 1.56).  Shortly after the Federal Circuit handed down its decision in Therasense, the USPTO published a notice in the Federal Register proposing to change the Office's definition of materiality in Rule 56 to be consistent with the materiality standard enunciated in Therasense, and seeking comments regarding the proposed change.

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

• "Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011)," September 15, 2011
• "USPTO Proposes Change in Duty of Disclosure," July 21, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc): Judge O'Malley's Opinion," May 30, 2011
• "USPTO Studying Therasense Decision, Will Issue Guidance Soon," May 26, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc): The Dissenting Opinion," May 26, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc)," May 25, 2011

2.  Federal Circuit Issues Decision in AMP v. USPTO

Two months after giving the patent community some clarity with respect to inequitable conduct, the Federal Circuit issued its decision in Association for Molecular Pathology v. United States Patent and Trademark Office — the Myriad gene patenting case.  The decision, however, was somewhat fractured, with Judge Lourie writing for the majority; Judge Moore authoring a concurring opinion, joining certain parts of the "majority" opinion and for other parts, concurring with the result; and Judge Bryson concurring-in-part and dissenting-in-part.  On the substantive issues, the majority reversed the District Court's finding that "isolated DNA" was not patent-eligible under the "products of nature" "exception," affirmed the District Court on the diagnostic method claims under the Bilski "machine or transformation test," and reversed on the sole screening method claim at issue.  Biotech practitioners and applicants no doubt breathed a sigh of relief as to the Court's finding of patent-eligibility for the composition of matter ("gene") claims.  Following the decision, the Federal Circuit denied petitions for panel rehearing filed by both Plaintiffs/Appellees and Defendants/Appellants.  Last month, counsel for Plaintiffs/Appellees (the American Civil Liberties Union (ACLU) and Public Patent Foundation (PubPat)) filed a petition for certiorari with the Supreme Court, ensuring that the case will likely be on next year's Top Stories list.

While the Federal Circuit was addressing the gene patenting issue in the United States, the Australian Senate was addressing the issue Down Under.  In September, the Legal and Constitutional Affairs Legislation Committee of the Australian Senate issued a recommendation that the Senate not pass The Patent Amendment (Human Genes and Biological Materials) Bill 2010, which would have prevented the patenting of biological materials that are identical or substantially identical to materials as they exist in nature (such as genes and proteins).

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

• "Plaintiffs File Petition for Certiorari in AMP v. USPTO," December 8, 2011
• "News from Abroad: The Gene Patents Debate in Australia — An Update," December 1, 2011
• "Like Two Ships Passing in the Night: U.S. and Europe Consider Patent Eligibility of Biological Materials," November 22, 2011
• "Australian Senate Committee Issues Recommendation on Gene Patenting Bill," October 6, 2011
• "Federal Circuit Denies Petition for Rehearing in AMP v. USPTO," September 18, 2011
• "Federal Circuit Denies Plaintiff(s)' Petition for Rehearing in AMP v. USPTO," September 14, 2011
• "Defendants File Petition for Rehearing in AMP v. USPTO," August 30, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 29, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 28, 2011
• "CyberSource and the Tragedy of Bad Analogies," August 24, 2011
• "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?" August 23, 2011
• "WFU Law Professor Says Federal Circuit Failed as 'Keeper of the Constitution' in AMP v. USPTO," August 22, 2011
• "AMP v. USPTO: Standing," August 4, 2011
• "AMP v. USPTO: Judge Bryson's Opinion," August 3, 2011
• "AMP v. USPTO: Judge Moore's Concurring Opinion," August 2, 2011
• "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2011)," August 1, 2011
• "Standing in AMP v. USPTO: The Plot Thickens," July 29, 2011
• "Federal Circuit Issues Decision in AMP v. USPTO," July 29, 2011
• "Myriad Writes to Federal Circuit on Standing Issue," July 28, 2011
• "AMP v. USPTO: Oral Argument at the Federal Circuit," April 7, 2011
• "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO — Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "BIO Survey Shows Support for DNA-Based Patents Despite Some Reservations," January 9, 2011

1.  Leahy-Smith America Invents Act Signed Into Law

On September 8, the Senate voted 89 to 9 in favor of H.R. 1249, the House version of the Leahy-Smith America Invents Act (AIA).  The House had passed the bill by a 304-117 margin on June 23.  Eight days following Senate passage, on September 16, President Obama signed the Leahy-Smith America Invents Act into law.  Certain provisions of the AIA took effect within days of enactment (e.g., prioritized examination and a 15% fee surcharge); some provisions will take effect on September 16, 2012 — one year after enactment (e.g., supplemental examination and inter partes review); and the remaining changes will take effect on March 16, 2013 — 18 months after enactment (e.g., first-inventor-to-file and derivation provisions).  The effective date provisions of § 3(n) of the AIA, however, will force patent practitioners and applicants to deal with two distinct regimes — the old first-to-invent and the new first-inventor-to-file — for years and decades to come.

