Mayo Collaborative Services v. Prometheus Laboratories, Inc.

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Mayo v. Prometheus
Seal of the United States Supreme Court.svg
Supreme Court of the United States
Argued December 7, 2011
Decided March 20, 2012
Full case nameMayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc.
Docket no. 10-1150
Citations566 U.S. 66 ( more )
132 S. Ct. 1289; 182 L. Ed. 2d 321; 2012 U.S. LEXIS 2316
Argument Oral argument
Case history
PriorPatent held invalid, 2008 WL 878910 (S.D. Cal.); reversed, 581 F.3d 1336 (Fed. Cir. 2009); vacated and remanded in light of Bilski v. Kappos , 130 S.Ct. 3543 (2010); reversed anew, 628 F.3d 1347 (Fed. Cir. 2010); certiorari granted, 131 S.Ct. 3027 (2011)
Holding
Patent claims directed to a diagnostic method, that is based on a newly discovered natural correlation and utilizes well-known routine methods of analysis, were not patent eligible subject matter, because such method did not add an "inventive concept to application of the natural laws". [1]
Court membership
Chief Justice
John Roberts
Associate Justices
Antonin Scalia  · Anthony Kennedy
Clarence Thomas  · Ruth Bader Ginsburg
Stephen Breyer  · Samuel Alito
Sonia Sotomayor  · Elena Kagan
Case opinion
MajorityBreyer, joined by unanimous
Laws applied
35 U.S.C.   § 101

Mayo v. Prometheus, 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter. [2]

Contents

The basic idea behind the court's decision in Mayo is as follows: although a discovery of a new natural phenomenon (or a law of Nature) would satisfy the non-obviousness requirement, patent claims, that either wholly pre-empt the natural phenomenon or add no additional "inventive concept" to this discovery, do not meet patent-eligible subject matter criterion. [3]

The decision was controversial, with proponents claiming it frees clinical pathologists to practice their medical discipline, and critics claiming that it destabilizes patent law and will stunt investment in the field of personalized medicine, preventing new products and services from emerging in that field. [4] A 2017 study concluded, that the decision in Mayo promoted biotech businesses and non-profit institutions to "increase use of trade secrecy" rather than the more traditional patenting, with substantial detriment to the society. [5]

Parties to the case

The case arose in a dispute between Mayo Collaborative Services and Prometheus Laboratories concerning a diagnostic test. Mayo Collaborative Services is a for-profit [6] diagnostic testing lab offering diagnostic services that operates as a subsidiary of Mayo Foundation for Medical Education and Research, [7] which is a nonprofit corporation [8] affiliated with the Mayo Clinic. Mayo Collaborative Services does business as "Mayo Medical Laboratories", has 3,200 employees working in 58 laboratories and offers services worldwide. [9]

Prometheus is a specialty pharmaceutical and diagnostics company in the fields of gastroenterology and cancer; it was bought by Nestlé in 2011. [10] Prometheus sells diagnostic kits and also offers diagnostic services as a diagnostic testing lab.

Patents at issue

The two US patents in the case are 6,355,623 [11] and 6,680,302, [12] which are owned by Hospital Sainte-Justine in Montreal. The patents concern the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn's disease and ulcerative colitis. [2] Different people metabolize these drugs differently, so doctors have to work with patients to find the right dose. If the dose is too high there are too many side effects, while if the dose is too low the drug does not work. When the patents were filed, the metabolites of these drugs were known, most importantly, 6-thioguanine, but the "right" level of these metabolites was not known. The scientists at Hospital Sainte-Justine identified the threshold level for effectiveness, [13] and filed for patent protection on methods to use that threshold level to determine dosage.

