Center for Public Genomics

BRCA Resources

BRCA RESOURCES

For more information, view the Duke Center for Public Genomics BRCA Gene Patenting Case archive.

 

---------------Post-SCOTUS Ramifications------------

Court Documents for Counsyl v. Myriad Genetics

Counsyl, Inc. v. Myriad Genetics, Inc.

On September 20th, 2013, Counsyl preemptively filed for a declaratory judgment that "Myriad has no rights against Counsyl" regarding claims from 8 patents and demanded a jury trial. The jury trial is scheduled for January 8th, 2014 at 10am.

Complaint for declaratory judgment and jury trial: full complaint filed on September 20th, 2013 by Counsyl 

Patents at issue (relevant claims highlighted)

US Patent 5,709,999: Claim 6

US Patent 5,747,282: Claims 5, 6

US Patent 5,753,441: Claims 8, 23, 33

US Patent 6,951,721: Claim 5

US Patent 7,250,497: Claims 1-20

US Patent 5,837,492: Claims 5, 9

US Patent 6,033,857: Claim 4

US Patent 6,051,379: Claims 1-20, 24, 25, 40, 41

 

Court Documents for Myriad Genetics v. Gene by Gene

Myriad Genetics, Inc. v. Gene by Gene Ltd.

On July 10, 2013, Myriad Genetics filed suit against Gene by Gene (DNATraits) for infringement of claims from 9 patents.

Complaint demand for jury trial: full complaint filed on July 10, 2013 by Myriad Genetics

Amici Curiae brief: filed on August 21, 2013 by ACLU, PUBPAT, AMP, BCA, and AARP in support of defendants

Patents at issue (relevant claims highlighted)

Same patent claims as Myriad Genetics v. Ambry Genetics; however, claims 32 and 33 of US Patent 6,051,379 were excluded.

 

Court Documents for Myriad Genetics v. Ambry Genetics

Myriad Genetics, Inc. v. Ambry Genetics, Corp.

On July 9, 2013, Myriad Genetics filed suit against Ambry Genetics for infringement of claims from 10 patents.

Complaint demand for jury trial: full complaint filed on July 9, 2013 by Myriad Genetics

Motion for preliminary injunctive relief and memorandum in support: petition for injunction filed on July 9, 2013 by Myriad Genetics

Ambry's answer and counterclaims: filed by Ambry Genetics on August 5, 2013

Amici Curiae brief: filed on August 21, 2013 by ACLU, PUBPAT, AMP, BCA, and AARP in support of defendants

Patents at issue (relevant claims highlighted)

US Patent 5,709,999: Claim 6

US Patent 5,747,282: Claims 6, 16, 17

US Patent 5,753,441: Claims 7, 8, 12, 23, 26

US Patent 5,837,492: Claims 29, 30

US Patent 6,033,857: Claim 4

US Patent 5,654,155: Claims 2, 3, 4

US Patent 5,750,400: Claims 2, 3, 4, 5, 6, 7

US Patent 6,051,379: Claims 32, 33 (These two claims were excluded in Myriad v.Gene by Gene.)

US Patent 6,951,721: Claim 5

US Patent 7,250,497: Claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19

Other Resources Regarding SCOTUS Decision

Sharing Clinical Reports/Free the Data!

DNA Project Aims to Make Public a Company's Data on Cancer Genes: NY Times article published on 12 April 2013 on Sharing Clinical Reports.

Free the Data! Project: Additional information on Genetic Alliance website

 

------------Association of Molecular Pathology----------
v. US Patent and Trademark Office

Plaintiffs and Defendants

Plaintiffs: The Public Patent Foundation (Counsel for Plaintiffs); The American Civil Liberties Union (counsel for plaintiffs); Association for Molecular Pathology; American College of Medical Genetics; American Society for Clinical Pathology; College of American Pathologists; Breast Cancer Action; Boston Women’s Health Book Collective.

Defendants: United States Patent and Trademark Office; Myriad Genetics; University of Utah Research Foundation

Court Documents for Association of Molecular Pathology v. US Patent and Trademark Office

Supreme Court of the United States

ACLU reply brief

Amici Curiae Brief of Academics in Law, Medicine, Health Policy, and Clinical Genetics: brief written in support of petitioners (this brief, as well as other available amici briefs for this case, are available via Patent Docs blog)

Brief for Petitioners

Amici Curiae Brief of Academics in Law, Medicine, Health Policy, and Clinical Genetics: brief written in support of neither party

Amici Curiae Brief of Fifteen Law Professors: brief written in support of petitioners

Amicus Curiae Brief of AARP: brief written in support of petitioners

For a complete list of amicus briefs (and accompanying links), see the website of the American Bar Association

Petition for a Writ of Certiorari: filed by ACLU and Public Patent Foundation on September 25, 2012

US Court of Appeals for Federal Circuit

US CAFC Ruling: decided on August 16, 2012 by the US Court of Appeals for Federal Circuit

Order for Oral Argument: filed April 30, 2012 by the US Court of Appeals for Federal Circuit

Appellees Brief on Remand (ACLU): supplemental brief on behalf of the appellees (available via ACLU website)

United States Amicus Brief: brief written by the United States solicitor general in support of neither party (available via Christopher Holman's IP blog)

Supplemental Brief for the Appellants (Myriad): supplemental brief by the defendant-appellant (available via Christopher Holman's IP blog)

James Watson Amicus Brief: brief written by James Watson in support of neither party

Supreme Court of the United States

Petition for a Writ of Cert.: Association for Molecular Pathology et al., (petitioners) v. Myriad Genetics Inc., et al., (respondents) petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit.

