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PATENT

Association for Molecular Pathology, et al. v. Myriad Genetics, Inc.

in
Oral argument: 
April 15, 2013
Court below: 
United States Court of Appeals for the Federal Circuit

Myriad Genetics first identified and isolated the BRCA1 and BRCA2 genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Myriad claims patents on the isolated BRCA genes along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and "primers" used in diagnostics. The Patent Act defines the scope of patentable subject-matter in 35 U.S.C. § 101; however, the Supreme Court has consistently held that laws of nature, abstract ideas, and natural phenomenon cannot be patented. Myriad claims that the isolated and modified genes that they hold patents for never occur in nature, and subsequently are patentable subject-matter. Conversely, the Association for Molecular Pathologists contends that Myriad only isolated, and did not modify, a gene already existing in nature and that this isolated gene performs a similar function as the gene in natural form. The district court held that naturally-occurring genes were not patentable subject-matter, but the Federal Circuit court reversed. How the Supreme Court decides this case will greatly impact the scope of patentable subject-matter. A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public.

Questions Presented: 

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ("isolating") the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:

  1. Are human genes patentable?
  2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
  3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

LIMITED TO QUESTION 1 PRESENTED BY THE PETITION.

Issue

Whether Myriad’s claimed invention, the sequence of certain human genes in both isolated and purified forms, falls within the scope of inventions for which a patent may be granted.

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Written by: 
Jonathan Goddard
Zachary Glantz
Edited by: 
Brandon Bodnar
Acknowledgments: 

The authors would like to thank Professor Oskar Liivak for his insight into this case.

Additional Resources: 

Vernon Hugh Bowman v. Monsanto Company

in
Oral argument: 
February 19, 2013
Court below: 
United States Court of Appeals for the Federal Circuit

Monsanto Company, a producer of herbicide resistant soybean seeds and technology, sued Vernon Hugh Bowman, a soybean farmer, for patent infringement.  Bowman replanted second-generation seeds, which were the product of seeds purchased from a licensed Monsanto technology distributor.  Monsanto argued that by planting the product of Monsanto’s herbicide resistant seeds instead of purchasing new ones, Bowman was in violation of the Technology Agreement for the seeds.  The Federal Circuit upheld a district court decision awarding Monsanto damages for violation of their patented technology, reasoning that Monsanto's herbicide resistant technology was covered by patent regardless of whether it was the original seed or a product of the original seeds. Bowman contends that Monsanto’s patent rights were exhausted once he bought the seeds and that use of progeny seeds is an expected use of the product.  Monsanto responds that in the case of self-replicating technologies the patent extends to the technology, here, the trait of herbicide resistance, rather than the seed itself. 

Questions Presented: 

Patent exhaustion delimits rights of patent holders by eliminating the right
 to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose--namely, for planting.                                      

The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Issue

May patent holders enforce their rights on the

Written by: 
Dean Caruvana
Claire Holton-Basaldua
Edited by: 
Brandon Bodnar
Additional Resources: 

Jerry W. Gunn, et al., v. Vernon F. Minton

in
Oral argument: 
January 16, 2013
Court below: 
The Supreme Court of Texas

The Respondent, Vernon F. Minton ("Minton"), leased a software that he developed to the National Association of Securities Dealers, Inc. ("NASD") and NASDAQ Stock Market, Inc. ("NASDAQ") and later applied for and was granted a patent for the software. Subsequently, Respondent Minton filed a patent infringement lawsuit against NASD and NASDAQ, but the trial court dismissed the lawsuit due to the "on-sale bar" rule, codified in § 102(b) of the United States Patent Act. The rule invalidates patents that apply to inventions sold more than a year prior to the application date of the patent. Minton then filed a legal malpractice lawsuit against his attorneys, Petitioner Jerry W. Gunn, et al., who represented Minton in the patent infringement case and argued that if not for Gunn's failure to raise at trial the experimental use exception to the on-sale bar, he would have won the patent infringement lawsuit. The issue in this case concerns whether the federal courts should have exclusive jurisdiction over legal malpractice claims that arise from patent litigation. Gunn argues that the federal issue in the case is too insubstantial to be heard in federal court and, furthermore, that significant state interests and Congressional intent require that the case be heard in state court. Minton claims, however, that the federal issue is substantial and that based on the federal interests and Congressional intent, this case should be decided in federal court. The Supreme Court's decision will affect the efficiency and uniformity of this country's patent law and patent-related malpractice litigation. Such effects would impact the growth and development of the technology and science industries. 

Questions Presented: 

Did the Federal Circuit depart from the standard this Court articulated in Grable & Sons Metal Products, Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005), for "arising under" jurisdiction of the federal courts under 28 U.S.C. § 1338, when it held that state law legal malpractice claims against trial lawyers for their handling of underlying patent matters come within the exclusive jurisdiction of the federal courts? Because the Federal Circuit has exclusive jurisdiction over appeals involving patents, are state courts and federal courts strictly following the Federal Circuit's mistaken standard, thereby magnifying its jurisdictional error and sweeping broad swaths of state law claims - which involve no actual patents and have no impact on actual patent rights - into the federal courts?

