The Prometheus decision reflects that Supreme Court is obviously concerned about the possibility that a patent claim might preempt a law of nature and thereby broadly restrict use and application of the underlying principles.  Perhaps the concern is heightened by the fact that the claimed method relates to treatment of disease, and the prospect of preempting such treatment is troubling.  The reasoning set forth in the opinion, however, is anything but helpful.

The court dismisses a suggestion that virtually any step beyond a law of nature should transform an unpatentable law of nature into a potentially patentable application, sufficient to satisfy §101 whereby patentability could be determined under applicable novelty and obviousness analyses pursuant to 35 U.S.C. §102 and 103, saying that such an approach would render the “law of nature” exception to §101 a “dead letter.” The court, never the less, decides the status of the claimed subject matter under §101 under a point of novelty approach, leaving the reader to puzzle about which part of the opinion should be considered as determinative of what is proper under the law.

Our patent world was fairly “rocked” last week by the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision* .  Now that the dust is starting to settle (and hopefully the “verbal vitriol” being thrown is starting to subside), I’ve reflected more on what this decision means for the patent-eligibility of analytical and diagnostic method specifically, and the informed interpretation of patent law generally.  What I see expressed by Breyer’s opinion in this case is both ominous and alarming.  Frankly, for the past 5 or 6 years, I’ve witnessed “patent law despotism” and “patent hostility” being expressed by the Supreme Court like I haven’t seen since the 1970’s.

For those who have “cheered” Breyer’s opinion in Mayo Collaborative Services, the end result, the invalidation of Prometheus’ claimed drug dosage calibration method as patent-ineligible under 35 U.S.C. § 101, is the least bothersome to me.  That Prometheus’ claimed method would satisfy 35 U.S.C. § 101 was problematical to me after the Supreme Court’s decision in Bilski v. Kappos based on the final “determining step” and the “wherein clauses” which inform you (indirectly) when the dosage of the administered thiopurine drug  is too high or too low.  What Prometheus’ claimed method needed to do was use the measured metabolite levels gained by the “determining step” and, as guided by the “wherein clauses,” to achieve a useful result.  As Steve Hansen has kindly pointed out on this blog, Claims 1 and 13, respectively, of Prometheus’ related U.S. Pat. No. 6,987,097 do exactly that by stating that the drug dosage should be increased (if the metabolite levels measured are too low) or should be decreased (if the metabolite levels measured are too high).  If Claims 1 and 13 of the ’097 patent can’t pass the “patent-eligibility” bar under 35 U.S.C. § 101, then I don’t know what method or process claim can.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish.  Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.”  While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods (as well as related medical diagnostic methods) generally under 35 U.S.C. § 101.

Briefly, the claimed method in Mayo Collaborative Services determined (calibrated) the proper dosage of thiopurine drugs to treat both gastrointestinal and non-gastrointestinal autoimmune diseases.  What the claimed method sought to do was optimize therapeutic efficacy while minimizing toxic side effects.  The claimed method had essentially only two steps:  (1) administering a thiopurine drug to a patient; and (2) determining the level of metabolites of the drug in the patient after administration.  The claimed method also concluded with some “wherein clauses” that, if certain drug metabolites were below a certain level, that would indicate a need to increase the amount of the drug administered.  Conversely, if those drug metabolites were above a certain level, that would indicate a need to decrease the amount of the drug administered.  See CAFC: Method for Calibrating Drug Dosage Is Transformative.

The sky is falling!  Those who feel the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is terrible are right, although many won’t likely fully apprehend the gravity of the situation at first.  Those in the biotech, medical diagnostics and pharmaceutical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning.  An enormous number of patents will now have no enforceable claims.  Hundreds of billions of dollars in corporate value has been erased.  But that might be a good thing.  Immediate attention now must turn to Congress.  Thank goodness that the technical amendments to the America Invents Act are outstanding.  This will provide a perfect opportunity for Congress to save an industry that employs many millions of people, while at the same time undoing a pathetic, narrow-minded decision of the Supreme Court.

