January 5th, 2016
This is a guest post from Chisum Patent Academy.
Patent Law Developments 2015: A Quick Recapitulation
Donald S. Chisum
Co-Founder, Chisum Patent Academy
In terms of case law, legislation and other developments in patent law, calendar year 2015 had no first order block buster comparable to the Supreme Court’s 2014 Alice decision on patentable subject matter pertaining to computer implemented inventions or Congress’ 2011 enactment of the America Invents Act. Nevertheless, there were important decisions by both the Supreme Court and the Court of Appeals for the Federal Circuit that commanded the attention of every patent professional.
In terms of volume of case precedents by the Supreme Court and the Federal Circuit, 2015 equaled 2014 as the busiest years ever, each year having about 140 precedential decisions. Below [attached] is a quick review of the most significant of those precedents.
December 30th, 2015
I 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. Read the rest of this entry »
December 28th, 2015
On December 23rd, Harold (“Hal”) Wegner sent Director Lee a one-page Vision of Patent-Eligibility “Trees”, Not the “Forrest” (attached). A very brief summary of his proposed 4-step process might read:
1) Is any element of the claim being examined one of the three judicial exceptions to 101?
2) If “yes”, is the claim to a combination of steps or elements that renders the claimed invention different from the exception?
3) If “yes”, does the combination [the claim taken as a whole] yield an ‘inventive step’? This requires an obviousness search and examination, and
4) If “yes”, the invention is both patent-eligible under s. 101 and nonobvious under s. 103 (emphasis is mine).
Read the rest of this entry »
December 16th, 2015
Although the Australian High Court held that claims to naturally occurring DNA (e.g., BRCA1 nucleic acid) were not patent eligible because they were not a “manner of manufacture,” since the encoded information therein was not “made” by human action, in contrast to the USPTO, the Australian Patent Office issued “Examination Practice” guidelines dealing with the requirements to patent products of nature. The Guidelines generally left their Bergy-like examination standards intact outside of the nucleic acid arena. A copy of those guidelines can be found at the end of this post.
Naturally occurring nucleic acid molecules derived from genetic material or synthesized, including fragments thereof like primers, probes and iRNA, as well as cDNA are not patent-eligible since they “merely replicate the genetic information of a naturally occurring organism.”
More encouraging is the reaffirmation by the Australian PTO that “technical subject matter” including recombinant or isolated proteins, pharmaceuticals, methods of treatment and “applications of computer technology” remain patent-eligible, as do plant and microorganisms. The key factor seems to lie in determining whether or not the substance of the claims was “made” – created or modified by human action – or is “artificial.” Merely “artificial” is a bar, but it appears to include inspecting the claim for replicants – Dolly? — or synthetic versions of naturally occurring materials. While the physical difference between the claim and the material in its natural state is one factor to be weighed, the heartening sentence is that “[i]solation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.”