By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories.  For 2017, we identified nineteen 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 #19 to #15 and stories #14 to #10, and today we count down stories #9 to #5 as we work our way towards the top four stories of 2017.  As with our other lists (2016, 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 2017" on January 17, 2018 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.

9.  Federal Circuit Affirms Inequitable Conduct Determination in Regeneron Pharmaceuticals v. Merus

In July, a divided panel of the Federal Circuit affirmed a District Court decision finding Regeneron's U.S. Patent No. 8,502,018, which is directed to transgenic mice expressing human variable domain immunoglobulin (Ig) genes, unenforceable due to inequitable conduct.  It was undisputed that during prosecution of the '018 patent, four references were known to Regeneron and its counsel that were not cited to the U.S. Patent and Trademark Office — these references were cited by a third party during prosecution of a related application after Regeneron received a Notice of Allowance for the '018 patent.  While Regeneron did not submit these references to the Office during prosecution of the application that issued as the '018 patent, Regeneron did cite these references in all other pending related applications.  The District Court, applying the rubrics of the Federal Circuit's decision in Therasense, Inc. v. Becton, Dickinson and Co., found the '018 patent unenforceable due to inequitable conduct.  In particular, the District Court determined that the uncited references were "but-for" material (i.e., the patent would not have granted but for the non-disclosure because the undisclosed references rendered the granted claims unpatentable), not cumulative to references considered by the Examiner, and there was an intent to deceive the Examiner by not disclosing the uncited references.  With respect to the second prong of the Therasense test — intent to deceive — the District Court had cataloged instances of litigation misconduct in drawing an adverse inference that there was an intent to deceive.  The District Court findings included improperly withholding and citing on privilege logs documents clearly not privileged (such as experimental data), withholding as privileged information where the privilege had been waived, and withholding evidence of patent prosecution counsels' reasoning and state of mind relevant to whether counsel had an intent to deceive.  In affirming the District Court's decision, the panel majority reviewed the litigation misconduct described by the District Court and found that the District Court's decision to draw an adverse inference that there was an intent to deceive was not an abuse of discretion.  Judge Newman penned a strong dissent, based on her conviction that "my colleagues apply incorrect law and add confusion to precedent," writing that "[t]he panel majority thus convicts Regeneron, its counsel, and its scientists, with no trial, no evidence, and no opportunity to respond in their defense."

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

• "Regeneron Pharmaceuticals, Inc. v. Merus N.V. (Fed. Cir. 2017)," July 28, 2017

8.  Supreme Court Interprets "Substantial Portion" in § 271(f)(1)

In February, in Life Technologies Corp. v. Promega Corp., the Supreme Court reversed a determination by the Federal Circuit that there could be circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States, holding instead "that a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f)(1)."  Promega had sued Life Technologies for infringement of several of its patents, alleging that Life Technologies sold genetic testing kits that were not covered by the license agreement between the parties.  In reversing the Federal Circuit, the Supreme Court pointed out that Life Technologies manufactured all but one component of its kits in the United Kingdom — manufacturing Taq polymerase in the United States and then shipping the Taq polymerase to its United Kingdom facility to be combined with the other four components of the kit.  Turning to the question of whether, as a matter of law, a single component could ever constitute a "substantial portion" so as to trigger liability under § 271(f)(1), the Court answered that question in the negative, holding that "one component does not constitute 'all or a substantial portion' of a multicomponent invention under §271(f)(1)," and adding that to resolve the question presented in the instant case, the Court did not need to define how close to "all" of the components "a substantial portion" must be.  The Supreme Court therefore reversed the judgment of the Federal Circuit and remanded the case since only a single component of the patented invention at issue was supplied from the United States.

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

• "Life Technologies Corp. v. Promega Corp. (2017)," February 22, 2017

7.  Supreme Court Interprets BPCIA in Amgen v. Sandoz

The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc. in June, marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs.  The Court described the BPCIA as "a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement" related to biosimilar applications.  This process begins with the disclosure by a biosimilar applicant of an abbreviated Biologics License Application (aBLA) and related information in order to "enable the sponsor to evaluate the biosimilar for possible infringement of patents it holds on the reference product."  Nevertheless, the Court held that the reference product sponsor (RPS) cannot seek enforcement of the disclosure provision in 42 U.S.C. § 262(l)(2)(A) by injunction under federal law.  This was essentially the result reached by Federal Circuit.  However, the Supreme Court reversed and remanded the question whether the disclosure provision was enforceable under state law, or whether the BPCIA pre-empted any state law claim.  With regard to the 180-day notice-of-commercial-marketing provision of the statute, the Court reversed the Federal Circuit and held that the notice may be provided "either before or after receiving FDA approval."