The Supreme Court took claim 1 of the '623 patent as exemplary:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The dispute

Prometheus is the exclusive licensee of these patents and sells diagnostic kits based on them. [2] Mayo bought and used these kits until 2004, when it decided to offer its own diagnostic tests to its clients at Mayo and worldwide, without buying the kit from Prometheus. [2] In June 2004 Prometheus sued Mayo for infringement in the Southern District Court of California, and in March 2008 the district court held the patents invalid under §101 (the section of US law governing patentable subject matter.) [14]

The debate between the two companies is based on a certain diagnostic test, specifically concerning the use of thiopurine drugs, which are used to treat autoimmune diseases. The problem with thiopurine drugs is that different patients metabolize them differently, which causes difficulty in determining whether a patient's dosage is too high or too low. While too low of a dosage is simply ineffective, too high of a dosage can cause various toxic effects including pancreatitis, hepatotoxicity, and myelosuppression (reduction in the ability to produce blood cells). Prometheus had a patent on how to properly treat patients using thiopurine drugs that included an administering step in which a doctor would administer the drug to the patient, a determining step in which the doctor measures the metabolite levels in the patient's blood, and a step to either increase or decrease the dosage based on the results. According to the patent, if the level of thiopurine metabolite is less than about 230 picomoles (pmol) per 8x10^8 red blood cells, then the dosage needs to be increased, whereas if the level of thiopurine metabolite is greater than about 400 pmol per 8x10^8 red blood cells, then the dosage needs to be decreased. Prometheus sold diagnostic tests based on the patent, and Mayo bought and used those diagnostic tests. However, in 2004, Mayo announced it would begin to use and sell their own test. This caused Prometheus to sue Mayo for patent infringement.

District Court ruling

The District Court characterized the claims as having three steps: (1) administering the drug to a subject, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required. All parties acknowledged that the first two steps, by themselves, were already known, and that the third step contained the novel matter that drove the patent filing. Mayo argued that only the third step mattered, and that the claims covered unpatentable subject matter. Prometheus argued that all the steps in the claims had to be considered, and that the whole process was new and was patentable subject matter.

The court found that the first two steps were just "data-gathering", leaving the third step as merely an unpatentable mental step, comprising the correlation, because no step required a change in administered dose. [15] Further, the court found that the inventors of the patents did not invent the correlation, because the metabolites detected according to the patent claims "are products of the natural metabolizing of thiopurine drug, and the inventors merely observed the relationship between these naturally-produced metabolites and therapeutic efficacy and toxicity." Having determined that the claims encompass the correlations themselves, the District Court held that the claims "wholly preempt" the correlations. [16]

These two findings—that the claims cover only natural phenomena, and that the claims cover any application of the natural phenomena—led squarely to a rejection under §101, just as if someone tried to claim Einstein's equation "E=mc2" as opposed to, for example, an innovative machine that made use of that law of nature.

First Federal Circuit decision

Prometheus appealed, and in September 2009 the Federal Circuit reversed the District Court, finding that the claims were patentable. [17] [16] [18] The Federal Circuit found that the District Court erred in its analysis of the first two steps. The Federal Circuit found that these steps were not just "data gathering", but rather that they called for two physical transformations—first administering the drug to the patient, which transforms the patient, and secondly measuring the metabolites, which involves several concrete, transformative steps. The Federal Circuit relied on its own decision In re Bilski in this analysis; in that decision, the court stated that if a method requires a specific machine for its implementation, or involves a physical transformation, it is patentable.

The Federal Circuit also found that the District Court erred in not treating each claim as a whole. The decision said:

[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter. After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101. [16]

Finally, the Federal Circuit found that because the claims are directed to an entire process, and not just the correlation itself, the claims do not preempt all applications of the correlation. [16]

Remand and second Federal Circuit decision

Mayo appealed to the Supreme Court, [19] and in June 2010 the Supreme Court granted certiorari and immediately vacated the Federal Circuit decision and remanded the case back to the Federal Circuit for further consideration in light of the Supreme Court's ruling on the Bilski case (in other words, it issued a GVR Order). [20] The Supreme Court's Bilski decision made the machine-or-transformation test less absolute, calling it only an "important clue" to patentability.

