Patent prosecution in proteomics

Abstract

I. INTRODUCTION: AN INTELLECTUAL PROPERTY OVERVIEW Some find the concept of intellectual property hard to grasp, often because it's hard to determine the monetary worth of ideas. One simple example of the value of intellectual property is the common occurrence of expensive and high-stakes infringement lawsuits. One of the costliest examples is the decades-long case of Eastman Kodak vs. Polaroid, which resulted in the destruction of Kodak's instant photography business, as well as more than three billion dollars in infringement damages, compensation and legal fees, and research and manufacturing costs. (1) Even lawsuits that result in settlements, such as that filed by the University of California against Genentech for the company's manufacture and sale of the growth hormone product Protropin[R], can be severe ($200 million in the case of UC vs. Genentech) punishments for the defendants. (2) That is not to mention the hundreds of thousands of dollars lost by both sides on legal and courtroom fees and on time spent by employees and management embroiled in the suit. Although successful suits filed by small companies can result in large settlements or infringement damages from industry juggernauts, companies without the proverbial deep pockets typically do not have the resource to spend on lengthy, costly litigation. The price of resolving patent disputes can sometimes cripple a business, compared with the modest cost of building an effective IP portfolio. Thus, successful companies stand to benefit more from a strong IP portfolio to accompany equally strong and innovative research and development. Besides, with sound and successful innovation, a company can avoid being mired in litigation over a technology that it has long since improved upon. From a different angle, those still questioning the value of intellectual property can look at the value derived from successful licensing of IP. The well-known Cohen-Boyer recombinant DNA patents, often credited as key catalysts of today's biotech industry, were reported to have earned $37.3 million in licensing royalties in 1997 alone. (3) While U.S. legislation, such as the Bayh-Dole Act, allowed for transfer of ownership of many government-funded inventions from the U.S. government to the universities, (4) resulting in successful licensing of almost half of university-born inventions, (5) the fact is that an estimated 3% of all patents are actually licensed. (6) Thus an effective IP prosecution strategy should take note of the competing demands for licensing revenue and defense from litigious competitors. On the one hand, well-written patents are needed to defend the core technologies a company builds upon, and on the other hand an aggressive patenting strategy is needed to map the course a company sees itself undertaking. The latter can result in licensing deals, or serve as a useful method for sidestepping unwanted litigation, by keeping far ahead of the competition. This Article presents a brief overview of intellectual property rights and the various areas in proteomics to which IP rights may be applicable. The perfection of an IP portfolio is of interest to startups and their investors, whereas licensing agreements are of interest to manufacturers and customers. Technology transfer, including licensing and business agreements, is not covered in this Article. Instead, issues and complications related to national and overseas patent prosecution in this relatively new field will be discussed. A. Patents United States patents offer protection for any process, machine, manufacture, or composition of matter, or any improvement thereof, that are novel, useful, and non-obvious. (7) The Agreement in Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreements) in 1994, a multilateral concord proposed by the council administering the WTO's intellectual property agreement, (8) defines patentable matter as any invention that involves an innovative step and has a potential industrial application. …