Nanobiotechnology, synthetic biology, and RNAi: patent portfolios for maximal near-term commercialization and commons for maximal long-term medical gain.

AuthorMackey, Thomas M.

ABSTRACT INTRODUCTION I. PRESENT AND PROBABLE FUTURE SCIENTIFIC KNOWLEDGE AND TECHNOLOGICAL CAPACITIES A. The Present and Near Future: Incremental Progress B. In 20-to-40 Years: Revolutionary Progress, Effecting Leaps Forward in Medicine 1. Interim Work Towards the Probable Revolutionary Advances: Identification and Removal, or Circumvention, of Scientific and Technological Obstacles 2. Medical Leaps in 20-to-40 Years: Vastly Improved Risk Identification, Prevention, Diagnosis, and Treatment for Common and Commonly Lethal Chronic Diseases II. THE EFFECTIVE USE OF PATENT PORTFOLIOS TO NAVIGATE THROUGH COMPLICATED AND UNCERTAIN LEGAL, SCIENTIFIC, AND TECHNOLOGICAL TERRITORIES A. The Patent Portfolio: The Main Unit of IP Value in All Three Technologies B. Patent Thickets and Low Quality Patents: Consequences of Patenting Too Early, Too Many, and Too Broadly in NB/BN, Synthetic Biology, and RNAi C. Prosecuting to Maximize Patent Portfolio Value When the Pertinent Patent Law, Science, and Technology are All Uncertain and Quickly Changing 1. KSR Int'l Co. v. Teleflex, Inc. and Pertinent Likely Provisions of the Patent Reform Act: Effects on Patent Prosecution a. The Heightened Obviousness Bar for Post-KSR NB/BN, Synthetic Biology, and RNAi Claims to Combinations b. Possible Forthcoming Statutory and PTO Rule Changes That Would Help Further Weed Out Patent Thickets and Increase Patent Validity: Creating a One-Year Post-Grant Opposition Period, Reducing the Litigation Estoppel Effect of Inter Partes Reexaminations, and Empowering the PTO to Make Rules That Limit Continuations 2. Just-Now-Learning that Human Genetic Regulation is Not What We Thought: Specific Consequences for Prosecuting NB/BN, Synthetic Biology, and RNAi Patents 3. General Strategies and Tactics in Patent Prosecution that Maximize Patent Portfolio Value in NB/BN, Synthetic Biology, and RNAi III. DESIGNING AND EXECUTING ROADMAPS THAT MAXIMIZE COMMERCIAL VALUE: USE OF PATENT PORTFOLIOS, LICENSES, VENTURE CAPITAL, AND ACQUISITIONS A. Early Thorough Integrative Research Planning that Culminates in a Multi-Dimensional Modifiable Roadmap B. Maintaining and Modifying the Roadmap to Maximize Commercial Value C. Using the Patent Portfolio to Facilitate Commercial Development D. Exclusive Licensing E. Maximizing Patent Portfolio Value to Obtain and Maintain Venture Capital F. Through the Minds of Prospective Buyers: How Pharmaceutical and Biotechnology Companies Acquire NB/BN, Synthetic Biology, and RNAi Technology IV. OVERCOMING NEAR-TERM OVER-OPTIMISM TO REALIZE LONG-TERM REVOLUTIONARY GAINS: A SOBERING LOOK AT THE MODEST MEDICAL GAINS IN FIGHTING AMERICA'S TOP THREE KILLERS--HEART DISEASE, CANCER, AND CEREBROVASCULAR DISEASE V. POLICY PRESCRIPTIONS: FURTHER WEED OUT THE PATENT THICKETS, INCREASE PATENT QUALITY, AND SHIFT THE MAIN FOCUS FROM MAXIMIZING NEAR-TERM COMMERCIALIZATION TO MAXIMIZING LONG-TERM MEDICAL PROGRESS A. Further Weed Out the Patent Thickets and Increase Patent Quality: Why KSR and the Patent Reform Act Probably Will Not Suffice and How We Could Do More 1. Additional Changes Recommended: Prosecution History Estoppel, Improved Injunctive Relief to Deter Holdups from Trolls, and Removal of the Prior Art Limit to Reexaminations 2. Impractical Given the Extraordinary Cross-Industry Nature of the Technologies: Extensive Industry-Specific Patent System Reform B. Parallel Science and Technology Commons 1. Commons for Pertinent Upstream Basic Science and Technology: Which Commons Type for Valid and Reliable Building Block Standards in the Three Nascent Technologies? 2. Which Commons Type for Very High Risk and Very Long-Term Technological Developments That Could Truly Revolutionize Medicine? CONCLUSION INTRODUCTION

