Litigation – Page 11 – IP Law Watch

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

Another Piece in the Software Patent Puzzle – The Federal Circuit’s First Take on Alice

Jul 28 2014

The Federal Circuit recently released its first interpretation of the Supreme Court’s late June decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, et al. (Alice) In Digitech Image Tech., LLC v. Electronics for Imaging, Inc., et al. (Digitech) the Federal Circuit added a few more wrinkles to the emerging law of software patent eligibility.

In Digitech, the Federal Circuit held that all of the asserted claims of U.S. Patent No. 6,128,415 were ineligible for patenting. The patent was directed to device profiles, which are data structures used to correct for hardware-specific distortions in digital image processing systems. 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

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

Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable

Dec 05 2013

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] HCA 50

The High Court of Australia yesterday issued its long awaited decision in a dispute between Apotex Pty Ltd (Apotex) and Sanofi-Aventis Australia Pty Ltd and related entities (collectively, Sanofi) concerning Sanofi’s Australian patent entitled “Pharmaceutical for the treatment of skin disorders” (Patent). In summary:

The majority (French CJ, Crennan, Keifel and Gageler JJ, Hayne J dissenting) held that assuming all other requirements for patentability are met, a method (or process) for medical treatment of the human body can be a “manner of manufacture” and therefore patentable for the purposes of section 18 of the Patents Act 1990 (Cth) (Act). Read More

Category:Litigation