Academic journal article Marquette Intellectual Property Law Review

Repurposing - Finding New Uses for Old (and Patented) Drugs: Bridging the "Valley of Death," to Translate Academic Research into New Medicines

Academic journal article Marquette Intellectual Property Law Review

Repurposing - Finding New Uses for Old (and Patented) Drugs: Bridging the "Valley of Death," to Translate Academic Research into New Medicines

Article excerpt

I. INTRODUCTION II. DRUG REPURPOSING     A. Growth of Drug Repurposing     B. Academic Drug Development and the "Valley of Death"     C. Repurposing to Traverse the Valley of Death--Is There        Sufficient Exclusivity?     D. Repurposing to Traverse the Valley of Death--Can I Find        New Uses for Your Drug? III. PATENT LAW AND REPURPOSING     A. Statutory Law and History     B. Statutory Interpretation and Common Law        1. Creation of 35 U.S.C. [section] 271(e)(1)        2. Eli Lilly v. Medtronic: Setting the Stage for Merck v.          Integra        3. Merck v. Integra           a. The facts in Merck v. Integra           b. The issue of safe harbor protection scope           c. Scope includes research directed to IND and NDA              filing           d. The scope of the safe harbor protection extends beyond              safety studies           e. Scope not limited to studies included in IND, NDA or ANDA              filings        4. After Merck v. Integra     C. Summary of Current Law the Legal Issue IV. APPLYING THE LAW TO DRUG REPURPOSING     A. Repurposing Research     B. Implications of Merck and Momenta (M&M) for Repurposing        Research     C. Public Policy Considerations for Repurposing Research       1. Society Needs New Medicines - Repurposing Serves the          Greater Social Good       2. From Fairies to Financial Bias       3. Innovation - To Advance Science and the Useful Arts          Such as Medicine V. CONCLUSION 

I. INTRODUCTION

Most people have experienced the pain of seeing loved ones suffer, and perhaps die, from diseases that no adequate treatments exist for. We all understand, in very personal ways, the need for new and better therapies. However, the pipeline of new medicines from the pharmaceutical industry has been dwindling as research and development costs increase, and as productivity has been declining. (1) As a society, we now face a serious problem--indeed, a tipping point. While the pharmaceutical industry was once viewed as a growth industry embodying the spirit of innovation, its pipeline of new medicines is drying up. Could it be that the pharmaceutical industry, at least in its current form--focused on "blockbuster drugs"--has made that fateful transition from a growth--i.e. innovation-driven--industry, to a mature industry? If that is the case, where will the new medicines come from, especially for currently untreated diseases--the "unmet medical needs"? This comment will present legal and public policy arguments in support of one solution to this problem: drug repurposing; in particular, drug repurposing that is performed in university research labs and directed towards unmet medical needs. This comment will also include a fairly detailed description of the drug development process and analysis of the pharmaceutical industry. This is in part a bias of the author, who has previously worked in the pharmaceutical and biotechnology industries in drug development and co-founded two biotechnology companies, one of which is focused on drug repurposing.

Drug repurposing, sometimes referred to as repositioning, is increasingly being pursued as a solution to the problem of dwindling pharmaceutical pipelines; it is being proposed in both industrial and academic drug development settings. (2) Repositioning is the process whereby a drug that is patented for treating a particular disease is discovered to be useful for treatment of a second disease, and then is developed further for that purpose. (3) But can a researcher explore new uses for a patented drug without infringing on the patent owner's patent under 35 U.S.C. [section] 271? The answer to this question is a qualified "yes."

This comment will present background as to why drug repositioning, and especially repurposing, has moved to the forefront of public--e.g. university, government-funded research--and private drug development efforts. Then, the various intellectual property and business issues surrounding repurposing will be presented. …

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