LabCorp of Am. Holdings v. Metabolite Labs., Inc. | |
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Argued March 21, 2006 Decided June 22, 2006 | |
Full case name | Laboratory Corporation of America Holdings (d/b/a LabCorp) v. Metabolite Laboratories, Inc. et al. |
Docket no. | 03-1120 |
Citations | 548 U.S. 124 ( more ) |
Argument | Oral argument |
Opinion announcement | Opinion announcement |
Case history | |
Prior | Judgment for plaintiff, judgment as a matter of law for defendant denied, Metabolite Labs, Inc. v. Lab. Corp. of Am. Holdings, No. 1:99-cv-00870 (D. Colo. 2002); 370 F.3d 1354 (Fed. Cir. 2004), cert. granted, 546 U.S. 999(2005). |
Subsequent | Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 571 F. Supp. 2d 1199 (D. Colo. 2008) (partial relitigation); 599 F.3d 1277 (Fed. Cir. 2010) (denying jurisdiction and transferring appeal); 410 F. App'x 151 (10th Cir. 2011) (affirming summary judgment). |
Holding | |
Writ of certiorari dismissed as improvidently granted. | |
Court membership | |
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Case opinions | |
Per curiam | |
Dissent | Breyer, joined by Souter, Stevens |
LabCorp v. Metabolite, Inc., 548 U.S. 124 (2006), is the first case since Diamond v. Chakrabarty [1] 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. [2] 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.
In 1999, Metabolite sued LabCorp for infringement of a patent covering a diagnostic test. The single claim at issue, claim 13, is reproduced in full below: "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."
Claim 13 is a diagnostic method for detecting deficiencies of vitamins B6 and B12 that relies on the correlation of that condition with elevated levels of homocysteine. The claim instructs medical providers to test homocysteine levels in a patient, without specifying any specific means of doing so, and make logical inferences based on the test results and aware of the discovered correlation between elevated levels and vitamin deficiencies.
A jury found the defendants liable for indirect infringement of claim 13 and breach of contract. The district court ordered LabCorp to pay $4.7 million in damages and permanently enjoined LabCorp from conducting future such tests at physicians' requests. The decision was upheld by the United States Court of Appeals for the Federal Circuit, which further stated that doctors were 'directly infringing' Metabolite's patents each time such a test is ordered and interpreted. [3] LabCorp argued that the correlation is a principle of nature, and therefore the patent should never have been granted.
The US Supreme Court dismissed the case, although Justice Breyer, Justice Stevens, and Justice Souter dissented from this decision. Breyer's dissenting opinion cited numerous cases in which scientific and mathematical principles had been held to be patent ineligible, including O'Reilly v. Morse [4] and Gottschalk v. Benson . [5]
Had the case been heard, and had Metabolite's patent been invalidated, the case would have had broad implications for biotechnology companies, which may have extended far beyond patentability of correlations of biomarkers to disease states. Lori Andrews outlined various concerns regarding how routine academic practices might become actionable under the results of the case. [6] Metabolite's brief to the court suggested that overturning the patent might lead to invalidation of all drug patents on the grounds that the inventors "merely discovered that certain chemicals interact with the human body in ways directed by chemistry." This statement is flawed, because it refers to process claims, while pharmaceutical are claimed as compositions-of-matter.
In Mayo v. Prometheus in 2012 the Supreme Court unanimously held what the dissenting Justices argued for in this case. [7] That did not lead, however, to invalidation of all drug patents on the grounds that the inventors "merely discovered that certain chemicals interact with the human body in ways directed by chemistry." The only issue affected by Mayo v. Prometeus is the eligibility of method/process claims. Claims on articles of manufacture or compositions of matter are believed to be unaffected.
Homocysteine or Hcy: is a non-proteinogenic α-amino acid. It is a homologue of the amino acid cysteine, differing by an additional methylene bridge (-CH2-). It is biosynthesized from methionine by the removal of its terminal Cε methyl group. In the body, homocysteine can be recycled into methionine or converted into cysteine with the aid of vitamin B6, B9, and B12.
Homocystinuria or HCU is an inherited disorder of the metabolism of the amino acid methionine due to a deficiency of cystathionine beta synthase or methionine synthase. It is an inherited autosomal recessive trait, which means a child needs to inherit a copy of the defective gene from both parents to be affected. Symptoms of homocystinuria can also be caused by a deficiency of vitamins B6, B12, or folate.
