An Expansion to the Experimental Use Exception to Patent Infringement in the Works?

The US Patent and Trademark Office is requesting public feedback on the current experimental use exception’s impact on technology sectors—and the public’s appetite for expanding the exception.

Technology and life sciences industries are familiar with the well-developed body of case law applying to the experimental use exception to patent infringement, but this area of the law is getting special new attention from the US Patent and Trademark Office (USPTO), which published its notice requesting comments from the public on the experimental use exception on June 28, 2024.

Reiterating its central goal of promoting “scientific, technological, and social progress” and placing a particular emphasis on the judicially created exception’s effects on agricultural technology, the USPTO is soliciting input from public stakeholders on whether the judicially created experimental use exception is sufficient to support this objective in current times and, if not, whether a statutory experimental use exception should be implemented.

HISTORICAL CONTEXT AND CURRENT JURISPRUDENCE

Experimental use exception jurisprudence was first introduced in the landmark case of Whittemore v. Cutter, in which jury instructions approved by the court established that the question of infringement turned on the prospect of benefit or profit for the accused infringer. [1]

In Whittemore, the court defined patent infringement as “the making of a machine fit for use, and with a design for profit,” stating that “it could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.”

Over time, US courts in experimental use cases have continued to rely on the prospect of profit or benefit to the accused infringer as the deciding factor, with more recent cases explicitly excluding from the exception any “use that is in any way commercial in nature” and “is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.” [2]

With respect to the life sciences industry, critics of the narrow applicability of the current exception have indicated that competitive benefits to the accused infringer often overlap with or stifle scientific inquiry into new therapies for patients.

MODELS FOR STATUTORY IMPLEMENTATION IN LIFE SCIENCES: THE ‘SAFE HARBOR’ PROVISION AND PAST LEGISLATIVE ATTEMPTS

Currently, there are only a few limited statutory exceptions barring a charge of infringement codified by statute, including the “research exemption” for plant variety protection [3] and the “safe harbor” provision implemented under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act). [4]

The “safe harbor” provision, which shields from infringement the importation, sale, offer for sale, production of, or use of patented drugs and/or biologics in preparation for seeking FDA approval (i.e., preapproval testing/preclinical research), was codified in response to the US Court of Appeals for the Federal Circuit’s decision in Roche Products Inc. v. Bolar Pharmaceutical Co., [5] earning the nickname of the “Bolar” exemption. Despite the statute and case law dating to 1984, there remains uncertainty about the scope and actual safety to be found within the “safe harbor.”

Past legislative attempts in the US to codify exceptions to patent infringement have been unsuccessful but provide additional examples of expanding the research exception for infringement. The Patent Competitiveness and Technological Innovation Act of 1990 [6] sought to enact a specific research exemption from patent infringement, wherein it provided protection from infringement in instances where a patented invention was made or used “solely for research or experimentation purposes unless the patented invention has a primary purpose of research or experimentation.”

Additionally, the Genomic Research and Diagnostic Accessibility Act of 2002 [7] explicitly exempted from infringement the use of “any patent for or patented use of genetic sequence information for purposes of research,” excepting those entities “directly engaged in the commercial manufacture, commercial sale, or commercial offer for sale of a drug, medical device, process, or other product using such patent for or patented use of genetic sequence information.”

These statutory examples may provide models for implementing a broader-reaching experimental use provision via the United States Code. In particular, current “Safe Harbor” jurisprudence permits the use, importation, or sale of patented drugs/biologics for comparative testing for premarket approval submissions to the FDA; an expanded statutory provision might provide protection for experimental testing of patented inventions falling outside the drug/biologic field akin to the provisions set forth in previous failed attempts as set forth above.

COMPARATIVE INTERNATIONAL PERSPECTIVES ON RESEARCH EXCEPTION TO PATENT INFRINGEMENT

Globally, many jurisdictions, including those in Europe, South America, and Asia, have codified “Bolar-type” exceptions. However, many of these jurisdictions also have statutory experimental use exceptions broader than such “Bolar-type” exemptions which apply to any experimental use for any technical field—not just drugs and/or biologics. For example, the United Kingdom exempts uses of an invention “done privately and for purposes which are not commercial” or “done for experimental purposes relating to the subject-matter of the invention.” [8]

SCOPE OF PUBLIC INPUT

The USPTO is seeking input on the impact of the current experimental use exception on various technology sectors, including quantum computing, artificial intelligence, agriculture, life sciences, and climate-mitigation technologies. The agency is particularly interested in understanding how the current jurisprudence affects investment, research and development, commercialization, and patent enforcement.

The Questions for Public Comments are available at Experimental Use Exception Request for Comments, and the USPTO will be accepting comments from interested members of the public until September 26, 2024.