Can a Research Plan Invoke Derivation Under 35 U.S.C. § 102(f)?

By: Yuichi Watanabe and Xue “Sherrie” Holdman


On January 26, 2017, the Court of Appeals for the Federal Circuit rendered a decision on the uncommon issue of derivation in Cumberland Pharms. Inc. v. Mylan Institutional LLC.[1]  Derivation is a legal concept that ensures that a patent is not issued to someone who is not the true inventor.

Prior to the America Invents Act (AIA), derivation was codified in 35 U.S.C. § 102(f), which provides that a person is not entitled to a patent if “he did not himself invent the subject matter sought to be patented.”[2]  The AIA eliminated derivation as an invalidity defense from § 102, but instead established a derivation proceeding under § 135(a), which allows an applicant of a later-filed application to challenge an earlier applicant’s right to a patent before the Patent Trial and Appeal Board of the USPTO if the earlier applicant derived the claimed invention from the later applicant.[3]

The Federal Circuit in the Cumberland decision addressed the derivation standard under pre-AIA 35 U.S.C. § 102(f).  The opinion was authored by Judge Taranto and joined by Judge Moore and Judge Reyna.


Case Discussion

Cumberland Pharmaceuticals Inc. (“Cumberland”) owns U.S. Patent No. 8,399,445 (‘445 patent), which claims acetylcysteine compositions substantially free of chelating agents, specifically EDTA (edetate disodium or edetate), and covers Cumberland’s chelating-agent-free formulation of Acetadote®.[4]  When Mylan Institutional LLC filed an abbreviated new drug application (ANDA) to market its own chelating-agent-free acetylcysteine formulation, Cumberland sued Mylan Institutional LLC and Mylan Inc. (collectively “Mylan”) for infringement of the ‘445 patent in the District Court for the Northern District of Illinois.[5]

Mylan stipulated to infringement of claims 1-14 of the ‘445 patent should they be held valid and enforceable.[6]  At trial, Mylan argued that the asserted claims of the ‘445 patent is invalid because the claimed invention had been derived from the FDA who first conceived the idea to remove EDTA from the prior-art formulation.[7]

Mylan’s derivation defense relied on the following facts: (1) the FDA, in response to Cumberland’s application for permission to market the original EDTA-containing formulation of Acetadote®, gave Cumberland instructions to provide “a description of the pharmacological properties for Edetate in the drug product”;[8] (2) shortly after responding to the FDA letter, Leo Pavliv, the Cumberland official responsible for Acetadote® and the named inventor on the ‘445 patent, had the idea of testing the stability of an acetylcysteine formulation without EDTA;[9] and (3) the FDA approved of Pavliv’s idea to do a study regarding the use of Edetate as a component in the drug product,[10] and then approved the EDTA-containing product on the condition that Cumberland would evaluate the potential benefit of Edetate disodium on the stability of the product and would include in their study a comparison of the current concentration of Edetate to a formulation with a lower concentration and no concentration of Edetate.[11]

In evaluating Mylan’s defense, the Federal Circuit noted that a derivation challenge invokes the rule that an applicant is not entitled to a patent if there was a “prior conception of the claimed subject matter and communication of the conception” to the named inventor, and this conception requirement borrows from the conception standard for prior invention.[12]  The Federal Circuit also applied the approach that, inventors named on an issued patent are presumed to be correct and a person seeking to change the inventorship must meet prove its case by clear and convincing evidence.[13]  Thus, for Mylan to succeed on its derivation defense, it must show, by clear and convincing evidence, that the specific idea to remove EDTA from Acetadote® (or a similar product that met all the other ‘445 patent claim elements) and not add another chelating agent was conceived by someone at the FDA and communicated to Pavliv. [14]

The Federal Circuit agreed with the district court that Mylan did not carry this burden.[15]  Specifically, Mylan has failed to show that anyone other than Pavliv ever conceived of an EDTA-free Acetadote formulation.[16]  The claims of the ‘445 patent require that the product be “free of chelating agents,” and Mylan did not prove that an FDA person conceived of a formulation of Acetadote® that simply removes EDTA, without adding another chelating agent in its place, before Pavliv thought of it.[17]  Rather, the FDA merely requested justification for the inclusion of EDTA in the drug product, which is not the same as a suggestion to remove it or to remove it and not replace it with another chelating agent.[18]

Mylan argued that the request for data to support the inclusion of EDTA required Cumberland to undertake research that inevitably led it to the invention.  The Federal Circuit disagreed, stating that derivation is not proved by showing conception and communication of an idea different from the claimed invention even where that idea would make the claimed idea obvious.  The Federal Circuit further explained that a “general goal or research plan” does not constitute the “definite and permanent idea” required for conception, and that a “bare hope” of a result never before achieved is not sufficient for conception.[19]

In the end, the Federal circuit found that Mylan failed to establish that the FDA specifically conceived of removing EDTA from the prior-art Acetadote® without adding any other chelating agents, as required by the claim language.[20]  As a result, the Federal Circuit affirmed the district court’s final judgment of validity and infringement.[21]


Conclusion

Although this decision addresses derivation under pre-AIA 35 U.S.C. § 102(f), the issue of the original or true inventor remains relevant post-AIA.  The Federal Circuit clarified that a derivation defense will not succeed without proof of conception and communication of a definite and permanent idea that is specifically claimed in the patent, and this could have important implications for pharmaceutical companies who need to comply with FDA requirements.


[1] 2017 U.S. App. LEXIS 1375 (Fed. Cir. Jan. 26, 2017).

[2] 35 U.S.C. § 102(f) (2006).

[3] 35 U.S.C. § 135 (2013).

[4] Cumberland, 2017 U.S. App. LEXIS 1375 at 1, 3.

[5] Id. at 1-2.

[6] Id. at 7-8.

[7] Id. at 8. Mylan also argued that the invention would have been obvious in light of certain prior art communications from the FDA.

[8] Id. at 3-4.

[9] Id. at 4-5.

[10] Id.

[11] Id. at 5-6.

[12] Id.

[13] Id. at 10.

[14] Id.

[15] Id.

[16] Id. at 10-11.

[17] Id. at 11.

[18] Id. at 12.

[19] Id. at 12-13.

[20] Id. at 15.

[21] Id. at 23.