Posts Tagged ‘intellectual property’

FDA Publishes “Purple Book” for Biologicals/Biosimilars

Thursday, September 11th, 2014

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked here is the publication from BIO’s new Intellectual Property Newsletter that links to the FDA press release from the FDA Blog.

CDER List of Licensed Biological Products

CBER List of Licensed Biological Products

 

Australia: Cancer Voices v Myriad Opinion Affirmed

Friday, September 5th, 2014

This is a guest post from Paul Cole.

An opinion was handed down earlier today by the Federal Court of Australia – Full Court (Allsop C.J., Downsett, Kenny, Bennett and Middleton J.J., D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014))(1). In an outcome strikingly at variance with that before the US Supreme Court, it affirmed the opinion of Nicholas J. that claims for isolated nucleic acids are for a manner of manufacture for purposes of s.18(1)(a) of `Australian Patents Act 1990 and s.6 of the Statute of Monopolies (Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013)(2) [The links for footnoted items can be found at the end of the post.]

In its opening remarks, the Full Court held that expressions such as “the work of nature” or “the laws of nature” are not found in the statute, nor are they useful tools of analysis. Adopting the reasoning of Frankfurter J. in Funk Brothers Seed Company v Kalo Inoculant Company, [1948] USSC 22; 333 US 127 (1948), it confuses the issue to use such terms. They could fairly be employed to challenge almost any patent.

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101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

Thursday, September 4th, 2014

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.

“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.

“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”

Scanned from a Xerox multifunction device

Scanned from a Xerox multifunction device[1]

Scanned from a Xerox multifunction device[2]

Scanned from a Xerox multifunction device[3]

 

FDA’s New Biosimilars Guidance

Monday, August 11th, 2014

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.

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August 09, 2014

FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded

By James E. Valentine* & James C. Shehan

On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.”  But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).