4.  Supreme Court Refuses to Grant Certiorari in American Axle v. Neapco Holdings

In May, there was a brief moment of hope in the patent community when the Solicitor General provided the government's views to the Supreme Court in an amicus brief in American Axle & Manufacturing, Inc., Petitioner v. Neapco Holdings LLC.  In the first sentences of the Discussion section of the brief, the Solicitor General writes:  "The court of appeals held that claim 22 of the '911 patent, which claims a method of manufacturing automobile driveshafts that uses specific mechanical structures and calibrates particular physical properties, is patent-ineligible under Section 101.  That holding is incorrect."  Thus, the Solicitor General expressed the government's view that the Supreme Court should grant certiorari with respect to Question 1 of the Questions Presented.  That moment of hope, however, was cut short by the Supreme Court in June, when the Court denied certiorari in American Axle, thereby refusing (once again) to address the morass in patent subject matter eligibility created by its decisions in Bilski v. Kappos; Mayo Collaborative Services v. Prometheus Laboratories; Alice Corp. v. CLS Bank International; and Association for Molecular Pathology v. Myriad Genetics, Inc.  For a Court whose political inclinations became more evident in 2022, the chorus of dissent regarding the state of subject matter eligibility law from the patent community, industry groups, the U.S. Patent and Trademark Office, members of Congress, half (at last count) of the judges on the Federal Circuit, and the Solicitor General has fallen on particularly deaf ears, the Court's refusal in American Axle being the latest.  To many, American Axle represented the Gordian Knot in patent-eligibility that had been unartfully tied by the Court with help from the Federal Circuit.  The case was possibly the best opportunity yet to clarify what was meant by the remarkably vague two-part test set forth in Alice.

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

• "In re Smith (Fed. Cir. 2022)," September 15, 2022
• "Think Twice About Appealing a § 101 Rejection to the PTAB," September 13, 2022
• "Realtime Adaptive Streaming LLC v. Netflix, Inc. (Fed. Cir. 2022)," July 31, 2022
• "USPTO Director's Blog Post Extolling Certainty in § 101 Determinations Paradoxically Increases Uncertainty," July 26, 2022
• "CareDx, Inc. v. Natera, Inc. (Fed. Cir. 2022)," July 19, 2022
• "The Supreme Court Sidesteps America's Patent Eligibility Crisis," June 30, 2022
• "Supreme Court Denies Cert in American Axle," June 30, 2022
• "Solicitor General Provides Government Views in American Axle & Mfg. Inc. v. Neapco Holdings Co.," May 24, 2022
• "Repifi Vendor Logistics, Inc. v. Intellicentrics, Inc. (Fed. Cir. 2022)," March 23, 2022
• "Mentone Solutions LLC v. Digi International Inc. (Fed. Cir. 2021)," February 8, 2022

3.  WTO Waiver Permits Use of COVID-19 Vaccine Patents -- But WTO Declines to Extend Waiver (For Now) to COVID-19 Diagnostics and Therapeutics

In March, it was reported that the United States, European Union, India, and South Africa had reached an agreement on a waiver with respect to patents for COVID-19 vaccines.  Progress on the compromise appeared to have been made during a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).  And then only a few months later, the World Trade Organization (WTO) Ministerial Conference issued a June 17 Ministerial Decision, which permits an eligible Member, defined as including all developing country Members, to "limit the rights provided for under Article 28.1 of the TRIPS Agreement . . . by authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic."  The "subject matter of a patent" is defined in the Decision as including the ingredients and processes necessary for the manufacture of COVID-19 vaccines.  Eligible Members can apply the provisions of the Decision until 5 years from the date of the Decision (i.e., June 17, 2027).  The Decision also included a provision that "[n]o later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics."  Despite a December request from nine delegations (Argentina, Bangladesh, Bolivia, Egypt, India, Indonesia, Pakistan, South Africa, and Venezuela) calling on the WTO General Council to extend the June 17 Decision to COVID-19 therapeutics and diagnostics, the WTO instead further extended the deadline to decide whether to extend the June 17 Decision.

