Top Three Stories of 2012

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen 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, Tuesday, and Wednesday we counted down stories #15 to #4, and today we count down the top three stories of 2012. As with our other lists (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.

3. Implementation of Leahy-Smith America Invents Act Continues

The U.S. Patent and Trademark Office began the year by publishing five notices of proposed rulemaking in January to implement various provisions of the Leahy-Smith America Invents Act. Another four notices of proposed rulemaking and a practice guide for proposed trial rules were published in February. Over the summer, the Office issued three more notices of proposed rulemaking and a guidance document on the first-inventor-to-file (FITF) provisions of the AIA. In July, the Office began issuing final rules to implement AIA provisions, with the final rules corresponding to the notices of proposed rulemaking issued earlier in the year. By mid-August, the Office had issued eight final rules and a patent trial practice guide. The Office also held a roundtable in September to obtain public input on issues relating to the Office's proposed rules to implement the first-inventor-to-file provisions of the AIA. In February, the Office started to exercise its new fee setting authority under the AIA by submitting a proposed fee schedule to the Patent Public Advisory Committee (PPAC), with the PPAC holding two public hearings on the proposed schedule. In September, the PPAC issued a report on the proposed schedule, which the Director considered before publishing a notice setting and adjusting certain patent fees. The publication of the proposed fee schedule initiated a 45-day comment period, which ended in November. The Office is expected to publish a final notice on fees in the coming weeks, with the fee schedule taking effect 45 days after publication (to provide Congress with an opportunity to review the schedule). Earlier in the year, the Office issued AIA-mandated reports on the prior user rights defense provisions of the AIA and on international patent protections for small businesses. While the Office collected public comments on genetic diagnostic testing and held two public hearings on the matter, the Office was unable to meet the deadline for submitting its AIA-mandated report on genetic diagnostic testing to Congress (and, in fact, has scheduled a roundtable on January 10 to discuss the topic further). The Office also opened its first satellite office in Detroit, and after considering public input on locations for additional satellite offices, announced that it would be opening three additional offices in Dallas, TX; Denver, CO; and California's Silicon Valley. Throw in a series of AIA roadshows, webinars, and a Twitter chat, and it has been a busy year for the Office as it implements changes brought about by the AIA, and for applicants and practitioners as they try to keep up with these changes. And FITF is only 72 days away.

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

• "USPTO Issues Final Rule Implementing Micro Entity Status," December 26, 2012
• "USPTO News Briefs," December 20, 2012
• "USPTO to Hold Roundtable on Genetic Diagnostic Testing," December 4, 2012
• "IPO Submits Comments on Proposed Fees," November 14, 2012
• "USPTO Holds Live Chat on AIA," November 13, 2012
• "USPTO News Briefs," October 30, 2012
• "PPAC Issues Report on USPTO Patent Fees Proposal," October 9, 2012
• "Rules Changes Implementing the Inventor's Oath or Declaration Provisions of the AIA," October 4, 2012
• "More on USPTO's Proposed New Fees - Part II," September 19, 2012
• "More on USPTO's Proposed New Fees," September 11, 2012
• "USPTO Proposes New Patent Fees and CPI Adjustments to Certain Fees," September 6, 2012
• "USPTO News Briefs," September 5, 2012
• "USPTO News Briefs," August 27, 2012
• "USPTO Issues Several Final Rules for Implementing AIA Provisions," August 15, 2012
• "USPTO Issues Final Rule to Implement Miscellaneous Post Patent Provisions of AIA," August 8, 2012
• "USPTO Issues Final Rule for Implementing Statute of Limitations Provisions for Office Disciplinary Proceedings," July 31, 2012
• "USPTO Issues Final Rule for Preissuance Submissions," July 25, 2012
• "USPTO to Open Three More Satellite Offices," July 2, 2012
• "Docs at BIO: Session on Prior User Rights as a New IP Option," June 20, 2012
• "USPTO Report on Genetic Testing Delayed," June 18, 2012
• "BIO International Convention 2012 Preview - Part III: BIO and the America Invents Act," June 14, 2012
• "USPTO Issues Proposed Rules for Implementing Micro Entity Status," June 4, 2012
• "USPTO News Briefs," May 23, 2012
• "USPTO Posts Comments on Genetic Diagnostic Testing," May 22, 2012
• "USPTO Posts Comments on Proposed Fees Changes," March 19, 2012
• "A Glimpse under the Hood: How the USPTO Proposes to Adjust Patent Fees," March 14, 2012
• "USPTO Proposes Fees Changes," March 1, 2012
• "USPTO News Briefs," February 20, 2012
• "USPTO Holds First Hearing on "Second Opinion" Genetic Testing," February 16, 2012
• "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing," February 16, 2012
• "USPTO to Hold Hearing on Genetic Diagnostic Testing," February 15, 2012
• "USPTO Proposes More Rules for Implementing AIA Provisions," February 13, 2012
• "USPTO Issues Proposed Rulemaking for Supplemental Examination Provisions of AIA," February 8, 2012
• "PPAC to Hold Public Hearings on Proposed Fee Schedule," February 1, 2012
• "Interpreting 35 U.S.C. § 102 under the America Invents Act," January 31, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Oath or Declaration Provisions," January 30, 2012
• "USPTO News Briefs," January 26, 2012
• "USPTO News Briefs," January 18, 2012
• "USPTO Issues Report on Prior User Rights," January 17, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

