The US Court of Appeals for the Federal Circuit imposed limits on what the Patent Trial and Appeal Board (PTAB) is authorized to do by statute when dealing with challenged claims in an inter partes review (IPR) that it finds to be too indefinite to apply prior art. Samsung Elecs. Am., Inc. v. Prisua Eng’g Corp., Case Nos. 19-1169, -1260 (Fed. Cir. Feb. 4, 2020) (Bryson, J).
Executive Summary
Trademark jurisprudence in 2019 may be best summarized in two words: questions and answers. Decisions handed down at the district court level have teed up key questions that are poised to be answered by the United States Supreme Court in the 2020 term—such as the protectability of certain “.com” trademarks, as well as the standard for obtaining particular damages in trademark infringement disputes. For brand owners and trademark practitioners, 2019 will also go down as a year that provided answers to many important questions. For example, on numerous occasions in 2019, the Trademark Trial and Appeal Board answered questions as to whether certain designs or designations have the capability to function as a source-identifying trademark. The United States Patent and Trademark Office (USPTO) answered questions relating to the cannabis industry and how the 2018 Farm Bill would be applied in the review of US trademark applications listing goods or services for CBD products. And, the Supreme Court answered an important question for trademark licensees regarding their rights when a trademark licensor goes bankrupt. This report provides a summary of 2019’s most important questions and answers when it comes to trademark law, and serves as a useful guide for navigating trademark prosecution and enforcement efforts into the year ahead.
Trademarks
2020 Outlook
As we await further answers to our most pressing trademark questions in 2020, we anticipate that this year will bring unique opportunities to apply traditional tenets of trademark law to modern-day disputes and business considerations. So long as marketing efforts continue to incorporate influencers, short-form and interactive content, artificial intelligence, blockchain technologies, and other initiatives to elevate brand profiles, trademark practitioners and the courts will need to be creative in applying traditional interpretations of relevant trademark laws and policies to trademark protection strategies and infringement disputes. In 2020, the USPTO also will be forced to continue to address the ever-crowded brand space by furthering its crack-down on fraudulent trademark applications, clearing dead weight from the USPTO register, and maintaining its strict registrability and failure-to-function assessments to make room for new and growing brands. Finally, in 2020 and beyond, we expect that trademark considerations will continue to color other legal matters and disputes, including corporate transactions, data ownership and privacy, and bankruptcy and restructuring, thus showing the immense commercial value and power of brands.
The US Court of Appeals for the Federal Circuit expanded the Markush doctrine, determining that the claim language “comprising . . . [at least] . . . a group consisting of . . .” absent some basis or extrinsic evidence for limiting the group, such a group could capture an alleged infringement having an additional component present, as long as the additional component is “functionally similar” to the component identified in the Markush group limitation. ,Amgen Inc. v. Amneal Pharm. LLC, Case No. 18-2414 (Fed. Cir. Jan. 7, 2020) (Lourie, J).
Finding that inherency can be used to show the presence of a missing claim limitation, the US Court of Appeals for the Federal Circuit affirmed a district court decision that asserted claims in pain management method patents were invalid as obvious. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361 (Fed. Cir., Dec. 27, 2019) (Reyna, J.).
Persion has US Food and Drug Administration (FDA) approval for its extended release hydrocodone product, Zohydro ER, and also owns two patents directed to methods of treating pain with extended release hydrocodone in patients with mild to moderate hepatic impairment. Persion sued Alvogen for infringement of certain claims in these two patents after Alvogen filed an Abbreviated New Drug Application (ANDA) requesting approval from the FDA to market a generic version of Zohydro ER. The asserted claims include: (i) non-adjustment claims directed to administering a dose of hydrocodone to patients with mild to moderate hepatic impairment without adjusting the dose relative to a healthy liver patient, and (ii) pharmacokinetic claims directed to pharmacokinetic parameters achieved after treatment with hydrocodone.
The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).
EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.
Hospira appealed.
In a unanimous decision authored by Justice Sotomayor, the Supreme Court of the United States held that the US Patent and Trademark Office (PTO) is not entitled to recover its attorney’s fees in an appeal to a district court from an adverse decision of the Patent Trial and Appeal Board (PTAB) under 35 USC § 145. Peter v. NantKwest, Inc., Case No. 18-801 (Supr. Ct. Dec. 11, 2019) (Sotomayor, Justice).
The question posed in this case was:
[W]hether such “expenses” [in § 145 proceedings] include the salaries of attorney and paralegal employees of the United States Patent and Trademark Office (PTO).
The answer was a resounding “no.”
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