In December 2010, the Federal Circuit issued its new ruling on the case. [21] The Federal Circuit essentially re-iterated the arguments it had made the first time. [15] [22] Its decision acknowledged the Supreme Court's Bilski decision, but still found the first two steps were transformative and that the claim as a whole was patentable. The Federal Circuit went into more depth on the third step, the "mental step", noting that:

a subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole. [21]

Supreme Court decision

Mayo again appealed to the Supreme Court, which agreed to take the case. It was argued on December 7, 2011 and the court handed down a unanimous decision on March 20, 2012. [2] The Supreme Court reversed the Federal Circuit and basically reiterated the findings of the District Court. [23] [24]

The court called the correlation between the naturally-produced metabolites and therapeutic efficacy and toxicity to be an unpatentable "natural law" and found the first two steps to be not "genuine applications of those laws[, but] rather ... drafting efforts designed to monopolize the correlations." [2] The court said, "Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." [2] A commentator on the ruling wrote: "The conclusion here is that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art." [23]

The court seemed to be aware of the impact its decision would have on the diagnostics industry, [24] as it ended its decision by writing:

In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we must recognize the role of Congress in crafting more finely tailored rules where necessary.... We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable. [2]

Reactions and aftermath

Opinions critical of the decision

The decision was controversial. Those opposed to it found the reasoning poor, considered the decision to be destabilizing of patent law, and expressed concern about long-term effects on medicine.

Gene Quinn, a well-known pro-patent spokesman, blogging in IP Watchdog, stated one view of the decision: "The sky is falling! Those who feel the Supreme Court's decision in Mayo is terrible are right." He added:

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.

Quinn then called for the Federal Circuit to overrule Mayo, as he asserted it had done with other erroneous precedents and predicted that it would do so with Mayo:

How long will it take the Federal Circuit to overrule this inexplicable nonsense? . . . Those well acquainted with the industry know that the Supreme Court is not the final word on patentability, and while the claims at issue in this particular case are unfortunately lost, the Federal Circuit will work to moderate (and eventually overturn) this embarrassing display by the Supreme Court. This will eventually be accomplished the same as it was after the Supreme Court definitively ruled software is not patentable in Gottschalk v. Benson, and the same as the ruling in KSR v. Teleflex will be overruled. . . . [T]here is still a lot of work left to be done by the Federal Circuit to finally overrule the Supreme Court's KSR decision. It took almost 10 years to overrule Gottschalk v. Benson, so we are likely in for a decade of work to moderate the nonsense [Mayo] thrust upon the industry this morning. [25]

Kevin Noonan, a biotech patent lawyer and editor of the Patent Docs blog, criticized this decision and the Supreme Court broadly, for undermining precedent and the stability of patent law, thus broadly undermining the biotech industry. Noonan wrote:

It is also clear that the Court has little time for the specifics of patent law generally, not surprising from a Court who characterized obviousness law as "gobbledygook" not so many years ago. . . . [T]he Court also signaled its willingness to credit their theories of what drives and sustains innovation against the arguments, based on actual experience, from groups and individuals who have created companies and been involved in innovation in the biotechnology industry. And the Court seems equally ready to be influenced by the consumers of innovation, such as amicus the American Medical Association, who understandably wish to have the maximum freedom to have their patients benefit from new technology (and the minimum interference from patent holders who would reduce their opportunities to profit therefrom). [26]

Robert R. Sachs, a patent lawyer and co-founder of The Bilski Blog, wrote:

The Court's analysis creates a framework for patent eligibility in which almost any method claim can be invalidated. . . . Reading the Court's treatment of Prometheus' claim, one would think that claims are some type of qualitative instruction manual, a recipe that speaks to "audiences" such as doctors, about which things are "relevant to their decision making." Claims are no such thing: they are definitions that articulate a specific combination of steps or structures. They are objective in form and design, not subjective or advisory. The notion that the claims here "trust" doctors to "use those laws" is at best silly, and at worst badly misguided. Reducing the claim to this "instruction manual" allows the Court to analogize the claim to Einstein "telling linear accelerator operators about his basic law"—a low point in modern legal reasoning. [27]

