After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories.  For 2016, 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.  In two prior posts, we counted down stories #20 to #16 and stories #15 to #11, and today we count down stories #6 to #10 as we work our way towards the top five stories of 2016.  As with our other lists (2015, 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 2016" on January 18, 2017 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.

10.  Sandoz and Amgen Seek Supreme Court Review of Federal Circuit's Decision in Amgen v. Sandoz

In 2015, the Federal Circuit, in a seriously fractured decision, construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) in Amgen v. Sandoz.  In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument), and extended the statutory exclusivity period enjoyed by innovator biologic drug makers relating to when the biosimilar applicant can enter the marketplace (as Amgen argued).  The Federal Circuit subsequently denied petitions for rehearing and rehearing en banc filed by both parties.  The Federal Circuit's decision in Amgen v. Sandoz came in third in our Top Stories of 2015 list.  Last year, Sandoz petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision (and Amgen then conditionally cross-petitioned).  One month after Sandoz petitioned for certiorari, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, arguing that Sandoz had refused to comply with certain of the "patent dispute resolution" provisions of the BPCIA.  In June, the Supreme Court invited the Solicitor General to submit briefs on Sandoz's petition and Amgen's cross-petition to provide the views of the United States, and in December, the Solicitor General recommended that the Court grant both petitions, counseling that the Court should overturn the Federal Circuit's determination that a biosimilar applicant cannot provide notice of commercial marketing under the statute prior to FDA approval, but to affirm the Federal Circuit's decision that the disclosure provisions of the statute are not mandatory.

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

• "Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen," December 12, 2016
• "Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States," June 21, 2016
• "Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar," March 7, 2016
• "Sandoz Petitions for Certiorari over 180-day Notice Provision in BPCIA," February 17, 2016

9.  Supreme Court Grants Certiorari in Venue Case

In March, Sen. Flake of Arizona introduced S. 2733, the "Venue Equity and Non-Uniformity Elimination Act of 2016," which would amend 28 U.S.C. § 1400 to limit the venues in which patent holders could bring patent infringement lawsuits.  The bill is narrowly tailored to one particular perceived problem -- the use of the Eastern District of Texas as the venue of choice by patent trolls.  In May, in In re TC Heartland, the Federal Circuit concluded that Congress did not restrict what could be considered a proper venue when it passed the Federal Courts Jurisdiction and Venue Clarification Act of 2011.  Interestingly, during oral argument in TC Heartland, Judge Moore commented that the changes TC Heartland was seeking might be more appropriately made by Congress.  Within days of that comment, the VENUE bill was introduced.  In December, the Supreme Court joined the discussion when it granted a petition for writ of certiorari in TC Heartland.

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

• "Patent Trolls Beware! -- Supreme Court to Review Patent Venue Statute," December 14, 2016
• "In re TC Heartland (Fed. Cir. 2016)," May 5, 2016
• "The VENUE Act -- A Last-Ditch Attempt at Patent Reform?" March 28, 2016

8.  Supreme Court Rejects Federal Circuit's Seagate Test for Deciding Enhanced Damages

In June, the Supreme Court overturned the Federal Circuit's In re Seagate Tech. LLC jurisprudence in Halo Electronics, Inc. v. Pulse Electronics, Inc., and a companion case, Stryker Corp. v. Zimmer, Inc.  The Federal Circuit's Seagate test had created a two-pronged analysis for deciding willfulness, wherein a district court was instructed to find that infringement occurred "despite an objectively high likelihood" that the accused infringer's actions constituted infringement, as well as a subjective component, that the risk of infringement "was either known or so obvious that it should have been known to the accused infringer."  Chief Justice Roberts delivered the opinion of the unanimous Court that swept away the complexities of the Federal Circuit's Seagate test for a simple discretionary standard to be applied by district courts and the Federal Circuit.  While eschewing any "precise rule or formula" the Court directed district courts to exercise their discretion "'in light of the considerations' underlying the grant of that discretion," and emphasized that enhanced damages should not be "meted out in the typical infringement case" but are warranted only for "egregious infringement behavior" (providing a host of synonyms for such behavior, including "willful, wanton, malicious, bad-faith, deliberate, consciously wrongful, flagrant, or -- indeed -- characteristic of a pirate").

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

• "Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. (2016)," June 13, 2016
• "Trolls v. Pirates: Supreme Court Oral Argument Reviewing Enhanced Damages," February 23, 2016

7.  Federal Circuit Finds Method of Producing Multi-Cryopreserved Hepatocytes to Be Patent Eligible

In July, the Federal Circuit engendered a glimmer of hope that it will once again take up its mantle of patent law expertise regarding the proper judicial interpretation of 35 U.S.C. § 101, in its decision in Rapid Litigation Management Ltd. v. Cellzdirect, Inc.  The case arose following summary judgment in the District Court that the claims were invalid under § 101.  The invention is directed to methods for producing pure cultures of mature hepatocytes to be used "for testing, diagnostic, and treating purposes."  The inventors found, contrary to the art, that certain hepatocytes in a hepatocyte population could be frozen and thawed multiple times and retain viability.  In an opinion by Chief Judge Prost joined by Judges Moore and Stoll, the panel noted that the eligibility inquiry need not extend past step 1 of the Mayo/Alice test because the District Court erred in finding that the claims were directed to a law of nature.  On the contrary, according to the panel "the claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles[; r]ather, the claims of the '929 patent are directed to a new and useful laboratory technique for preserving hepatocytes."  Viewed in this way, as being a "constructive process," directed to achieving "a new and useful end," the panel indicated that this "is precisely the type of claim that is eligible for patenting."

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

• "Rapid Litigation Management Ltd. v. Cellzdirect, Inc. (Fed. Cir. 2016)," July 6, 2016

6.  Federal Circuit Defines Eligibility for Covered Business Method Review

The America Invents Act (AIA) defines a covered business method (CBM) patent as "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions."  For the purpose of determining whether a CBM review is to be instituted, the Patent Trial and Appeal Board considers "whether the patent claims activities that are financial in nature, incidental to a financial activity, or complementary to a financial activity."  In November, in Unwired Planet, LLC v. Google Inc., the Federal Circuit resolved the issue, determining that the PTAB's "reliance on whether the patent claims activities incidental to or complementary to a financial activity as the legal standard to determine whether a patent is a CBM patent was not in accordance with law."  As a result, the Court vacated the PTAB's decision, and remanded the case.

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

• "Kayak Software Corp. v. International Business Machines Corp. (PTAB 2016)," December 27, 2016
• "Unwired Planet, LLC v. Google Inc. (Fed. Cir. 2016)," November 21, 2016
• "Plaid Technologies Inc. v. Yodlee, Inc. (PTAB 2016)," September 29, 2016
• "BMC Software, Inc. v. zIT Consulting GmbH (PTAB 2016)," September 28, 2016
• "HP Inc. v. Big Baboon, Inc. (PTAB 2016)," July 20, 2016
• "Corelogic, Inc. v. Boundary Solutions, Inc. (PTAB 2016)," June 2, 2016
• "AT&T Mobility LLC v. Intellectual Ventures II LLC (PTAB 2016)," May 24, 2016
• "Qualtrics, LLC v. OpinionLab, Inc. (PTAB 2016)," April 26, 2016
• "Motorola Mobility, LLC, v. Intellectual Ventures I, LLC (PTAB 2016)," March 31, 2016
• "Square, Inc. v. Protegrity Corp. (PTAB 2016)," March 24, 2016
• "Blue Calypso, LLC v. Groupon, Inc. (Fed. Cir. 2016)," March 6, 2016