Patent Case Summaries April 26, 2023

Patent Case Summaries | Week Ending April 21, 2023

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Amgen Inc. v. Sandoz Inc., et al., Nos. 2022-1147, -1149, -1150, -1151 (Fed. Cir. (D.N.J.) Apr. 19, 2023). Opinion by Lourie, joined by Cunningham and Stark.

Amgen produces and markets apremilast, a drug used for treating psoriasis and related conditions, and Amgen owns three patents covering the drug. After Sandoz submitted an Abbreviated New Drug Application seeking approval to market a generic version of apremilast, Celgene (the patent owner at the time) sued Sandoz for infringement. Amgen later acquired the patents and was substituted as the plaintiff.

Sandoz argued that the asserted claims of all three patents were invalid as obvious. As to the first patent, the district court held that Sandoz failed to establish that a skilled artisan would have had a reason or motivation to achieve the claimed invention with a reasonable expectation of success. The district court also relied on objective indicia of nonobviousness, including unexpected results, a long-felt but unmet need, and commercial success of the drug. As to the second patent, the district court held that Amgen met its burden of demonstrating a March 2002 priority date, which resolved the obviousness inquiry because Sandoz did not argue that art prior to March 2002 rendered the claims invalid. As to the third patent, the court held that the claims were invalid as obvious. Sandoz appealed as to the first and second patents, and Amgen cross-appealed as to the third.

The Federal Circuit affirmed. For the first patent, the Federal Circuit saw no clear error in the district court’s holding that Sandoz did not meet its burden of establishing that the prior art gave a skilled artisan reason or motivation to achieve the claimed invention, and failed to show that a skilled artisan would have had a reasonable expectation of success. The Federal Circuit also held that the district court did not err in its finding of strong objective indicia of nonobviousness. In particular, the Federal Circuit deemed the unexpected potency of apremilast “to be dispositive.” The court also affirmed the district court’s findings pertaining to the other objective indicia of nonobviousness.

For the second patent, the Federal Circuit ruled that the district court did not clearly err in finding that the claims were entitled to a March 2002 priority date based on the filing date of the provisional application. The provisional application actually disclosed the particular form of apremilast claimed in the patent. That ruling resolved the validity inquiry, as Sandoz did not present invalidating art prior to the March 2002 date.

Lastly, for the third patent, the Federal Circuit affirmed the determination that the claims were invalid as obvious. The district court had credited expert testimony establishing that it was well within a skilled artisan’s ability to titrate an apremilast dose for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis. The Federal Circuit noted that it has previously held that varying a dose in response to the occurrence of side effects is a well-known standard medical practice that may well lead to a finding of obviousness. The Federal Circuit accordingly saw no error in the district court’s obviousness finding.

View Opinion Inc. v. ITC, No. 2022-1228 (Fed. Cir. (ITC) Apr. 20, 2023). Opinion by Moore, joined by Prost and Hughes.

Corning Optical Communications filed an ITC complaint alleging FS violated 19 U.S.C. § 1337 by importing high-density fiber optic equipment that infringed four Corning patents. The ALJ issued an initial determination finding infringement of all four patents and finding that certain challenged claims are enabled, and the Commission upheld those determinations. The Commission also construed the claim term “a front opening” to mean “an opening located in the front side of a fiber optic module” and ruled that the term encompasses one or more openings. FS appealed.

The Federal Circuit affirmed both the finding of enablement and the challenged claim construction.

Regarding enablement, FS argued that claim language reciting “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” or “a fiber optic connection of at least one hundred forty-four (144) fiber optic connections per U space” is not enabled because the specification enables only up to 144 fiber optic connections per U space. The Federal Circuit stated that open-ended claims like those at issue here “may be supported if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.” The court ruled that substantial evidence supported the Commission’s finding that Corning’s claims have an inherent upper limit of about 144 connections per U space and that the specification enabled skilled artisans to approach that limit.

Turning to claim construction, the Federal Circuit rejected FS’s argument that “a front opening” should be limited to a single front opening. The Federal Circuit explained that, “generally, the terms ‘a’ or ‘an’ in a patent claim mean ‘one or more,’ unless the patentee evinces a clear intent to limit ‘a’ or ‘an’ to ‘one.’” The court held that the claim language and written description at issue here “do not demonstrate a clear intent to depart from this general rule.” Indeed, the specification disclosed embodiments with one or more front openings.

View Opinion

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