What is all the fuss about?  Earlier today the United States Supreme Court issued its decision in Mayo v. Prometheus, holding that the process claims at issue in the case are not patent eligible subject matter. To make matters worse,  Justice Breyer, writing for a unanimous Court, continually acknowledged that the claims at issue did not specifically cover a law of nature because there were “administering” and “determining” steps.  Yet, he and the other Justices determined that those “administering” and “determining” steps were well known and conventional, thus meaning that the claims lacked patent eligible subject matter.  Come again?  Did all nine of the Supreme Court Justices just conflate patent eligibility with novelty and non-obviousness?  Yes they did!  But it gets worse — they explicitly admitted doing so!  The Supreme Court also further specifically ignored the Government’s objective, reasonable and until today correct assertion that any step beyond a statement of a law of nature transforms the claim into one that displays patent eligible subject matter, with issues of whether those steps are known to be properly resolved by 102 and 103.

One of the most common questions I receive, dating back to the very beginning of IPWatchdog.com, is whether recipes can be protected by any form of intellectual property.  Typically the question presents specifically by a reader asking whether a recipe can be patented, or how once can patent a recipe.

In most cases the typical recipe for a “killer Margarita” or “the best barbeque sauce ever” will not be patentable because they won’t be unique enough, typically failing on the non-obviousness requirement.  Of course,  the only way to know for sure is to understand how the Patent Office reaches its conclusions relating to what can and cannot be patented.  It is certainly possible to obtain a patent on a recipe or food item if there is a unique aspect, perhaps if there is something counter-intuitive or a problem (such as self live or freshness) is being addressed.  The trick will be identifying a uniqueness that is not something one would typically think to try.

Yesterday in Mayo Collaborative Services v. Prometheus Laboratories the Supreme Court addressed the question of patent eligible subject matter under 35 U.S.C. §101 for the first time since the Bilski decision last year.

Briefly, one of the claims in issue recites a method of optimizing treatment for an immune-mediated gastrointestinal disorder where a specific drug is administered to a patient, the level of a specific metabolite is determined in the patient’s blood, and a particular high metabolite level of a particular value indicates a need to reduce the dosage and a particular low metabolite level at a particular value indicates a need to increase the dosage. Another claim recites the same method, except excluding the administering step. Administering the drug was known in the art. Detection of the metabolites was known in the art. However, the correlation between specific metabolite levels and effectiveness or toxicity of the drug was not known.

Earlier today, at 10:05 am precisely, the United States Supreme Court heard oral arguments in the case styled Mayo Collaborative Services v. Prometheus Laboratories.  A press release issued by the AIPLA sums the cautious optimism of many: the Supreme Court “appeared to move closer to the Federal Circuit’s understanding of patent eligible subject matter.”  Of course, no one will really know for some time, and there is certainly enough reason to worry after the oral argument.  Predictably Justice Breyer seems ready to rule virtually all process claims unpatentable, and surprisingly Chief Justice Roberts seemed more in agreement with Breyer than anyone else.

In all likelihood it will be at least a couple months before we know the outcome of this case, which holds in the balance the future of medical treatment claims.  In fact, the average length of time for the Supreme Court to decide patent cases since Markman in 1996 is about 3 months.  The most recent Supreme Court cases have lingered on average over 5 months.  How the Supreme Court operates is one of the better mysteries in our form of government, and there will be absolutely no signaling of when to expect a decision.  The Supreme Court will just one day announce a decision.  Notwithstanding, I’m going to hazard a guess that we will have a decision between the end of March 2012 and the end of May 2012.  I don’t see this as an end of the term opinion.

