Existing portfolios should be carefully reviewed and care must be taken in drafting new patent applications to withstand section 101 scrutiny in the US, as Judith Kim, director, and Scott Schaller, of counsel, at Sterne Kessler Goldstein & Fox, describe.
Patent-eligible subject matter in the US includes four statutory categories defined in title 35, section 101 (§101) of the US code as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”.
Laws of nature, natural phenomena, and abstract ideas have been held by the US Supreme Court to be implicit exceptions to patent-eligible subject matter under §101, with the exceptions rationalised as a means to prevent the monopolisation of the basic scientific and technological tools required for future innovation. These judicial exceptions arguably did not play a large role in US prosecution or enforcement of biotechnology and pharmaceutical patents until recent years.
Instead, innumerable patents were issued with claims directed to, for example, isolated genes, isolated biological products, and diagnostic tests, in the decades before the Supreme Court’s holdings in Mayo Collaborative v Prometheus Labs (Mayo) and Association for Molecular Pathology v Myriad (Myriad).
You need a subscription to continue reading this content.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
News stories up to a week old and feature articles on the day of publication are accessible with a BASIC FREE ACCOUNT.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’; and for basic access to the latest news on the website and weekly email news alerts choose the 'BASIC FREE ACCOUNT' registration.
Alice Corp v CLS Bank; Sterne Kessler Goldstein & Fox; patentability; Mayo Collaborative v Prometheus Labs; section 101 (§101) of the US code