PERSONALIZED MEDICINE TAKES OFF WHILE DIAGNOSTIC ASSAYS ARE GROUNDED

A front-page article yesterday in the New York Times and other major newspapers reminded me that drug development and methods of medical treatment will be driven by the genomics of increasingly sub-divided patient populations. As reported by GenomeWeb, summarizing an article in Nature (Sept. 23, 2012), “members of the Cancer Genome Atlas presented a multifaceted genetic analysis of breast cancer, characterizing four main subtypes of the disease and uncovering shared molecular features between one of these subtypes and tumors from another part of the body.”

I won’t try to go into detail about their findings, but they were able to connect one particularly nasty form of “triple negative” breast cancer to ovarian cancer. Ironically, post-Myriad, “triple negative” basal-like breast cancer and ovarian cancers shared mutations and other alterations in genes such as BRCA1/2. This suggests that drugs like the platins that are useful to treat ovarian cancer, but are not generally used for breast cancer, might be efficacious to treat this new “subclass” of tumor.

Exciting, hopeful results indeed, which involved inter alia whole exome sequencing of 510 tumors from 507 women and miRNA sequencing on 697 samples. But the Federal Circuit has interpreted the Mayo v. Prometheus decision as compelling them to hold that the conclusions – dare I call them “diagnostic” conclusions – from this massive effort are no more than conventional post-data gathering steps that do not convert the natural laws governing cancer differentiation and response into patent-eligible subject matter. Remember – and I won’t let you forget (see my post of Aug. 16) – that this claim was invalidated in both of the Fed. Cir.’s Myriad opinions, as an “abstract idea”:

2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene…in a tissue sample for a subject with the germline sequence of the wild-type BRACA2 gene…wherein an alteration in the germline sequence of the subject indicates a predisposition to cancer.

So now we are much closer to knowing what sub-class of cancer a patient with a certain “alteration” may possess but, from a patent law standpoint, does it matter? Remember, again, that application of a natural law to a narrow technical field does not yield a patent-eligible claim (Flook). The Fed. Cir. missed its chance to clearly state why a diagnostic conclusion is an application of a natural law that renders the use of the natural law patent-eligible, and not just fold its legal hand with “Accordingly, Myriad’s challenged method claims are indistinguishable from the claims the Supreme Court found invalid under s. 101 in Mayo.” The court could have held that the claim element of providing a diagnosis is not trivial post-solution activity, and clarified that the presence of a mental step does not disqualify a claimed method from patent protection.

To be even more post-apocalyptic, consider a claim to a method of treating cancer x by administering an effective treatment amount of drug y. Isn’t the physician’s or the patient’s mental processes implicated in such a claim? Who decides whether or not the amount administered is effective or not? The interaction of drug y with the cancer cells certainly implicates natural laws, and the Supreme Court has ruled that administering any drug is a conventional activity. I hope I am going too far with this, but I am already getting Prometheus-based rejections from Examiners, who no longer have to worry about messy analyses of anticipation, obviousness or s. 112.

When physicians were threatened with liability for infringing surgical method patents back in the 90’s, they used their clout to quickly amend s. 287 to exempt themselves and their employers from damages due to such infringement. I propose that it is time to amend s. 101 to add a sentence that legitimizes patents on methods of medical treatment and diagnostic methods. How about, “The term process shall include methods of medical treatment and the diagnosis of physiological conditions practiced on the human body.” Of course, I am inviting debate over the “definitions section” but bring it on.

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