Dev A. Ghose, a Proposal to Modify the Utility Standard for Patenting Biotechnology Research Tools

• Citation: Vol. 56 No. 6
• Publication year: 2007

A PROPOSAL TO MODIFY THE UTILITY STANDARD FOR PATENTING BIOTECHNOLOGY RESEARCH TOOLS

INTRODUCTION

In modern biotechnology, the use of a biotechnology research tool ("BRT") facilitates the discovery of and "timely access to new, safer, [and] more effective drugs."¹For example, nanobiotechnology research tools assist investigations of "physiological function at the molecular level, such as interactions between actin and myosin (the molecular machines that drive muscle contraction)," and "[i]mprov[e] the specificity and timing of drug delivery" to target cells.²Because biotechnological discoveries build upon a framework of previous discoveries and set the foundation for future innovation, BRTs can serve both as end products for sale to customers as well as tools for future discovery.³Although the market for BRTs is relatively young, certain segments of the BRT market are expected to grow by 240% in the near future.⁴Patent protection is critical to commercialize BRTs and for entry into the market with a BRT product.⁵Without patent protection, firms with a BRT as their technology platform risk being unable to obtain complementary assets like scientific expertise and venture capital.⁶Thus, the inability to patent impedes not only the prepatent incentives to invent and disclose, but also the postpatent incentive to commercialize.⁷In turn, this impedes consumers' access to safer and more effective drugs.⁸

The BRT industry is in a state of confusion as to the protection and patentability of BRTs.⁹In Integra LifeSciences I, Ltd. v. Merck KGaA,¹⁰the majority and dissenting opinions of the Court of Appeals for the Federal Circuit (CAFC) cited different definitions of BRTs and could not come to a consensus as to whether the technology at issue was research tools.¹¹The Supreme Court explicitly refused to express an opinion on the implications of the dispute on the research tool issue.¹²Although the Court's opinion did not address the utility standard for obtaining patent protection for BRTs, the opinion threw the BRT industry into a state of confusion as to the protection of BRTs.¹³

Subsequently, the CAFC added a new dimension of confusion-this time, to the fundamental ability to patent a BRT. In In re Fisher,¹⁴the CAFC surprisingly departed from the liberal utility standard stated in In re Brana¹⁵and reverted to the antiquated standard of "specific" and "substantial" utility articulated in Brenner v. Manson¹⁶(the "Brenner articulation").¹⁷

This Comment addresses the issue of utility for patentability of BRTs and proposes that Congress legislate the utility requirement of patentability for the class of inventions that can be defined as BRTs. Specifically, this Comment proposes that Congress abrogate the Brenner articulation of utility for BRTs by codifying the Federal Trade Commission's (FTC's) definition of BRTs.¹⁸The

Brenner articulation, pronounced in 1966, could not possibly have conceived of the generation of biotechnological innovation that has given birth to BRTs like monoclonal antibodies.¹⁹Thus, the U.S. Supreme Court's interpretation of the utility requirement to provide for patentability of inventions that exhibit a "specific" and "substantial" utility is no longer appropriate in the context of BRTs.

This Comment recognizes that the inability to patent BRTs due to a failure to meet the antiquated Brenner articulation of utility is a problem that could signal a death knell to numerous biotechnology firms with a BRT as their technology platform. Although patent scholars frequently note that the Brenner standard of utility is an abnormal policy lever that is neither grounded on sound interpretation of Congressional intent nor premised on a rational agency interpretation,²⁰no scholar has offered a proposal for Congress to legislate the utility requirement to resolve this abnormality. By calling for legislative action, this Comment departs from the general consensus that changes in the patent system should be achieved through judicial, agency, or law and economics methods.²¹As this Comment will show, both the judicial branch and the United States Patent and Trademark Office (PTO) have vacillated on this issue of utility for biotechnological inventions and cannot be relied upon to formulate patent policy in this context.²²Thus, Congress should legislate the utility requirement for BRTs to provide explicit direction to both the judiciary and the PTO.²³

