Posts Tagged ‘Supreme Court’

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…)

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.

Sequenom’s En Banc Petition

Friday, August 14th, 2015

Sequenom’s Petition for Rehearing En Banc – Panel Ignored “Inventive Concept” in Combined Steps of the Claimed Method

mandmsFor any of us practitioners encountering increasing numbers of s. 101 rejection rejections of diagnostic claims based on Mayo and the March 2014 PTO Guidance – and that is pretty much any life sciences patent attorney – this brief is a “must read.” (A copy of this brief is available at the end of this post.) This brief puts it all out there, both criticizing the panel, proposing a new rule for method claims incorporating natural phenomenon and illustrating how the panel’s application of the Mayo Rule threatens method of medical treatment claims as well as diagnostic method claims.

If I start trying to summarize the Brief, I will not be able to stop. Instead of arguing that the Mayo Supreme Court decision was wrong, the Brief distinguishes the regimen claims in Mayo from the Sequenom claims – that were based on the discovery of cffDNA in maternal serum which, in turn permitted the non-invasive determination of the condition of the fetus. The opinion of the Brief’s authors is that the Sequenom claims adhere to the rationale of Diehr, a decision ignored by the panel. I will quote two paragraphs below, but picking just one to quote is like having to stop after eating a single M&M or one potato chip – nearly impossible:

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“If Wishes Were Horses” – Roberts’ Dissent from Myriad

Monday, June 29th, 2015

horses2After reading Obergefell v. Hodges, 576 U.S.___(2015), (a copy is found at the end of this post) I was struck by Justice Robert’s dissent – which excoriates the majority for legislating from the bench and basing its opinion on “social policy.”

In AMP v. Myriad, Justice Roberts joined in a unanimous opinion holding that segments of DNA are patent-ineligible “natural products,” reversing a Fed. Cir. panel decision that held DNA to be patent-eligible as a novel chemical molecule.

But what if Justice Roberts disagreed with his brethren and penned a dissent? I have repeatedly taken the position that Myriad was decided on policy grounds, which required the Justices to decide that a novel chemical compound is not a “composition of matter” under s. 101, but is something else.

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