Patent Infringement Defenses

Experimental Use Exception

Research, Bolar safe harbor, and the narrow limits of "it's just for science."

Quick Answer

The common law experimental use exception is essentially dead — Madey v. Duke (Fed. Cir. 2002) confirmed even university research can infringe. The real safe harbor is 35 U.S.C. § 271(e)(1) (the Bolar Amendment), which broadly protects activities reasonably related to FDA submissions for drugs, biologics, and medical devices.

Common Law Exception

The Narrow Common Law Research Exception

The common law experimental use exception dates to Whittemore v. Cutter (C.C. Mass. 1813), where Justice Story stated that making a patented item purely to satisfy philosophical curiosity — with no intent to profit — is not infringement.

For nearly two centuries, courts interpreted this exception variably. The Federal Circuit in Roche Products v. Bolar Pharmaceutical (1984) held it inapplicable to commercial activities. Then Madey v. Duke University (Fed. Cir. 2002) effectively narrowed the common law exception to near-extinction:

"The [exception] only exists for actions taken 'for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.' It does not apply to use that 'is in furtherance of the legitimate business of the [user].'" — Madey v. Duke

Duke University had a legitimate business in obtaining research grants and furthering its educational mission. Using patented laboratory equipment in federally funded research served that business. The exception did not apply. After Madey, practically no research conducted in a university, corporate lab, or contract research organization qualifies for the common law exception.

Bolar Safe Harbor

35 U.S.C. § 271(e)(1) — The Statutory Safe Harbor

Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), which added § 271(e)(1) in direct response to Roche v. Bolar. The provision reads:

"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."

In Merck KGaA v. Integra Lifesciences I, Ltd. (S.Ct. 2005), the Supreme Court held the safe harbor broad — it covers all uses with a "reasonable basis" for believing they could produce information relevant to an FDA submission, even pre-clinical research and use of patented research tools in preclinical studies, as long as the information could be useful to a future regulatory submission. The safe harbor is NOT limited to activities expressly required by the FDA or to the final approved product's active ingredient.

Side by Side

Common Law vs. § 271(e)(1)

	Common Law Exception	§ 271(e)(1) Bolar Safe Harbor
Source	Common law / judicial doctrine	35 U.S.C. § 271(e)(1) (statutory)
Scope after Madey (2002)	Effectively limited to idle curiosity — nearly meaningless	Broad — all FDA-regulated products
Covers commercial purpose?	No — commercial purpose defeats it	Yes — generic drug manufacturers use it commercially
Covers university research?	No — Madey eliminates this	Yes — if tied to FDA submission
Covers research tools?	No	Yes — Merck v. Integra (2005) confirmed
Product types covered	Any patented invention (theoretical)	Drugs, biologics, medical devices, diagnostics
Key limitation	No commercial purpose whatsoever	Must be 'reasonably related' to FDA submission

FAQ

Does using a patented invention for research avoid patent infringement?

Almost never under the common law exception. The Federal Circuit held in Madey v. Duke University (Fed. Cir. 2002) that even nonprofit academic research is not exempt if it is in furtherance of the institution's legitimate business — and universities have a business in conducting research. The common law experimental use exception is limited to truly idle curiosity with no commercial purpose or business benefit — an essentially theoretical test that covers almost nothing in practice.

What is the Bolar safe harbor (35 U.S.C. § 271(e)(1))?

35 U.S.C. § 271(e)(1) exempts from patent infringement activities '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.' This broad safe harbor covers generic drug manufacturers conducting bioequivalence studies, clinical trials, and other activities needed to file an ANDA or NDA, as confirmed in Merck KGaA v. Integra Lifesciences I Ltd. (S.Ct. 2005).

Does the § 271(e)(1) safe harbor cover medical devices and diagnostics?

Yes — the safe harbor extends beyond drugs to any 'Federal law which regulates the manufacture, use, or sale' of the relevant product, including FDA-regulated medical devices (21 U.S.C. §§ 510(k), PMA) and diagnostics. Merck v. Integra (2005) confirmed the safe harbor's broad scope applies to activities beyond the specific drug being tested, including research tools used in the development process — as long as there is a 'reasonable basis' that the use could produce information useful for an FDA submission.

Can a research tool patent block academic or industrial research under § 271(e)(1)?

Research tool patents occupy a gray zone. In Integra Lifesciences I Ltd. v. Merck KGaA (Fed. Cir. 2003), the court initially held that use of patented peptides as research tools for early-stage drug discovery was NOT protected by § 271(e)(1) because the nexus to FDA submission was too attenuated. The Supreme Court reversed in 2005, broadening the safe harbor. But if the patented research tool is the end product itself (not a means to FDA submission), the safe harbor may not apply.

Is the common law experimental use exception different from § 271(e)(1)?

Yes — they are distinct legal doctrines. The common law exception (traced to Whittemore v. Cutter, 1813) covers purely philosophical or curiosity-driven uses with no commercial purpose — effectively never applies after Madey. The statutory § 271(e)(1) safe harbor is specific to FDA-regulated products and is far broader and more practically useful. Many defendants claim both but should focus on § 271(e)(1) when FDA-regulated product development is at issue.