Hikma Pharms. and West-Ward Pharms petition for cert. to reverse the Fed. Cir.’s decision in Vanda v. West-Ward that methods of medical treatment are patentable.

The Supreme Court’s now-infamous Mayo decision, invalidated claims to a method for determining the optimal dose range of an immunosuppressive drug by measuring the blood concentration of its metabolite. However, it contained language explicitly stating that claims directed to new uses for an existing compound were patent-eligible. Since such uses can include subsequently discovered second medical uses – as our UK colleagues would call them—The PTO and the Fed. Cir. in Vanda continued to allow diagnostic claims that included the further step of treating the condition that had been diagnosed. The basic rationale was that, while a diagnostic correlation may be a natural phenomenon, the treatment step is a practical application of the knowledge gained by the diagnosis. So, post-Vanda, we life sciences prep/pros folks could breathe a bit more easily.

Vanda has now filed its Brief in Opposition to Hikma’s Petition for Cert., so it seems appropriate to send you a few observations. To begin with, Hikma has framed the question presented is “whether patents that claim a method for medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.” Vanda disputes the underlying premise, arguing that the Fed. Cir. ruling was not so broad, and did not, as Hikma argues, effectively reverse Mayo.

While Hikma is forced to concede that the use of an old drug for a new purpose “would demonstrate the creativity necessary to satisfy Section 101,” but argues that the Vanda claims to “administering a prior art drug for a prior art purpose—are utterly conventional.” Hikman characterizes Mayo as addressing the patent-eligibility of “medical diagnosis claims.” Even accepting, as we must, the Supreme Court’s finding that the relationship between the blood concentration of the metabolite and “the likelihood that a dosage of the [immunosuppressive] drug will prove ineffective or cause harm” is a naturally occurring phenomenon, the “diagnosis claims” in Mayo were not followed by any method-of-treatment step based on the concentration that is observed. This seems like a fairly crucial omission from the claims.

The Mayo claims like other claims that are directed to optimizing the efficacy of a known drug are a subset of “medical diagnosis claims” that are more properly referred to a regimen claims. The patentee may hold a patent to a new drug and to its use, claimed broadly, but such pioneering patents are often followed by add-on patents claiming improved regimens for administering the drug. These patents are disfavored by the Fed. Cir., and the court has, for example, routinely invalidated such patents as inherently anticipated by the prior art, or as just plain obvious. See, e.g., Yeda Res. and Dev. v Mylan (my post is from Oct. 18th). However, regimen claims cast as improved method-of-treatment claims issue routinely and find their way into the Orange Book, but that’s just Hatch-Waxman at work.

But I think that Hikma goes too far when it argues that “[u]nder the decision below [in Vanda], virtually any diagnosis claim – including the claims at issue in Mayo—can be redrafted as a treatment claim and avoid Section 101 scrutiny.” This is certainly true in the case of the Mayo claims, that could have been redrafted: “A method for administering an immunosuppressive drug to a patient in need thereof comprising administering an amount of the drug to the patient so that the concentration of [the metabolite of the drug] falls into the optimal range.” However, that is not what Prometheus intended to claim. Rather, they went after a claim to a method for determining a regimen. That permitted the S. Ct. to discount the administration and measurement steps as simple data gathering steps, since the subject was not recited as being under any course of treatment.

More importantly, many diagnostic claims cannot be redrafted as method-of-treatment claims. Put simply, this is because a patient may receive a diagnosis of a condition for which there is no treatment. Genetic markers have been found for a group of patients that have a family history of very early onset Alzheimer’s disease. It is important to be able to identify members of the tragic population before they develop the disease, since they can be used to evaluate efficacy of test drugs to delay the disease. But today, there is no treatment that will arrest this form of dementia.

While Hikma thinks that this application of the draftman’s art is contrary to the spirit of Mayo, it eliminates the need to conduct the Mayo/Alice 2B analysis to determine whether or not the claim contains a further inventive concept or simply recites conventional post-solution activity. Drafted as method-of-treatment claims, the method-of-treatment step is the “solution”.

Hikma’s closing to Section II of its petition even loses grammatical poise: “The PTO has thus ensured that all future method-of-treatment patents will issue without undergoing any real scrutiny for an inventive concept. Patentees are now free to claim routine, conventional applications of natural laws, provided those laws are used to treat patients.” Of course, laws don’t treat patients, doctors do, and maybe that’s all we need to recognize to carry out a Step 2A inquiry. Also, many commentators have pointed out, the requirement for an “inventive concept” – the flash of genius – was dropped from re-written Section 103. It doesn’t offend me that claims comprising method-of-treatment steps carried out by humans are passing the requirements of Step 2A of the Mayo/Alice test. Whether or not routine, conventional applications of natural laws are being claimed (“Fire. Hot!”) is just the task that Section 102 and 103 analysis was made to determine.

This article was originally published on Patents4Life.com.

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