Harman Patil (Editor)

Research tool patents

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One of the vigorously debated topics related to the protection of biotechnology inventions has been the issue of patents on biotech research tools. Research tools are usually used in very early stages of biotech research, for example, to identify promising biomedical entities, biostructures, etc. Research tool patents typically claim methods or compositions used to discover novel, biologically important compounds and therapeutics. Proponents of patenting argue that the patent system acts as an incentive for biotech/pharma companies to invest in R&D aimed at developing biotech research tools. Proponents rationalize that potential profits lead patentees to encourage research use of their patents. Opponents of patents on biotechnology research tools argue that research-tool patents can impede future research by creating “patent-thickets” thereby creating prohibitive economic barriers to the use of patented research tools. Some scholars go even further by claiming that because university-based researchers typically do not harness the patent system as do private-sector researchers, a research exemption should be crafted to specifically cover the academic sector. Recent U.S. court decisions (Teva cases against Sandoz and Mylan) suggest that if a research tool is used to gather information to submit to the FDA seeking approval, § 271(e)(1) (safe harbor exemption) probably applies. Moreover, if the FDA requires certain information, gathering such information—pre- or post-approval—using a research tool should also be subject to § 271(e)(1).

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Research tool patents Wikipedia