United States – Page 12

Biosimilars – The New Forefront for Pharmaceutical Litigation

Jul 16 2014

A recent United States statute establishes an expedited pathway for FDA approval of biosimilars (also known as follow-on biologics) – the Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act. A biologic is a drug derived from a living organism or living cells and is best exemplified by Humira®, the branded antibody for treatment of rheumatoid arthritis. Simply put, a biosimilar is a molecule that copies a branded biologic and is for all practical purposes highly identical to the branded biologic in structure and function. Read More

The USPTO and Laws of Nature, Natural Products and Natural Phenomena

Jul 11 2014

New Approach to Patentable Subject Matter

The United States Patent Office periodically issues guidance for examiners often in response to a recent court decision or new statute. These guidelines (the Guidance) do not have the force of law but nevertheless establish the specific procedures that the Examiners apply during examination of patent applications.

Examination guidelines were issued on 4 March 2014 to address two recent court decisions related to the subject matter eligibility of certain claims under 35 U.S.C. § 101. Examiners will use tests described in the Guidance to determine the patent eligibility of any claim related to laws of nature, natural phenomena and natural products. Read More

Abstract Ideas and the USPTO

Jul 11 2014

The Patent Office’s First Take on CLS Bank v. Alice

On 25 June 2014, new examination guidelines (the Guidance) from the United States Patent Office were issued in response to the Supreme Court’s decision in Alice Corp. v. CLS Bank International. This case addressed the subject matter eligibility under 35 U.S.C. § 101 of claims related to an abstract idea. The Guidance provides preliminary instructions for analysing claims involving an abstract idea and its applicability to technology areas, including the software and business method fields, which are worthy of attention from applicants.

Software Is Still Patentable, With Caveats

Jun 20 2014

On Thursday, the Supreme Court issued its long-awaited opinion on software and business method patents in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, et al. In a unanimous opinion written by Justice Thomas, the Court held all of Alice’s claims to be ineligible for patenting. The decision tightens the standards for patent eligibility but does not eliminate software patents or computer-implemented business methods. Read More

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