patent litigation

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In what is certain to become a landmark decision, the Federal Circuit has resolved a long-standing question that divided patent litigators and judges alike: does IPR estoppel apply to physical systems (“system art”) described in patents or printed publications? The Court answered with a resounding “no.” See Ingenico Inc. v. IOENGINE (“Op.”). While such systems may qualify as prior art under 35 U.S.C. §§ 102 or 103, the Court reaffirmed that “Congress excluded [them] in IPR proceedings.” Id. at 13.

The Supreme Court recently declined to review a Federal Circuit decision that could have significant implications for patent owners that rely on the Amazon Patent Evaluation Express (“APEX”) program.  

The APEX program offers a streamlined way for utility patent owners to request removal of allegedly infringing product listings on Amazon.com, without filing a suit in district court. To initiate the process, the patent owner identifies up to 20 product listings that allegedly infringe one claim of a patent. Amazon then notifies the sellers, who may (1) agree to an independent infringement analysis by a neutral third party, (2) engage with the patent owner directly to resolve the dispute, (3) file a declaratory judgment action in U.S. district court, or (4) do nothing—at which point Amazon removes the product listings.

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell, LLC, the Court affirmed the Patent Trial and Appeal Board’s inter partes review final written decision in favor of the patent owner, Jadi Cell, LLC, upholding claims in U.S. Patent No. 9,803,176 (the “ ’176 Patent”) directed to stem cells derived from umbilical cord subepithelial layer (“SL”) tissue with specific cell marker expressions (“Claimed Cells”).

Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences, and consumer electronics industries. With the power to block infringing products from entering the U.S., the ITC has become an increasingly attractive option for patent holders seeking swift and decisive remedies. 

Mirror Worlds Technologies, LLC (“Mirror Worlds”) sued Meta Platforms, Inc. (“Meta”)—formerly Facebook, Inc.—in the Southern District of New York for patent infringement. The lawsuit involved three patents related to storing, organizing, and presenting data in time-ordered streams. These patents purportedly introduced a unique method for automatically storing documents in chronological order with timestamps. Mirror Worlds accused several Facebook features, including the News Feed, Timeline, and Activity Log, of infringing these patents.

As generative artificial intelligence (AI) continues to transform industries, its impact on patent law is raising critical legal questions. From the recognition of AI as an inventor and potential infringement risks posed by the AI-generated outputs to the use of AI in patent validity challenges, the legal landscape is rapidly evolving. This article explores how generative AI is reshaping patent litigation, including the legal implications for inventorship, infringement and validity.

In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art combination that taught the claimed elements but lacked an indication of success. Ultimately, the Federal Circuit found that the patent’s success where the prior art failed – inactivation of the bacteria without a photosensitizer did not support a finding of obviousness.

The Federal Circuit recently reversed a jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno Therapeutics, Inv. v. Kite Pharma, Inc.. This case further builds on the application of the written description requirement to claims that recite functional limitations, and is instructive to patent prosecutors.

Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation.  After all, communications with regulatory bodies are often performed by non-attorneys who may not appreciate the consequences of their statements in future litigation. And while in ideal circumstances the patentee’s attorneys will ensure accurate and consistent communications and try to put potentially inconsistent statements in context, it is not always possible to do so once the genie is out of the bottle. Belcher Pharmaceuticals, LLC v. Hospira, Inc., exemplifies the dire consequences that can result from inconsistent communications with regulators—particularly if a defendant can point to a single source for those communications.