Patents – Page 12 – IP Law Watch

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.

Proposed Australian-New Zealand Single-Desk Patent System Abandoned

Nov 15 2016

The proposed single application (SAP) and examination (SEP) processes for Australia and New Zealand have recently been abandoned, more than five years after they were first introduced. The SAP and SEP would have allowed applicants wishing to obtain patents in both countries to file a common application that would be examined by a single examiner at either IP Australia or IPONZ. Once accepted under each country’s law, two separate patents would be granted. Patent examiners would have had to learn to apply the laws of the other country.

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.

Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions

Oct 25 2016

The Federal Circuit’s recent decision in Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc., addressed the effect of the Supreme Court’s decision in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), on the issue of whether termination of instituted inter partes review (“IPR”) proceedings based on a failure to meet the statutory filing requirements for a petition (namely, to identify all real parties-in-interest) would be barred from review by 35 U.S.C. § 314(d). The Court found that Cuozzo did not disturb Federal Circuit precedent as to the § 314(d) bar on review for reconsiderations of institution decisions.

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By: Rebecca M. Cavin, James (Kwangho) Jang, Jason A. Engel

Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung

Oct 12 2016

In a precedential opinion issued en banc on Friday, October 7, 2016, the Federal Circuit overturned a panel decision, affirming and reinstating the district court’s judgment and the jury’s verdict. The majority opinion scrutinized and at times scolded the panel for taking on a role well outside of its appellate function and erroneously relying on extrinsic evidence to modify an agreed to and unappealed claim construction and hold claims invalid for obviousness. The majority characterized the appellate court’s function as “limited” and “requiring appropriate deference be applied to the review of fact findings.”

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By: Jason A. Engel, Rebecca M. Cavin, Gina A. Jenero

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]

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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.

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

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.”

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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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Category:Patents