Myriad Revisited – The Consequences of Prometheus Unbound

In my last post on Prometheus, I concluded: It is hard to think of a diagnostic assay claim 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 benchmark level (which could be normal or pathological)…all of these assays seem to have been converted into no more that the discovery of laws of nature” with unpatentable pre-solution and post-“processing” steps. I wrote that the key phrase in the decision may be that the steps were “specified at a [too] high level of generality.”

But how much generality is too much generality? Justice Breyer teases patent attorneys like Gypsy Rose Lee at her best – offering a glimpse of a rule, then whisking it away from an ever more agitated audience. For example, at page 18 of the slip op. he writes:

“We need not, and do not, now decide whether were the steps at issue here less conventional, these features [the administration, assay and indication steps] of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves.”

The reader of this opinion keeps waiting for Justice Breyer to give us some  hint of the degree of unconventionality or amount of significance that would suffice in the context of a diagnostic test “to transform an unpatentable law of nature into a patent-eligible application of such a law”, but none is forthcoming. Instead, there is a lengthy discussion of a UK decision – Neilson v. Haford – that involved an improved method of blowing air into a furnace by using a pre-heated receptacle chamber for the air. Breyer writes: ‘thus, the claimed process included not only a law of nature but also several unconventional steps (such as inserting the receptacle, applying heat to the receptacle externally, and blowing the air into the furnace that confined the claims to a particular, useful application of the principle.” Slip. op. at 14-15.

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Indian Patent Office Grants Compulsory License To Bayer Drug

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 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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Supreme Court Reverses In Prometheus v. Mayo!

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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Happy Birthday To Me – Patents4Life is Three!

Three years ago, when I started this Blog (or is it “Blawg”?), the hot topics were In re Kubin and the summary affirmance of Classen by the Fed. Cir. Today, along with the looming AIA regulations, Mayo v. Prometheus and Caraco are awaiting decision by the Supreme Court, and St-Gobain Ceramics v. Siemens and  AMP v. Myriad are awaiting decisions on their petitions for cert. The old Chinese curse, “May you live in interesting times!” is “new again”, even if “The Art of War” is not on the Times  bestseller list (but “American Sniper” is).

Well, the IP world around us has been nothing if not interesting. It is foolish to try to predict what will hold our (and the courts’ ) interest over the next year, much less three years. However, a trend that is easy to spot is the interest exhibited by the current Supreme Court in IP cases. When I did my list of the top ten IP stories of 2011, six of them involved the Supreme Court.

Another one is the rise of IP and bioethics issues related to “personal genomics”, “genome-scale testing” or “companion diagnostics” (however you wish to term it). Today, the journal, Narrative Inquiry in Bioethics announced that it will publish an issue devoted to personal stories from individuals who have received results from genome-scale testing – such as from a SNP profile (bet you haven’t heard that term in a while). On the flight home from AUTM, I read a story about one such individual in the LA Times – a professor who had his entire genome sequenced and posted it so that any group could venture a diagnosis or other observation. One group spotted a marker for type II diabetes, which the prof obligingly developed after recovering from a viral infection.

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