This is an attempt to hit moving targets that, if captured as freeze-frames, would defy ready characterization. I predict probable developmental paths and consider feasible, though less probable, alternative developmental paths for three polymorphic nascent technologies in the life sciences: nanobiotechnology (NB/BN), (1) synthetic biology, and interference RNA (RNAi). (2) These three nascent technologies have enough similarities and differences in terms of patent portfolio issues, probable paths to commercial development, and promises for future medical advances to be fruitfully compared and contrasted in this Article. (3) Developmental paths will evolve as congressional statutes, federal court doctrine, and U.S. Patent and Trademark Office (PTO) procedure also evolve over the coming years and decades, in part as both causes and effects of how the technologies evolve. (4) Because of the great uncertainties involved in these evolutions, part of this Article thus focuses on a key to commercializing particular nascent life science technologies--building effective patent portfolios--under conditions of high scientific, technological, and legal uncertainty, where decision-making itself is poorly understood. (5)

The technological and scientific landscapes are even more complex than they are uncertain, although the uncertainty is a large part of the multilayered complexities in the pertinent sciences and technologies. (6) The breadth and overlap--and potentially overwhelmingly large number--of NB/BN, synthetic biology, and RNAi patent portfolios, complex as they are, are exceeded in complexity by the broad and overlapping technologies that these portfolios could potentially cover. (7) This second, greater complexity is exceeded still by a third: multilayered and overlapping intracellular human genetic mechanisms and epigenetic systems. (8) The fact that our pertinent human biology is even more complex than the extremely multifarious and challenging technologies should give us some pause when we hear of potential major medical breakthroughs, such as prophylactics or cures for cancers, coming from the technologies anytime soon. (9)

Although possible, it is not likely that such prophylactics or cures could come without a much more complete picture of the pertinent chemistry (e.g., cellular and systemic structures) and physics (e.g., pertinent quantum mechanical and classical forces and their influences on normal and pathological conditions). (10) We need a deeper and more precise understanding of various cellular mechanisms and epigenetic systems (in the case of cancer, this would require, inter alia, a much better comprehension of the forces that promote and prevent carcinogenesis and metastasis). (11)

In Part I, I briefly survey each of the three nascent technologies, creating overviews of likely near-term and long-term future developments. In Part II, I look at efficacious patent portfolio construction and management primarily from the standpoint of how a patent practitioner could assist a government agency, university, or start-up that is looking to develop and commercialize an NB/BN, synthetic biology, or RNAi invention. In Part III, I further examine how a practitioner could use patent portfolios to help his or her client via exclusive licensing, getting and maintaining venture capital, and becoming an attractive target for acquisition by a large pharmaceutical or biotechnology company. Intellectual property (IP) is typically one of the most valuable assets of a government agency, university, or start-up seeking to commercialize innovation in cutting edge applications in the life sciences. (12) An effective IP portfolio and a carefully planned and executed exclusive license between a government agency or university and a start-up are often crucial to receive venture capital, which has thus far been the lifeblood of most start-ups with very high input costs. (13) New complicated technologies almost invariably involve high input costs, thus creating incentives to maximize IP protection early, broadly, and often. (14) In NB/BN, synthetic biology, and, to a lesser extent, RNAi, patents that were too broad in scope were pursued and granted too early and too often to too many inventors. (15)

Many patent thickets and invalid patents either loom or already exist, creating barriers to commercialization in sectors in all three nascent industries. (16) Patents that become entangled in thickets probably face formidable validity and infringement challenges if and when the pertinent technology becomes commercially viable. (17) The thickets thus create barriers to gaining that commercialization in the first place, partly because venture capitalists are understandably wary of investing in a company that is likely to face patent litigation. (18) Fortunately, the federal courts, Congress, and the PTO are in the process of creating changes in the law which will help weed out the thickets and increase patent quality, (19) although they have not gone far enough. In Part V.A, I advocate further legal changes that could effect additional patent thicket weeding and increases in patent quality. Finally, in Part V.B, I recommend an increase in the ratio of long-term rigorous, ambitious, and publicly funded research and development (R&D) to patent portfolio-driven near-term commercial R&D in these technologies. The prescription is based mainly on projections that increasing this ratio would probably direct and expedite progress towards removing or circumventing scientific and technological obstacles to revolutionary medical applications of the technologies. (20) The greatest long-term prospects--in terms of public good payoffs--are the improvements in health and increases in longevity that these still largely undeveloped life science technologies could provide via high-tech and highly personalized medicine. (21)

  1. PRESENT AND PROBABLE FUTURE SCIENTIFIC KNOWLEDGE AND TECHNOLOGICAL CAPACITIES

    NB/BN, synthetic biology, and RNAi are life science technologies that, just in the last few years, have attained a large amount of public and private funding--and much patenting as well--largely because of their perceived commercial potential in many areas, most...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT