Wellington
By guest blogger Doug Calhoun
On 20 March the Supreme Court of theUnited States (SCOTUS) issued a decision unanimously allowing an appeal by the Mayo Clinic anddeclaring invalid two patents that a lower court had found Mayo to be infringing: (see
The background to the invention is described on the web page of one of the inventors: (see
In Yves Théoret’s own words:
“[We study] the relationships that exist between concentrations of medications andtheir metabolites (medication transformation products) in plasma and blood cells, and therapeuticresponse, according to genetic characteristics of individuals or a given population (FrenchCanadians, Amerindians, American Blacks, Asians). These characteristics (or polymorphisms) cantranslate into a deceleration or an acceleration in the enzymatic transformation of medicationand/or an amplification or reduction in medicated response on specific tissue sites. By determiningthese various variables, it is possible to individualize and optimise therapeutic treatment whileminimizing toxic effects.”“Our studies with thiopurines (6-mercaptopuirine or Purinethol; azathioprine or Imuran)administered to children have made it possible to validate this axiom. Thus, patients with anactivity deficiency of a particular transferase enzyme (thiopurine methyltransferase) have higherconcentrations of active metabolites (nucleotides of 6-thioguanine) and a higher percentage oftherapeutic response than patients who do not have reduced enzymatic activity. The sex and age ofthe patient are also determining factors when it comes to the pharmacokinetics of the medication andtherapeutic response. Facing the obvious impracticality of performing pharmacokinetics (measuringthe concentration of the medication and its metabolites per unit of time) on all drugs administeredto children with various ailments, we also study the possible relationships between the intensity ofthe drug dose (quantity administered per unit of time) and the therapeutic response as evaluated byvarious parameters (white blood cell count, gastric acidity, hepatic enzymes). Specialized softwaremakes it possible to determine these relationships.”
In the words of the patents, the invention “provides a method of optimising therapeuticefficacy of 6-mercaptopurine drug treatment of an immune-mediated gastrointestinal disorder” –the goldilocks level of dosage.
The SCOTUS decision (pages 5 and 6) focused on one representative claim (claims define theinvention of a patent – the rest is background):
“A method of optimizing therapeutic efficacy for treatment of an immune-mediatedgastrointestinal disorder, comprising:
(a)administering a drug providing 6-thioguanine to asubject having said immune-mediated gastrointestinal disorder; and
(b)determining the levelof 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 µmol per 8x108 red blood cells indicates aneed to increase the amount of said drug subsequently administered to said subject, and
whereinthe level of 6-thioguanine greater than about 400 µmol per 8x108 red blood cells indicates a needto decrease the amount of said drug subsequently administered to said subject.”
The decision then went on to analyse the claims. On page 11 it came to theconclusion:
“… the claims inform a relevant audience about certain laws of nature; anyadditional steps consist of well understood, routine, conventional activity already engaged in bythe scientific community; and those steps, when viewed as a whole, add nothing significant beyondthe sum of their parts taken separately.”
Going back a step, SCOTUS was making a determination of whether or not the invention claimed waspatent eligible - whether it fitted within the definition of an invention:
“Any new and useful process, machine, manufacture, or composition of matter, or anynew and useful improvement thereof.”
It did.
But then SCOTUS went on (from page 2) to consider if it was nevertheless excluded under any ofthe three judge-made exclusions to patent eligibility: “phenomena of nature, mental processes andabstract intellectual concepts.” It focused on the first of these exclusions. The balancing actit said it was performing was to exclude patents for the “basic tools of scientific andtechnological work” - while at the same time recognising “that too broad an interpretation ofthis exclusionary principle could eviscerate patent law. For all inventions at some level embody,use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”
The premise (Page 8) on which SCOTUS came to the conclusion that the patents were invalidwas:
“Prometheus’ patents set forth laws of nature—namely, relationships betweenconcentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurinedrug will prove ineffective or cause harm.”
This is a breathtaking extrapolation. Go back up and read Dr. Théoret’s first paragraph. There is a huge variability between people, based on their genetic make up, causing different ratesof metabolising the thiopurines they are taking. The relationships are hardly “laws of nature”within the meaning given in earlier SCOTUS decisions referred to in this one. Determining that aparticular range of metabolites in the blood for a particular disorder is the goldilocks range ishardly going to pre-empt a “basic tool of scientific and technological work”.
What is a law of nature? One example is that nothing can travel faster than the speed of light(except maybe neutrinos between Geneva and northern Italy!). I think a definition most scientistscould agree on is that it is an hypothesis that has not been disproved by so much experimentationthat it is generally agreed to be correct. But remember the scientist’s lament, “a beautifulhypothesis - ruined by an ugly fact.”
SCOTUS justices generally deal with matters concerning the interpretation of the constitution. And a training in and understanding of science is not a prerequisite to being appointed. But a lackof understanding of science, or a wilful overlooking of what a law of nature is to a scientist, hasled to this decision. And there is no appeal from here.
And who is the winner? The MayoClinic :
Although it is a non-profit organisation, it brings in handsome sums of money and any premium itmight have had to pay for the Prometheus diagnostic kits will hardly make what it charges itspatients any cheaper.
And the losers?
Prometheus Laboratories will now lose its exclusivity in marketing the diagnostic kits used tocarry out the patented method. The patents were due to expire in seven years time, so itsinvestment in commercialising the invention will have to be recouped in competition with supplierswho have contributed nothing to getting the science from the lab to the market place.
But the real losers are Ste-Justine’s hospital (the French language children’s hospital inMontreal – my home town) and the taxpayers of Quebec who fund the public health system thatSte-Justine’s is a part of. They will lose the royalty income stream the patents were generating.
And where does this leave the Myriad Genetics gene patents appeal pending before SCOTUS?
One
Watch this space.
~ Doug Calhoun
IP Mentor