Part I of this Comment traces the law of utility in the legislative, judicial, and patent appeals branches of the federal government and shows how judicial and agency action on the utility requirement does not correctly interpret Congressional intent. The vacillation of the PTO is exposed in Part II, further demonstrating the need for an express statement from Congress on the issue of utility for BRTs. Part III presents this Comment's proposal. Although legal scholarship often employs broad concepts to promote an issue, this Comment provides specific instruction to Congress because the FTC definition was formulated with a substantial investment of time, resources, and feedback from all sectors of the BRT industry.²⁴Part IV entails a detailed discussion of multiple rationales that support the codification of the FTC definition. Included in this Part are discussions of practical considerations, various economic theories, concerns about industry-specific legislation, commercialization principles, and an illustration of the magnitude of the issue.²⁵

This Comment proposes that Congress codify a definition of utility for BRTs to provide explicit direction to the PTO and to provide a workable standard that can be relied upon by industry. Although this Comment's argument is based on the recent cases of In re Fisher²⁶and Merck KGaA v. Integra LifeSciences I, Ltd.²⁷it does not express an opinion as to the patentability of the particular inventions at the center of those cases. This Comment should be taken for what it is-a proposal that will enable the members and institutions of the BRT industries to have a reliable definition of utility. Subsequent to a resolution of this issue, the judiciary can address other patent doctrines relating to BRTs, including the common law experimental use and statutory noninfringing use doctrines that were implicated in the Merck KGaA decision.

I. THE LAW OF UTILITY

The Constitution charges Congress with the authority to enact legislation to "promote the Progress of Science and useful Arts."²⁸To receive a patent in the United States, a patent claim must satisfy the following requirements: (1) statutory subject matter, (2) utility, (3) novelty, (4) nonobviousness, and (5) written language sufficient to enable one of ordinary skill in the art to create and use the invention without undue experimentation.²⁹With respect to the utility requirement, BRTs must evince the heightened standard of utility as stated in the Brenner articulation.³⁰However, this articulation does not correctly interpret Congressional intent.³¹To fully understand this issue, Congressional, judicial, and patent office action on the utility requirement must be analyzed. The first section of Part I briefly summarizes Congressional action on the utility requirement. The second section of Part I addresses the critical cases implicating the utility requirement for biotechnological inventions.

A. Congressional Action on Utility

The Patent Act of 1790 provided for the patentability of "any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used."³²After a series of revisions and amendments,³³

Congress enacted the Patent Act of 1952,³⁴which provides that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . may obtain a patent therefor."³⁵The legislative materials surrounding the enactment of Sec. 101 of the Patent Act are unhelpful to judicial interpretation of the term "useful."³⁶Additionally, the words "process, machine, manufacture, or composition" do not manifest a Congressional policy on what it deems useful, but rather comprise the "statutory subject matter" requirement of patentability.³⁷

However, it is clear from a plain reading of the statute that Congress did not intend for inventions in the biotechnological arts, including BRTs, to be subjected to a significantly heightened standard of usefulness or utility.³⁸

Section 101 is simply devoid of any language suggesting a heightened standard.³⁹Additionally, when interpreting patent statutes, "courts should not read into the patent laws limitations and conditions which the legislature has not expressed."⁴⁰Thus, Congress did not intend to subject BRTs to the heightened standard of utility as stated in the Brenner articulation.

Although one could argue that Congress is too burdened to specify industry-specific standards, thus necessitating judicial interpretation to delineate Congressional policy, this argument is undermined by the instances of industry-specific legislation and specific modifications of patent policy. For example, Congress has defined the term "useful" in the context of inventions comprising nuclear materials.⁴¹In 1954, Congress specified that the term

"useful" excludes patenting of inventions useful solely in the utilization of special nuclear material or atomic energy in nuclear weapons.⁴²In addition, Congress has modified the patent policy landscape significantly in the last twenty years by establishing the CAFC, passing the 1988 Process Patents Amendment Act, passing the Bayh-Dole Act, and passing the Hatch-Waxman Act.⁴³Currently, Congress is debating passage of a new Patent Act,⁴⁴which has potential to overhaul the patent system.⁴⁵

Thus, it is clear that there is no Congressional intent for the heightened standard of utility applied to biotechnological inventions as stated in Brenner. Because the Supreme Court manifested a real concern for preventing the blocking of downstream research,⁴⁶this Comment...