Patents – Page 16 – IP Law Watch

Special Leave Sought to Appeal Gene Sequencing Decision to the High Court of Australia

Sep 25 2014

We recently reported on the decision by a five judge bench of the Full Court of the Federal Court of Australia (Full Court) which found that Myriad Genetics Inc’s patent covering the isolated BRCA1 gene is valid. The Full Court unanimously rejected an appeal by Ms. Yvonne D’Arcy from a decision by Justice Nicholas at first instance. Read our alert here.

It is now being reported that Ms. D’Arcy has sought special leave to appeal the decision to the High Court of Australia (High Court).

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 Patent Examination Reports Issuing Faster Than Expected in Some Technology Areas

Sep 12 2014

Prior to commencement of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which came into effect in April 2013, the Australian Patent Office was inundated with requests for examination from applicants wishing to have their applications examined under the current law.

This flood of examination requests led the Patent Office to last year advise that first examination reports would likely issue, on average, about 19 months after examination is requested. We have recently been advised by the Patent Office that the backlog of applications awaiting examination is starting to clear and that examination reports are now issuing, on average, about 16 months after examination is requested. 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

Are you Ready for Commencement of New Zealand’s New Patents Act?

Aug 30 2014

New Zealand patent law has been completely overhauled and modernised. Details of the changes can be found here. The new law commences on 13 September 2014, which is only two weeks away!

The new provisions raise the requirements for patentability and the requirements for patent specifications and bring New Zealand patent law into substantial conformity with the patent laws of other developed countries, such as Australia. Among the new provisions is a provision which denies patentability to alleged inventions where the contribution to the art lies solely in it being a computer program. Read More

AstraZeneca Loses Latest Bout Over Rosuvastatin Patents

Aug 12 2014

The Full Federal Court of Australia has upheld the first instance judgment of the Federal Court of Australia that the three patents protecting AstraZenica’s rosuvastatin products (marketed as Crestor) are invalid.

In judgment handed down on 12 August 2014, the court unanimously dismissed the appeals by AstraZeneca against generic pharmaceutical companies Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd. 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

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

Category:Patents