Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd., Appeal No. 2019-2050 (Fed. Cir. July 14, 2020)

In this week’s Case of the Week, the Federal Circuit addressed inventorship issues in a series of United States patents covering methods for treating cancer. The treatments arose from Dr. Tasuku Honjo’s Nobel Prize-winning discovery of an inhibitory receptor on T cells, PD-1, which operates to inhibit T cell activity when it binds to one of its ligands such as PD-L1 or PD-L2. These ligands are expressed by some cancer cells, and the claimed treatments covered the use of antibodies to block the PD-1/PD-L1 receptor-ligand interaction, effectively stimulating the immune response against tumor cells that would otherwise have been hidden by their expression of the ligands.

At issue was whether the patents should have named as co-inventors Dr. Gordon Freeman and Dr. Clive Wood, with whom Dr. Honjo collaborated throughout the 1990s to explore the role of PD-1 in the immune system. Among other contributions, Drs. Freeman and Wood discovered the PD-L1 ligand; Dr. Wood discovered that PD-1/PD-L1 binding inhibits the immune response; Drs. Freeman and Wood discovered that anti-PD-1 and anti-PD-L1 antibodies can block the pathway’s inhibitory signal; and Dr. Freeman performed immunohistochemistry experiments confirming that PD-L1 is expressed by various tumors. The district court considered these to be significant contributions to the conception of the claimed inventions, and determined that Dr. Freeman and Dr. Wood were co-inventors of the claimed treatments.

The decision was appealed by Ono Pharmaceutical Co., an assignee of Dr. Honjo’s rights in the patents in suit. Ono argued that the claimed treatments covered the use of specific antibodies developed through Dr. Honjo’s and others’ in vivo experiments with mice in the early 2000s, and that Drs. Freeman and Wood’s earlier work was too speculative and generalized to have contributed significantly to the particular claimed methods. Ono also argued that Drs. Freeman and Woods’ work was published prior to these experiments, and so should no longer qualify as a significant contribution to conception, and that the patents in suit had issued over a provisional patent application relating to Drs. Freeman and Woods’ work, demonstrating that the patents were novel and non-obvious over their individual contributions.

The Federal Circuit rejected Ono’s arguments, and affirmed the decision of the district court. The Court explained that Ono’s reasoning would result in an unnecessarily heightened joint inventorship standard, requiring each joint inventor to individually have conceived the complete invention and participated in a particular moment of conception. Instead, the law requires only that each joint inventor contribute in some significant manner to the conception or reduction to practice of the invention, even if the contribution may be less than other inventors’ and they are not physically working together on the invention at the same time. As such, the fact that Drs. Freeman and Wood were not present for certain experiments leading to the claimed methods was immaterial to their status as joint inventors.

The Court found Ono’s argument concerning Drs. Freeman and Woods’ provisional application to be irrelevant, explaining that joint inventorship does not depend on whether a claimed invention is novel or nonobvious over a particular researcher’s contribution, which is simply not probative of whether the collaborative research efforts led to the inventions or whether each researcher’s contributions were significant to their conception.

The Court also declined to adopt Ono’s reasoning that research made public before the conception of a total invention cannot qualify as a significant contribution to that invention. The Court held that while earlier publication of an invention may be a potential hazard to patentability, and simply informing an inventor about the state of the prior art does not make one a joint inventor, a collaborative enterprise is not negated by a joint inventor disclosing something less than the total invention to others. The Federal Circuit found that to be especially true in this case, where the collaborators had worked together for a year prior to the disclosure, which occurred just a few weeks prior to the alleged conception of the total invention. In such circumstances, the Court found no principled reason to discount genuine contributions to conception just because portions of that work were published prior to conception for the benefit of the public.

Finally, the Court rejected Ono’s arguments that because certain claims were directed only to specific PD-1 antibodies to inhibit the receptor on the T cell, without reference to PD-L1, Drs. Woods and Freeman’s work concerning the PD-L1 ligand could not have been a significant contribution to those claims. The Federal Circuit found that Dr. Honjo’s discovery of the PD-1 receptor was itself insufficient for him to have conceived of the claimed methods, because unless one knows that the PD-1 receptor binds to a ligand such as PD-L1 to inhibit the immune response, there would be no reason to use anti-PD-1 antibodies to treat tumors. As such, the Court found that the claims did not need to expressly recite PD-L1 for Dr. Freeman’s and Dr. Woods’ work on the PD-1/PD-L1 interaction to have significantly contributed to conception of those claims.

The opinion can be found here.

By Jason A. Wrubleski


Mayborn Grp., Ltd. v. ITC, Appeal No. 2019-2077 (Fed. Cir. July 16, 2020)

In a case arising from the International Trade Commission, the Court upheld an exclusion order against a party that was not party to original litigation concerning the patent at issue. After finding infringement of the patent at issue, the ITC issued a general exclusion order (GEO). The patent owners notified Mayborn of the proceedings in October 2018, but Mayborn took no action. After the GEO had issued, the patent owners notified Mayborn that its products infringed the patent in violation of the GEO. Mayborn then petitioned the ITC to rescind the GEO under a rule that allows the Commission to rescind or modify an order if “the conditions which led to such exclusion from entry or order no longer exist.” The ITC denied the petition, and Mayborn appealed the denial of the petition. The Court found that Mayborn had standing to appeal, but affirmed the ITC because Mayborn had not presented a change in conditions as required by the relevant statute.

The opinion can be found here.

By Nika Aldrich

Packet Intelligence, LLC v. NetScout Systems, Inc., Appeal No. 2019-2041 (Fed. Cir. July 14, 2020)

In this appeal from the U.S. District Court for the Eastern District of Texas, the Federal Circuit deals with issues relating to, among other things, pre-suit damages and patent marking requirements. After finding NetScout’s products infringe the patents-at-issue, one of which was subject to the marking requirements of 35 U.S.C. § 287(a), the district court awarded Packet Intelligence pre-suit damages. NetScout appealed that award, asserting that Packet Intelligence’s licensees failed to properly mark their products. The Court agreed with NetScout and reversed the district court’s award of pre-suit damages. First, it explained that the alleged infringer holds the initial burden of production to articulate the products it believes are unmarked “patented articles.” The low bar of that burden is met by simply notifying the patentee that certain licensees sold specific unmarked products that the alleged infringer believes practice the patent. The burden then shifts to the patentee to prove the identified products do not practice the patent. The Court held that NetScout met its initial burden, but that Packet Intelligence failed to then prove the identified products did not practice the patent. Evidence that the inventors removed from their patent application any reference to the identified products did not support an inference that those products do not practice the patent. And a witness’s conclusory testimony failing to address which claim limitations were purportedly missing from the products is similarly insufficient to meet the required burden.

The Court also held that Packet Intelligence could not preserve the award of pre-suit damages with evidence of direct infringement of two method patents (which are not subject to the marking statute’s requirements). Method claims are not directly infringed by the mere sale of an apparatus capable of performing the claimed process; rather, to prove infringement, one must produce evidence that the claimed method was actually used and, thus, infringed. Because Packet Intelligence failed to properly mark certain infringing products, the Court held that it cannot circumvent § 287 and include those products in its royalty base simply by arguing that infringement of related method claims drove sales of those products.

The opinion can be found here.

By Erin M. Forbes

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