Hans Sauer, an attorney for the biotech industry trade group, BIO, said, "We are troubled that the Court's opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases." [28]

Kendrew H. Colton, a Chicago patent attorney, said that, because the ruling applies to the thousands of diagnostic patents that have already issued and puts them at risk of being invalidated, investors in personalized medicine "may revisit the value proposition for investments already made and may curtail or redirect future investments in new projects." [4]

Opinions supportive of the decision

On the other hand, those in favor of the decision found it "a very high quality piece of legal craftsmanship" that "may well be the Supreme Court's finest work in the patent-eligibility field." [29] Dr. Robert Wah, Chairman for the American Medical Association, said that the Supreme Court had "prevented irreparable harm to patient care with today's unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body's natural responses to illness and medical treatment", and said that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research." [30]

Another commentator, Professor Richard H. Stern, who teaches computer law at The George Washington University Law School, praised the decision because in it "the court for the first time agreed upon a full harmonisation of its prior and at times seemingly inconsistent judgments on patent-eligibility and how to determine it." [31] In the same vein, this commentator praised the decision for reaffirming earlier precedents such as O'Reilly v. Morse and Neilson v. Harford , which the lower court in the Mayo case had ignored or seemingly misunderstood.

A business-oriented commentator viewed the decision as seeking to strike a balance between competing policy considerations:

While the collective groans of patent professionals the world over are hard to ignore after the decision in Prometheus, it was a necessary evil to safeguard against the likely potential for financial posturing of companies with exclusive rights over processes of the human body. Ultimately, the conclusion in Prometheus is premised upon the public policy consideration that certain types of medical and diagnostic findings should not be afforded patent protection, as the need for unencumbered access to critical scientific data and study in the medical community overwhelms any alleged monetary disincentive suffered by the patent applicant. The Court recognized that patent protection should not serve as a stumbling block for continued scientific innovation and improvement in medical treatment methodologies. [32]

Response by the US Patent and Trademark Office

Prior to the Mayo v Prometeus decision the USPTO practice of patent eligibility of chemical diagnostic method was governed by the 2006 CAFC decision in LabCorp v. Metabolite, Inc. , which held such claims patent-ineligible based on machine-or-transformation test. The US Supreme Court dismissed its own writ of certiorari for LabCorp v. Metabolite, Inc. as improperly granted, but the minority opinion in that case suggested a test, which was eventually adopted in Mayo v. Prometeus.

The Mayo decision made medical diagnostics methods a patentable subject matter. US Patent and Trademark Office released preliminary guidelines for patent examiners in light of this case on March 21, 2012. [33] On July 3, 2012, it issued a more substantial set of "interim guidelines" for "process claims in which a law of nature, natural phenomenon, or naturally occurring relation or correlation is a limiting element or step" [34] that replaced the preliminary guidelines. [35]

Soon after "Mayo" (in 2014) the Supreme Court decided another patentable subject matter case in Alice Corp. v. CLS Bank International . In June 2020 the Office issued new guidelines on subject matter eligibility, which implement Mayo/Alice decisions and were incorporated into the MPEP, particularly in Sections 2103 through 2106.07(c). [36]

See also

Related Research Articles

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Neither software nor computer programs are explicitly mentioned in statutory United States patent law. Patent law has changed to address new technologies, and decisions of the United States Supreme Court and United States Court of Appeals for the Federal Circuit (CAFC) beginning in the latter part of the 20th century have sought to clarify the boundary between patent-eligible and patent-ineligible subject matter for a number of new technologies including computers and software. The first computer software case in the Supreme Court was Gottschalk v. Benson in 1972. Since then, the Supreme Court has decided about a half dozen cases touching on the patent eligibility of software-related inventions.

