Category:Litigation

1
Special Leave Sought to Appeal Gene Sequencing Decision to the High Court of Australia
2
Australian Courts Confirm Status Quo for Patenting Gene Sequences
3
On Tap at the U.S. Supreme Court: An Important Trademark Case
4
AstraZeneca Loses Latest Bout Over Rosuvastatin Patents
5
A Second Helping of Kebab
6
FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act
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Another Piece in the Software Patent Puzzle – The Federal Circuit’s First Take on Alice
8
Biosimilars – The New Forefront for Pharmaceutical Litigation
9
Software Is Still Patentable, With Caveats
10
Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable

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

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).

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Australian Courts Confirm Status Quo for Patenting Gene Sequences

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.

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

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

AstraZeneca Loses Latest Bout Over Rosuvastatin Patents

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

A Second Helping of Kebab

Additional Damages for Past Trade Mark Infringements

In June 2014 the Federal Court made its first award of additional damages for trade mark infringement under the ‘Raising the Bar’ amendments to the Trade Marks Act 1995 (TM Act). We reported on the original judgment in our 23 June 2014 alert, which you can find here.

Today, the Federal Court of Australia handed down another judgment in that case. This second judgement suggests that additional damages may also be available for trade mark infringements that occurred before 15 April 2013.

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

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

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

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

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

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:

  1. 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

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