New guidelines issued in March by the U.S. Patent and Trademark Office (PTO) limit patent subject-matter eligibility across industries. The guidelines are the result of two recent U.S. Supreme Court decisions that have had a drastic impact on the biotechnology and biomedical industries. The impact of these cases, which featured claims involving diagnostic methods and gene patents, were initially thought to be limited to these industries. However, the resulting guidelines are extremely broad and will have a detrimental effect on the pharmaceutical industry as well as any business with intellectual property involving “natural products.”
Title 35 of the United States Code provides the requirements for obtaining a patent. The claimed invention must be novel and nonobvious; however, before that determination is even begun, the patent examiner must first determine whether the claimed invention meets the requirements of subject-matter eligibility under 35 U.S.C. §101. In a previous Supreme Court decision involving genetically modified organisms, the §101 requirement was interpreted to include “anything under the sun that is made by man” as patentable subject matter. But that is no longer the case.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.
For questions call 1-877-256-2472 or contact us at [email protected]