2. Supreme Court Grants Certiorari in AMP v. Myriad

Six days after issuing its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court issued an Order granting the petition for writ of certiorari in Association for Molecular Pathology v. Myriad, vacating the judgment, and remanding the case back to the Federal Circuit for further consideration in light of the Mayo decision. As we noted yesterday, the Federal Circuit decided on remand that claims to isolated human DNA satisfy the requirements of 35 U.S.C. § 101, with each member of the panel issuing opinions that tracked their earlier opinions (the Federal Circuit's decision placed #5 on our 2012 list of top stories). In September, the American Civil Liberties Union (ACLU) and Public Patent Foundation (PubPat) again filed a petition for certiorari with the Supreme Court, which the Court granted on November 30. The Court's grant was limited to the first question presented -- whether human genes are patent-eligible -- and the Court denied certiorari on the other two questions (thus letting stand the Federal Circuit's determination that screening methods using genetically transformed cells are patent-eligible under the Court's Mayo v. Prometheus precedent, and that a declaratory judgment plaintiff must cite actual injury to have standing). The Supreme Court's grant of certiorari in AMP v. Myriad ensures that this case will be a top story again in 2013.

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

• "Supreme Court Grants Cert in AMP v. Myriad," November 30, 2012
• "Myriad Files Responsive Brief Opposing Certiorari," November 29, 2012
• "AMP v. Myriad Briefed and Distributed for Conference - Update," November 19, 2012
• "AMP v. Myriad Briefed and Distributed for Conference," November 13, 2012
• "Plaintiffs (Again) File Certiorari Petition in Myriad Case," September 25, 2012
• "Patent Eligibility and Biology," August 23, 2012
• "The Proper Scope of DNA (or 'Gene') Patent Claims," August 1, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "The Aussies Are At It Again," June 14, 2012
• "Supreme Court Remands Myriad Case," March 26, 2012

1. Supreme Court Issues Decision in Mayo v. Prometheus

On March 20, the Supreme Court unanimously held in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic drug were invalid for "effectively claim[ing] underlying laws of nature themselves." In the nine months since the Supreme Court issued its decision, applicants and practitioners have tried to gauge the impact of the decision and have asked whether claims perceived to be directed to "laws of nature" can, in fact, be written to pass Constitutional muster. The U.S. Patent and Trademark Office responded to the Mayo decision by issuing preliminary guidance on the day after the decision, and then followed up with interim guidance in July. It did not take the lower courts long to apply Mayo, with the District Court for the District of Columbia in SmartGene, Inc. v. Advanced Biological Laboratories SA invalidating diagnostic method claims in view of Mayo only ten days after the Supreme Court issued its decision. In November, the Federal Circuit made its "first" attempt to implement the Supreme Court's jurisprudence on the scope of patent eligibility for diagnostic method claims in PerkinElmer, Inc. v. Intema Ltd. (we did not count the Federal Circuit's decision on remand in AMP v. Myriad, as the diagnostic method claims in that case had already been held patent-ineligible under the "machine-or-transformation" test set forth in In re Bilski). As we wrote at the time, PerkinElmer stands as the most recent cautionary tale of how diagnostic methods claims must be crafted -- narrow, specific, encompassing particular assaying and detection steps, and encompassing some (any) patentable feature other than the naturally occurring correlation between a marker and disease. Whether this will be sufficient to render the subject matter of such claims as patent-eligible remains an open question.

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

• "PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)," November 20, 2012
• "Patent Eligibility and Biology," August 23, 2012
• "Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons,'" August 6, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "USPTO Issues Interim Guidance Regarding Mayo v. Prometheus," July 5, 2012
• "BIO International Convention 2012 Preview: BIO and the Prometheus Supreme Court Case," June 5, 2012
• "Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?" April 11, 2012
• "SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012)," April 10, 2012
• "USPTO Issues Preliminary Guidance on Mayo v. Prometheus," March 27, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (or Can These Claims Be Saved?)," March 26, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Court's Decision Means," March 22, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said," March 21, 2012
• "Early Reaction to Supreme Court Decision in Mayo v. Prometheus," March 20, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)," March 20, 2012