On September 13, 2023, Sen. Maggie Hassan, D-N.H., joined by Sen. Mike Braun, R-Ind., introduced a bill designed to require pharmaceutical drug and biological product manufacturers to provide additional and consistent information to both the Food and Drug Administration (FDA) and U.S. Patent and Trademark Office (PTO) for newly submitted or approved drug applications. A parallel bill was introduced in the House by Reps. Annie Kuster, D-N.H., and Diana Harshbarger, R-Tenn.
According to the sponsors of these bills, drug manufacturers are supposedly “able to unfairly extend the exclusivity period for a drug by submitting partial information for their initial patent, in order to help secure subsequent patents down the road” due to “incomplete coordination” between the FDA and PTO. They say their proposed legislation, S 2780 and HR 5429, titled the Medication Affordability and Patent Integrity Act, is aimed at “lower[ing] prescription drug costs by closing [such] oversight gaps.”1
Proposed Disclosures
The Act seeks to amend the existing Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 355(b)) and Public Health Service Act (PHSA) (42 U.S.C. § 262) by adding new certification and disclosure requirements for drug approval. The sponsor of any application submitted or approved under the FDCA or PHSA would need to certify to both the FDA and PTO that information submitted to each agency is consistent with information submitted to the other. The sponsor must also submit to the PTO any information “material to patentability” of “applicable patents” that it submitted to the FDA as part of its drug application or subsequent communications with the FDA.
The Act defines “the information” to include:
- “any statement or characterization of analytical or clinical data” disclosed to the PTO that has been or will be used in a submission to FDA to support approval of a drug application;
- “any statement or characterization with respect to an applicable patent, including any statement or characterization of prior art” submitted to the PTO in support of patentability; and
- “other information, as the Secretary or the Secretary of Commerce may require.”
The Act does not provide any guidance on what types of “other information” the FDA or PTO may require sponsors to disclose. Notably, it would require, for the first time, that sponsors certify any statements regarding patentability or prior art (i.e., earlier work by others in the field that may bear on a patent application) to the FDA.
The universe of “applicable patents” for small molecule drugs is defined to include any patent or patent application issued, assigned, or licensed to the drug application sponsor that claims the drug that is the subject of the application, as well as its formulation, composition, method of use, or methods of manufacturing. The inclusion of manufacturing patents makes this universe broader than patents a sponsor could list in the FDA’s Orange Book. For biological products, “applicable patents” include any patent issued, assigned, or licensed by a reference product sponsor for which that sponsor could reasonably assert a claim of infringement. Across the board, the Act purports to give the Secretary wider discretion on which patents are covered by stating that the legislation could apply to “such other patent or application for a patent as the Secretary determines appropriate.”
Enforcement
Not only would the Act add compliance with its requirements as a condition for drug approval, it also would provide another defense for generic and biosimilar drug manufacturers against patent infringement suits. The legislation seeks to amend the Patent Act (Chapter 28 of U.S. Code 35) by adding a new defense to infringement of a drug patent based on failure to comply for the courts to adjudicate. Accused infringers may submit as a defense to a claim of patent infringement that the patentee “negligently or intentionally” failed to disclose the required information under this Act.
The Act is, however, silent as to how the FDA or PTO are to enforce against alleged false certifications.
Potential Impact
The proposed legislation primarily affects drug and biological product innovators. If enacted, it may require them to coordinate their submissions for approval of new drug applications with patent applications protecting drug innovations as well as add another layer of complexity to pharmaceutical patent litigation for parties and the courts.
While the proposed legislation does not appear to apply retroactively to any issued patents, it may apply to patent applications that are still pending before the PTO. The Act states that it would apply to any original drug application submitted on or after the proposed Act is enacted and any “applicable patent” issued on or after enactment. For patents that have already issued, the proposed Act would also apply to any FDA submissions and communications made regarding those patents after the Act is enacted.
1Press release from Sen. Hassan, dated Sept. 13, 2023.
