Archive for March, 2012

Mayo v. Prometheus – A European View

Thursday, March 29th, 2012

A Guest Post from Paul Cole, European Patent Attorney, Lucas & Co; Professor of IP law, Bournemouth University.

Is a claim to an assay patent-eligible when all its features are known save for how it should be interpreted? The interpretation is clinically significant because it allows a family of drugs to be administered safely even though a minority of patients are at risk of significant and in some instances fatal side-effects. Before the invention knowledge was available to enable the practical steps in the assay to be carried out and measurements had been made but their clinical interpretation was not understood.

A European answer is to be found partly in the “any hardware” approach first set out in T 931/95 PBS PARTNERSHIP/Controlling pension benefits system and approved by the Enlarged Appeal Board in in G 3/08 PRESIDENT’S REFERENCE. It was pointed out that a computer-readable data storage medium had the technical effects of being computer-readable and of being capable of storing data and is patent-eligible under EPC arts 52(2) and (3). On that basis it could not become ineligible merely because it was storing computer program X, any more than a cup which was a technical article could become ineligible merely because it was decorated with picture X. There was no case-law to support the view that a claim to “a computer-readable storage medium with program X written on it” should lose its technical character merely because it was too generic or functionally defined.

(more…)

Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Thursday, March 29th, 2012

What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. As I wrote here on March 26, 2010, Title IV of the law is “Improving Access to Innovative Medicial Therapies” – Subtitle A and is referred to as the “Biologics Price Competition and Innovation Act of 2009.” It can be most easily be followed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590. The Act amends section 351 of 42 USC 262 and 35 USC 271(e). In my March 26th post I reviewed many of its Hatch-Waxman-like features.

Since enactment, there have been many seminars, workshops and symposia about how best to implement these procedures at the FDA/USPTO, and the FDA has finally begun to work with the stakeholders to provide a regulatory pathway for generic biologicals. Without such a pathway –as currently – a generic biological has to endure the same NDA route to approval as any other new drug. Questions of what degree of “biosimilarity” should be required and what the market exclusivity period should be for the first generic biological to be approved have been hotly debated.

(more…)

Supreme Court Remands In Myriad Appeal

Monday, March 26th, 2012

Today, as predicted by many commentators, the Supreme Court set aside the ruling by the Fed. Cir. that claims to isolated DNA sequences that are the BRCA 1 or 2 gene, or fragments thereof, are patentable subject matter. The Supreme Court ordered the Fed. Cir. to reconsider its 2-1 panel decision in view of its recent opinion in Prometheus that assays to optimizing drug efficacy based on measuring metabolite levels were no more than attempts to patent natural phenomena.

It is not entirely clear what guidance the Prometheus opinion provides for the appealed DNA claims in the Myriad decision. After all, the claims closest to the invalidated Prometheus claims were the claims to a method of locating mutations in a subject’s BRCA DNA by comparing it to a benchmark, or wild-type BRCA sequence. In the Supreme Court’s opinion, Justice Breyer contrasted the claims at issue with claims to a new compound:

 “Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the [Promethus claims] do not confine their reach to particular applications of those  [natural laws].”

To invalidate claims to isolated DNA sequences, the Fed. Cir. and the Supreme Court would have to specifically interpret Chakrabarty to require that, to be “new” under section 101, a compound must exhibit a utility not possessed by the compound pre-isolation, even if the compound pre-isolation is structurally different than the compound post-isolation.  If the Fed. Cir. were simply to rely on In re Bergy, as I and others have suggested in previous posts on Myriad, it is difficult to imagine the Fed. Cir. reversing itself on this issue.

Even if gold in a streambed is not different from gold in a Krugerrand, isolated DNA in a “test tube”  is different from a DNA sequence that is one part of chromosomal DNA. However, the Supreme Court just added a “something more” requirement to a claim to optimizing a drug regimen, and the Court may be poised to put a “something more” requirement on a structurally novel chemical compound. I just hope that if the judges or justices go down this path, and hold that isolated DNA is a “natural product,”  they give us some hint of how to meet the “something more” requirement, going forward. They might also consider what “going forward” means.

“Handbook of Quality Procedures Before the EPO”

Monday, March 26th, 2012

The ECP, epi and Business Europe have collaborated to produce a downloadable, fifty page guide to practice before the EPO. While not binding on Examiners, it was issued under the authority of the EPO and is a sort of mini-MPEP, intended for use by both applicants and Examiners. A copy is provided at the end of this post. You can read more about it here.

Handbook_of_quality_procedures_before_EPO_en