Precedential and Key Federal Circuit Opinions

1.  TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes)

Prost, J. The Court affirmed the district court’s order to delist from the Orange Book certain patents directed to components of a metered inhaler device. In order to be listed in the Orange Book, a patent must both claim the drug and be infringed by the NDA product. The fact that an NDA could infringe a patent does not mean that the patent “claims” the underlying drug within the meaning of the listing provision. The Court also explained that for a patent to “claim the drug[] for which the applicant submitted the application,” such a patent must claim at least the active ingredient identified in the application. Patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application. 

2.  HONEYWELL INTERNATIONAL INC. v. 3G LICENSING, S.A. [OPINION] (2023-1354, 01/02/2025) (Dyk, Chen, Stoll)

Dyk, J. The Court reversed the decision of the Patent Trial and Appeal Board declining to hold certain challenged claims unpatentable as obvious. The Court explained that the Board improperly concluded that a person of ordinary skill in the art would not have been motivated to modify the prior art because the patent’s main objective was to solve a different goal. The problem motivating the patentee may be only one of many addressed by the patent’s subject matter and any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed. Additionally, the Court held the Board’s finding that the IPR petitioners had not sufficiently shown motivation to combine was not supported by substantial evidence, where the Board ignored an expert’s unrebutted statement. The Court also explained that the Board’s decision appeared to conflate the relevant standards for obviousness and anticipation by finding it significant that the prior art reference did not propose the modification. The Court also found that the Board erred in finding no motivation to combine because of uncertainty as to which modification would be best. The claimed modification needed only to be desirable in light of the prior art and not the “best” or “preferred” approach.

3.  NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC. [OPINION] (2023-2218) (Lourie, Prost, Reyna)

Lourie, J. The Court reversed the district court’s determination that the claims lack an adequate written description and affirmed the determinations that the claims were not shown to be invalid as either non-enabled or obvious. The Court found adequate written description and enablement of what was expressly claimed, namely a combination of two drugs, and it was error to focus the inquiry on description or enablement of later-discovered complexes of such drugs. Such complexes were not expressly claimed, and while they may have improved upon the basic or underlying invention claimed in the patent, they cannot be used to “reach back” and invalidate the asserted claims. The Court saw no clear error warranting reversal of the district court’s obviousness analysis based on its factual findings or applications of law.

4.  BEARBOX LLC v. LANCIUM LLC [OPINION] (2023-1922) (Chen, Bryson, Stoll)

Stoll, J. The Court affirmed the district court’s dismissal of plaintiff’s state law conversion claim, the district court’s exclusion of a supplemental expert report, and the district court’s denial of inventorship. The Court found the conversion claim preempted by federal law because the conversion claim, as pled, was essentially an inventorship cause of action and patent infringement cause of action, and thus sought “patent-like protection” for ideas that are unprotected under federal law. The Court found that the district court did not abuse its discretion in finding a supplemental expert report untimely, nor in concluding that the Pennypack factors supported its decision. The Court also found that the district court’s inventorship determination was not erroneous where plaintiff failed to prove by clear and convincing evidence that the alleged inventor either conceived of, or communicated prior to the named inventor’s independent conception, the subject matter of any claim of the patent.

5.  LYNK LABS, INC. v. SAMSUNG ELECTRONICS CO., LTD. [OPINION] (2023-2346) (Lourie, Prost, Stark)*

Prost, J. The Court affirmed the Board’s unpatentability determinations. The Court held that a published patent application, which is a “printed publication” under § 102(e)(1), is prior art as of a time before it became publicly accessible—as of its filing date. The Court then agreed that the plain and ordinary meaning of “a plurality of LEDs connected in series” may include individual LEDs connected in series or groups of LEDs connected in series because both include a “plurality of LEDs” connected in series, and found that substantial evidence supports the Board’s finding that the prior art disclosed this claim limitation. The Court also agreed that, in view of the specification, a forward voltage of the LEDs of the LED circuit array “matches” the rectified input AC voltage output of the driver encompasses voltage that is less than a forward voltage of the LEDs of the LED circuit.

*WilmerHale represented amicus curiae Intel Corporation in the appeal. For more on this case, see WilmerHale’s client alert, “Federal Circuit’s Decision Confirms That Published Patent Applications Are Prior Art In IPRs As Of Their Filing Date.”