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.

Honeywell Int’l Inc. v. Arkema Inc., et al., Nos. 2018-1151, -1153 (Fed. Cir. (PTAB) Oct. 1, 2019). Opinion by Reyna, joined by Newman and Hughes.

The Federal Circuit held that the Patent Trial and Appeal Board abused its discretion by rejecting Honeywell’s request for authorization to file a motion for leave to petition the Director for a Certificate of Correction.

During post-grant review proceedings involving a Honeywell patent, Honeywell discovered that, during prosecution of the challenged patent, it inadvertently failed to make certain amendments to the list of priority applications. Honeywell became aware of the mistake after institution, at which time it sought authorization to file a motion for leave to request a Certificate of Correction under 35 U.S.C. § 255. The Board denied Honeywell’s request, and the proceedings continued until the Board issued a final written decision finding the challenged claims unpatentable. Honeywell appealed.

The Federal Circuit held that “the Board abused its discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate.” As the Federal Circuit explained, § 255 “does not grant the Board authority to determine whether a mistake in an issued patent is of ‘minor character’ or ‘occurred in good faith.’ That authority is expressly granted to the Director.” The Federal Circuit therefore vacated the Board’s final written decisions and remanded.

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American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, et al., No. 2018-1763 (Fed. Cir. (D. Del.) Oct. 3, 2019). Opinion by Dyk, joined by Taranto. Dissenting opinion by Moore.

American Axle & Manufacturing (AAM) sued Neapco for infringement of a patent directed to a method for manufacturing driveline propeller shafts with liners that are designed to attenuate vibrations transmitted through a shaft assembly. The parties filed cross-motions for summary judgment as to the eligibility of the asserted claims under 35 U.S.C. § 101. The district court held that the asserted claims are ineligible because they “are directed to laws of nature: Hooke’s law and friction damping,” and because additional claimed steps were “well-understood, routine, conventional” steps that “add nothing significant beyond the sum of their parts taken separately.” AAM appealed.

The Federal Circuit affirmed, stating that the claims are directed to the application of Hooke’s law. The court rejected AAM’s contrary arguments because “the elements of the method here that AAM argues take the patent outside the realm of ineligible subject matter … are not actually claimed in claim 1 or claim 22 of the patent,” and “these unclaimed features cannot function to remove claims 1 and 22 from the realm of ineligible subject matter.” The court continued: “What is missing is any physical structure or steps for achieving the claimed result of damping two different types of vibrations. The focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work.” Additionally, the Federal Circuit agreed with the district court that “nothing in the claims qualifies as an ‘inventive concept’ to transform the claims into patent eligible matter.”

Judge Moore dissented on the basis that “the majority’s decision expands § 101 well beyond its statutory gate-keeping function and the role of this appellate court well beyond its authority.” In her view, the majority relied on § 101 even though “the majority’s concern with the claims at issue has nothing to do with a natural law and its preemption and everything to do with concern that the claims are not enabled.” Judge Moore noted that, “We cannot convert § 101 into a panacea for every concern we have over an invention’s patentability, especially where the patent statute expressly addresses the other conditions of patentability and where the defendant has not challenged them.”

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OSI Pharmaceuticals, LLC v. Apotex Inc., et al., No. 2018-1925 (Fed. Cir. (PTAB) Oct. 4, 2019). Opinion by Stoll, joined by Newman and Taranto.

The Federal Circuit reversed the Patent Trial and Appeal Board’s determination that certain method-of-treatment claims would have been obvious over “Schnur” in view of “Gibbs” or OSI’s 10-K. 

In an IPR, Apotex challenged the patentability of claims directed to a method of treating non-small cell lung cancer (NSCLC) by administering a therapeutically effective amount of a pharmaceutical compound known as erlotinib. The Board determined that the challenged claims would have been obvious over Schnur in view of Gibbs or OSI’s 10-K. First, Schnur discloses 105 different compounds, including erlotinib, with therapeutic uses for treating human tumors, but without discussion of NSCLC. Next, Gibbs is a review article stating that “ZD-1839” and erlotinib “appear to have good anti-cancer activity in preclinical models, … particularly in patients with non-small cell lung cancer.” However, the Federal Circuit explained that, of the two articles cited in support of this statement, one “does not discuss erlotinib at all,” and the other “does not discuss NSCLC at all.” Finally, OSI’s 10-K describes erlotinib as targeting NSCLC but “discloses no data regarding erlotinib’s effect on NSCLC.”

The Federal Circuit ruled that, when the references are properly read, the Board’s finding that they would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal is not supported by substantial evidence. “As an initial matter, in reaching its conclusion, the Board misinterpreted the asserted references to teach more than substantial evidence supports.” The references “do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC,” and it was undisputed that NSCLC treatment was highly unpredictable. The Federal Circuit emphasized that the statement in Gibbs—a review article—relied on by Apotex was not supported by the articles that Gibbs cited. The Federal Circuit explained that, “reading Gibbs in the context of its cited articles reveals that [the noted] statement cannot be referring to erlotinib.” Moreover, the Federal Circuit observed that Gibbs, Schnur, and OSI’s 10-K “do not disclose any information about erlotinib’s efficacy in treating NSCLC in a mammal.” Properly viewed, the references “provide no more than hope.”

The Federal Circuit emphasized that, “To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’” But “on these particular facts, a reasonable fact finder could not find a reasonable expectation of success.” The Federal Circuit therefore reversed the Board’s finding of unpatentability of the challenged claims based on obviousness.

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