“The Patent System as it stands today has to a considerable extent “just growed”, without much reference to fundamental principles, escaping the social planning of men into unexpected byways…”
The profundity of this statement made by Edith Penrose way back in 1951 commenting on the economics of the international patent system is relevant even today, if only with greater vigour. This was not a hoarse-throated cry of some emotionally-charged self-proclaimed self-styled pseudo-intellectual seeking to do away with the system of patents altogether, but a pithy observation from a balanced individual that the system had/has probably been subverted and has outgrown its purpose for which it was originally envisaged. I couldn’t help thinking in these lines while going through the facts of Classen v. Biogen et al in an appellate decision delivered by the US Federal Circuit Court just last week on the 19th.
Parties, Forum and Decision
Plaintiff-Appellant: Classen Immunotherapies Inc.
Defendant-Appellees: Biogen, GSK and Merck
Forum: US Court of Appeals for Federal Circuit
Decision: Appeal Dismissed, Patent Invalidated
Facts of the Case
The plaintiff, Dr.Classen, was granted 3 US patents all of which apparently claimed an inverse relationship between the regular use of an early immunization schedule and the chances or risk of contracting a chronic disease at a later stage in life. The interesting part is that the immunization schedule was already a part of the prior art; the focal point of the so-called “invention” was its prognostication of a secondary benefit of the vaccination schedule in the long run.
The defendants who had been selling vaccines with the said schedule prior to the grant of the patent stood accused of infringement of the patents subsequent to its grant for, according to the patentee, the defendants now sold their medicines taking “undue advantage” of the plaintiff’s “invention”, which is the supposed correlation between vaccination and probability of contracting a chronic disease in the long term. Stated otherwise, the very act of thinking and drawing a conclusion based on the plaintiff’s “invention” amounted to infringement of the patent.
Though I haven’t gone through the trial Court judgment, I personally agree with the trial Court’s grant of a summary judgment against the patentee which was affirmed by the Court of Appeals in a near-fitting brief decision of just a paragraph. The Court held thus:
“In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they “transform a particular article into a different state or thing.” Bilski, 545 F.3d at 954. Therefore we affirm.”
Once again it’s the US CAFC to the rescue after the USPTO allowed such a preposterous patent. But this judgment too is not without its pitfalls because the Court here has gone on to repeat its stand on the validity of the transformation test which it expounded on in the Bilski case (here I would like a good friend, senior and Frequently Anonymous reader to relate this test to my take on the patentability of softwares); it would be relevant to take note of Judge Rader’s opinion in the Bilski case where though he concurred with his brothers on the final decision, he was of the opinion that the Court could and should have avoided a long-winded discussion on transformation by rejecting the application in that case on the grounds that it claimed an idea and since ideas are “unclaimable”/ineligible subject-matter, no patent could be granted.
The gravamen of the issue which I think is of greater consequence to both the legal and medical community is that the Classen case is the second instance where the Court could have clarified its stance on the legality and wisdom of grant of patents to diagnostic methods. An earlier instance, which I am aware of, is LabCorp v. Metabolite (2006) where the Supreme Court dismissed the case on technical grounds and hence did not address the issue. More importantly, the eligibility of the subject-matter under s.101 was never raised in Labcorp in the Court of Appeals; the arguments were limited to ss.102 and 112 of the US Patent Act and the impugned claim and patent were held valid.
In Labcorp, the plantiff-patentee’s US patent 4940658 claimed an assay for sulfhydryl amino acids and methods for detecting and distinguishing cobalamin and folic acid deficiency. In simple terms, the premise of the patent was this; amino acid-homocysteine is metabolized by cobalamin and folate i.e Vitamin B12 and Folic acid. Presence of higher-than-normal levels of total homocysteine in an assay would indicate cobalamin and folate deficiency. The patent claimed four things: first, a particular assay which was to be used to test levels of vitamin deficiency; second, correlating the level of total homocysteine in the aforementioned assay with vitamin deficiency (this was claim 14), a panel test for finding individual levels of deficiencies of cobalamin and folate (this was claim 18) and finally, a broad claim on correlating the level of homocysteine in no specific assay with vitamin deficiency (claim 13).
The 13th claim (no wonder!) was the disputed claim and naturally so; it reads thus:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
In my opinion, there are quite a few issues involved here:
1.Does the claim covet a scientific principle or does it claim a method of diagnosis?
2.Does a diagnostic method always translate to a principle of nature?
3.Are diagnostic methods eligible subject-matter?
Claim 13 at the end of the day merely relates to discovery for it simply establishes the presence of a correlation between the presence of one thing and its effect on the presence or otherwise of another, both of which exist in nature. Interestingly, this issue was never raised in the Court for the Court was too busy analysing the claim’s compliance with the enablement and description criteria under s.112. As regards the third question, i shall answer it indirectly; though my stand is not that diagnostic methods are patentable in the US, patents on such methods do exist in good number. Having said this, it should also be pointed out that the jurisprudence is not clear-cut and does take a very tortuous route. Also, to answer the question of eligibility would resolve the other two issues as well (or is it the other way round?). Before I elaborate further, I would like to make a few observations.
The Indian Patents Act for all accusations of non-compliance of TRIPS, increasingly seems to be a very sensible one, particularly the definition, rather negative definition of what constitutes an invention under s.3 appears to be useful in the light of the experiences on either sides of the Atlantic. s. 3(i) clearly precludes patent-eligibility of diagnotic methods. (I am sure there are a few, as always, who would call this section an escapist attempt consistent with our “nihilistic karmic philosophy”. The response to such a critique will have to wait for now).
Too often do we find Courts across the board in several jurisdictions taking one of these two extremes- either outmoded and dated perceptions of science and technology as perceived by law hold them back from acknowledging the inventive effort involved in a host of new technologies (software and biotech for instance) or, Courts go out of their way to accommodate new technologies (again software and biotech) in direct contravention with certain fundamental and hence indispensable principles of patent law and jurisprudence without a vision, thereby muddling the scene entirely (the late Justice Shri Anandmoy Bhattacharya in his inmitable style would have called it a “hodge-podge”)
What then is the solution? I must honestly admit that I really have nothing new to offer but for a call for revisiting established views. In what sense, would be the next question. A clear line of distinction between “invention”, “inventive step” and “inventive concept” has to be drawn on the basis of a revaluated standard of what constitute “science” and “technology”. This is critical because the nature, scope, content and subject-matter of a patentee’s right turn on the very definitions of these terms. Not just that, these definitions have implications on other aspects of patent law such as an infringement analysis based on the doctrine of equivalents/equivalence (by sheer coincidence, this judgment comes at a most opportune moment because it provides greater motivation to undertake a deeper study of seemingly “obvious” terms and concepts). Would a putative definition serve the interests of the system better? I am not sure because one would have to undertake a broad-based comparative study not only of technology-specific jurisprudence but also of the treatment in various jurisdictions.
In a future post, I shall try to put forth what I have understood of these terms. Until then, quite a bit of research is required.