Endo v. Actavis: Court Adopts Magistrate's Recommendation Finding Drug Method of Use Claims Facially Invalid Under 35 USC 101

In a September 28, 2015 post I reported on Endo v. Actavis, wherein a magistrate judge’s Report and Recommendation from a magistrate judge in the District of Delaware recommending invalidation of a drug method of treatment patent for patent ineligibility on a motion to dismiss under Rule 12(b)(6).  The magistrate judge essentially found the claim to be highly analogous to method of treatment claims found to be patent ineligible by the Supreme Court in Mayo v. Prometheus, and in my post I explained why the decision was consistent with my long-standing concern that an expansive interpretation of the literal language of Mayo threatened the validity of drug method of use claims in general.

In a November 17, 2015, Order Adopting Report and Recommendation, the district court judge hearing the case adopted the magistrate judge’s recommendation in its entirety and dismissed Endo’s Counts relating to infringement of U.S. Patent No. 8,808,737 (the '"737 patent"), finding the patent to be “facially invalid.”

 The district court judge rejected several arguments made by Endo in support of patent eligibility of the claims.

Of particular significance to the patentability of method of use claims in general, Endo argued “that the Magistrate Judge's reliance on the similarities between the '737 patent's representative claim and the claim involved in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), was in error because the claim at issue in Mayo did not require that anyone act upon or apply the method in a tangible way, while claim 1 of the '737 patent actually requires that the lower dose be administered.”  As I mentioned in my previous post, many of us have held out hope that even post-Mayo a method of treatment claim that explicitly recites administration of the drug to a patient would remain patent eligible.  The district court judge, however, agreed with the magistrate judge’s conclusion that “limitations at issue in Mayo do in fact mirror the analogous limitations of Claim 1 of the '737patent.” 

The court considered the following side-by-side comparison of the language of the Mayo and Endo claims: "indicates a need to [increase/decrease] the amount of said drug subsequently administered to said subject"(Mayo) vs. "orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief"(Endo), and concluded that the “slight difference in phrasing is immaterial, because neither formulation provides any sort of 'inventive concept.'"

The court further found Endo’s argument that the '737 patent does not claim a law of a nature, but rather"a new and useful process," to be “thoroughly unconvincing.”  The district court found that Endo had essentially admitted in their briefing that the '737 patent claims a natural law as its invention based on the following statement by Endo: “[I]t is true that the claimed inventions relate to the unexpected discovery that the bioavailability of oxymorphone is increased in patients with renal impairment.”

 

This is troubling, because while the patent statute explicitly states that a “discovery” can be patented, this court apparently construes a patent owner’s use of the term “discovery” as an admission that the “discovery” is a natural phenomenon.  If anything that can be discovered is a natural phenomenon, the availability of patent protection for innovation in the life sciences would appear to be extremely limited post-Mayo.

Endo made the policy argument “that the reasoning employed by the Magistrate Judge's Report and Recommendation would in effect invalidate all pharmaceutical method-of treatment patents using an existing, well-known compound.”  The district court responded that “this case is hardly the poster child for [such] a policy argument,” and speculated that patent protection would still be available for method of use claims are directed towards an invention embodying “creative steps or inventive leaps aside from the discovery of a natural law.”

But if the discovery that a chemical compound has therapeutic effect on a patient is to be considered a “natural law,” which appears to be the case under the rationale of this decision, how successful will a pharmaceutical company be in arguing that use of that chemical compound for its therapeutic effect constitutes a sufficient “inventive leap” to satisfy the new post-Mayo patent eligibility standard?