Bristol-Myers Squibb v. Merck – Mayo/Alice Rule Reaches Medical Treatment Methods.

In Bristol-Myers Squibb v. Merck, Civil Action No. 150572-GMS (D. Del., 2016), Bristol-Myers sued Merck for inducing infringement of U.S. Pat. No. 9,073,994. Claim 1 reads:

“A method of treating a metastatic melanoma comprising intravenously administering an effective amount of a composition comprising a human or humanized anti-PD-1 monoclonal antibody [and a carrier] to a human with the [cancer], wherein the administration of the composition treats the [cancer] in the human.”

It would be hard to write a more straightforward method of medical treatment claim. Merck moved for dismissal of the Complaint on the basis that it could not infringe a patent that is facially invalid under s. 101:

“According to Merck, [the patent] is directed to a natural phenomenon and the patent claims do not transform such natural phenomenon into a patent-eligible invention because the claims contain no inventive concept. Merck asserts that the ‘994 patent claims that the natural phenomenon is the body’s own mechanism for regulating the immune system… Merck claims the [patent] recites no inventive contribution beyond the natural phenomenon itself.”

Bristol-Myers’ argument is not much more than a paraphrase of Judge Lourie’s opinion in Prometheus v. Mayo II (App. No. 2008-1403). Bristol responded that the patent is a method of treatment claim “that merely relies on the human body’s ability to respond to the disease… [Bristol argues that] Merck’s argument ‘misses the point that every method of therapeutic treatment at its basic level relies on the biological activity of the patient’s immune system.”’ The drug results in an “immune response that would not otherwise occur in the patient’s natural state.”

This should have been an easy one for the court. Merck moved to dismiss the suit for failure to state a cause of action, motion denied. Well, Merck’s motion was denied, but not before the judge exhibited a remarkable loss of his bearing. The judge ruled, not unexpectedly, that the claim recited a natural phenomenon. But the judge was hesitant to rule that the “claims do significantly more than simply describe these natural relations… Do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws…Whether the claims amount to an implementation step is a complicated factual determination that the court could better resolve after discovery.”

Say what? How about ruling that the “enough” is the ability to treat the cancer? How about ruling that the “implementation step” is giving the patient a drug that would restore his/her natural correlation – that would block activation of the PD-1 pathway to activate the immune system? After all, this sort of anti-cancer vaccination therapy was on the cover of last week’s TIME magazine. It can’t be that hard to understand. As Judge Lourie wrote for the panel in Prometheus II (Part III):

“[t]he claims recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites.”

Yes, I am aware that Prometheus II was repudiated by the Supreme Court, but this is the same Court that in Myriad stated that applications of newly discovered genes would be patent-eligible. Perhaps the judge in Delaware is trying to buy time, hoping for clearer direction, perhaps he is scared of ultimate reversal, perhaps he found the biochemistry confusing.  But this decision does nothing to “cabin” Mayo [the verb de jour], if anything it encourages the anti-patent natives to burn the cabin to the ground.

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3 Responses to Bristol-Myers Squibb v. Merck – Mayo/Alice Rule Reaches Medical Treatment Methods.

  1. george liu says:

    Merck’s argument is astonishing in two ways; one is that there will be no more biotech/pharma patents because all drugs function at the mercy of our body; the other is, I am curious, whether they file any patent applications by themselves. I believe advocating, but never believe baseless advocating; I value reasonableness in life.

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  3. Babies and bathwater?

    Justice demanded some policy response to avoid the mass destruction being levied on innocent infringers of junky computer claims. The political branches are too paralyzed and patent law is too complex, so it was left to the patent courts, of which there are only two with meaningful power, and only one highly focused on patents.

    The framers of the patent act saw fit to bifurcate eligibility and patentability. A reasonable policy response could have been to massively streamline patentability findings so they do not cost a million bucks a pop. Because eligibility logically precedes patentability and can be determined for $50K, the eligibility inquiry has been bent into pretzels to accommodate a hugely pressing policy need.

    I hope the Supreme Court can set things right at some point, since its beyond hope that the political branches will become functional again anytime soon. The three judicial exceptions to eligibility arose for a reason and remain important, but until they are backed by specific doctrine, we will be stuck with district courts”knowing it when they see it”. Yet that is still preferable to the racketeering pre Mayo/ Alice.

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