Patents – Page 13 – IP Law Watch

High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

Oct 08 2015

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

Australian High Court Rules Rosuvastatin Low Dose Patent Obvious

Sep 16 2015

In an eagerly awaited decision¹ the Australian High Court has upheld a decision of a five judge bench of the Full Federal Court that AstraZeneca’s patent relating to low dosages of rosuvastatin is invalid on the basis that the claims lack an inventive step.

Section 7(3) of the Patents Act 1990 (Act) as it existed at the priority date of Astra Zeneca’s patent imposed a threshold requirement that in order to be considered for assessing inventive step a document must be “ascertained, understood and regarded as relevant” by a person skilled in the art.

Is Australia’s Innovation Patent System on Borrowed Time?

Aug 19 2015

On 5 August 2015, the Australian Patent Office (IP Australia) released a consultation paper seeking feedback from interested stakeholders on the Advisory Council on Intellectual Property’s (ACIP) recommendation that the Australian Government should abolish the innovation patent system.

Introduced in 2001 under the Howard Government, the innovation patent system is Australia’s second tier patent right having a shorter term,eight years, and a lower threshold of invention (i.e. an ‘innovative step’ as opposed to an ‘inventive step’ required for a standard patent).

Extension of Term for Australian Patents Relating to AbbVie’s Blockbuster Drug HUMIRA Denied

Aug 12 2015

In a recent decisionthe Australian Patent Office has rejected applications to extend the term of three patents related to the highly successful anti-inflammatory drug HUMIRA.

The patents are part of a family in which extensions of term had been granted in connection with earlier patents. These earlier extensions were based on the initial listing of HUMIRA on the Australian Register of Therapeutic Goods (ARTG) for the treatment of rheumatoid arthritis.

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

Jul 24 2015

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute? (describing the parties’ oral arguments before the Federal Circuit). Amgen Inc. (“Amgen”) appealed the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional and that the 180-day notice provision does not require licensure. See Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional.

To read the full alert, click here.

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

Jun 22 2015

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs. However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”

To read the full alert, click here.

BPCIA: A “Choose Your Own Adventure” Statute?

Jun 17 2015

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional, and that the 180-day notice provision does not require licensure in Amgen, Inc., et al. v. Sandoz, Inc., et al., Case No. 14-cv-04741-RS (N.D. Cal. March 19, 2015).

To read the full alert, click here.

Amgen Prevails on Temporarily Excluding Zarxio® From Market

May 12 2015

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal Circuit in excluding the biosimilar from the market, at least temporarily. On May 5, 2015, the Federal Circuit granted Amgen’s motion for an injunction “preventing Sandoz [ ] from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until this Court resolves the appeal.” Amgen Inc. et al. v. Sandoz Inc. et al., Appeal No. 2015-1499, Dkt. 105 (Fed. Cir. March 27, 2015).

To read the full alert, click here.

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

Apr 27 2015

In September 2014, the 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 biological equivalent of the pharmaceutical Orange Book. See FDA Releases a Purple Book for Biosimilars. The Purple Book has now been updated to include Sandoz, Inc.’s (“Sandoz”), Zarxio® (filgrastim), the United State’s first biosimilar approved under the Biologics Price Competition and Innovation Act (“BPCIA”). See FDA Approves First Biosimilar: Sandoz’s Zarxio®.

To read the full alert, click here.

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

Apr 01 2015

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that the FDA mandate compliance with the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) information exchange provisions, often referred to as the “Patent Dance.” In particular, Amgen requested that the FDA require a biosimilar applicant to certify that it will timely comply with Section 351(l)(2)(A) of the BPCIA by providing the brand holder with a copy of the biosimilar application and information describing the process(es) used to manufacture the biosimilar product covered by the application.

To read the full alert, click here.

Category:Patents