Protecting Both Intellectual Property And Progress

• Published date: 08 September 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Wolf, Greenfield & Sacks, P.C.
• Author: Ms Emma L. Frank

The Hatch Waxman safe harbor provision exempts otherwise infringing uses of patented materials if they are in furtherance of a regulatory submission, but the use of patented research tools may fall outside its protection.

The goal of most biopharmaceutical companies is to develop an FDA-approved treatment. But FDA approval takes time, money, and often the use of patented materials for developing, testing, and screening new drugs'which runs the risk of liability for patent infringement. The Hatch Waxman "safe harbor" provision exempts activities that would otherwise infringe a patented invention, as long as those activities are "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs"¹. And, according to the United States Supreme Court, a "patented invention ... is defined to include all inventions," not just drug compounds². But this safe harbor provision is not without its limits.

The United States Court of Appeals for the Federal Circuit has held that "research tools ... may not be covered" by the safe harbor provision³. These research tools are patented inventions that are "used in the development of ... regulatory submissions, but [are] not [themselves] subject to the [regulatory] approval process"⁴. How the courts approach the issue of research tools, therefore, has real impacts on the activities of companies looking to develop drugs and patent holders who want to enforce their intellectual property.

The purpose of the Hatch Waxman safe harbor provision

Understanding why the safe harbor provision was created is important to understanding why research tools fall outside its protection. The Hatch Waxman Act was enacted with the goal of correcting two distortions to the term of a patent in the context of pharmaceuticals that are subject to premarket regulatory approval. The safe harbor provision was an important part of Congress's remedy to this situation.

The first distortion comes at the beginning of a patent's term, as testing and other regulatory requirements may prevent a patent owner from deriving commercial benefit during the early years of patent protection. This distortion is corrected by providing term extension for patents claiming products that are "subject to a regulatory review period before its commercial marketing or use"⁵. Under this statute, a patent's term can be extended by a period of time that represents a portion of the regulatory review period that...