United States – Page 12

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

Sep 15 2014

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products. Read More

Australian Courts Confirm Status Quo for Patenting Gene Sequences

Sep 05 2014

Today, a five-judge bench of the Full Court of the Federal Court of Australia unanimously decided that Myriad Genetics Inc’s (Myriad) patent covering the isolated BRCA1 gene (Patent) is valid.

In Yvonne D’Arcy v Myriad Genetics Inc & Anor (5 September 2014) the Full Federal Court rejected the reasoning of the U.S. Supreme Court, when it found in 2013 that certain claims of a closely related U.S. Patent of Myriad were invalid as the claim to isolated nucleic acid was a claim to a “product of nature” and not patentable subject matter.

For the pro-patent lobby and the biotech industry, this is good news for innovation in life sciences in Australia.

PTO Seeks to Improve Patent Quality

Sep 04 2014

At the same time that it announced an almost 50% reduction in its backlog of request for continued examinations over the past year, the U.S. Patent and Trademark Office (USPTO) announced a new initiative to improve patent quality. During the quarterly Patent Public Advisory Committee (PPAC) meeting in August, USPTO Commissioner for Patents, Peggy Focarino, said the new focus on quality was a result of the PTO approaching optimal steady state application pendency and the AIA creating a sustainable fee reserve to fund such initiatives. Read More

On Tap at the U.S. Supreme Court: An Important Trademark Case

Sep 03 2014

During its next term, which begins in October 2014, the U.S. Supreme Court will continue to decide important intellectual property cases.

In B&B Hardware, Inc. v. Hargis Industries, Inc., the Court will tackle an issue that has long vexed trademark owners and their lawyers: ‘how much deference to give determinations by the Trademark Trial and Appeal Board (TTAB) on the issue of likelihood of confusion, when a subsequent infringement action is brought in federal court?’. In other words, must a court accept the TTAB’s decision on likelihood of confusion, even though the TTAB’s jurisdiction is limited to a trademark’s registrability? Read More

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

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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