After reflecting upon the events of the past twelve months, Patent Docs presents its 13th annual list of top patent stories.  For 2019, we identified fifteen 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 #15 to #11, and today, we count down stories #10 to #6, as we will work our way towards the top five stories of 2019.  As with our other lists (2018, 2017, 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 2019" on January 22, 2020 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.  Federal Circuit Applies Doctrine of Equivalents (And Not Only in "Exceptional" Cases)

In May, the Federal Circuit dismissed Amgen's doctrine of equivalents argument in Amgen Inc. v. Sandoz Inc., stating that "[t]he doctrine of equivalents applies only in exceptional cases and is not 'simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims,'" citing its pre-Warner-Jenkinson v. Hilton Davis Chemical Co. precedent in London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).  The Court based its decision on the reasoning that "Sandoz does not infringe claim 7 under the doctrine of equivalents because its one-step, one-solution purification process works in a substantially different way from the claimed three-step, three-solution process" recited in Amgen's claims.  Four months later, the Federal Circuit issued an order modifying its opinion to read:  "The doctrine of equivalents applies only in exceptional cases and is not 'simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims.'"  In between its May decision and September order in Amgen, the Federal Circuit issued at least five decisions applying the doctrine of equivalents (and issued a sixth decision applying the doctrine in November).

The doctrine of equivalents is a Supreme Court-created patent doctrine that arose in Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) (an uncharacteristically pro-patent decision by the Court, the doctrine recognized that an "unscrupulous copyist" could practice a claimed invention without literal infringement in some circumstances, and as a consequence the patent right could be turned into a "hollow and useless thing").  The doctrine fell into disfavor at the Federal Circuit during the 1990's and arguably provided the first inkling to the Supreme Court that the Federal Circuit's patent jurisprudence would benefit from the Court's closer oversight.  In Warner-Jenkinson Co. v. Hilton Davis Chem. Co. and Festo v. Shoketsu Kinzoku Kogyo Kabushiki, the Supreme Court reiterated the vibrancy of the doctrine; nevertheless, its successful assertion has continued to decline.  Thus, the Federal Circuit's decision in UCB, Inc. v. Watson Laboratories Inc. in June, affirming a District Court's determination in ANDA litigation that the generic challenger's product infringed under the doctrine, was a welcome surprise.

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

• "Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019)," November 27, 2019
• "Federal Circuit Issues Order Clarifying Status of Doctrine of Equivalents," September 5, 2019
• "Ajinomoto Co. v. International Trade Commission (Fed. Cir. 2019)," August 13, 2019
• "Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)," August 12, 2019
• "Amgen Inc. v. Coherus BioSciences Inc. (Fed. Cir. 2019)," August 11, 2019
• "Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2019)," July 24, 2019
• "UCB, Inc. v. Watson Laboratories Inc. (Fed. Cir. 2019)," July 16, 2019
• "Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2019)," May 12, 2019

9.  Federal Circuit Finds More Method of Treatment Patents Eligible

Following on the heels of its 2018 decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l, the Federal Circuit issued two more decisions concerning the patent eligibility of method of treatment claims in 2019.  In Vanda, which made our Top Stories list last year (coming in at #12), the Federal Circuit affirmed a District Court decision finding that the claims of U.S. Patent No. 8,586,610, which are directed to methods of treating a patient suffering from schizophrenia with iloperidone, were not invalid under 35 U.S.C. § 101.  In April, the Federal Circuit decided Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., reversing a District Court decision holding the claims of U.S. Patent No. 8,808,737, which are directed to methods of using oxymorphone to treat pain in patients with impaired kidney function, to be ineligible under 35 U.S.C. § 101.  In reversing the District Court, the Federal Circuit determined that the asserted claims of the '737 patent were legally indistinguishable from the claims at issue in Vanda.  Only a few weeks earlier, the Federal Circuit decided Natural Alternatives International, Inc. v. Creative Compounds, LLC, reversing and remanding a District Court decision granting a motion for judgment on the pleadings that the asserted claims of six patents, which relate to the use of beta-alanine in dietary supplements to increase the anaerobic working capacity of muscle and other tissue, were not patent eligible.  The United States closed 2019 by filing a brief in response to a Supreme Court order inviting the Solicitor General to express the views of the United States on the petition for certiorari filed by Petitioners Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Ltd. (previously West-Ward Pharmaceuticals International Ltd.) in Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc.  The Solicitor General concluded that Vanda "is not an optimal vehicle for bringing greater clarity because the court of appeals majority arrived at the correct result," noting that "[i]n cases involving medical-diagnostic methods, by contrast, the Federal Circuit's recent decisions suggest that the court might well have reached different outcomes if it were not bound by the Mayo framework."  The Solicitor General therefore recommended that "[t]he Court should await a case in which lower courts' confusion about the proper application of Section 101 and this Court's precedents makes a practical difference."  The Supreme Court is scheduled to discuss Hikma's petition at Conference on January 10, 2020.

