Patents – Page 14 – IP Law Watch

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).

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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®.

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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.

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Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

Mar 23 2015

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a biosimilar of Amgen’s Neupogen® (filgrastim), to see what, if any, guidance the district court would provide on the interpretation of the BPCIA. See Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. This litigation has sparked additional interest in view of FDA’s recent approval of Zarxio®, which has led to industry-wide speculation regarding the litigation’s potential impact on Sandoz’s ability to market its now approved biosimilar. See FDA Approves First Biosimilar: Sandoz’s Zarxio®. The District Court of the Northern District of California has now provided an answer, siding with Sandoz’s interpretation that the BPCIA’s patent dance provisions are optional and the 180 day notice provision does not require licensure, and denying Amgen’s request for a preliminary injunction.

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High Court to Consider Whether Isolated Genetic Material is Patentable in Australia

Feb 19 2015

On 13 February 2015, the High Court of Australia (High Court) heard and granted Yvonne D’Arcy’s application for special leave to appeal the Full Federal Court of Australia’s (Full Federal Court) decision in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115.

The unanimous decision of the five-judge bench of the Full Federal Court was that Myriad Genetics Inc’s patent claims directed to particular isolated BRCA1 genes were patentable subject matter in Australia.

Single Patent Filing and Examination in Australia and New Zealand Almost a Reality

Feb 17 2015

As we reported late last year, the Intellectual Property Laws Amendment Bill 2014 was read by the Australian House of Representatives. On 9 February 2015, the bill passed the Australia Senate and will soon become law in Australia as the Intellectual Property Laws Amendment Act 2015.

One significant aspect of the new law is the introduction of a Single Application Process (SAP) and a Single Examination Process (SEP) for Australia and New Zealand patent applications. Read More

Australia’s Very Exclusive Patent Licensee Club

Feb 11 2015

Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

The Full Federal Court of Australia (Court) has held that an ‘exclusive licensee’ within the definition of the Patents Act 1990 (Cth) (Patents Act), must be granted the exclusive right to undertake ALL of the activities falling within the meaning of “exploit”. Accordingly, a grant of a licence to advertise, market, promote, sell and distribute, but not manufacture, does not create an “exclusive licensee”, as defined in the Patents Act. There can only be one exclusive licensee and the patentee cannot reserve any of the exclusive rights to exploit to itself. Read More

Teva and Its Potential Impact on Patent Litigation

Jan 30 2015

The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not indefinite with respect to the phrase “molecular weight.” During trial, the District Court construed the phrase “molecular weight” by considering expert declarations from both parties relating to different ways to calculate a molecular weight, and how the specification supported or conflicted with each of the ways to calculate molecular weight. The District Court credited Teva’s expert declaration at the expense of Sandoz’s expert declaration.

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ODAC Committee Votes to License Sandoz’s Zarxio®

Jan 09 2015

Sandoz Inc. filed the first biosimilar application under the Biologics Price Competition and Innovation Act on July 24, 2014 for a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim). The FDA issued a Briefing Document for the Oncologic Drugs Advisory Committee Meeting held January 7, 2015 concluding that Sandoz’s biosimilar, referred to as EP2006 in the FDA’s Briefing Document, is highly similar to and has no clinically meaningful differences from Neupogen®.

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Patent Office Issues New Examination Guidelines for Subject Matter Eligibility

Dec 19 2014

On December 16, 2014, the United States Patent and Trademark Office published new guidelines for determining patent eligibility under 35 U.S.C. § 101. These guidelines do not have the force of law, but nevertheless establish the specific procedures that the Examiners apply during examination of patent applications. These guidelines are effective immediately, supersede previous guidelines regarding nature-based products, and supplement previous guidelines regarding abstract ideas. Based on Supreme Court decisions, the new guidelines set forth an analytical framework that is designed to “promote[] examination efficiency and consistency across all technologies” and is particularly relevant for patents directed to natural products, software, and business methods.

To read the full alert, click here.

Category:Patents