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

• "Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) — One Last Dance . . . ," December 14, 2017
• "HUMIRA® Biosimilar Update — Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins," September 28, 2017
• "Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)," August 10, 2017
• "Sandoz Inc. v. Amgen Inc. (2017)," June 12, 2017
• "Sandoz, Amgen, and the Federal Government at the Supreme Court — Timing of BPCIA 180-Day Notice of Commercial Marketing Provisions," April 27, 2017
• "Supreme Court Hears Oral Argument in Sandoz v. Amgen — Patent Dancing and Missing Puzzle Pieces," April 26, 2017
• "Supreme Court Preview — Sandoz Inc. v. Amgen Inc. — 180 Day Notice of Commercial Marketing Provisions of BPCIA," April 25, 2017
• "Supreme Court Preview — Sandoz Inc. v. Amgen Inc.," April 24, 2017
• "Supreme Court to Review BPCIA — Amgen v. Sandoz Petitions for Writs of Certiorari Granted," January 15, 2017

6.  New Administration Withdraws U.S. from TPP Agreement

Only days after being sworn into office, President Trump made good on one of his signature campaign promises and notified the other twelve countries that were considering ratifying the Trans-Pacific Partnership (TPP) Agreement (i.e., Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) that the United States was withdrawing from the treaty and that he would not ask Congress to ratify it.  The President's stated reasons for doing so, reiterated many times during his campaign, were that the treaty was bad for American workers and part of a pattern of trade agreements that had taken jobs from U.S. workers and encouraged businesses to offshore capital and production capacity in favor of countries where labor was cheaper than in the U.S.  Some in the patent community thought the President was wrong to withdraw from the TPP, believing that the agreement was generally favorable to American interests and would have had no effect on the U.S. job market, in part because the provisions of the treaty favored American innovators, specifically biotechnology and pharmaceutical companies, but all creative industries (including film, recording artists, and writers, among others) whose efforts are not offshored.  In July, the United States Trade Representative released the summary of its objectives for NAFTA renegotiation, including its objectives for the intellectual property and competition provisions of the agreement.  However, the provisions that the USTR indicated it would be seeking — which appear to be intended to create a template for future bilateral or multilateral agreements — reestablish the basic framework initially negotiated by the Obama Administration as part of the TTP, which President Trump had rejected as a "continuing rape of our country."  The Trump Administration's decision to pursue many of the same intellectual property protection objectives in renegotiating NAFTA as had been negotiated as part of TPP was all the more remarkable in light of the decision by the other TPP member states (also in July) to continue to seek a broader free trade market with the same sort of intellectual property requirements.

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

• "The Trump Administration's Intellectual Property and Competition Objectives for NAFTA Renegotiation: What Was Wrong with the TPP?" July 20, 2017
• "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement," January 26, 2017

5.  Supreme Court Expands Exhaustion Doctrine in Impression Products v. Lexmark

In May, the Supreme Court unsurprisingly reversed the Federal Circuit regarding the metes and bounds of the patent exhaustion doctrine.  The Court ruled in Impression Products, Inc. v. Lexmark International, Inc. that the doctrine precludes a patentee from using the patent laws to enforce any agreement that restricts a purchaser's post-sale ownership rights in a patented article, and that the doctrine extends to patented products sold abroad.  The decision reversed Federal Circuit precedent that permitted patentees to limit the scope of rights transferred to purchasers upon sale of a patented article, provided that such restrictions were "clearly worded" (Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992)) and further expanded the scope of exhaustion to include sales made outside the U.S., which the Federal Circuit had held were outside the reach of exhausting U.S. patent rights (Jazz Photo Corp. v. International Trade Commission, 264 F.3d 1094 (Fed. Cir. 2001)).  The decision represents a culmination of the Court's delineation of the expansive scope of exhaustion regarding intellectual property rights that can be found in Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008), and (in the copyright context) Kirtsaeng v. John Wiley & Sons, Inc., 568 U.S. 519 (2013).

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

• "Patent Exhaustion and Pharmaceuticals, October 10, 2017
• "Impression Products, Inc. v. Lexmark International, Inc. (2017)," May 30, 2017