The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*

Many of us in the patent world (me included) have pounded our heads against the reasoning (not result) expressed in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  See A Matter of Patent Law Despotism: The Nonsensical Reasoning in the Supreme Court’s Mayo Collaborative Services Decision Part 2*.  The reasoning in Mayo Collaborative Services makes no patent law logical sense on numerous grounds, including disregarding an important paragraph in the Supreme Court’s 1981 case of Diamond v. Diehr that is not only binding precedent, but also tells us that Breyer’s opinion repeatedly does what this paragraph from Diehr says not to do in an analysis of method or process claims under 35 U.S.C. § 101.

But the question now becomes what do we do to keep the reasoning in Mayo Collaborative Services from exploding into completely irrational, as well as patent law insane doctrine?  The way forward to patent-eligibility rationality, as well as sanity, is through the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC.  See CAFC on Patent-Eligibility:  A Firestorm of Opinions in Classen.  Put differently, there may yet be “light” in this currently “dark” patent-eligibility tunnel.

In the interest of full disclosure, in my first article on Mayo Collaborative Services, I had stated that the claimed methods in Classen “[are] now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.  See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision*.  Having now reviewed the Classen remand, and especially the claimed methods involved in that case carefully, I’ve completely changed my mind on the correctness of that statement.  The claimed methods which were upheld in the Classen remand are very different from those which went down in Mayo Collaborative Services.  Also, the primary reasoning in the Classen remand for why the claim methods there were deemed patent-eligible under 35 U.S.C. § 101 is very different from that used in the Federal Circuit decision that was reversed in Mayo Collaborative Services.

Judge Newman wrote the majority opinion (joined by Chief Judge Rader) for the Classen remand decision.  Briefly, Classen involved three related patents (the ‘739 patent, the ‘139 patent, and the ‘283 patent) directed generally to a method for essentially evaluating an immunization schedule for a treatment group, relative to a control group.  But where the ‘739 and ‘139 patents differ from the ‘283 patent is in how this immunization schedule calibration method is claimed.

In the ‘283 patent, this immunization schedule method is claimed simply as “immunizing” the mammals in the control group according to the immunization schedule and then “comparing” the “incidence, prevalence, frequency or severity of [the] chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.”  (As my patent attorney brother Mark has astutely observed, how the method is claimed in the ‘283 patent leaves much to be desired because it never says what “end result” is caused by this claimed method).  By contrast, the ‘739 and ‘139 patents start out similarly to the ‘283 patent in defining the claimed method initially as “screening a plurality of immunization schedules” by “identifying” first and second groups of mammals, “immunizing” the first and second groups by different immunization schedules, and then “comparing” the effectiveness of the different immunization schedules.  But where the claimed methods of the ‘739 and ‘139 patents part company with the ‘283 patent is in an additional “immunization” step which is carried out on a “subject” by using the “lower risk” immunization schedule (characterized by the majority opinion as the “optimum schedule”) that resulted from the initial “screening” step.  (Or to use my brother Mark’s words, we now have an “end result” caused by the “immunization” step of the method claimed in the ‘739 and ‘139 patents.)

Fortunately for us, Judge Newman’s majority opinion digs into the language of claims of the three patents.  Judge Newman especially noted the significant difference between what was claimed in the ‘739 and ‘139 patents, versus what was claimed in the ‘283 patent.  As Judge Newman astutely observed, the ‘283 claims of the patent “stand[] in contrast the ’139 and ’739 patent claims, which include the subsequent step of immunization on an optimum schedule.”  With that significant difference in mind, Judge Newman’s opinion ruled that the ’139 and ’739 patent claims passed the “threshold inquiry” for patent-eligibility under 35 U.S.C. §101, while those of the ‘283 patent did not.

In the verbiage of Judge Newman’s opinion for why the ’139 and ’739 patent claims passed the “threshold inquiry,” while those of the ‘283 patent did not, resides the following “kernel of truth”:  “The ‘283 [patent] do not include putting this knowledge [of immunization schedules] to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases” (emphasis added).  In fact, Judge Newman’s opinion is almost prescient in pointing to the “immunization” step for why the claims in the ‘139 patent and the ‘739 patent made the patent-eligibility grade under, while those of the ’283 patent did not.  (Newman also very carefully noted that these claims in the ’139 and ’739 patents “may not meet the substantive criteria of patentability as set forth in [35 U.S.C.] § 102, § 103, and § 112”).

So why is this reasoning in Judge Newman’s opinion so prescient?  Because it does not rely (at least not primarily) on the now doomed “transformative” step reasoning of the Federal Circuit remand decision that was reversed in Mayo Collaborative Services.  We are also no longer talking strictly about some “abstract idea,” “natural phenomena,” or a “law of nature” (to use the mumbo-jumbo of Mayo Collaborative Services).  Instead, using the words of Newman’s opinion, we’re talking about a “flesh and blood” method that puts the “knowledge” gained into a patent-eligible claim format that causes a real world “practical use.”  That makes the mumbo-jumbo “law of nature” reasoning of Mayo Collaborative Services completely inapplicable (and therefore distinguishable) with respect to the “immunization” step claims of Classen’s ’139 and ’739 patents, and any other method or process claims that are crafted to achieve a “useful result” like these “immunization” step claims.  (Sorry Justice Breyer, the “draftsman’s art” does matter.)

The “additional views’ opinion authored by Chief Judge Rader (also joined by Judge Newman) in the Classen remand is likely now “dead letter” (to also use Justice Breyer’s words with regard to the suggested approach by the U.S. Solicitor General in Mayo Collaborative Services.)  But the primary views and approach expressed in Judge Newman’s opinion about focusing on whether the claimed method or process achieves a real world, “useful result,” point the way forward to rendering any degree of objective and rational “order” out of the confused, conflicting, and illogical mumbo-jumbo reasoning expressed in Mayo Collaborative Services in determining patent-eligibility under 35 U.S.C. § 101.  If you want to refer to this approach as resurrecting the currently discarded “tangible, concrete, and useful result” (TCU) test, so be it.  (And please do remember that 35 U.S.C. § 101 does refer to the need for the invention to be “useful.”)  We could do far better relying upon an objective test like TCU (or whatever you want call Judge Newman’s primary approach in the Classen remand), then trying to divine, like a Ouija board, how to apply the mumbo-jumbo reasoning expressed in Mayo Collaborative Services.

*© 2011 Eric W. Guttag.  Posted March 30, 2012 on IPWatchdog.com