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Gene patents in the United States

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A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents.

Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.[1]

History

The United States has been patenting chemical compositions based upon human products for over 100 years. The first patent for a human product was granted on March 20, 1906 for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford [2] Judge Hand argued that natural substances when they are purified are more useful than the original natural substances. [3]

In 1980, the U.S. Supreme Court, in Diamond v. Chakrabarty, upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner for the United States Patent and Trademark Office had rejected the patent of a living organism, but Chakrabarty appealed. As a rule, raw natural material is generally rejected for patent approval by the USPTO. The Court ruled that as long as the organism is truly "man-made," such as through genetic engineering, then it is patentable. Because the DNA of Chakrabarty's organism was modified, it was patentable.

Controversy

Law professor Rebecca S. Eisenberg argues that gene patents produce an "anticommons" at odds with an ideal scientific commons.[4]

Others claim that patents have not created this "anticommons" effect on research, based on surveys of scientists.[5][6]

Professional societies of pathologists have criticized patents on disease genes and exclusive licenses to perform DNA diagnostic tests. In the 2009 Myriad case, doctors and pathologists complained that the patent on BRCA1 and BRCA2 genes prevented patients from receiving second opinions on their test results. Pathologists complained that the patent prevented them from carrying out their medical practice of doing diagnostic tests on patient samples and interpreting the results.[7]

Another example is a series of lawsuits filed by the Alzheimer’s Institute of America (AIA) starting in 2010, concerning a gene patent it controls. The patent covers a genetic mutation that predisposes to Alzheimer's, and more importantly, it applies to transgenic mice carrying the mutation. These mice are widely used in Alzheimer's research, both by academic scientists doing basic research and by companies that use the mice to test products in development. Two of these suits are directed to companies that were started based on inventions made at universities (Comentis and Avid), and in each of those cases, the university has been sued along with the company. While none of the suits target universities that are conducting basic research using the mice, one of the suits is against Jackson Labs, a nonprofit company that provides transgenic mice to academic and commercial researchers and is an important repository of such mice.[8]

While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), it is difficult to find controversy surrounding patents on genes that are used to manufacture therapeutic proteins (for an example of patents on therapeutic proteins, the drug candidate that is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene patent, US Patent 6,770,468.[1]) There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes.[2]

Myriad Genetics case

Further information: Association for Molecular Pathology v. U.S. Patent and Trademark Office

In 2009, a lawsuit, Association For Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al. was filed against Myriad Genetics and the U.S. Patent and Trademark Office by professional medical organizations, doctors, and patients, represented by the American Civil Liberties Union and the Public Patent Foundation of the Benjamin N. Cardozo School of Law, New York, in the U.S. District Court for the Southern District of New York

The complaint challenged specific claims on isolated genes and diagnostic methods in seven of Myriad's 23 patents on BRCA1 and BRCA2. Some of these patents are owned by Myriad and some of them were licensed from University of Utah. More specifically, the plaintiffs wanted certain claims declared invalid on the grounds that they are not patentable subject matter- that the isolated genes are unpatentable products of nature and that the diagnostic method claims are mere thought processes that do not yield any real world transformations.

Many patent lawyers had predicted that the courts would throw out this case.[9]

However, United States District Court Judge Robert W. Sweet accepted the case, and on March 29, 2010 ruled that the claims were invalid.[9][10]

Other claims, which were not challenged in the lawsuit, still stand.[9][7]

Judge Sweet's 152–page decision ruled that the challenged claims to the isolated gene sequences had been "improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic methods were found invalid under the recent In re Bilski decision.[9] Because the case could be decided with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed them without prejudice.[9][7]

However, on March 30, 2010, Myriad announced that it will appeal the decision.[11] On June 16, 2010, Myriad filed its Notice of Appeal. Oral arguments were heard at the Federal Circuit on April 4, 2011.[12]

On July 29, 2011 the Federal Circuit overturned the District court in part, and upheld the decision in part.[13] The Federal Circuit overturned the District Court's finding that the claims covering isolated gene sequences are invalid and also overturned the invalidity of some of the diagnostic claims; the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences - that have no transformative step - are invalid. [14][15] Further appeals are likely; on October 12, 2011 the ACLU and the Public Patent Foundation said they intended to petition the Supreme Court to overturn the decision. [16]

On March 26, 2012, the Supreme Court vacated the Federal Circuit, and remanded the case back to that court for reconsideration in light of the Supreme Court ruling in the Mayo Collaborative Services v. Prometheus Laboratories, Inc.[17]

On August 16, 2012, the Federal Circuit issued a decision [18] reversing the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter. It also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics was directed to a patent-ineligible scientific principle. It affirmed the lower court’s decision, that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible. Such claims were held to include no transformative steps and therefore cover only patent-ineligible abstract, mental steps.

The Federal Circuit’s rationale in upholding patent eligibility is based on the fact that the claimed isolated DNA molecules were man-made and the product of human ingenuity. According to the majority, as compared to native DNA, isolated DNA molecules are distinct chemical entities. [19]

See also

References

  1. ^ "Federal Register - Utility Examination Guidelines - Comments and Responses". January 5, 2001. Retrieved April 5, 2010. See Comment 2 in which this objection is specifically raised and addressed.
  2. ^ Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), Learned Hand, J.
  3. ^ Dutfield, Graham. "DNA Patenting: Implications for Public Health Research." Bulletin of the World Health Organization, May 2006, Volume 85, Issue 5.
  4. ^ http://journals.lww.com/academicmedicine/fulltext/2002/12001/why_the_gene_patenting_controversy_persists.9.aspx
  5. ^ http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174
  6. ^ Science Progress Blog
  7. ^ a b c "Association For Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al" (PDF). The New York Times. March 29, 2010. Retrieved March 30, 2010.
  8. ^ Patent dispute threatens US Alzheimer's research; Lawsuit could expose hundreds of scientists to property-rights litigation. Erika Check Hayden, 5 April 2011, Nature 472, 20 (2011) | doi:10.1038/472020a
  9. ^ a b c d e Schwartz, John and Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010.{{cite news}}: CS1 maint: multiple names: authors list (link)
  10. ^ Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Retrieved March 29, 2010.
  11. ^ Barton, Suzanne. Director, Investor Relations, Myriad Genetics, Inc. "Federal District Court Rules Isolated DNA Claims are Not Patentable: Myriad to Appeal Decision to the Federal Circuit Court of Appeals".
  12. ^ http://www.patentlyo.com/patent/2011/04/federal-circuit-hears-myriad-gene-patent-case.html
  13. ^ http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf
  14. ^ Pollack, Andrew (July 29, 2011). "Gene Patent in Cancer Test Upheld by Appeals Panel". The New York Times.
  15. ^ http://www.patentlyo.com/patent/2011/07/federal-circuit-isolated-human-dna-molecules-are-patentable.html
  16. ^ http://www.sltrib.com/sltrib/money/52711149-79/court-myriad-genes-aclu.html.csp
  17. ^ . July 26, 2012 http://www.reuters.com/article/2012/03/26/us-myriadgenetics-patent-idUSBRE82P0YJ20120326. {{cite news}}: Missing or empty |title= (help)
  18. ^ "Federal Circuit Decision of August 16, 2012" (PDF). Federal Circuit. August 16, 2012. Retrieved 2012-08-16.
  19. ^ Sterne, Kessler, Goldstein & Fox P.L.L.C. (September 7, 2012). "Federal Circuit Reaffirms the Patentability of Isolated DNA in Association for Molecular Pathology v. Myriad". The National Law Review. Retrieved September 10, 2012.{{cite web}}: CS1 maint: multiple names: authors list (link)
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