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.  Yesterday, we counted down stories #20 to #16, and today we count down stories #15 to #11 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.

15.  Magistrate Finds Method Claims Patent Eligible and Kit Claims Patent Ineligible

In one of several patent eligibility determinations that we reported on in 2016, Magistrate Judge Donald L. Cabell of the U.S. District Court for the District of Massachusetts recommended in August that Defendants' joint motion to dismiss under Fed. R. Civ. P. 12(b)(6) in Oxford Immunotec Ltd. v. Qiagen, Inc. be allowed in part and denied in part.  Oxford, which develops tests to diagnose and monitor patients with auto-immune diseases, asserted that Qiagen's development, use, and sale of a tuberculosis ("TB") test infringed six of Oxford's patents.  Oxford's patents relate to a claimed method using eight peptides from ESAT-6, a unique protein produced by Mycobacterium tuberculosis, the bacterium that causes TB.  Finding that Oxford "discovered a law of nature -- namely which specific peptides in ESAT-6 are most likely to induce a recognition response by the T-cells of patients who have TB without creating false positive responses by the T-cells of those who have merely been vaccinated," but also determining that the peptides are "contained in an intact ESAT-6 strand," Judge Cabell recommended that Qiagen's motion to dismiss be allowed with respect to infringement of the kit claims and denied with respect to infringement of the method claims.

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

• "Oxford Immunotec Ltd. v. Qiagen, Inc. (D. Mass. 2016)," September 5, 2016

14.  Federal Circuit Provides Some Clarity on BPCIA's Notice of Commercial Marketing Provision

In 2015, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") in Amgen v. Sandoz as "a riddle wrapped in a mystery inside of an enigma."  And one of the provisions of the BPCIA that was still shrouded in mystery after Amgen v. Sandoz was the notice of commercial marketing provision found at 42 U.S.C. § 262(l)(8)(A).  While describing the provision as both mandatory and stand-alone (independent of the information-disclosure and patent-exchange provisions that comprise the rest of § 262(l)), the Court limited the holding to cases in which the biosimilar applicant failed to comply with disclosure provision of § 262(l)(2)(A).  In July, the Federal Circuit provided some clarification regarding this provision in Amgen Inc. v. Apotex Inc., noting that the notice is always mandatory -- even when the biosimilar applicant engaged in the so-called "patent dance."  The Court also held that this provision is enforceable by injunction.  In our report on the decision, we noted that it may not solve the entire riddle that is the BPCIA, and in fact may end up creating more confusion.  For example, the opinion suggests that the FDA may begin providing tentative licensure for a biosimilar product, although such action is not specifically provided for in the BPCIA and the FDA has not suggested that it would take such action.

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

• "Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)," July 11, 2016
• "Does the "Notice of Commercial Marketing" Provision in the BPCIA Stand Alone? -- Amgen v. Apotex Case Preview," March 2, 2016

13.  Massachusetts Court Finds No Per Se Ethical Violation for Simultaneous Representation of Clients Competing in Same Technology Area

Although technically issued in late December 2015, our report on Maling v. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP was posted at the start of 2016, and therefore narrowly missed the "deadline" for making last year's Top Stories list.  Nevertheless, the determination by the Supreme Judicial Court of Massachusetts in Maling that the simultaneous representation by a law firm in the prosecution of patents for two clients competing in the same technology area for similar inventions is not a per se violation of Rule of Professional Conduct 1.7 is of significance to many firms performing patent prosecution on behalf of their clients.  Although the decision likely came as a relief to most practitioners working in private practice, the Massachusetts Court warned about the significant financial and reputational risks of violating Rule 1.7, noting that "[n]othing we say here today, however, should be construed to absolve law firms from the obligation to implement robust processes that will detect potential conflicts."  Although this case involves the Massachusetts Supreme Judicial Court's application of Rule 1.7 of the Massachusetts Rules of Professional Conduct, and therefore is not binding authority in any other jurisdiction that has adopted Rule 1.7 of the Model Rules, the decision nevertheless could have had a chilling effect on all intellectual property law firm practices had it come out differently.

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

• "No Per Se Ethical Violation for "Subject Matter Conflicts"," January 12, 2016

12.  Federal Circuit Finds Patent Agent-Client Privilege

In March, the Federal Circuit addressed the issue of whether communications between a patent agent and a client are privileged.  The Court had not previously addressed the subject, although there had been a split between district courts that had considered the issue.  A divided panel, however, determined in In re Queen's University at Kingston that there is a patent agent-client privilege.  In October, the U.S. Patent and Trademark Office proposed to amend the rules of practice before the Patent Trial and Appeal Board "to recognize that, in connection with discovery conducted in certain proceedings at the [USPTO], communications between U.S. patent agents and foreign patent practitioners and their clients are privileged to the same extent as communications between clients and U.S. attorneys."  However, the Office's notice makes it clear that "communications between clients and U.S. patent agents relating to patent application matters would be protected as privileged under the rule, but communications between these parties regarding litigation strategies would not be protected."

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

• "PTAB Update -- Patent Office Proposes Rule Amendment to Recognize Patent Agent-Client Privilege," October 26, 2016
• "In re Queen's University at Kingston (Fed. Cir. 2016)," March 16, 2016

11.  PTAB Must Articulate Its Reasoning in Final Written Decisions

In January, the Federal Circuit determined in Cutsforth Inc. v. MotivePower, Inc. that the Patent Trial and Appeal Board must provide a thorough explanation of its reasoning when it issues Final Written Decisions.  The Court indicated that "[w]hen the Board determines that modifications and combinations of the prior art render a claimed invention obvious, the Board must fully explain why a person of ordinary skill in the art would find such changes obvious."  In December, the Federal Circuit vacated and remanded another PTAB decision in In re NuVasive, Inc., reiterating the need for the Board to enunciate a reasoned basis for finding obviousness.

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

• "In re NuVasive, Inc. (Fed. Cir. 2016)," December 8, 2016
• "Cutsforth Inc. v. MotivePower, Inc.," January 31, 2016