Posts Tagged ‘biotechnology law’

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…)

Patenting “Natural Products” Down-Under Post-Myriad

Wednesday, December 16th, 2015

iStock_000063710003_SmallAlthough 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.”


Ariosa v. Sequenom – Cert. Denied

Thursday, December 3rd, 2015

iStock_000016880645_SmallNot surprisingly, the Fed. Cir., on December 2nd, denied Sequenom’s petition for rehearing en banc of the invalidation of certain of the claims of U.S. Pat. No. 6,258,540 which were directed to methods of detecting and using cffDNA. (Appeal no. 2014-1139, 2014-1144). (A copy of the decision can be found at the end of this post.) Judge Newman was the lone dissenter. Judge Lourie, joined by Judge Moore, and Judge Dyk wrote separate concurrences that read like dissents (“Mayo made us do it!”). The concurrences are not lengthy, but they bring into focus – finally – the basics of the s. 101 debate. A summary of their opinions might go like this: Disembodied abstract ideas and natural phenomena like mathematical formulae and drug metabolites in the blood –or cffDNA per se– are not patent-eligible. However, real-world applications of the phenomena, such as a new method of performing a specific prenatal diagnosis using amplified cffDNA, as recited in claim 21 of the ‘540 patent, should be found to meet the Mayo two-part test for patent-eligibility.


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.