Posts Tagged ‘biotechnology law’

“The Good Wife” Defends GMOs

Tuesday, October 7th, 2014

Last Sunday’s episode of “The Good Wife” featured a Christian mediation between a farmer (Robert Joy) sued by a Pioneer-like company, represented by the actor Richard Thomas, for saving GMO corn seed for replanting. The facts were a mash-up of J.E.M. Ag Supply v. Pioneer Hi-Bred., 534 U.S. 124 (2001), and Monsanto Canada v. Schmeiser, 1 S.C.R. 902 (2004). In the former case, JEM was selling Pioneer’s hybrid seed that had been “saved” by farmers from a previous crop of the seed, in violation of the shrink wrap-type license on the original Pioneer seed they had purchased at JEM. In Monsanto-Canada, a farmer saved and replanted glyphosate-resistant canola seed from a field he claimed was contaminated by “GMO” pollen from neighboring fields.

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American Calcar v. Amer. Honda Motor Co. – Therasense Goes Out For a Test Drive

Tuesday, September 30th, 2014

On Friday, in American Calcar v. Amer. Honda Motor Co., App. No. 2013-1061 (Fed. Cir., September 26, 2014) a divided Fed. Cir. panel affirmed the district court’s ruling, following remand, that three patents on a multimedia system for vehicle information and control were invalid due to inequitable conduct (IC) by Calcar’s founder, Mr. Obradovich. The patents were all part of one family and the “priority patent” is U.S. Pat. No. 6,009,355. The primary evidence of inequitable conduct was the failure by Obradovich to disclose the owner’s manual of an Acura model that Calcar used as the basis of its specification. (A copy of the decision can be found at the end of this post.)

The Fed. Cir. had reversed the court’s earlier finding of inequitable conduct for a number of reasons, including judicial error in relying on jury findings of IC rather than ruling from the bench on equitable grounds, applying the “reasonable examiner” standard instead of the “but for” Therasense standard to resolve materiality, and use of a “sliding scale” to find intent based on a strong showing of materiality.

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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]