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

• "WTO TRIPS Council Recommends That General Council Extend Waiver Deadline," December 18, 2022
• "Nine Countries Seek Extension of WTO Waiver to COVID-19 Therapeutics and Diagnostics," December 11, 2022
• "Status of Proposed Extension of TRIPS Waiver in WTO," December 8, 2022
• "C4IP Presents Webinar on COVID Waiver Extension," December 5, 2022
• "Moderna Sues Pfizer and BioNTech over mRNA Vaccine Technology," August 31, 2022
• "U.S. Trade Representative Releases 2022 Special 301 Report," April 28, 2022
• "U.S. Chamber of Commerce Supports House and Senate Legislation Prohibiting Biden Administration from Negotiating Modifications to WTO TRIPS Agreement Without Congressional Authorization," April 24, 2022
• "Senators Send Letter to Commerce Secretary Regarding WTO Waiver Compromise," March 28, 2022
• "The Proposed WTO IP Waiver: Just What Good Can It Do? -- An Analysis," March 24, 2022
• "IP Associations "Concerned" by Reports of TRIPS Waiver Compromise," March 24, 2022
• "More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise," March 21, 2022
• "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver," March 16, 2022

2.  Supreme Court to Address Scope of Disclosure Necessary to Satisfy Enablement Requirement of 35 U.S.C. § 112(a)

In November, the Supreme Court surprised the patent community by granting Amgen's petition for certiorari in Amgen v. Sanofi on the second of the Questions Presented in its petition:

2.  Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial "'time and effort,'" Pet.App. 14a [emphasis added].

This Question, and how the Court has been petitioned to address it, directly concerns the scope of disclosure necessary to satisfy the statutory requirements of 35 U.S.C. § 112(a), a question of particular importance for genus claims in pharmaceutical and biotechnology patents.  As always, it is impossible to discern the Court's reasoning for granting certiorari.  Here the Court will wade into a question that involves balancing the scope of genus claims and their preclusive preemptive effect on future development of related but not expressly disclosed species, on the one hand, and the need for a patentee of an invention capable of a multiplicity of (relatively) minor structural changes to be able to protect an invention from trivial infringers, on the other hand.  How this issue is addressed will likely make our top stories list for 2023.

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

• "Supreme Court Grants Certiorari in Amgen v. Sanofi," November 6, 2022

1.  Impact of Russian Invasion of Ukraine on Global Patent Systems

On February 24, 2022, Russia invaded Ukraine in a major escalation of the Russo-Ukrainian War, which began in 2014.  The invasion has resulted in tens of thousands of deaths on both sides.  It has caused Europe's largest refugee crisis since World War II, with 8 million Ukrainians being displaced within their country by late May, and more than 7.9 million having fled the country as of the beginning of the year.  Many countries imposed sanctions on Russia, affecting the economies of Russia and the world, and provided humanitarian and military aid to Ukraine, totaling over $80 billion from 40 countries as of August 2022.

The impact of the invasion was also felt by the global patent community.  In March, the U.S. Patent and Trademark Office announced that it had "terminated engagement with officials from Russia's agency in charge of intellectual property, the Federal Service for Intellectual Property (commonly known as Rospatent), and with the Eurasian Patent Organization [EAPO]," noting that the termination of engagement with Rospatent and EAPO was in keeping with guidance issued by the U.S. Department of State.  As part of that termination, the USPTO announced that it would no longer grant requests to participate in the Global Patent Prosecution Highway (GPPH) at the USPTO when such requests are based on work performed by Rospatent as an Office of Earlier Examination under the GPPH.  Russia responded to the actions of the USPTO and other patent offices by issuing a Resolution permitting uncompensated use of certain patents without patentee consent -- the patents at issue being held by patent holders who are "associated with foreign states" that commit "unfriendly actions" in relation to Russian legal persons and individuals.