Yesterday The Hartford announced via press release that it had invented a faster way to deliver life insurance, which is now patent pending.  Can you that be true?  As with many things associated with the law, particularly patent law, a simple, straightforward answer is not possible.  In a nutshell, it is possible that one could patent a method of more quickly delivering life insurance if the process is new and non-obvious.  However, given the law that the United States Patent and Trademark Office is required to apply there will need to be much more than a real world business method, or “pure business method” as they are sometimes referred to.

“Today’s consumers are used to buying products online and receiving them at home within 48 hours,” said Brian Murphy, who heads The Hartford’s life insurance business. “We see no reason why they should have to wait more than a month to receive a new life insurance policy. By creating a new way of assessing a person’s risk factors and reordering the underwriting process, we can now provide consumers with life insurance coverage in a fraction of the time it used to take.”  But surely a reordering of the underwriting process isn’t enough for a patent, is it?

A little over a year ago the United States Supreme Court issued its decision in Bilski v. Kappos. The critical question presented to the Court for consideration was whether the Federal Circuit erred by creating the so-called “machine or transformation” test, which requires a process to be tied to a particular machine or apparatus, or transform an article into a different state or thing, in order to be patentable subject matter. The Supreme Court held that the machine-or-transformation test is not the sole test for patent eligibility under §101, but rather that it was an important clue, thereby overruling the Federal Circuit who had earlier ruled that the machine or transformation test was the singular test to determine whether an invention is patentable subject matter.

But what practical effect did the Supreme Court ruling in Bilski v. Kappos have? Truthfully, not much at least in terms of the day to day approach of patent attorneys and the U.S. Patent and Trademark Office.  Certainly, the decision was important in that it preserved the patentability of at least some business methods and preserved the patentability of software, both of which continue to remain patentable in the United States.  What has transpired since the Supreme Court’s decision, however, is not much different, if at all different, than what happened day-to-day prior to the decision.

This week marks the first anniversary of the Supreme Court issuing its decision in Bilski v. Kappos. The decision held that the machine-or-transformation test is not the exclusive test for patent eligibility, and that the three traditional exclusions of natural phenomena, abstract ideas, and laws of nature still apply.

Since that time, 182 decisions involving statutory subject matter eligibility have been issued by the USPTO’s Board of Patent Appeals and Interferences (“the Board”). District Courts issued 6 decisions in the past year that substantively addressed statutory subject matter under § 101, while the Federal Circuit issued 3 decisions on the subject. The day after Bilski issued, the Supreme Court denied cert in In re Ferguson, and just recently picked up Mayo Collaborative Servs. v. Prometheus Labs for review.  See Supreme Court Accepts Appeal on Patented Medical Diagnostics.

Court Watchers know that there are approximately 8,000 peti­tions filed with the Supreme Court each year and an additional 1,200 applications of various kinds are filed per year that can be acted upon by a single Justice.  There is simply not enough time to consider each case where Supreme Court review is sought, so the Court has historically been very selective in choosing cases, normally only issuing full opinions in roughly 85 cases each year. Notwithstanding, this Supreme Court has shown great interest in patent matters, particularly questions of fundamental importance such as what is patent eligible subject matter (See Bilski v. Kappos and Mayo v. Prometheus), what is considered obvious (See KSR v. Teleflex) and the appropriate level for the presumption of validity of an issued patent (See Microsoft v. i4i).  The Roberts Court is no doubt placing its stamp on patent law, and it does not appear as if that will cease any time soon.

Notwithstanding, tomorrow is an anniversary of a peculiar Supreme Court event.  Five years ago the United States Supreme Court decided not to issue a ruling in the case of Laboratory Corporation of America v. Metabolite Laboratories. This may not seem like an appropriate event to revisit, or even a noteworthy decision at all, but the issue in the case — what is patent eligible subject matter — has continued to be a question of great concern to the courts, including the Supreme Court.  Indeed, with the Supreme Court recently granting cert. in Mayo v. Prometheus, it seems that it is only a matter of time before the issues in Lab Corp. make their way to a decision on the merits by the Supreme Court.

