Life Sciences – Page 3

The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids

Nov 28 2016

In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Sciences GmbH [2016] APO 83, the Australian Patent Office has once again confirmed that nucleic acids are patentable in Australia.[1]

The opposed application relates to methods of producing polyunsaturated fatty acids in the seeds of transgenic plants. The application included claims directed to a recombinant nucleic acid molecule comprising nucleic acid sequences coding for a polypeptide with Δ6-desaturase activity, a polypeptide with Δ5-desaturase activity, a polypeptide with Δ6-elongase activity and a polypeptide with Δ5-elongase activity, as well as one or more copies of a promoter and a terminator.

Review of Australia’s Gene Technology Regulations: An Opportunity to Strengthen Australia’s Biotechnology Industry

Nov 23 2016

As Australia faces the challenges that come with the end of the resources boom and a shift away from many traditional manufacturing industries, the biotechnology industry represents an important opportunity for economic growth. With an increase in the demand for biotech products comes the potential for Australia’s biotechnology sector to offer substantial growth and investment opportunities if supported by the right policy settings. It was recently reported that the sector is expected to grow at a rate of 4.4% a year until 2021, bringing AUD8,675M of revenue to industry.[1]

Further, last year alone, more than 630 biotechnology patent applications including claims referring to “nucleic acids” were filed with the Australian Patents Office – many claiming subject matter that no doubt will test the boundaries of what constitutes patentable subject matter.[2]

In an industry that has undergone rapid technological advancement since the Regulator last conducted a technical review (which resulted in amendments being made to the Gene Technology Regulations 2001 (Gene Technology Regulations) in 2011), it is timely that the Australian Gene Technology Regulator (Regulator) has initiated a technical review of the Gene Technology Regulations.

Nucleic Acids Remain Patentable in Australia

Oct 27 2016

A recent Patent Office decision in Arrowhead Research Corporation [2016] APO 70¹ (“Arrowhead”) has confirmed that nucleic acids can still be patented in Australia.

Following the High Court of Australia’s ruling in D’Arcy v Myriad Genetics Inc [2015] HCA 35² (“Myriad”), the Australian Patent Office has been broadly objecting to claims that encompass isolated nucleic acids. This practice has frustrated applicants and their attorneys who consider many of the objections to be reactionary, and not consistent with the facts and principles set out in Myriad. In a very recent decision, the Patent Office has confirmed that nucleic acids remain patentable subject matter in Australia by allowing claims directed to interfering RNA compositions.

In Myriad, the High Court clearly stated that it would not be concerning itself with “gene patents” generally, but with the disputed claims specifically (at [37]). Those claims defined isolated nucleic acids per se that were useful in the detection of breast cancer. While acknowledging that the claims defined a product created by human action, the High Court considered that the “substance” of the claims was information, which could not be the subject of a valid claim.

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

Oct 03 2016

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi^® and Amjevita^®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel^®. The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA. Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions. Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

Remicade® Update: Double Patenting Redoubles in Post-Gilead Biosimilar Case

Sep 21 2016

On August 17, 2016, in Janssen Biotech, Inc. v. Celltrion Healthcare Co., District of Massachusetts Judge Mark Wolf faced a double patenting fact pattern that had not been adjudicated in a district court case since the Federal Circuit decided Gilead Sciences Inc. v. Natco Pharma Ltd. [1] Judge Wolf held U.S. Patent No. 6,284,471 (the “’471 patent”) invalid for obviousness-type double patenting over U.S. Patent No. 6,790,444 (the “’444 patent”) because the ’471 patent expired later due to the changes to patent terms under the Uruguay Round Agreements Act (“URAA”), even though both patents claim priority to the same application and the ’471 patent issued years before the ’444 patent. [2]

Please click here to view the full alert.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

Aug 19 2016

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events regarding Humira® that took place over the past two months: (1) Amgen Inc., which is pursuing a biosimilar version of Humira®, received a recommendation toward approval from the U.S. Food and Drug Administration (“FDA”); (2) AbbVie sued Amgen for patent infringement in the U.S. District Court for the District of Delaware, alleging that Amgen infringed several of its patents by seeking FDA approval of its biosimilar version of Humira®; and (3) the U.S. Patent and Trademark Office instituted inter partes review (“IPR”) of a Humira® patent at the request of Boehringer Ingelheim.

Please click here to view the alert.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

Jul 21 2016

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”)[1] and must wait 180 days after giving Amgen post-licensure notice before commercially marketing its FDA-licensed biosimilar product.[2] In affirming the district court’s preliminary injunction against Apotex until the end of the 180-day period, the Federal Circuit followed its previous holding in Amgen v. Sandoz,[3] a split-panel decision. The court reiterated the bright-line rule that a biosimilar applicant must provide notice of commercial marketing to a reference product sponsor after the FDA grants licensure of the biosimilar product and cannot launch its product until 180 days following that post-licensure notice.

Please click here to view the alert.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Kenneth C. Liao

Federal Circuit Holds That an Offer to Sell a Drug Product Was a Patent-Invalidating Offer for Sale under Pre-AIA § 102(b) Even Though the Offer Lacked “Safety and Liability Terms”

Jun 07 2016

On May 13, 2016, the Federal Circuit determined that Merck’s crystalline calcium salt of tetrahydrofolic acid (“MTHF”) had been the subject of a commercial offer for sale, and held Merck’s MTHF claim in U.S. Patent No. 6,441,168 is invalid under the on-sale bar provision of pre-AIA § 102(b). Specifically, the Federal Circuit held that Merck made an invalidating offer to sell MTHF when it sent a fax that included price, quantity, and delivery terms, and rejected the district court’s determination that additional, industry standard “safety and liability terms” were required for there to have been an “offer for sale.”

Please click here to view the alert.

by Trevor M. Gates, Theodore J. Angelis, Peter Giunta

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

Jun 06 2016

By: Trevor M. Gates, Theodore J. Angelis, and Peter Giunta

The Federal Circuit recently held that filing an abbreviated new drug application with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including Delaware), subjected Mylan to specific personal jurisdiction in Delaware.

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U.S. Patent Office Issues New Examples of Patent Eligibility Analysis of Life Sciences Claims

May 12 2016

By Aaron J. Morrow, Margaux L. Nair and Robert M. Barrett

United States Intellectual Property Alert

On May 4, 2016, the United States Patent Office published a subject matter eligibility update for determining patent eligibility under 35 U.S.C. § 101. The Update supplements the previous guidelines and includes additional life science claim examples to assist patent examiners (“Examiners”) in making eligibility determinations. The Update indicates that Examiners should use the additional claim examples in conjunction with the prior guidelines which were published by the Patent Office on December 16, 2014. The additional examples include illustrative claim sets directed to vaccines, methods of diagnosing and treating a disorder, dietary sweeteners, gene screening, a paper-making machine, and a method of hydrolyzing fat.

To read the full alert, click here.

Category:Life Sciences