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Deuterated drugs; updates and obviousness analysis.
1a College of Pharmacy , University of New Mexico Health Sciences Center , Albuquerque , NM , USA.
Expert Opinion on Therapeutic Patents
|September 9, 2017
Summary
Selective deuteration modifies drug pharmacokinetics and toxicity, with significant commercial interest. Legal aspects, including patent obviousness and Inter Partes Review, are crucial for deuterated drug development and litigation.
Area of Science:
- Medicinal Chemistry
- Intellectual Property Law
Background:
- Selective deuteration offers a route to modify drug pharmacokinetics and toxicity.
- Deuterated drugs represent a significant commercial market, nearing $5 billion in transactions.
- Regulatory progress, including FDA approvals like deutetrabenazine, highlights the field's advancement.
Purpose of the Study:
- To review recent developments in deuterated drugs, focusing on scientific and commercial progress.
- To analyze the legal landscape surrounding deuterated drugs, specifically patent 'obviousness' (35 U.S.C. §103) and Inter Partes Review (IPR).
- To provide expert opinion on the impact of patent law on the future of deuterated drug development.
Main Methods:
- Review of recent scientific literature and FDA approvals.
- Analysis of patent prosecution and Inter Partes Review (IPR) proceedings related to deuterated drugs.
- Examination of patent strategies employed by major pharmaceutical companies regarding priority dates.
Main Results:
- The FDA has approved deutetrabenazine, showcasing regulatory progress in deuterated drugs.
- Two IPR petitions concerning deuterated drugs have been instituted, involving arguments under §103.
- Analysis suggests that pharmaceutical companies often aim for later priority dates in their patent filings.
Conclusions:
- Patent 'obviousness' remains a key consideration in ongoing patent applications for deuterated drugs.
- Inter Partes Review (IPR) is an emerging legal mechanism that will likely influence the interpretation of §103 in this field.
- Despite legal challenges, patents with later priority dates continue to be issued, indicating potential for future litigation in the deuterated drug space.
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