Top Stories of 2015: #16 to #20

McDonnell Boehnen Hulbert & Berghoff LLP

After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories.  For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Today, we count down stories #20 to #16, and then in the coming week, we will work our way towards the top stories of 2015.  As with our other lists (2014, 2013, 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 2015" on January 21, 2016 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

20.  USPTO Launches Patent Quality Initiative

In February, the U.S. Patent and Trademark Office announced the launch of a comprehensive and enhanced patent quality initiative, and kicked off the initiative by requesting comments from the public on how the Office could enhance patent quality.  The Office indicated that its quality efforts would be aimed at improving patent operations and procedures, enhancing the customer experience, and improving existing quality metrics, and would target three "patent quality pillars": (1) excellence in work products (i.e., issued patents and Office actions), (2) excellence in measuring patent quality, and (3) excellence in customer service.  The Office followed the announcement of the quality initiative with a two-day "Quality Summit" in March.  Earlier this month, the Office invited stakeholders to submit patent quality-related topics that should be the subject of a case study as part of an enhanced patent quality initiative pilot program.  The Office regularly performs case studies to investigate specific quality-related issues as well as review individual examiner work products, and such case studies allow the Office to investigate how a particular issue is being treated or addressed across hundreds or thousands of applications, and where appropriate, to take action to remediate quality issues or to formulate best practices to further enhance quality.

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

• "USPTO Seeks Topics for Quality Case Study Pilot Program," December 21, 2015
• "USPTO Launches Enhanced Patent Quality Initiative," March 5, 2015

19. TPP Moves Forward

For the past six years, a dozen countries have negotiated the Trans Pacific Partnership (TPP) treaty, a multilateral free trade agreement, with the negotiations shrouded in secrecy.  This secrecy was not absolute, with the Wikileaks website periodically publishing purported drafts of the agreement.  With the announcement in October that the parties had come to substantial agreement on the treaty, Wikileaks once again released portions of the agreement, and in November, the Obama Administration released the approved text of the agreement.  One of the more controversial provisions of the agreement would reduce the term of market exclusivity of biologic drugs from 12 years as provided by the Biologic Price and Competition and Innovation Act (BPCIA) to 7 years.  However, there has been vociferous opposition to the agreement, despite Congress having granted the President so-called "fast-track authority" for the TPP.  As a consequence, Congress can ratify the agreement but cannot amend the agreement or filibuster Senate consideration.  Given the level of political opposition, in addition to the antipathy of the Republican Party to anything the President proposes, it is likely that the agreement will not be ratified, if it ever is, until a new Administration takes power in January 2017.

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

• "What Are the IP Provisions of the TPP?" November 9, 2015
• "What May Be the IP Provisions of the Trans Pacific Partnership Agreement," October 15, 2015
• "Transparency and the Trans-Pacific Partnership Treaty," March 11, 2015

18.  Myriad Settles with Diagnostic Companies

In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad filed suit against six genetic diagnostic test providers (Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp) and was itself sued in declaratory judgment actions by three others (Quest, Invitae, and Counsyl).  Five of these actions were consolidated in the District of Utah, where Myriad's preliminary injunction motion was denied on the grounds that Myriad was unlikely to prevail on the merits regarding the asserted claims in view of the Supreme Court's Myriad opinion, and late last year, the Federal Circuit affirmed that determination.  Following those setbacks for Myriad, several companies opposing Myriad (Ambry Genetics, LabCorp, Invitae, and Pathway Genomics) issued press releases in January announcing that the action against them had settled.  The press releases from those companies stated that Myriad's infringement allegations had been dismissed "with prejudice" and that each of the parties had received a "covenant not to sue" by Myriad.  The only financial considerations announced were that each party would bear its own costs of the litigation.  In February, Myriad settled with the remaining defendants.  In diagnostic patent news unrelated to the above litigation, but nevertheless of interest to applicants and practitioners, the U.S. Patent and Trademark Office issued its report on so-called "second opinion" genetic diagnostic testing, more than three years after the June 2012 deadline mandated by Section 27 of the Leahy-Smith America Invents Act.

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

• "PTO Releases Report on Confirmatory Genetic Diagnostic Testing," October 6, 2015
• "Koepsell and Noonan on Gene Patenting," May 28, 2015
• "Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative," April 30, 2015
• "The ACLU, Working for the Man," March 24, 2015
• "Game Over for Myriad -- Update," February 16, 2015
• "Game Over for Myriad," February 10, 2015
• "Myriad Throws in the Towel," January 27, 2015

17.  USPTO Announces PTAB Rules Changes

In March, U.S. Patent and Trademark Office Director Michelle Lee issued a statement on the PTO Blog indicating several "quick-fix" and proposed rule changes.  Among the "quick fix" changes, the Office nearly doubled the number of pages for a motion to amend, with opposition briefing and reply briefing receiving a commensurate amount of additional pages.  These changes were followed by a first "Final Rules" package of amendments to the Rules of Practice before the Patent Trial and Appeal Board (PTAB), which was issued in May, and a second rules package introduced in the form of a Notice of Proposed Rulemaking in August.  No sweeping changes were proposed in the second rules package, and with respect to the change many stakeholders were hoping for (i.e., to the Broadest Reasonable Interpretation (BRI) standard for construing claims), the Board affirmed the use of the BRI standard in all but the most limited circumstances, relying heavily on the Federal Circuit's decision in In re Cuozzo.

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

• "Single-APJ Institution Pilot Program -- USPTO Requests Written Comments for IPR Proceedings," August 27, 2015
• "Views from the Director's Office on Post-Grant Reviews by the PTAB," August 26, 2015
• "PTAB Finally Proposes Rule Amendments: The More Things Change . . . ," August 19, 2015
• "Final 'Ministerial' Rule Amendments for Practice Before the PTAB," May 20, 2015
• "USPTO Director Announces 'Quick-Fix' and Anticipated Changes to PTAB Practice," March 30, 2015

16.  District Court Patent Decisions Are Cause for (Initial) Concern

A pair of district court decisions in the District of Delaware bear watching to see how (or if) the Federal Circuit weighs in.  In Immersion Corp. v. HTC Corp., the trial court construed 35 U.S.C. § 120 to prohibit filing a continuation application on the day its immediate parent granted, contrary to established U.S. Patent and Trademark Office practice (the lower court refusing to grant the Office any deference in the matter).  The decision, if affirmed, may well put more patents at risk than Myriad, Mayo, and Alice combined.  Speaking of Mayo, the trial court in Endo Pharmaceuticals Inc. v. Actavis Inc. found claims directed to methods of using oxymorphone to treat pain in patients with renal impairment to be facially invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter, relying heavily on the Supreme Court's decision in Mayo.

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

• "Endo Pharmaceuticals Inc. v. Actavis Inc. (D. Del. 2015)," December 9, 2015
• "IPO Files Amicus Brief in Immersion Corp. v. HTC Corp.," August 17, 2015
• "Immersion Corp. v. HTC Corp. (D. Del. 2015)," March 18, 2015

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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