The “Safe Harbor” Provision: An Affirmative Defense to Patent Infringement

Patent law bestows certain exclusive rights to patent owners. For example, under section 271(a) of the Patent Act, patent owners have the exclusive right to make, use, offer to sell, or sell any patented invention within the United States, or import any patented invention into the United States, during the term of the patent. But these exclusive rights are not absolute. The “Safe Harbor” provision creates an important exception.

Section 271(e) of the Patent Act provides a Safe Harbor defense for defendants for their otherwise infringing activities by stating:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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 or veterinary biological products.

The purpose of the Safe Harbor provision is to facilitate market entry upon patent expiration. Prior to the Safe Harbor provision, competitors' activities involving a patented invention during the patent term constituted an act of infringement, even if undertaken for the sole purpose of obtaining FDA approval. Because such activities could not begin until patent expiration, patent owners enjoyed a de facto patent term extension while competitors spent time following patent expiration obtaining FDA premarket approval necessary for market entry. The Safe Harbor sought to eliminate this de facto patent term extension by allowing competitors to begin the regulatory approval process while the patent was still in force, followed by market entry immediately upon patent expiration.

During the COVID-19 pandemic, there have been a number of cases where defendants involved in developing COVID-19 vaccines have attempted to use the Safe Harbor as an affirmative defense to patent infringement complaints. For example, a pharmaceutical company which was analyzing patient samples using a patented product to evaluate COVID-19 neutralizing antibody levels, asked a federal judge to dismiss a lawsuit based on the Safe Harbor affirmative defense.

The claims in the asserted patent covered the Patent Owner’s “mNeonGreen” product, which is a fluorescent protein used as a biological tag in genetic engineering work. The Patent Owner argued that:

• The Defendant used the mNeonGreen product as a “research tool” in the development of FDA submissions, but the mNeonGreen product itself is not subject to FDA approval; and
• The invention claimed in the patent at issue is not subject to FDA approval.

The court agreed with the Patent Owner and dismissed the Defendant’s motion to dismiss. The impact of the Safe Harbor provision on products and patents in the medical field should always be a critical consideration. If you have any questions or would like more information on the Safe Harbor, we would be happy to speak with you.