Patent law is a complex field that constantly evolves, addressing the intersection of innovation and intellectual rights. The availability of defenses for accused infringers is a critical factor of patent infringement. Section 271(e), paragraph 1, of the United States Patent Act, provides a defense to certain actions. However, because Justice Scalia has noted that the section is not “an elegant piece statutory draftsmanship”, and is “not exactly in every aspect”, the analysis of its applicability will be highly fact-dependent.
Understanding Section 271(e)(1):
The Patent Act’s Section 271(e).1. provides a safe harbour for actions that would otherwise be considered patent infringement. It states:
Infringement of patent occurs when, except as provided by this title, anyone without authority who makes, uses or offers to sell any patented product within the United States, or imports any such product into the United States during the period of the patent, violates the patent.
The safe harbor provision in Section 271(e), however, makes an exception to certain activities. This is largely related to the approval and development of veterinary biological products or drugs. It states:
The use of a patented invention […] for reasonable purposes related to the submission and development of information in accordance with a Federal Law that regulates the manufacturing, use or sale of pharmaceuticals or veterinary biologic products shall not constitute an act of infringement.
Section 271(e), subsection 1, provides a defense against patent infringement lawsuits for companies that engage in reasonable activities related to the creation and submission of required information by federal regulatory agencies, such as the Food and Drug Administration.
Dual purpose of 271 (e) (1):
The purpose of section 271(e).1 is to encourage innovation in the pharmaceutical sector, while balancing the interests of the patent holders with the public. This provision acknowledges the importance of developing and approving new drugs for the public’s health and welfare. By providing a safe harbour for certain activities relating to the development and the submission of information required under federal drug regulations prior to the expiration date of the patent, section 271(e),(1) seeks to facilitate the timely introduction of new drugs to the market (generics).
Section 271(e), paragraph 1, is also intended to protect the rights of patent owners. The provision does not negate the patent protection, even though it allows limited exceptions for patent infringement. The provision ensures that the patent holders maintain their exclusive rights, while maintaining a balance between public interest and timely access to safe pharmaceutical products. Section 271(e), which provides a defense for certain activities relating to regulatory compliance acknowledges the necessity of conducting research and testing while not unduly burdening the patent rights.
Section 271(e).1. has a dual purpose to promote innovation while protecting the rights of the patent holders. It allows for the necessary activities relating to the development of information and the submission of that information. It is a limited safe harbour that aims to balance the interests of all parties in the complex world of pharmaceutical research, regulatory approval, and development.
U.S. Supreme Court Cases Shaping Section 271(e)(1) Defenses
- Roche Products, Inc. V. Bolar Pharmaceutical Co. (1984)
The U.S. Supreme Court’s decision in Roche Products, Inc., v. Bolar Pharmaceutical Co. laid the foundations for Section 271 (e)(1) defences. Bolar was a pharmaceutical firm that performed studies and tests for Roche’s patent drug. These were required to submit an Abbreviated New Drug Application, or ANDA, to the FDA. This is why 271(e), or the “Bolar Defense”, is also known as the “Bolar Exemption” or “Bolar Defense”. The Court found that Bolar’s activities fell under the safe harbor provisions of Section 271(e), as they were reasonable related to the submission and development of information in accordance with federal drug regulations.
- Eli Lilly and Co. and Medtronic, Inc. (1996)
The Eli Lilly and Co. Medtronic, Inc. Case clarified the limits of Section 271 (e)(1). The Supreme Court considered whether the defense applied to experiments that involved patented inventions but were not directly related to FDA’s regulatory process. The Court found that section 271(e),(1) covers only activities “reasonably” related to the FDA’s requirements for information and development. This excludes experiments that are unrelated to regulatory approval.
- Eli Lilly and Co. V. Barr Laboratories, Inc. (2002
In Eli Lilly and Co., v. Barr Laboratories, Inc., The Supreme Court examined whether the Section 271 (e)(1) defence applied to the submission of an ANDA for generic drugs. The Court clarified the safe harbor does not protect generic drug manufacturers against patent infringement claims if the activities were conducted after FDA approval for the generic drug to be marketed.
- Warner-Lambert Co. V. Apotex Corporation. (2002)
Warner-Lambert Co. V. Apotex Corporation. The case addressed whether “off-label uses” of patented drugs are covered by the Section 271 (e)(1) defense. The Supreme Court has ruled that section 271(e), which protects activities solely related off-label use of approved drugs does not cover those uses that do not require information to be submitted to the FDA.
- Merck KGaA v. Integra I Lifesciences Ltd. (2005)
In Merck KGaA v. Integrated Lifesciences I Ltd. the Supreme Court expanded Section 271(e).1 by adding preclinical studies to the safe harbor provisions. Merck argued that studies on animals performed to gather information about potential drug candidates are protected by the statute. The Court agreed and ruled that non-clinical, preclinical, studies reasonably related to providing information to FDA were eligible for safe harbor protection.
- Merck KGaA v. Integra Health Sciences II, Ltd. (2006)
After the Merck case the Supreme Court revisited this issue in Merck KGaA v. Integra Health Sciences II, Ltd. The question was whether the safe harbor clause covered activities that went beyond the FDA initial submission. The Court held the Section 271(e),(1) defense applies to activities after approval, including conducting clinical trials for additional safety and efficacy information.
The conclusion of the article is:
Section 271(e), paragraph 1, of the United States Patent Act, can be a powerful defense in cases of patent infringement. The U.S. Supreme Court has influenced the interpretation and application Section 271(e).1 defense. It has established boundaries and clarified its scope. From Roche Products, Inc. V. Bolar Pharmaceutical Co. The Supreme Court’s decision and subsequent cases, such as Merck KGaA v. Integra I and II and Eli Lilly and Co. v. Medtronic and others have helped to explain the permissible actions protected under the Safe Harbor provision.
As new cases and refinements to this defense may occur, it is vital that stakeholders in the pharmaceutical sector stay up-to-date on the evolving jurisprudence around Section 271(e). The U.S. Supreme Court’s and other federal court decisions influence the rights of accused infringers and patent holders in drug development and regulatory approval.
Understanding the intricacies surrounding Section 271(e), and following relevant case law can help stakeholders navigate the patent landscape, especially with respect to claims and defenses for infringement.
The post Section 271.e.1) Defenses in Patent Infringement: An Analysis of U.S. Supreme Court cases first appeared on Attorney at Law Magazine.