The Great Dichotomy: Patent Protection vs. Regulatory ApprovalNovember 2, 2021

As a scientist in discovery mode, the primary focus is often on points of novelty and seeking patent protection for the invention.  The supporting data in the patent application serves as proof that this is a unique innovation, has never been seen before, and overcomes key challenges.  However, when the product is regulated, converse arguments are made with agencies further downstream in the development pipeline.  The product in commercial form may be positioned to be substantially equivalent to what is already out there in the market. Ideally, there are no unexpected properties.  For the regulatory agencies, the story to be told from a risk perspective is that there is nothing new to see here – with supporting data as proof,  comparing the new product side by side to existing products in the submission.

Working through this “great dichotomy” of arguing for strong IP protection and obtaining expedient regulatory approvals is a complex maze, and withholding relevant information from the Patent Office can result in dire consequences.  Once a patent application is publicly available, regulators can and do read this information, and will ask questions.  Equally, patent examiners will read publicly available regulatory materials, often even if the applicant doesn’t list and submit them as part of non-patent literature in an information disclosure statement.

A recent case, Belcher v. Hospira, reinforces the need for applicants to ensure they are fulfilling the duty of disclosure to the Patent Office consistent with their regulatory dossiers and communications.  The Federal Circuit recently affirmed the district court’s decision to invalidate a patent for inequitable conduct, for failing to disclose material references to the United States Patent and Trademark Office, where contradictory arguments were made at the Patent Office and the FDA.

In 2012, Belcher submitted a literature based new drug application with the FDA which relied upon data from prior products and references, and described the in-process pH range of 2.8 to 3.3 as “old” vs. a range of 2.4 to 2.6 for their product referred to as “new”.  In 2013, responding to the FDA’s questions on manufacturing process, Belcher stated that the only difference between the a prior product and Belcher’s proposed formulation was related to the pH, and that the pH was a “very minor change”, providing literature references as support.  Due to continued questions from the FDA, Belcher’s regulatory consultants recommended the product’s pH be kept in a range of 2.8-3.3 to expedite regulatory approval with the FDA by leveraging stability validation data from the previously approved product rather than incur the cost and time of conducting their own studies.

In 2014, Belcher filed a patent directed to the formulation.  In this patent application, they stated that the idea of raising the pH above the range of 2.2 to 2.6 “was contradictory to one skilled in the art” before the claimed invention. Throughout prosecution, Belcher continued the argument of criticality for the 2.8-3.3 pH range as a key point of novelty, and did not disclose the references and statements made to the FDA. Belcher did not merely withhold this information from the Patent Office, but also used emphatic language to argue that the claimed pH range of 2.8 to 3.3 was a “critical” innovation.  Final issued claims included formulations having a pH between 2.8 and 3.3. The district court held that this was inequitable conduct before the United States Patent and Trademark Office because a material reference was not disclosed, and subsequently, the patent was invalid, as upheld by the Federal Circuit.

It is critical to coordinate IP and regulatory strategies early in the product lifecycle, to ensure appropriate and consistent advocacy both with the Patent Office and the regulatory agencies. Such coordination is especially critical given the past and future efforts to enhance communication between the USPTO and federal agencies as detailed here: USPTO called to step up interagency cooperation. Careful review of any public disclosure is always essential to protect intellectual property rights, but when working with regulated technologies the stakes are even higher to ensure statements made in a patent filing don’t step out of line with what will be stated in subsequent regulatory filings.  Absent such oversight, there are risks both for market authorization as well as patent validity and enforcement.

Cassie J. Edgar, Patent Attorney and Chair of the Regulatory Law practice group, advises clients in intellectual property, regulatory law, crisis management, compliance, stewardship, lobbying, and matters with USDA, FDA, EPA, and FTC. For additional information, please visit MVS or contact Cassie directly via email at

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