Life Sciences – Page 4

High Court to Consider Whether Isolated Genetic Material is Patentable in Australia

Feb 19 2015

On 13 February 2015, the High Court of Australia (High Court) heard and granted Yvonne D’Arcy’s application for special leave to appeal the Full Federal Court of Australia’s (Full Federal Court) decision in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115.

The unanimous decision of the five-judge bench of the Full Federal Court was that Myriad Genetics Inc’s patent claims directed to particular isolated BRCA1 genes were patentable subject matter in Australia.

Australia’s Very Exclusive Patent Licensee Club

Feb 11 2015

Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

The Full Federal Court of Australia (Court) has held that an ‘exclusive licensee’ within the definition of the Patents Act 1990 (Cth) (Patents Act), must be granted the exclusive right to undertake ALL of the activities falling within the meaning of “exploit”. Accordingly, a grant of a licence to advertise, market, promote, sell and distribute, but not manufacture, does not create an “exclusive licensee”, as defined in the Patents Act. There can only be one exclusive licensee and the patentee cannot reserve any of the exclusive rights to exploit to itself. Read More

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation

Dec 12 2014

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory judgment action due to lack of Article III jurisdiction. In particular, the industry has been waiting to see whether the Federal Circuit would uphold the district court’s ruling that Sandoz’s lawsuit was barred by the Biologics Price Competition and Innovation Act (“BPCIA”). Unfortunately, the Federal Circuit declined to address the district court’s interpretation of the BPCIA, providing no further guidance on the topic. Instead, the Federal Circuit simply affirmed the district court’s ruling that there was no subject matter jurisdiction, relying on Hatch-Waxman generic drug cases as precedent.

To read the full alert, click here.

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Dec 09 2014

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of guidance on this subject has already sparked litigation, including the recent litigation between Amgen Inc. (“Amgen”) and Sandoz Inc. (“Sandoz”) discussed in our previous client alert, Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. However, Amgen and Sandoz are not the only parties that have brought disputes involving the BPCIA to the courts for resolution.

To read the full alert, click here.

FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act

Aug 06 2014

On 24 July 2014, over four years after the enactment of the Biologics Price Competition and Innovation Act, the FDA accepted its first biosimilar application from Sandoz Inc. (Sandoz). Sandoz’s application is for a biosimilar version of Amgen Inc.’s (Amgen) Neupogen® (filgrastim). Neupogen® is a pharmaceutical analog of human granulocyte colony stimulating factor that is used to treat neutropenia, a condition where the body does not make enough neutrophils, a type of white blood cell. Amgen’s Neuprogen® is indicated for use by patients receiving strong chemotherapy to reduce their risk of infection. Read More

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.

Category:Life Sciences