State Street Bank and Trust Company v. Signature Financial Group, Inc., 149 F.3d 1368, also referred to as State Street or State Street Bank, was a 1998 decision of the United States Court of Appeals for the Federal Circuit concerning the patentability of business methods. State Street for a time established the principle that a claimed invention was eligible for protection by a patent in the United States if it involved some practical application and, in the words of the State Street opinion, "it produces a useful, concrete and tangible result."

Business method patents are a class of patents which disclose and claim new methods of doing business. This includes new types of e-commerce, insurance, banking and tax compliance etc. Business method patents are a relatively new species of patent and there have been several reviews investigating the appropriateness of patenting business methods. Nonetheless, they have become important assets for both independent inventors and major corporations.

Diamond v. Diehr, 450 U.S. 175 (1981), was a United States Supreme Court decision which held that controlling the execution of a physical process, by running a computer program did not preclude patentability of the invention as a whole. The high court reiterated its earlier holdings that mathematical formulas in the abstract could not be patented, but it held that the mere presence of a software element did not make an otherwise patent-eligible machine or process patent ineligible. Diehr was the third member of a trilogy of Supreme Court decisions on the patent-eligibility of computer software related inventions.

Parker v. Flook, 437 U.S. 584 (1978), was a 1978 United States Supreme Court decision that ruled that an invention that departs from the prior art only in its use of a mathematical algorithm is patent eligible only if there is some other "inventive concept in its application." The algorithm itself must be considered as if it were part of the prior art, and the claim must be considered as a whole. The exact quotation from the majority opinion is: "Respondent’s process is unpatentable under §101, not because it contains a mathematical algorithm as one component, but because once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention." "The fact that the algorithm may not have actually been known previously and that, when taken in combination with other claim elements, it might produce an invention that is novel and nonobvious, plays no part in the analysis."

LabCorp v. Metabolite, Inc., 548 U.S. 124 (2006), is the first case since Diamond v. Chakrabarty in which the U.S. Supreme Court indicated a renewed interest in examining the limits of patentable subject matter for advances in life sciences. Although the Court initially agreed to hear the case, it was later dismissed in 2006 with three Justices dissenting. The defendant's petition to the Supreme Court raised an issue not addressed in opinions from the lower courts: the claim at issue was directed to patent ineligible subject matter and therefore invalid.

<span class="mw-page-title-main">Thiopurine</span> Class of chemical compounds

The thiopurine drugs are purine antimetabolites widely used in the treatment of acute lymphoblastic leukemia, autoimmune disorders, and organ transplant recipients.

Freeman-Walter-Abele is a now outdated judicial test in United States patent law. It came from three decisions of the United States Court of Customs and Patent Appeals—In re Freeman, 573 F.2d 1237, In re Walter, 618 F.2d 758 ; and In re Abele, 684 F.2d 902 —which attempted to comply with then-recent decisions of the Supreme Court concerning software-related patent claims.

Bilski v. Kappos, 561 U.S. 593 (2010), was a case decided by the Supreme Court of the United States holding that the machine-or-transformation test is not the sole test for determining the patent eligibility of a process, but rather "a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101." In so doing, the Supreme Court affirmed the rejection of an application for a patent on a method of hedging losses in one segment of the energy industry by making investments in other segments of that industry, on the basis that the abstract investment strategy set forth in the application was not patentable subject matter.

AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352 was a case in which the United States Court of Appeals for the Federal Circuit reversed the decision of the United States District Court for the District of Delaware, which had granted summary judgment to Excel Communications, Inc. and decided that AT&T Corp. had failed to claim statutory subject matter with U.S. Patent No. 5,333,184 under 35 U.S.C. § 101. The United States Court of Appeals for the Federal Circuit remanded the case for further proceedings.

CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, is a United States Court of Appeals for the Federal Circuit case that disputed patent eligibility for the '154 patent, which describes a method and system for detecting fraud of credit card transactions through the internet. This court affirmed the decision of United States District Court for the Northern District of California which ruled that the patent is actually unpatentable.

Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), was a 2014 United States Supreme Court decision about patent eligibility of business method patents. The issue in the case was whether certain patent claims for a computer-implemented, electronic escrow service covered abstract ideas, which would make the claims ineligible for patent protection. The patents were held to be invalid, because the claims were drawn to an abstract idea, and implementing those claims on a computer was not enough to transform that abstract idea into patentable subject matter.

DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, was the first United States Court of Appeals for the Federal Circuit decision to uphold the validity of computer-implemented patent claims after the Supreme Court's decision in Alice Corp. v. CLS Bank International. Both Alice and DDR Holdings are legal decisions relevant to the debate about whether software and business methods are patentable subject matter under Title 35 of the United States Code §101. The Federal Circuit applied the framework articulated in Alice to uphold the validity of the patents on webpage display technology at issue in DDR Holdings.

Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, is a 2015 en banc decision of the United States Court of Appeals for the Federal Circuit, on remand from a 2014 decision of the U.S. Supreme Court reversing a previous Federal Circuit decision in the case. This is the most recent in a string of decisions in the case that concern the proper legal standard for determining patent infringement liability when multiple actors are involved in carrying out the claimed infringement of a method patent and no single accused infringer has performed all of the steps. In the 2015 remand decision, the Federal Circuit expanded the scope of vicarious liability in such cases, holding that one actor could be held liable for the acts of another actor "when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance." In addition, the court held that where multiple "actors form a joint enterprise, all can be charged with the acts of the other[s], rendering each liable for the steps performed by the other[s] as if each is a single actor."

Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, is a controversial decision of the Federal Circuit in which the court applied the Mayo v. Prometheus test to invalidate as patent-ineligible a patent said to "solve ... a very practical problem accessing fetal DNA without creating a major health risk for the unborn child." The rationale for denying patent-eligibility in this case allegedly stems from claims being directed toward non-eligible subject matter , "if the APPLICATION [of this discovery] merely relies upon elements already known in the art."

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.

In US patent law, non-obviousness is one of the requirements that an invention must meet to qualify for patentability, codified as a part of Patent Act of 1952 as 35 U.S.C. §103. An invention is not obvious if a "person having ordinary skill in the art" (PHOSITA) would not know how to solve the problem at which the invention is directed by using exactly the same mechanism. Since the PHOSITA standard turned to be too ambiguous in practice, the U.S. Supreme Court provided later two more useful approaches which currently control the practical analysis of non-obviousness by patent examiners and courts: Graham et al. v. John Deere Co. of Kansas City et al., 383 U.S. 1 (1966) gives guidelines of what is "non-obvious", and KSR v. Teleflex (2006) gives guidelines of what is "obvious".

<span class="mw-page-title-main">Patentable subject matter in the United States</span>

Patentable subject matter in the United States is governed by 35 U.S.C. 101. The current patentable subject matter practice in the U.S. is very different from the corresponding practices by WIPO/Patent Cooperation Treaty and by the European Patent Office, and it is considered to be broader in general.

