Inequitable Conduct in the FDA/PTO Interplay

Belcher Pharma v. Hospira, Inc. (Fed. Cir. 2021)

The Federal Circuit has confirmed that Belcher’s U.S. Patent No. 9,283,197 is unenforceable due to inequitable conduct based upon materials withheld during prosecution.  The patent covers l-epinephrine formulations at pH between 2.8 and 3.3 and with certain impurity level limitations. During prosecution, the examiner found a prior art reference with a wider encompasing pH range of 2.2 to 5.0, but the patentee successfully argued that its narrower range was a critical element of the invention and necessary to prevent racemization of the l-epinephrine.

Prior to the application’s issuance, Belcher’s Chief Science Officer (Rubin) obtained possession and tested samples from two competing products (JHP & Sintetica) and found that they were both within the claimed pH range and within the claimed impurity levels.  In addition, Rubin was in possession of a reference (Stepensky) that disclosed an overlapping pH range (3.25 to 3.7).  In fact, while the application was pending, Rubin communicated with the FDA regarding these samples.  However, none of them were disclosed to the USPTO.

Patent applicants and their attorneys are bound by a duty of candor and good faith in dealing with the USPTO.  As part of this, 37 C.F.R. § 1.56 establishes a duty to disclose information material to patentability.  This duty exists as long as the patent application is pending and applies to all “individuals associated with the filing or prosecution of [the] patent application.” The Office has generally tied the duty only to human-persons, and so the duty has not been applied directly to corporate applicants.  As here, the focus is typically whether there is an individual person who has a duty and who failed their duty.

Patent examiners rarely exert their investigatory authority and so patents associated with a duty-of-candor violation are rarely uncovered until litigation.  At that point, the patent is not automatically invalid. Rather, the patent may be deemed unenforceable due to inequitable conduct during prosecution, but only if the violation is both material and intentional.

To prevail on an inequitable conduct defense, a defendant must establish both the materiality of the withheld reference and the applicant’s intent to deceive the PTO.

Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1334 (Fed. Cir. 2012) (citing Therasense).

Duty: Rubin testified that he was helped draft the patent application, including the claims and also helped formulate responses to office actions. That was enough to bind Rubin with the duty of candor.

Materiality: Here, the claims were found obvious by the district court based upon the withheld prior art, a finding that was not appealed. That was enough for the Federal Circuit to conclude that the documents were material to patentability.

Intent: On deceptive intent, the case lacked direct evidence that Rubin intended to deceive the USPTO, but the district court found sufficient circumstantial evidence within the repeated discussion of the references with the FDA. In particular, Rubin modified the proposed pH range from a wider range to the narrower range in order to take advantage of the data from Sintetica reference product and thus expedite FDA approval.

Unenforceability affirmed.

I’ll note here that some of you might be thinking — but the claims are obvious anyway.  I’ll be curious to see whether the inequitable conduct finding results in an unfair competition claim against Belcher.

Second note – Belcher was a quite inexperienced patent applicant at the time that likely was part of the failures here.


6 thoughts on “Inequitable Conduct in the FDA/PTO Interplay

  1. 4

    Re: “..some of you might be thinking — but the claims are obvious anyway.”
    Yes but there is also more here than just the direct relevance of known and uncited prior art by a prosecution participant – the decision suggests that what could be called “affirmative misrepresentations” were made to the PTO examiner, which is a real kiss of death for inequitable conduct unenforceability.

    1. 4.1

      Will the prevailing party in this IC case also recovery its attorney fees under 35 U.S.C. § 285 and the Supreme Court’s 2014 Octane Fitness decision?

  2. 3

    Interesting side note (at least to me): There are two patents claiming priority to the ‘197 patent – Belcher has filed reissues to delete the benefit claim, presumably in an attempt to protect them from infectious unenforceability. I know reissue cannot cure the patent at issue of IEC – not sure whether it can cure related patents (my hunch is a court would frown upon such gamesmanship).

  3. 2

    Second note – Belcher was a quite inexperienced patent applicant at the time that likely was part of the failures here.

    Sorry, but no – that’s no excuse at all. They did have Counsel (who should have made the client fully aware of their duties), right?

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