Section 112 Requirements for Life Sciences Patents
Anagha Tendulkar, In-house Patent Counsel, Cipla, Section 112 Requirements for Life Sciences Patents
35 U.S.C. §112(a) of the US Patent Act is one of the integral parts of the quid pro quo patent system that balances the benefit of disclosure of the invention to the public and the inventor’s right to enjoy the monopoly over the invention for 20 years from filing of the patent application. Two key requirements of this statute are that the specification needs to have written description support for the invention (written description requirement) and that the specification be enabled in a manner such that the invention can be made and practiced by a person skilled in the art without having to perform “undue experimentation” (enablement requirement).
This article explores the enablement and written description requirements and how the courts have evaluated and interpreted the same. The enablement requirement is very nuanced and has received attention from the United States Supreme Court. The highest court has allowed a writ regarding the requirement which would potentially provide more clarity on the level of description and teaching necessary to meet the requirement. This article discusses this writ and the arguments made on both sides. This article further explores a written description case for which a writ of certiorari has been filed with the Supreme Court . This federal circuit case was earlier discussed in an article about written description, but the court has reversed the holding. The article will focus on this reversal and the issue presented to the Supreme Court.
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