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Issue(s)

Do the federal courts have exclusive j

Written by: 
Z. Lu
Sherry Jarons
Edited by: 
Brooks Kaufman
Additional Resources: 

Kappos v. Hyatt (10-1219)

in

Oral argument: Jan. 9, 2012

Appealed from: United States Court of Appeals for the Federal Circuit (Nov. 8, 2010)

PATENT, PATENT AND TRADEMARK OFFICE, NEW EVIDENCE, JUDICIAL REVIEW, DEFERENCE

Petitioner Gilbert Hyatt initiated a civil action under 35 U.S.C. § 145 against Respondent David Kappos, Director of the Patent and Trademark Office, after the PTO's Board of Patent Appeals and Interferences sustained rejections for seventy-nine of Hyatt’s patent claims. The district court disregarded new evidence presented by Hyatt, because he failed to present such evidence before the PTO when it was available, and granted Kappos summary judgment. The Federal Circuit initially affirmed, but later reversed the district court's ruling. Kappos argues that § 145 only affords Hyatt a review that is deferential to PTO determinations, and that new evidence can only be introduced if such evidence becomes available after the PTO proceedings. Hyatt counters that § 145 authorizes the district court to decide patent application de novo, and generally allows introduction of new evidence. The Supreme Court’s decision will clarify the procedure for judicial review of the patent application process.

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (10-1150)

in

Oral argument: Dec. 7, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (Dec. 17, 2010)

In this case, the Supreme Court will evaluate the validity of two patents held by Respondent Prometheus Laboratories. Prometheus had marketed a multistep medical test based on these patents, which describe the proper dosage range of powerful immunosuppressive drugs. However, after Petitioner Mayo Medical Laboratories announced its intention to market a competing medical test in 2004, Prometheus sued for patent infringement. Mayo now argues that the patents are invalid because they seek to monopolize a natural phenomenon, preempting all other uses of a naturally occurring correlation between metabolites and patient health. Prometheus, on the other hand, argues that the patents are valid because they involve concrete applications and cover patentable correlations, not just natural phenomena. The decision in this case may affect the cost and quality of patient health care, as well as the incentives for research and development in the medical industry.

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (10-844)

in

Oral argument: Dec. 5, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (April 14, 2010)

Petitioner Caraco Pharmaceutical Laboratories, a generic drug manufacturer, sought FDA approval to market the diabetes drug repaglinide. Pursuant to the Hatch-Waxman Act's expedited FDA application process for generic drugs, Caraco certified that its drug label would not conflict with Respondent Novo Nordisk’s patented repaglinide-metformin use combination. Relying on Novo’s description of its patent, the FDA denied the certification. Caraco invoked the Act’s counterclaim provision to compel Novo to revert to a narrower patent description. The United States Court of Appeals for the Federal Circuit found that Caraco could not assert the counterclaim. Caraco argues that the Federal Circuit’s reading of the counterclaim provision is incorrect and that the purpose of the counterclaim provision—to “correct” misleading patent descriptions—supports reversal. Novo asserts that the statute plainly permits a counterclaim only if Novo’s patent does not claim any approved method of use. The Supreme Court’s reading of the counterclaim provision may affect healthcare costs and the generic drug manufacturing industry.

Stanford University v. Roche Molecular Systems, Inc. (09-1159)

in

Oral argument: Feb. 28, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (Sept. 30, 2009)

BAYH-DOLE ACT, PATENT, PCR, POLYMERASE CHAIN REACTION, ROCHE, STANFORD UNIVERSITY, CETUS

In the late 1980s, Dr. Mark Holodniy, a Stanford University researcher, conducted part of his research at a private biotechnology company. The result of his work, which was partially funded by the government, was an improved method for testing the effectiveness of HIV treatments. Over the next few years, Roche Molecular Systems, the owner of the biotechnology company at which Dr. Holodniy conducted his research, incorporated his invention into its publicly sold HIV-testing kits. At roughly the same time, Stanford, Dr. Holodniy’s employer, began the process of patenting the invention under the University and Small Business Patent Procedure Act, commonly known as the Bayh-Dole Act. In 2005, Stanford sued Roche for patent infringement, arguing among other things that the Bayh-Dole Act gave Stanford the exclusive first right to acquire ownership of Holodniy’s invention. The district court ruled for Stanford, but the Federal Circuit reversed, holding that an assignment of ownership rights in an earlier confidentiality agreement between Holodniy and the biotechnology company trumped Stanford’s ownership rights. Now, the Supreme Court must decide whether the Bayh-Dole Act prevents individual inventors from assigning to third parties their ownership rights in federally funded inventions.

Global-Tech Appliances, Inc. v. SEB S.A. (10-6)

in

Oral argument: Feb. 23, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (Feb. 5, 2010)

PATENT, INFRINGEMENT, INDUCEMENT, STATE OF MIND

Respondent SEB S.A. owns a patent for a deep fryer featuring an inexpensive, insulated plastic outer shell. In 1997, Petitioner Pentalpha Enterprises, LTD, a subsidiary of petitioner Global-Tech Appliances, Inc. (collectively, “Global-Tech”), developed and manufactured a deep fryer that copied features of SEB's deep fryer. On August 27, 1999, SEB sued Global-Tech for patent infringement in the United States District Court for the Southern District of New York. The jury found Global-Tech liable for direct and active inducement of patent infringement, and Global-Tech appealed to the Court of Appeals for the Federal Circuit. That court affirmed, holding that Global-Tech acted with deliberate indifference to the risk of infringing SEB's patent. Global-Tech appealed, arguing that the Federal Circuit applied the wrong standard for the mental-state element of actively inducing patent infringement under 35 U.S.C. § 271(b). Global-Tech asserts that the proper standard is “purposeful, culpable expression and conduct to encourage an infringement,” the standard the Supreme Court articulated in MGM Studios, Inc. v. Grokster, Ltd. On the other hand, SEB argues that a patent infringer does not need to have actual knowledge of a patent to be liable for actively inducing patent infringement. The Supreme Court’s decision will affect patent litigation, the extent and cost of patent searches, and market competition and innovation.

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