Patent Case Summaries January 15, 2020

Patent Case Summaries | Week Ending January 10, 2020

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. Amneal Pharmaceuticals LLC, et al., Nos. 2018-2414, 2019-1086 (Fed. Cir. (D. Del.) Jan. 7, 2020). Opinion by Lourie, joined by Newman and Taranto.

Amneal, Piramal, and Zydus filed Abbreviated New Drug Applications (ANDA) seeking to enter the market with a generic version of Amgen’s Sensipar®, a formulation of cinacalcet hydrochloride used to treat certain hyperparathyroidism conditions. Amgen filed suit alleging that the proposed ANDA products would infringe Amgen’s patent. The district court construed the claims and held a bench trial on the issue of infringement, ruling that Amneal and Piramal do not infringe but that Zydus infringes certain claims.

On appeal, the Federal Circuit first addressed claim construction of two Markush groups. The claims use a “comprising” transition phrase, and one of the subsequent limitations requires a component that “consists of” items listed in a Markush group, causing the parties to dispute whether the group is closed to unrecited constituents. The Federal Circuit held that this language “does not forbid infringement of the claim if an additional component is present [and] functionally similar to the component identified in the Markush group limitation, unless there is a further basis in the claim language or other intrinsic evidence for precluding the presence of such additional components.” The court determined that “there is no such basis here.”

Turning to infringement, the Federal Circuit vacated the district court’s ruling as to Amneal because the presence of unlisted ingredients did not necessarily indicate that Amneal’s product does not infringe. As to Piramal, the Federal Circuit affirmed the district court’s finding of noninfringement because prosecution history estoppel barred Amgen from claiming an equivalent binder in the accused product. As to Zydus, the Federal Circuit affirmed the district court’s finding of infringement because the court did not err in relying on particular expert testimony. 

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Hospira, Inc. v. Fresenius Kabi USA, LLC, Nos. 2019-1329, -1367 (Fed. Cir. (N.D. Ill.) Jan. 9, 2020). Opinion by Lourie, joined by Dyk and Moore.

After Fresenius filed an Abbreviated New Drug Application seeking approval to market a generic version of Hospira’s dexmedetomidine product, Hospira filed suit for patent infringement. As pertinent here, Fresenius stipulated to infringement of one patent claim, and the district court held a bench trial on its validity, ultimately finding the claim obvious.

The Hospira patent at issue is directed to pharmaceutical compositions comprising dexmedetomidine, a drug used as a sedative. The district court found that the preferred embodiment, containing 4 µg/mL dexmedetomidine, was expressly taught in the prior art. The primary dispute centered on a claim limitation requiring no more than about a 2% decrease in the concentration of dexmedetomidine when stored in a glass container for at least five months. In finding obviousness, the district court relied on post-priority date data to analyze whether the limitation was inherent in the prior art. 

On appeal, the Federal Circuit affirmed the invalidity ruling because the district court’s factual findings were not clearly erroneous and supported a conclusion of obviousness. The Federal Circuit saw no error in the district court’s reliance on data obtained after the priority date for its inherency analysis. The Federal Circuit also ruled that any error in the district court’s analysis, by conflating the “necessarily present” inherency standard with the “reasonable expectation of success” obviousness standard, was harmless.

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Genentech, Inc. v. Hospira, Inc., et al., No. 2018-1933 (Fed. Cir. (PTAB) Jan. 10, 2020). Opinion by Chen, joined by Prost. Dissenting opinion by Newman.

Genentech owns a patent directed to methods of purifying antibodies and certain other proteins from impurities by “protein A affinity chromatography.” Hospira challenged certain claims via IPR, and the Patent Trial and Appeal Board held the claims unpatentable as anticipated or obvious.

Addressing the Board’s anticipation finding, the Federal Circuit explained that “a prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range.” In such cases, the court “must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention.” Applied here, the Federal Circuit ruled that substantial evidence supported the Board’s finding that the prior art’s disclosure was “within the claimed temperature range.” Also, Genentech did not challenge the Board’s finding that the claimed temperature range was not critical to performing protein A chromatography.

Addressing the Board’s obviousness determination, the Federal Circuit noted that “even a slight overlap in range establishes a prima facie case of obviousness.” The overlap creates a presumption of obviousness, requiring the patentee to demonstrate that “there is something special or critical about the claimed range” or that the process parameter was not “result-effective.” The Federal Circuit analyzed the evidence and the Board’s findings and ruled that the obviousness findings were supported by substantial evidence.

Finally, the Federal Circuit addressed a constitutional challenge to the IPR process. Genentech argued that retroactive application of IPR to a patent issued prior to the AIA violates the Fifth Amendment’s Takings Clause. The Federal Circuit disagreed. Applying the recent Celgene opinion, the Federal Circuit stated that “application of IPR to Genentech’s patent, on grounds that were available for Patent Office reconsideration when the patent was issued and under the same burden of proof, does not create a constitutional issue.”

Judge Newman dissented because, in her view, substantial evidence does not support the Board’s conclusions. She explained that the majority made “a hindsight determination” since “no prior art shows the claimed method, or suggests that it should be attempted or that it might be successful.” The patented solution “was not known or obvious to the scientists who were attempting to solve the problem,” and “the experts for both sides agreed that the solution … was new to them.”

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Personal Audio, LLC v. CBS Corp., No. 2018-2256 (Fed. Cir. (E.D. Tex.) Jan. 10, 2020). Opinion by Taranto, joined by Moore and Reyna.

Personal Audio sued CBS for infringement of a patent that describes a system for organizing audio files, by subject matter, into “program segments.” A jury found in favor of Personal Audio on infringement and validity as to three claims of the patent. Prior to the district court’s entry of judgment, however, the Patent Trial and Appeal Board issued a final written decision in an IPR finding the same claims to be unpatentable. In a prior appeal, the Federal Circuit affirmed the Board. The district court therefore asked Personal Audio and CBS how they wished to proceed, and the parties agreed that CBS was entitled to judgment in its favor. Personal Audio then appealed that judgment.

The Federal Circuit affirmed, addressing two possible scenarios. First, the Federal Circuit ruled that to the extent that Personal Audio challenges the Board’s final written decision, “the district court lacked jurisdiction to consider the challenges, and we have no jurisdiction to review them on appeal from the district court’s judgment.” 

Second, to the extent that Personal Audio challenges the district court’s determination of the consequences of the prior appeal and its effect on this case, “Personal Audio conceded that governing precedent required judgment for CBS.” Therefore, “Personal Audio forfeited any argument that existing precedent allows this panel to do anything but reject” such challenges. The court explained that the panel “lacks authority to reconsider the precedent that Personal Audio agrees was adverse and controlling. Only the en banc court may reconsider this precedent within this court.”

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