Patents – Page 12 – IP Law Watch

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 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.

To read the alert, click here.

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.

What You Need to Know About the Recent Federal Circuit Rule Changes

May 02 2016

By: Devon C. Beane, Jason A. Engel, and Theodore J. Angelis

The U.S. Court of Appeals for the Federal Circuit recently implemented significant amendments to its Rules of Practice. The changes apply to all cases docked on or after April 1, 2016. In large part, the amendments were made to comport existing practices or requirements for electronic case filing with the Rules. Other changes, such as those relating to confidentiality, reflect a wholesale shift in Federal Circuit practice. This alert provides a brief overview of some of the more significant amendments. Please click here to read the full alert.

Pendulum Swings in Favour of Generic/Biosimilar Companies at Interlocutory Stage in AU

Dec 09 2015

By Naomi Pearce

FCA Confirms Commonwealth may Claim Relief Under “Usual Undertakings as to Damages”

The much anticipated Court of Appeal decision in Commonwealth of Australia v Sanofi ¹ was handed down on Monday. The decision is a win for the Commonwealth, and for generic/biosimilar companies in Australia, and (if upheld in any appeal) will result in Sponsors adopting a more circumspect approach to seeking interlocutory injunctions for patent infringement in Australia.

Except where a generic/biosimilar applicant has “cleared the way” (cleared any patent impediments to launch through the Courts in Australia) or all relevant patents have expired, interlocutory injunctions are routinely sought by the Sponsor, and are routinely granted.

Australian Patent Office Decides First Opposition Under Raising The Bar Act

Dec 08 2015

By Nigel Lokan

In the matter of CSR Building Products Limited v. United States Gypsum Company¹ the Australian Patent Office has heard and decided the first patent opposition in which the provisions of the IP Laws Amendment Act 2012 (Raising the Bar Act) apply.

The Raising the Bar Act introduced a number of changes to the Australian patent legislation with the intent of raising the standard required to support the grant of a patent and to bring Australia’s patent laws into line with those of its major trading partners. The Raising the Bar Act applies to all patent applications for which a request for examination was filed on or after 15 April 2013.

Productivity Commission’s broad IP review in Australia – Submissions due 30 November

Nov 20 2015

By Naomi Pearce

There are two weeks left to make submissions to the Productivity Commission (the Commission) on the Commission’s Intellectual Property Issues Paper published in October.

The IP Issues Paper can be found here and the process for making a submission (by 30 November) is outlined here.

Australian Patent Office Seeks Comment on Proposed Examination Practice Arising from the Myriad Genetics High Court Decision

Nov 06 2015

By Rachel Young and Nigel Lokan

The Australian Patent Office has commenced a public consultation on their proposed changes to examination practice, as a result of the recent High Court decision in D’Arcy v Myriad Genetics Inc¹.

As reported in our earlier blog² the High Court unanimously decided that claims directed to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide were not patentable subject matter.

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.

Category:Patents