Patent Protection of Pharmacologically Active Metabolites: Theoretical and Technological Analysis on the Jurisprudence of Four Regions

By Wang, Richard Li-dar; Huang, Pei-Chen | Santa Clara Computer & High Technology Law Journal, March 2013 | Go to article overview

Patent Protection of Pharmacologically Active Metabolites: Theoretical and Technological Analysis on the Jurisprudence of Four Regions


Wang, Richard Li-dar, Huang, Pei-Chen, Santa Clara Computer & High Technology Law Journal


Table of Contents  I.   Introduction  II.  Active Metabolites and Patent Law  III. Active Metabolites in U.S. Law       A. Marion Merrell Dow Inc. v. Baker Norton         Pharmaceuticals, Inc       B. Schering Corp. v. Geneva Pharmaceuticals, Inc       C. Analysis  IV.  Active Metabolites in European Law   V.  Active Metabolites in Indian Law  VI.  Noteworthy Court Decisions in Taiwan  VII. Theoretical and Technological Analysis and      Transnational Categorization       A. A Portion of Active Metabolites Deserves Patent      Protection       B. Possible Mode I: Inherent Anticipation Doctrine       C. Possible Mode II: Product of Nature Doctrine       D. Possible Mode III: Non-Practice Theory  VIII. Conclusion  I. Introduction 

Considering the theoretical foundations of the patent system from a utilitarian perspective, (1) the basic rationale for the existence of patent rights is to trigger a series of economic activities that benefit society by providing inventors (or their successors) with the legal right to exclude others from practicing their inventions (right to exclude). Innovation and invention are sources of technological improvement for society. However, because innovations possess the characteristics of public goods, they are often appropriated by competitors, resulting in free riding. (2) Providing inventors with exclusive rights can prevent competitors from copying inventions without their permission and destroying the opportunity to recover their research and development costs from the market. In this situation, patents act as incentives to invent. They encourage exploration of new inventions, and prevent free riding that may result in an insufficient investment of research and development. (3)

Additionally, when new inventions are developed, they must undergo a lengthy process of commercialization. Adequate product designs and efficient manufacturing processes must be instigated, which enable technological inventions to be actually applied to commercial commodities, thereby being employed in the market and benefiting the consuming public. Patents can provide incentives to commercialize as well. The protection of patent rights can attract necessary funding for supporting the expenditure of commercialization and market development. Furthermore, due to the fact that inventors have to disclose the technological content of their innovations when applying for patents, the exclusive patent terms induce inventors from keeping their innovations confidential. (4) This is a major incentive to disclose new technical development, and an important method for encouraging public accumulation and exchange of state-of-the-art technological information. (5)

However, the awarding of exclusive patent terms creates conflicting interest between inventors and the public. This conflict occurs in the pharmaceutical field as well. Drug patents can satisfy the profit demands of pharmaceutical manufacturers, and assist with accumulating and sustaining research and development funding and capability. However, the fact that patent protection excludes unlicensed generic manufacturers from producing the same drug often runs contrary to the patient's need for affordable medicine. Additionally, pharmaceutical companies often prosecute and obtain secondary patents to further extend the exclusivity period of brand-name drugs, which usually comes from primary patents on active ingredients of the drugs, so as to block generic manufacturers even longer and pursue the brand-name manufacturers' own interests. This strategy creates the phenomenon of "patent evergreening." (6) Medical products and pharmaceuticals are indispensable resources for saving human life and health. Extending brand-name exclusivity over time through secondary patents not only runs counter to fairness and equality, but is also closely related to public health. Recently, this problem of drug patent evergreening has received significant international attention. …

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