References

  1. ↑ "Mayo Collaborative Servs. V. Prometheus Labs., Inc. | Case Brief for Law School | LexisNexis".
  2. 1 2 3 4 5 6 7 8 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
  3. ↑ Cubert, Jeremy A. (January 2020). "Has the Sun Set for Life Science Patents?: Mayo, Myriad and the Patent Eligibility Divide". ACS Symposium Series. 1363: 61–71. doi:10.1021/bk-2020-1363.ch004. S2CID   229259955.
  4. 1 2 C&E News on SCOTUS Prometheus ruling: Patent Ruling Dismays Biotech
  5. ↑ Guerrini, Christi J; McGuire, Amy L; Majumder, Mary A; Bollinger, Juli M; Rowan, Paul J (December 1, 2017). "Constraints on gene patent protection fuel secrecy concerns: a qualitative study". Journal of Law and the Biosciences. 4 (3): 542–564. doi:10.1093/jlb/lsx034. PMC   5965503 . PMID   29868184.
  6. ↑ Business Record about "Mayo Collaborative Services, Inc." at Minnesota Secretary of State
  7. ↑ Company Overview of Mayo Collaborative Services, Inc. at Bloomberg Businessweek
  8. ↑ Business Record about "Mayo Foundation for Medical Education and Research" at Minnesota Secretary of State
  9. ↑ "Mayo website".
  10. ↑ Prometheus website
  11. ↑ "US6355623B2 - Method of treating IBD/Crohn's disease and related conditions wherein drug metabolite levels in host blood cells determine subsequent dosage - Google Patents".
  12. ↑ "Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders".
  13. ↑ Dubinsky, M. C.; et al. (2000). "Pharmacogenomics and metabolite measurement for 6-mercaptopurine therapy in inflammatory bowel disease". Gastroenterology. 118 (4): 705–713. doi: 10.1016/S0016-5085(00)70140-5 . PMID   10734022.
  14. ↑ "Prometheus v Mayo". Cases of Interest.
  15. 1 2 "Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)". Patent Docs.
  16. 1 2 3 4 "Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)". Patent Docs.
  17. ↑ Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581F.3d1336 ( Fed. Cir. 2009).
  18. ↑ "Patentable Subject Matter: Federal Circuit Upholds Patentability of Drug Dosage Method Claim". Patently-O. September 16, 2009.
  19. ↑ "Search - Supreme Court of the United States". www.supremecourt.gov.
  20. ↑ "Supreme Court Order granting Certiorari" (PDF).
  21. 1 2 Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628F.3d1347 (Fed. Cir.2010).
  22. ↑ "Prometheus Laboratories v. Mayo: The Broad Scope of Statutory Subject Matter". Patently-O. December 22, 2010.
  23. 1 2 "Mayo v. Prometheus: Natural Process + Known Elements = Normally No Patent". Patently-O. March 20, 2012.
  24. 1 2 "Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said". Patent Docs.
  25. ↑ Gene Quinn, Killing Industry: The Supreme Court Blows Mayo v. Prometheus
  26. ↑ Kevin Noonan, Mayo Collaborative Services v. Prometheus Laboratories—What the Court's Decision Means, Patent Docs (March 22, 2012).
  27. ↑ Robert R. Sachs, Punishing Prometheus: The Supreme Court’s Blunders in Mayo v. Prometheus, Patently-O (March 26, 2012).
  28. ↑ Hans Sauer, quoted in Early Reaction to Supreme Court Decision in Mayo v. Prometheus, Patent Docs (March 20, 2012).
  29. ↑ See Richard H. Stern, Mayo v Prometheus: No Patents on Conventional Implementations of Natural Principles and Fundamental Truths, [2012] Eur. Intell. Prop. Rev. 502, available at GW Law.
  30. ↑ Robert Wah, quoted in Early Reaction to Supreme Court Decision in Mayo v. Prometheus, Patent Docs (March 20, 2012).
  31. ↑ See Richard H. Stern, Mayo v. Prometheus: No Patents on Conventional Implementations of Natural Principles and Fundamental Truths, [2012] Eur. Intell. Prop. Rev. 502, available at GW Law.
  32. ↑ William J. Manolis, A Struggle for Clairvoyance Section 101 of the Patent Act as a Gatekeeper to Patent Eligibility: Mayo Collaborative Serv. v. Prometheus Laboratories, Inc., 15 Duq. Bus. L.J. 113, 136 (2013).
  33. ↑ "Patent Office's Preliminary Guidelines" (PDF).
  34. ↑ "Director's Blog: the latest from USPTO leadership". www.uspto.gov.
  35. ↑ "Patent Office's Interim Guidelines" (PDF).
  36. ↑ "MPEP".

Further reading

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