Posts Tagged ‘biotechnology news’

Canadian Hospital To Travel The Long And Winding Road Of “Gene Patenting”

Monday, November 3rd, 2014

Arguing that human DNA is a natural product, the Children’s Hospital of Eastern Ontario (CHEO) has filed suit in Federal Court to invalidate patents claiming human DNA or diagnostic methods that use it. It has been reported that CHEO was threatened by a U.S. company holding Canadian patents on genes associated with long QT syndrome, an inherited heart rhythm disorder. Currently, the hospital sends samples to the U.S. for testing, at a cost of about $4500, but says it can perform the test for about half that amount in Canada.

Of course, this suit was inspired by the Myriad decision in which the U.S. Supreme Court held that isolated human genes or fragments thereof are unpatentable as “natural products,” but that cDNA is a patent-eligible product of human ingenuity. The Federal Circuit has twice held that methods involving comparing a patient’s BRCA DNA sequences with a reference DNA sequence to identify mutations in the patient’s DNA sequence are patent-ineligible as “abstract ideas.” However, assay claims with more detail about the mutations or the manipulative steps involved were before either court on appeal. In Mayo v. Prometheus, the Supreme Court held that a method for optimizing the dose of a known class of drugs by measuring the levels of a metabolite in the patient’s blood was patent-ineligible as an attempt to patent a “natural phenomenon.” It will be very interesting to see which, if any, of these tortuous legal trails the Canadian courts will follow.

You can find more information here and here.

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]

 

BIO IP & Diagnostics Symposium

Tuesday, September 2nd, 2014

Warren Woessner will be moderating a panel on university-industry (from start-ups to big pharma) partnering in the area of companion diagnostics and personalized medicine at the BIO IP and Diagnostics Symposium, September 26th at the Alexandria Hilton. Since the first two sessions will discuss the disinclination of the Patent Office to issue any claims directed to diagnostic tests in view of Prometheus v. Mayo, it should be interesting to see how the future of claims to diagnostic testing will evolve - or if it will evolve within the patent system. As Yogi Berra said, “The future ain’t what it used to be.” Has the era of the mass extinction of life science patents that began with UC v. Lilly and the Metabolite Labs. dissent  continue to gather momentum, until the only question to discuss is “What’s Left to Patent?”

Ignorance is Bliss – for Teva

Monday, August 4th, 2014

I did not pay much attention to the fairly recent panel decision in Bristol-Myers Squibb Co. v. Teva Pharma. USA, 757 F.3d 967 (Fed. Cir. 2014). It seemed like a fairly routine panel affirmance of the district court’s finding that Bristol-Myers’ patent (5206244) on the nucleoside analog entecavir was obvious in view of a structurally similar nucleoside analog, 2′-CDG. The unexpected results asserted by B-M had been found insufficient to overcome a strong case of structural obviousness.

But when the IPO made the decision to file an amicus brief supporting B-M’s petition for rehearing en banc, my prep/pros radar sounded a warning and I read both the brief closely and the original opinion more closely. [A copy of the opinion and brief can be found at the end of this post.]

The district court found that the POSA would have been motivated to select 2′-CDG as the closest prior art molecule and to make the relatively small structural modifications required to arrive at entecavir, summarizing the law (correctly): “Obviousness, and expectation of success, are evaluated from the perspective of a person having ordinary skill in the art at the time of invention [e.g., the filing date of the B-M patent].”

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