Posts Tagged ‘USPTO’

Obama Launches Cancer Moonshot Task Force – But Where’s The Patent Power?

Monday, February 8th, 2016

iStock_000035457638_SmallOn January 28, 2016, the White House issued a Memorandum establishing the Moonshot Task Force “to double the rate of progress in the fight against cancer – and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more.” (A copy can be found at the end of this post.) The Task force, chaired by the VP, is to focus on “making the most of Federal Investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care.” No mention of the importance of patent protection so far.

The membership will consist of the heads of 13 executive branch departments, agencies, and offices, including NIH, DOE, FDA, and NSF, among other. The head of the Department of Commerce is included, but the USPTO is not mentioned once.  However, I have been informed by the PTO Press Secretary that the USPTO, including Director Lee and Chief of Staff Aiyer attended the February 4th Task Force Meeting. The Task Force is to provide a report before the end of the year that includes seven recommendations, including to “identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms.”

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Top Patent Law Stories In 2015

Wednesday, December 30th, 2015

iStock_000077488719_SmallI will try to keep this post as brief as possible, since I posted at length on all of the stories. There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in 2014. In no particular order, I pick:

1.  Ariosa v Sequenom. This Fed. Cir. decision that a method for isolating “cffDNA” from maternal blood is no more than a natural phenomenon was a big step backwards for the development of patent law in the area of “precision medicine” and clouds the future patent-eligibility of both natural products and methods of diagnosis and treatment. It is a pick to click with the Supreme Court. (There was also a PTO “July 2015 Update” of the December 2014 s. 101 Guidelines that really did not clarify anything.)

2.  Biosimilars Hit the Shelves. In April, the FDA finalized its biosimilars guidance and Sandoz soon launched the first biosimilar, a generic version of Neuprogen.

3.  Nautilus v Biosig. The Supreme Court redefined the “indefiniteness standard” of s. 112(2) so that a claim term must be reasonably certain to the POSA, not simply amenable to construction. In Dow v. Nova, this new standard compelled invalidation of the claims-in-suit. (more…)

Prometheus v. Roxane – A Glimpse of Christmas Future?

Monday, November 16th, 2015

iStock_000049739658_SmallA Fed. Cir. panel of Judges Dyk, Taranto and Hughes affirmed the district court’s invalidation of a Prometheus “add-on” patent (U.S. Pat. No. 6,284,770) to a method to treat a form of irritable bowel syndrome, IBS-D, with alosetron, as obvious in view of prior art related to the symptoms of the condition. The primary alosetron patent (the ‘880 patent) had expired. Although the claim did not recite optimizing the dosage of the drug, it still reminded me of the infamous claim in Mayo v. Prometheus, in that both claims were “regimen” type claims which claimed an improved method of treating a subset of patients. In Mayo, the subset was identified by determining which patients were receiving too much drug (= side effects) and which patients were receiving too little ( = not helped) – the subset was the group of patients who were (or could be) treated with the optimal amount of the drug, which was recited in the claim.

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Australian Patent Office Proposes “Coding Only” Sequence Ban

Thursday, October 22nd, 2015

iStock_000020072277_SmallComing soon after the High Court’s “Myriad decision” in Australia, the Australian Patent Office has proposed guidelines that would effectively limit the ban on patent-eligibility of DNA sequences to nucleic acids that code for polypeptides. While cDNA is still considered to be banned along with naturally-occurring RNA, man-made constructs such as iRNA, primers and probes are patent-eligible, even if their sequences occur naturally.

The Guidelines go even further in addressing some of the “Bergy issues” on the patent-eligibility of “natural products” in proposing that both microorganisms such as viruses and bacteria, as well as proteins, antibodies and small molecules isolated from natural sources will be patentable subject matter.

The USPTO could have taken a similar tack, particularly in view of the Supreme Court’s language in Myriad: “We merely hold that genes and the information they encode are not patent eligible under s.101 simply because they have been isolated from the surrounding genetic material.” Instead, the Office issued Guidelines that, in effect, banned patenting any substance or even specifically formulated mixtures  of substances that were “isolated from the surrounding [jungle of nature]”.  Myriad was not the appropriate decision for the USPTO to repudiate any reliance on  In re Bergy particularly in view of the dicta in the Fed. Cir. Myriad opinions that stated that Bergy was not applicable. There is an urgent need for the Fed. Cir. to reaffirm or repudiate Bergy (as well as to clearly state that methods of medical treatment or “medical procedures” are still patent eligible, if they are.)

You can read the article from Fisher Adams Kelly here.