United States: Patenting the Tools of Biotechnology

Over the last twenty-five years, the biological sciences have undergone a revolution that requires close attention from patent practitioners seeking to obtain meaningful protection for their clients’ intellectual property. From the development of genetic engineering in the 70’s through the sequencing of the human genome at the turn of the century, the pace and scope of the innovations that have spawned the biotechnology industry have been stunning. The innovations of the past quarter century have collectively brought about a radical change in the methodology of both biological and medical research, and the pace of discovery has not slowed.

Such rapid technological progress presents enormous challenges not only to the patent laws but to the patent practitioners as well. While the patent system by definition confronts new technologies, perhaps in no other field have the challenges to existing patent law been greater than in biotechnology. Many of the defining inventions in biotechnology – and the proprietary protection available to them – are qualitatively different from those in other technical fields. These differences reflect the fact that much of the valuable technology emerging from biotechnology involves methods and materials for designing or identifying new and useful compositions, rather than the novel compositions themselves. While the primary value of these biotechnology "research tools" lies in the commercial products they may generate, new intellectual property strategies are required to exploit the proprietary value of the research tools themselves.

Examples of these biotechnology research tools include phage display and combinatorial methods for generating vast libraries of peptides and non-peptide molecules; microarrays for displaying and screening libraries for useful compounds; nucleic acid sequencing and data mining methods for identifying useful genes and proteins; in silico methods for designing and testing new genetic networks; and synthetic methods for making and expressing whole genomes. In each case, various aspects of these research tools have been the subject of issued patents or patent applications. The claims of these patents do not cover the commercially valuable products that the methods have the potential to generate and inevitably raise the issue of how to obtain value from the patents.

Challenges to obtaining meaningful patent protection are amplified when the invention is a research tool so as to require particular attention and skill from practitioners seeking to protect such intellectual property. Included among these challenges are describing the invention sufficiently to satisfy the enablement and written description requirements and establishing acceptable utility in order to support claims of sufficient breadth to prevent competitors from "designing around." Even if a patent issues, enforcing claims that cover the methods of developing a commercial product, but not the product itself, can be difficult. In situations where licenses are offered or damages sought, determining the value of claims covering tools can be controversial.

These challenges require strategic planning to determine and effectuate appropriate and valuable proprietary protection. Decisions made without strategic forethought can result not only in a loss of the value of the research tool itself, but also have the potential to give competitors a head start in identifying a commercial product through use of the disclosed methods.

The purpose of the enablement requirement (as set forth in 35 U.S.C. 112, ¶1) is to permit others of skill in the art to practice the claimed invention using only the information contained in the patent in addition to art-known knowledge. The scope of enablement provided by the specification must be commensurate with the scope of the claims so that the entire claimed invention passes into the public domain once the patent protection terminates. In order to obtain broad claims whose scope is sufficient to prevent others from modifying the claim elements to avoid infringement, the specification must enable alternate elements. Independent of enablement, the written description requirement of §112, ¶1 further requires that the invention be sufficiently described as to establish that the inventor was in possession of the invention at the time the application was filed. The claimed invention must also have a utility as required by 35 U.S.C. 101. In other words, the invention must work as claimed and provide a specific, substantial and credible benefit to society.

The requirements of enablement, written description and utility are the roadblocks that prevent an applicant from obtaining claims to products resulting from the use of a claimed method. A description of the method alone does not provide an enabling description of the product nor does it establish that the inventor was in possession of the product. Furthermore, a description of the method cannot provide information with regard to the utility of a product yet to be generated. Certainly when the method is used and a particular novel product is identified and described, a patent can be filed claiming the particular product. However, products identified by separate use of the method may not fall within the claims of such a patent if the products are sufficiently dissimilar.

In a field that is advancing as fast as biotechnology, today’s methods may be obsolete tomorrow. It is therefore important to structure the claims to research tools in such a way as to cover modifications to the basic methodology. Separate claims should be drawn to different aspects of the invention so as to cover competitors who modify one aspect while keeping others the same. For example, where peptide libraries are generated and screened for receptor binding, claims can be drawn separately to novel methods of making the libraries, to the libraries themselves, and to methods of screening the libraries. Further, where alternative elements are described in the application, separate sets of claims should be constructed which substitute generic elements for the more specific. In addition, because the field is moving so quickly, it is important to describe multiple embodiments so as to be able to claim around prior art that may arise after filing.

When a patent, which claims research tools, issues, determining whether infringement occurs can be difficult; the commercial product may not provide any evidence that the claimed research tool was used. The use of patented research tools to identify a compound – such as by screening a library of ligands for receptor binding – can be considered "one time" infringement. The method is used to identify the active ligand, but thereafter the ligand is synthesized using conventional techniques. In addition, because proprietary protection does not attach until a patent issues, publication of a patent application may effectively permit a competitor to practice the invention without recourse to the applicant. In such a case, trade secrets may provide more valuable protection than would a patent. Thus, a patent, which describes a research method, may allow competitors the benefit of using the method without providing evidence of infringement or in some cases without infringing at all.

Even if infringement can be established, determining the value of a license to use or the damages resulting from unauthorized use is problematic. Tying the value of the claimed method to the commercial value of a resulting product is akin to basing royalties on a patented paintbrush to the sales of artwork created using the paintbrush. On the other hand, where the product could not have been identified but for the method, high value may be justified and obtainable.

With all these caveats, can patents based on biotechnology research tools ever be valuable? Yes. Numerous examples are available which demonstrate that strategically planned and well-managed patent portfolios can be financially profitable. Dyax Corporation, for one, holds patents covering phage display methodology to identify useful nucleic acids and peptides. While the patents claim only the methods of performing phage display and certain intermediates useful in the process, the portfolio has been successfully licensed to over 60 biotechnology or pharmaceutical companies and non-profit institutions. The non-exclusive licenses to companies carry upfront signing fees, annual maintenance fees, transfer or service fees, milestone payments tied to the U.S. Food and Drug Administration process and royalties based on sales of products "discovered, made or developed using a method covered by a claim" in the licensed patents.

While the recent advances in biotechnology present new and unique challenges to the patent practitioner, strategic planning and careful implementation can create a valuable intellectual property portfolio. A well considered strategy must take into consideration the types of claims that can and should be obtained to maximize protection without unnecessarily surrendering proprietary information. The use to be made of the portfolio – whether to license or enjoin others – should be determined in advance. Finally, licensing and litigation require skilled professionals able to understand the technology and accurately assess the value of the portfolio.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.