Part II – Mayo’s Brief Goes Back to A (Non-Precedential) Past

In my last post on Mayo v. Prometheus, I noted that Mayo is cutting a trail of (legal) tears to ultimately rely on the reasoning underlying the “LabCorp dissent” (548 U.S. 132, 136). In this dissent from a dismissal of cert. as improvidently granted, Justices Breyer, Souter and Stevens urged the Court to consider that all simple diagnostic tests that correlate a level of a chemical marker (like homocysteine) to a pathology (like a vitamin deficiency) were no more than an impermissible attempt to patent a natural phenomenon: “[T]he process is no more than an instruction to read some numbers in light of medical knowledge.”

Mayo relies heavily on the LabCorp dissent to support Part C of its argument that Prometheus’ metabolite level monitoring claims preempt all uses of a natural phenomenon – the correlation between the amount of drug administered and the metabolite levels that occur in the patient as a result of the treatment. “A second defect in Prometheus’ patents is that their administration and testing steps are ‘well known’ and ‘long prevalent in medical practice.” Mayo cites Flook and Bilski, but these decisions did not involve medical technology. Mayo continues: “Prometheus did not invent or make any contribution to either step. Nor was it the first to observe correlations between metabolite levels and dosage adjustments, a concept familiar to physicians for decades.” Pet. brief at 35-36. Apart from the fact that this is a 101/102 argument, Mayo still has not cited any case law. “Well known non-inventive steps cannot turn a natural phenomenon into patentable subject matter. See Morton v New York Eye Infirmary, 17 F. Cas. 879, 882-883 (S.D.N.Y. 1882).”

This troublesome early decision, in which the court denied William Morton et al. a patent for using ether to render patients insensible and unconscious of pain during surgery is characterized by Mayo thusly: “(denying patent for the process of anesthetizing patients with ether because ‘[t]he effect discovered was produced by old agents, operating by old means upon old subjects. The effect alone was new” and as a law of nature ‘is not patentable’)”. Pet. Brief at 36.

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , | 1 Comment

EPO Ruling On Inventiveness Of Drug Polymorphs

Thank you to Dr. Stefan Danner, a German and European Patent Attorney at DHS Patentanwaltsgesellschaft mbH in Munich for letting us post the current issue of the biotech IP newsletter dealing with the recent EPO decision concerning the patentability of drug polymorphs. A PDF of the entire newsletter is attached at the end of this post.

———————————-

On May 24, 2011, the EPO Technical Board of Appeal (TBA) 3.3.01 handed down decision T777/08 concerning the inventiveness of (specific) polymorphic forms of a drug previously only known in solid amorphous form. This decision caused considerable attention in the pharmaceutical industry.

The relevant claimed subject matter of European Patent EP 1 148 049 relates to crystalline forms II and IV of the statin drug atorvastatin hydrate that are characterized by an X-ray powder diffraction pattern expressed in terms of 20 angles, d spacings, and relative intensities with a relative intensity of >15% determined using CuKα radiation.

The full document can be found here 10.11. Inventive Polymorphs.

 

Posted in EP and UK Practice | Tagged , , , , , , , , , , | Leave a comment

Mayo’s Brief Goes Back To A (Non-Precedential) Future

You all may be suffering from Prometheus v. Mayo fatigue by now, but this remains the most important IP case before the Supreme Court, and may well alter the course of life sciences patenting for the foreseeable future. I know I am falling behind in posting on the appeal, but each party has now filed 59 page briefs. I recently finished Mayo’s brief (a copy provided at the end of this post along with Prometheus’ brief) and I wonder if they really want to clear the high legal fences they are “swinging for.”

The heart of their legal (vs. “This will hurt patients and inhibit research” policy) arguments are that Prometheus’ claims to administering to a patient having an immune-mediated g.i. disorder a drug providing 6-TG (the metabolite), measuring the levels of the metabolite wherein a level under x “indicates a need to increase” subsequent doses and a level over y “indicates a need to decrease” subsequent doses, improperly embed a law of nature or natural correlation with one or two information gathering steps that should be accorded no patentable weight.  (I disagree with the testimony of Prometheus’ expert as summarized by Mayo at page 25, that the doctor who receives the results would infringe even if they were not read. This summary ignores the claim limitation “indicates a need,” which is recognized as functional by Mayo at page 22 of the brief: “[The patents] advise physicians to think about the need for dosage adjustments when metabolites reach certain levels….” For more about “thinking” as a claim element, see below.

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , , , | 1 Comment

Commissioner for Patents Robert Stoll to Retire Effective Dec. 31st. Deputy Commissioner Focarino to succeed.

Since he became an Examiner in the chemical arts in 1982, Bob Stoll has been an increasingly important presence (some would say “force”) in the USPTO. He has held executive/administrative positions in the Office since 1979 and has been Commissioner since 2009. Margaret A. (Peggy)  Focarino is currently Deputy Commissioner, and already is one of the highest ranking women in PTO history. Interestingly, they both have undergrad degrees in science: Chem. E. for Bob and Physics for Peggy. Congratulations to both of you!

Posted in People | Tagged , , | Leave a comment