Posts Tagged ‘biotechnology news’

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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…)

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Posted in Patentable Subject Matter | 1 Comment »

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.

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Posted in Federal Court | 1 Comment »

Indian Patent Office Grants Compulsory License To Bayer Drug

Wednesday, March 21st, 2012

Finding that Bayer had failed the requirement to “work” the invention in India, e.g., manufacture and sell at a reasonable price, the Indian Patent Office granted Natco Pharma, an Indian company, a “compulsory license” to make, use and sell  a generic version of the anti-cancer drug Sorifenib. (A copy of this decision can be found here and also at the end of this post.) If your client/company/institution has an Indian patent on a drug, don’t forget to fill out the working forms that your associate should remember to send to you. However, this decision does not answer the question of whether or not an Indian company could seek approval to market a drug not yet approved by your client or its licensee in, say, the US or the EU, if the Indian company went through the NDA process in India. I know this sounds unlikely but, at the least, this decision should remind us all to take “working requirements” seriously, particularly for drugs that are moving through the approval processes outside of India.

Natco_vs_Bayer_Decision_of_Controller_of_Patents_Mumbai_9_Mar_2012

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Posted in Working Requirements | 1 Comment »

Supreme Court Reverses In Prometheus v. Mayo!

Tuesday, March 20th, 2012

In a decision dated March 20, 2012, Justice Breyer writing for a unanimous court, held that claims to administering a drug, followed by measuring the levels of metabolites of the drug, in order to optimize the amount administered, are not patent eligible, because they are attempts to monopolize naturally-occurring correlations. (A copy of the decision is also found at the end of this post.)

 The steps that the Fed. Cir. found transformative, namely the “administering step” of the drug and the “determining step” wherein the metabolite levels are measured, were disregarded as “simply telling doctors to engage in a well-understood, routine, conventional activity previously engaged in by scientists in the field,” citing Parker v. Flook. Citing Bilski, Benson and O’Reilly v Morse, the Court concluded:

“Further support for the view that simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena and abstract ideas cannot make those laws, phenomena and ideas patentable.”

The Court bought the argument that patent law can inhibit future discovery by improperly “tying up the use of laws of nature and the like.” Mayo had argued that the claims at issue inhibited research that would improve the assay, e.g., by refining the recited ranges of metabolite levels. But the Court apparently completely ignored those ranges as claim limitations –  and, without the high/low ranges, the claim would likely never have been allowed.

I have not had the time to read the entire text of the decision at this point, and these comments are based on the Syllabus, but the entire patent bar will be left to wonder what, if any, medical diagnostic claims will be patent-eligible in the future. In the Metabolite dissent, Justice Breyer and two other Justices would have invalidated a claim to measuring the level of homocystine in a fluid of a patient and arriving at a diagnosis of colbalamin deficiency, based on comparison of the homocystine level with a benchmark “normal” level.

It is hard to think of a diagnostic assay that does not either detect the +/- presence of a marker (like anti-HIV antibodies) or involve the comparison of the level of a marker of some sort (like homocystine or PSA) with a normal benchmark level. But now, all of these assays seem to have been converted into no more than the discovery of laws of nature. The key phrase in the decision may be “specified at a high level of generality” but I am too shocked by this decision to find any comfort in this “guidance.”

10-1150

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Posted in Patentable Subject Matter | 8 Comments »

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