Judge Sleet Denies Motion to Dismiss Citing Factual Dispute on Patent-Eligibility of Subject Matter

April 28, 2016

Publication| Intellectual Property

In Bristol-Myers Squibb Co., et al. v. Merck & Co., Inc., et al., C.A. No. 15-560-GMS (D. Del. Mar. 17, 2016), Judge Sleet denied the defendants’ 12(b)(6) motion to dismiss the patent infringement suit for failure to state a claim.  After considering the defendants’ argument that the patent claimed ineligible subject matter under 35 U.S.C. § 101, the Court permitted the suit to continue, concluding that the defendants failed to prove that the patent-in-suit was invalid on its face.

The action concerned a patent for lung cancer treatment.  Specifically, the patent claimed treatment for lung cancer by using antibodies that inhibit signals of cancer cells in the body.  Defendant Merck argued that the patent related to a natural phenomenon regarding the immune system, and that patent claims are unable to transform such natural phenomenon into a patent-eligible invention because they do not contain an inventive concept.  According to Merck, because the patent claimed “the natural operation of the body’s immune system via the PD-1 pathway,” the patent merely offers an “administering step” similar to the one deemed patent ineligible in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1298 (2012).  As such, Merck argued that Bristol-Myers Squibb’s patent was not valid.

In response, Bristol-Myers Squibb distinguished the patent-in-suit as a “method treatment claim” that relies on the body’s response to cancer, just like all other methods of therapeutic treatment that rely on “the biological activity of a patient’s immune system” at some level.  However, the patent also added the step of administering PD-1 antibodies to induce the body’s immune response against the cancer-related proteins that inhibit white blood cells from working.

While Judge Sleet rejected Bristol-Myers Squibb’s contention that the patent did not touch on a natural phenomenon, he concluded that material factual disputes existed regarding whether the claims do more than describe natural occurrences, instead relying on natural law but adding to it enough to render their processes patent-eligible.  Referring to the need for discovery to make such a complicated factual determination, Judge Sleet held that dismissal of the complaint would be inappropriate.

Analysis: The Court will rule on early 101 motions in some cases but allow discovery to proceed in others before considering the issue at the Rule 56 stage.

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