In March, the Office of Foreign Assets Control (OFAC) of the U.S. Department of the Treasury issued a General License authorizing "U.S. persons . . . to pay taxes, fees, or import duties, and purchase or receive permits, licenses, registrations, or certifications" for a limited time when such activities relate to transactions involving the Central Bank of the Russian Federation ("Bank of Russia").  According to the General License, transactions that were "ordinarily incident and necessary to such persons' day-to-day operations in the Russian Federation" were authorized "through 12:01 a.m. eastern daylight time, June 24, 2022."  As a result of the General License, Applicants prosecuting applications before Rospatent or paying annuities on Russian patents would have had to make some difficult decisions regarding the prosecution of those applications and maintenance of those patents by June 24.  But in May, the U.S. Patent and Trademark Office announced that the OFAC's publication of General License No. 31 "authorize[d] certain intellectual property-related transactions in Russia, including the filing and prosecution of any application to obtain a patent, trademark, or copyright, as well as renewal and maintenance fees."  Shortly after the USPTO's announcement, the Intellectual Property Owners Association (IPO) noted that General License No. 31 "clarifies previously issued General License No. 13, which left unresolved whether such payments constituted permissible 'payments for registrations, certifications, and licenses to conduct day-to-day operations' or were prohibited by Russian Harmful Foreign Activities Sanctions Regulations."

Shortly after Russia invaded Ukraine, the Ukrainian Institute of Intellectual Property (Ukrpatent) issued a statement declaring "that during this extremely difficult time for the country, during the military aggression of the Russian Federation against Ukraine, which became the reason for the imposition of martial law . . . the State Enterprise 'Ukrainian Institute of Intellectual Property' (Ukrpatent) continues to operate on a full-time basis providing all the necessary functions and continuous operation of the state system of legal protection of intellectual property."  Although the functions of the National Intellectual Property Authority from Ukrpatent were transferred to the Ukrainian National Office of Intellectual Property and Innovation (UANIPIO) in November (as part of Ukrainian IP reform begun in 2016; see announcement on UANIPIO website), patent protection in Ukraine has not ceased as a result of the conflict.

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

• "USPTO News Briefs," June 6, 2022 (Rospatent terminated as ISA/IPEA)
• "Treasury Department Issues General License Authorizing Certain Transactions Related to Patents, Trademarks, and Copyrights," May 10, 2022
• "U.S. Trade Representative Releases 2022 Special 301 Report," April 28, 2022
• "Treasury Department Authorizes Transactions Involving Bank of Russia Until June 24, 2022," April 10, 2022
• "USPTO News Briefs," April 4, 2022 (Rospatent PPH termination)
• "USPTO Provides Advice Regarding Dealings with Rospatent," March 22, 2022
• "Georgian and Estonian Patent Offices Join Other IP Offices in Expressing Support for Ukraine," March 13, 2022
• "Several Law Firms Close Russian Offices," March 13, 2022
• "Lithuanian Patent Office and EUIPO Join Other Patent Offices in Expressing Support for Ukraine," March 11, 2022
• "Russia Permits Uncompensated Use of Certain Patents without Patentee Consent," Match 11, 2022
• "Lithuanian Patent Office and EUIPO Join Other Patent Offices in Expressing Support for Ukraine," March 10, 2022
• "USPTO Terminates PPH with Rospatent and Terminates Engagement with NCIP," March 10, 2022
• "Life Sciences Business Leaders Call for Immediate and Complete Economic Disengagement from Russia," March 9, 2022
• "PRH Joins Other Patent Offices in Expressing Support for Ukraine," March 9, 2022
• "USPTO Terminates Engagement with Rospatent and EAPO," March 7, 2022
• "Ukrpatent Continues Normal Operations Despite Russian Aggression," March 6, 2022