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

• "Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals," December 8, 2019
• "Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019)," April 1, 2019
• "Natural Alternatives International, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019)," March 19, 2019

8.  Supreme Court: Prevailing Applicants Not Liable for USPTO's Attorney's Fees

Last month, in Peter v. NantKwest, Inc., the Supreme Court considered whether the U.S. Patent and Trademark Office could compel an aggrieved applicant to pay its attorney's fees in a § 145 review, regardless of who wins or loses.  The Court unanimously rejected the USPTO's arguments.  In doing so, the Court bolstered the "American Rule" on attorney's fees and preserved § 145 proceedings as a financially viable option for review of adverse Patent Trial and Appeal Board (PTAB) decisions.  The decision expressly considered only patent reviews, but it also applies to analogous reviews of trademark decisions.  Thus, it has impact on cases far more broadly than just § 145 proceedings.

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

• "Peter v. NantKwest, Inc. (2019)," December 11, 2019
• "Peter v. NantKwest: PTO Faces Skeptical Justices over Assessment of Fees," October 7, 2019
• "Supreme Court Grants Certiorari in Iancu v. NantKwest, Inc.," March 4, 2019

7.  Supreme Court: Federal Government Cannot Petition for Review in AIA Post-grant Proceedings

In June, the Supreme Court determined in Return Mail, Inc. v. United States Postal Service that federal government agencies cannot avail themselves of America Invents Act (AIA) post-grant proceedings.  This decision was based on the Court's determination that the government is not a "person" as that term is used in relation to inter partes review (IPR), post-grant review (PGR), and covered business method (CBM) proceedings.  To parties accusing the federal government of infringing their patents, the decision means that they will be free of AIA post-grant challenges from the accused agency.

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

• "Return Mail, Inc. v. United States Postal Service (2019)," June 10, 2019
• "Supreme Court Hears Oral Argument in Return Mail v. U.S. Postal Service," February 19, 2019

6.  Congressional Effort to Reform § 101 Slows

In April, Senator Thom Tillis (R-NC), Chair of the Senate Judiciary Subcommittee on Intellectual Property, and Senator Chris Coons (D-DE), Ranking Member, joined by Representative Doug Collins (R-GA-9), Ranking Member of the House Judiciary Committee, and Representatives Hank Johnson (D-GA-4), and Steve Stivers (R-OH-15), released a "bipartisan, bicameral framework on Section 101 patent reform."  A month later, the group released a draft bill proposing significant changes to 35 U.S.C. § 101 and the law of patent eligibility.  The draft bill would completely eliminate the notion of a judicial exception to patent eligibility as well as clarify that the § 101 inquiry is separate from those of §§ 102, 103, and 112.  In other words, patentable subject matter under the draft bill would likely be as broad or even broader than the "anything under the sun that is made by man" language of Diamond v. Chakrabarty.  In June, the Senate Subcommittee on Intellectual Property held hearings on its proposal to revise 35 U.S.C. § 101, and in particular the draft bill that was released in May.  Chairman Tillis and Ranking Member Coons (with an occasional third senator in the room) heard testimony from forty-five individuals representing a broad swathe of patent expertise including industry executives and groups, inventors, a former Federal Circuit judge, former U.S. Patent and Trademark Office officials, and law professors.  Following those hearings, Senators Tillis and Coons released a statement regarding their takeaway from the hearings.  If anything, their statement reflected an understanding that the law needs to change, the Senators are committed to doing so, and that they still need to work out the details.  Despite the whirlwind of activity in April, May, and June, legislative progress has slowed since Senators Tillis and Coons released their statement at the end of June, and the patent community awaits the Senators' next move.

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

• "Biotech Prospects for Patent Reform," June 26, 2019
• "Senators Tillis and Coons Release Statement on Recent Patent Reform Hearings," June 26, 2019
• "Senate Subcommittee on Intellectual Property Holds Hearings on Proposed Revisions to 35 U.S.C. § 101," June 17, 2019
• "ACLU (Predictably) Opposes Patent Subject Matter Eligibility Proposal," June 3, 2019
• "Senate Proposal for Section 101 Reform: Effect on Biotech/Pharma Inventions," May 23, 2019
• "Congress Proposes Draft Bill to Change 35 U.S.C. § 101," May 23, 2019
• "Congress Releases Framework for Section 101 Reform," April 17, 2019
• "Law Review Article Advocates Supreme Court's Patent Eligibility Law is Unconstitutional," February 20, 2019