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

• "AIA Overview: Changes in Requirements for the Inventor's Oath or Declaration," October 27, 2011
• "AIA Overview: Supplemental Examination," October 26, 2011
• "AIA Overview: Changes to Provisions Relating to Third Party Submissions of Prior Art," October 24, 2011
• "AIA Overview: Changes to Inter Partes Re-examination," October 23, 2011
• "AIA Overview: Post-grant Review Provisions," October 20, 2011
• "AIA Overview: Prior User Rights Defense," October 19, 2011
• "AIA Overview: First-Inventor-to-File Provisions," October 11, 2011
• "USPTO Seeking Comment on AIA Mandated Studies," October 10, 2011
• "USPTO Implements AIA Changes to Inter Partes Reexamination," September 28, 2011
• "USPTO Updates Fee Schedule, But Does Not Yet Offer Micro Entity Discount," September 27, 2011
• "USPTO Implements Prioritized Examination Track under AIA," September 26, 2011
• "President Signs AIA into Law; USPTO Begins Implementation of Act," September 20, 2011
• "Reaction to Senate Passage of H.R. 1249," September 11, 2011
• "Senate Passes H.R. 1249," September 8, 2011
• "Senate Votes to Invoke Cloture on H.R. 1249," September 6, 2011
• "Senate Cloture Vote on H.R. 1249 Scheduled for Tuesday," September 5, 2011
• "Patent Reform News Briefs," August 17, 2011
• "USPTO Seeks Input on Implementation of Leahy-Smith America Invents Act," August 8, 2011
• "Patent Reform News Briefs," July 12, 2011
• "House Passes H.R. 1249," June 23, 2011
• "Patent Reform Update II," June 21, 2011
• "Patent Reform Update," June 20, 2011
• "Is the End of Fee Diversion Dead in the Leahy-Smith America Invents Act?" June 19, 2011
• "AMA, ACLU and Their Friends Oppose (Leahy-Smith) America Invents Act," June 16, 2011
• "Manager's Amendment (and Others) to H.R. 1249 — Human Patenting," June 15, 2011
• "Debate over H.R. 1249 Continues," June 15, 2011
• "Manager's Amendment (and Others) to H.R. 1249 — Second Opinions in Genetic Diagnostic Testing," June 14, 2011
• "Patent Reform News Briefs," June 13, 2011
• "America Invents Act: Quo Vadis?" June 8, 2011
• "Patent Reform News Briefs," June 7, 2011
• "Not Necessarily Patent 'Reform,'" June 2, 2011
• "Commerce Secretary Provides Administration's Views on America Invents Act," May 31, 2011
• "Patent Reform News Briefs," May 11, 2011
• "Boundy Issues Call to Arms on America Invents Act," April 21, 2011
• "More Reaction to H.R. 1249," April 18, 2011
• "House Judiciary Committee Approves H.R. 1249," April 14, 2011
• "Reaction to Manager's Amendment to House Patent Reform Bill," April 13, 2011
• "House Judiciary Chairman Releases Manager's Amendment to H.R. 1249," April 12, 2011
• "Reaction to House Patent Reform Bill," March 31, 2011
• "House Introduces Its Version of 'America Invents Act,'" March 30, 2011
• "Patent Reform Discussion Moves to House," March 29, 2011
• "The Disappearance of Deceptive Intent in S. 23," March 23, 2011
• "'Reform' at the U.S. Patent and Trademark Office," March 22, 2011
• "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," March 21, 2011
• "Additional Opportunities for Pre- and Post-grant Review, and Brand New Patent Trial and Appeal Board in S. 23," March 17, 2011
• "Post-grant Review Provisions of S. 23," March 16, 2011
• "Inventor's Interests, If Not Rights, Limited by S. 23," March 15, 2011
• "What Are the Provisions of the Proposed "First-Inventor-to-File" System in S. 23?" March 14, 2011
• "Obama Administration Supports S. 23," March 9, 2011
• "Reaction to Senate Passage of S. 23," March 8, 2011
• "Senate Passes S. 23," March 8, 2011
• "Senator Feinstein Opposes First-to-File Provisions of Patent Reform Bill (S. 23)," March 3, 2011
• "Patent Reform Bill (S. 23) Debated and Amended on Senate Floor," March 2, 2011
• "More Reaction to Senate Patent Reform Legislation," February 24, 2011
• "Patent Reform Legislation Moves to Senate Floor," February 22, 2011
• "Reaction to Senate Patent Reform Bill (S. 23)," February 9, 2011
• "Judiciary Committee Votes on Patent Reform Bill," February 3, 2011
• "Here We Go Again," January 20, 2011
• "Rep. Latta Reintroduces False Marking Bill in the House," January 18, 2011