Earlier today the United States Supreme Court granted certiorari in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which sets up another foray into the patent eligible subject matter waters for the Supreme Court in the October 2011 term.  This appeal by Mayo will challenge the December 17, 2010 decision of the United States Court of Appeals for the Federal Circuit, one of the first patentable subject matter cases for the Federal Circuit in the wake of the Supreme Court’s decision in Bilski v. Kappos.  In fact, this case was returned from the Supreme Court to the Federal Circuit for further consideration in light of the Supreme Court ruling in Bilski v. Kappos.

A patent is a proprietary right granted by the Federal government to an inventor. There are three types of patents available in the United States: (1) a utility patent, which covers the functional aspects of products and processes; (2) a design patent, which covers the ornamental design of useful objects; and (3) a plant patent, which covers a new variety of living plant. Each type of patent confers “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. It is important to note, however, that patents do not protect ideas, but rather protect inventions and methods that exhibit patentable subject matter.

The United States Constitution grants to the Congress the power to grant patents; this power residing in the Congress is found in Article I, Section 8, Clause 8. Unlike most of the enumerated powers granted to Congress in the Constitution, the Intellectual Property Clause is a qualified grant of power, which does limit Congressional discretion in significant ways. The Congress does not have free reign to decide that patents should be easily or freely given, but rather must limit their exercise of power to the dictates of the clause itself.   See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989).  See also Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 5 (1966) (“The clause is both a grant of power and a limitation. This qualified authority, unlike the power often exercised in the sixteenth and seventeenth centuries by the English Crown, is limited to the promotion of advances in the ‘useful arts.’”).

On April 4, 2011, the United States Court of Appeals for the Federal Circuit heard oral arguments in the case dubbed Association for Molecular Pathology v. United States Patent and Trademark Office.  This case has been commonly referred to here and elsewhere as either the ACLU case or the Myriad Genetics case.  Myriad Genetics is the patent holder on various innovations relating to isolated DNA comprising an altered BRCA1 DNA and various methods of screening for cancer built upon various observations of the altered BRCA1 DNA. The patents challenged are U.S. Patent Nos. 5,747,282, 5,837,492, 6,593,473, 5,709,999, 5,710,001, 5,753,441 and 6,033,857.

Essentially, the American Civil Liberties Union (ACLU), along with researchers, competitors of Myriad Genetics and consumers filed a lawsuit challenging the constitutionality of gene patents and argued that gene patents should not be granted because patenting a gene is the same as patenting something that exists in nature.  While this argument did succeed at the District Court, it won’t succeed at the Federal Circuit.  The District Court Judge fundamentally based his ruling on the fact that, as he understood it, Supreme Court precedent “establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.”  First, this is truly an oversimplification of the purification issue and, second, it demonstrates an acute lack of understanding of the science involved.

Next on the agenda at the BIO Intellectual Property Counsels Committee Conference meeting in Seattle is the so-called Myriad case, Association of Molecular Pathology v. U.S.P.T.O, moderated by Andrew T. Serafini, Ph.D., Partner, IP Group & Life Sciences Practice, Fenwick & West LLP.  I have been following the case closely since its beginning, so I am keenly interested in the case.  I am separately working on a “readers digest like” summary of the oral arguments that took place at the Federal Circuit on April 4, 2011, so look for that in the coming days.

The first speaker on the second panel was Debra Greenfield, an attorney and Adjunct Assistant Professor, UCLA Center for Society and Genetics.  It was a bit difficult for me to follow her presentation, oddly enough, because she was reading her presentation.  Time and time again it seemed as if she was phrasing her background of the case and what is at stake as one who supports the ACLU challenge, ending with she looks forward to defending her position in the question and answer session.  As it turns out, she is in favor the the ACLU position, which caught me by surprise.  Let’s face it, the BIO IP attorneys are not exactly a friendly audience for her, but kudos to the program committee for attempting to provide a balance perspective of the case despite the obvious biases (which I share) of those in the audience.