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."
Megaloblastic anemia is a type of macrocytic anemia. An anemia is a red blood cell defect that can lead to an undersupply of oxygen. Megaloblastic anemia results from inhibition of DNA synthesis during red blood cell production. When DNA synthesis is impaired, the cell cycle cannot progress from the G2 growth stage to the mitosis (M) stage. This leads to continuing cell growth without division, which presents as macrocytosis. Megaloblastic anemia has a rather slow onset, especially when compared to that of other anemias. The defect in red cell DNA synthesis is most often due to hypovitaminosis, specifically vitamin B12 deficiency or folate deficiency. Loss of micronutrients may also be a cause.
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.
Folate deficiency, also known as vitamin B9 deficiency, is a low level of folate and derivatives in the body. Signs of folate deficiency are often subtle. A low number of red blood cells (anemia) is a late finding in folate deficiency and folate deficiency anemia is the term given for this medical condition. It is characterized by the appearance of large-sized, abnormal red blood cells (megaloblasts), which form when there are inadequate stores of folic acid within the body.
Hydroxocobalamin, also known as vitamin B12a and hydroxycobalamin, is a vitamin found in food and used as a dietary supplement. As a supplement it is used to treat vitamin B12 deficiency including pernicious anemia. Other uses include treatment for cyanide poisoning, Leber's optic atrophy, and toxic amblyopia. It is given by injection into a muscle or vein.
In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385, was an en banc decision of the United States Court of Appeals for the Federal Circuit (CAFC) on the patenting of method claims, particularly business methods. The court affirmed the rejection of the patent claims involving a method of hedging risks in commodities trading, as non-patentable subject matter. Most importantly, the Court concluded, that machine-or-transformation test "was proper test to apply to determine patent-eligibility of process", and that the “useful, concrete and tangible result” of State Street Bank v. Signature Financial Group and AT&T Corp. v. Excel Communications, Inc. should no longer be relied upon.
United States v. Glaxo Group Ltd., 410 U.S. 52 (1973), is a 1973 decision of the United States Supreme Court in which the Court held that (1) when a patent is directly involved in an antitrust violation, the Government may challenge the validity of the patent; and (2) ordinarily, in patent-antitrust cases, "[m]andatory selling on specified terms and compulsory patent licensing at reasonable charges are recognized antitrust remedies."
Neilson v Harford (1841) 151 ER 1266 is a 19th-century English patent law decision that several United States Supreme Court patent law opinions rely upon as authority. The question, as Baron Alderson posed it, was “[W]here is the difference between claiming a principle, which is to be carried into effect any way you will, and claiming a mere principle?” The answer, as the opinions of the various courts that have considered the matter develop, is nowhere.
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.
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.
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.
J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), was a decision of the United States Supreme Court holding for the first time that utility patents may be issued for crops and other flowering plants under 35 U.S.C. § 101. The Supreme Court rejected the argument that the exclusive ways to protect these plants are under the Plant Variety Protection Act (PVPA), 7 U.S.C. § 2321, and the Plant Patent Act of 1930 (PPA), 35 U.S.C. §§ 161-164.
Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U.S. 172 (1965), was a 1965 decision of the United States Supreme Court that held, for the first time, that enforcement of a fraudulently procured patent violated the antitrust laws and provided a basis for a claim of treble damages if it caused a substantial anticompetitive effect.
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 "bizzare 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.
United States v. Arthrex, Inc., 594 U.S. ___ (2021), was a United States Supreme Court case related to the Appointments Clause of the United States Constitution as it related to patent judges on the Patent Trial and Appeal Board (PTAB). In a complex decision, the Court ruled that these judges were considered "primary officers" under the Appointments Clause, normally subject to appointment through the US President and the US Senate, but to remedy the matter, the Court ruled that the constitutional issue is resolved by allowing the PTAB decisions to be subject to review by the appropriately-appointed Director of the Patent Office.
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 it is considered to be broader in general. Since the enactment of the subject matter requirement ca. 1970, the interpretation of the statute changed multiple times. Although Section 101 of Title 35 U.S.C. reads:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.