September 22, 2021

In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.

FDA acting Commissioner Janet Woodcock has additionally written to temporary USPTO head Drew Hirshfeld regarding possible ways that the two agencies could work together, such as having the FDA help train USPTO examiners on the use of FDA databases to aid in the USPTO examiners’ review of patent applications, and having the two agencies perform joint training on patent term extensions.  Such measures would appear to be appropriate on the surface and might result in stronger issued patents for pharma.

These measures appear to be in light of the recent Federal Circuit ruling in Belcher v. Hospira (Belcher Pharmaceuticals  v. Hospira, Appeal No. 2020-1799 (Fed. Cir., Sept. 1, 2021)).  In that case, the Federal Circuit upheld a finding by the U.S. District Court for the District of Delaware that Belcher’s U.S. Patent 9,283,197 was unenforceable due to inequitable conduct by Belcher’s Chief Science Officer.  The act resulting in inequitable conduct was making one statement to the USPTO regarding the composition that was the subject of the patent application claims, while making a contradictory statement to the FDA during the New Drug Application (NDA) review process.  In particular, citing the District Court record, the Federal Circuit noted that during the FDA NDA review process, “Belcher described the claimed pH range of 2.8 to 3.3 as “old”; that Belcher disclosed Stepensky, which teaches an overlapping pH range of 3.25 to 3.70; that Belcher had submitted data on Sintetica’s and JHP’s products showing a pH within the claimed range; and that Belcher switched from a lower pH range to the claimed 2.8 to 3.3 pH range at least in part to expedite FDA approval because that range matched the pH range of Sintetica’s products.” (Id. at 11).  However, before the USPTO, Belcher “did not merely withhold this information but also used emphatic language to argue that the claimed pH range of 2.8 to 3.3 was a “critical” innovation that “unexpectedly” reduced racemization.” (Id. at 11)  Further Belcher did not disclose the Stepensky reference to the USPTO, nor the Sintetica or JHP products.  More details regarding the actions that led to the finding of inequitable conduct, including the determination of the intent to deceive the USPTO examiner, can be found in the Federal Circuit ruling.  Read the full Belcher Pharmaceuticals, LLC. v. Hospira, Inc. Appeal here.

Why is this important?  Ultimately, this result could have been avoided if Belcher had their patent counsel review the FDA submissions to ensure that positions being taken at the USPTO during prosecution and at the FDA during the review process were not inconsistent.  This is similar to making sure that positions taken during the prosecution of foreign counterparts of a US patent application are not contradictory to positions taken before the USPTO during prosecution.  Of course, whether Belcher would have received its patent, or whether its NDA submission at the FDA would have been approved if their positions at both agencies had been consistent, is an entirely different question!

Ultimately, a pharma company should have any FDA submission reviewed by patent counsel prosecuting patent applications covering the subject of the submission, to ensure that the positions taken during the patent examination process are consistent with those taken before the FDA.  Of course, if the patent is prosecuted to allowance prior to the FDA submission process (as may often be the case), this review could also be of benefit, by having patent counsel note any conflicting positions being taken before the FDA, and working with FDA regulatory counsel to correct those positions.