Myriad Genetics Brief of Opposition: brief written on behalf of Myriad Genetics, opposing the petition for Writ of Certiorari.

Petitioners' Reply to Brief of Opposition: brief written by petitioners in response to Myriad Genetics' brief of opposition.

AARP Amicus brief: brief written on behalf of the American Association of Retired Persons in support of petitioners.

AMA Amicus brief: brief by the American Medical Association, et al., in support of petitioners.

Academics Amicus Brief: brief written by Drs. Gold, Evans, Bubela, Cook-Deegan, and Nicol in support of petitioners.

Canavan Foundation Amicus brief: brief written by Canavan Foundation, et al., in support of petitioners.

Cancer Council of Australia Amicus brief: brief written by Cancer Council of Australia, et al., in support of petitioners.

Erica George and Kali Murray Amicus brief: brief written by law professors Erika George and Kali Murray in support of petitioners.

Kaiser Permanente Amicus Brief: brief written by representatives from Kaiser Permanente in support of petitioners.

Knowledge Ecology Amicus brief: brief written by representatives from Knowledge Ecology International in support of petitioners.

National Women’s Health Network Amicus brief: brief written by advocates from the National Women's Health Network, et al., in support of the petition for Writ of Certiorari.

Yale Law Information Society Amicus brief: brief written by the Information Society Project at Yale Law School in support of the petition for Writ of Certiorari.

*Amicus briefs available at http://www.aclu.org/free-speech-womens-rights/aclu-challenges-patents-breast-cancer-genes-0)

US Court of Appeals for Federal Circuit (ruling on July 29, 2011)

US Court of Appeals for Federal Circuit Ruling: The Federal Circuit ruling (on July 29, 2011) that re-instated most of Myriad's patents (including their product claim to BRCA genes and fragments.)

Oral arguments from the C.A.F.C on April 4, 2011.

US Court of Appeals for Federal Circuit Disposition Sheet: The petition for panel rehearing of the CAFC decision, which was denied on September 13, 2011.

C.A.F.C. Amicus Briefs by the United States (Office of the Solicitor General) and Christopher Holman. (For over 20 other amicus briefs, see AMP v. USPTO—Briefing Update II: a PatentDocs posting from February 2011 providing links to all amicus briefs).

Federal District Court ( Southern District of NY; filed May 12, 2009, ruling on March 29, 2010)

Lawsuit against Myriad Genetics, filed May 12, 2009 in Federal District Court.

Judge Sweet’s March 2010 ruling: On March 29, 2010, Judge Robert Sweet ruled that, “[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter...”

Association for Molecular Pathology et al., v. United States Patent and Trademark Office: list of initial complaint and subsequent motions and rulings, filed May 12, 2009.

List of challenged claims in Association for Molecular Pathology et al., v. United States Patent and Trademark Office.

669 F. Supp. 2d 365 [S.D.N.Y. 2009]: Judge Sweet’s decision on November 1, 2009 to deny the defendants’ motion to dismiss the complaint.

 

------BRCA Patent Lawsuit Congressional Briefing--------

September 15, 2011

Issue Brief for Congressional Staff: Prepared by Robert Cook-Deegan to educate policymakers, advocacy groups, and other stakeholders about the Myriad Case.

The Myriad Genetics/Breast Cancer Gene Case: Can genes be patented? Robert Cook-Deegan’s presentation slides from the September 15, 2011 Congressional briefing.

(Brief) Patent Primer: Congressional briefing presentation slides from Kevin Noonan, PhD.

Speaker Bios: Background materials provided at the September 2011 Congressional briefing.

Patenting Nature: What ruling in Myriad Case means for Biotechnology and DNA Diagnostics: Editorial in ‘Cancer Letter’ by Robert Cook-Deegan, included in background materials provided at September 2011 Congressional briefing.

Patent Docs: Association for Molecular Pathology v United States Patent and Trademark Office: Article on the Myriad opinion by Kevin Noonan, used as background materials provided at September 2011 Congressional briefing.

Gene Watch Volume 23 Number 5-6, October-December 2010: Magazine used as background materials at September 2011 Congressional briefing.

 

------Documents Pertaining to US Patent 5,747,282-------

Kepler T, Crossman C, Cook-Deegan R. Metastasizing patent claims on BRCA1. Genomics. 2010 95(5): 312-4.  PMC2857658. Theoretical and empirical calculations claim 5 of the '282 patent, showing that molecules covered by the claim "hit" millions of sequences in the human genome outside of the BRCA1 gene.

Document log: File wrapper. Lists documents in the patent examination file at the US Patent and Trademark Office (USPTO) between 1995 and 2009.

Application for US Patent 5,747,282: filed June 7, 1995, pages 1-24.

Application for US Patent 5,747,282:  pages 25-51.

Application for US Patent 5,747,282: pages 52-77.

Application for US Patent 5,747,282: pages 78-102.

Application for US Patent 5,747,282: pages 1-102 (large file).

Claims in initial application for US Patent 5,747,282pages 168-176.

USPTO search notes from 1997: Document appears to be incomplete or refer to notes not included in file wrapper.

European Patent Office’s 1995 search report: listing relevant documents for assessing whether the claimed invention is new and involves an inventive step) for European patent application 95 30 5602.5.

Claims of European patent application 95 30 5602.5: filed in 1995 (pages 121-122).

European patent application 95 30 5602.5: pages 1-29.

European patent application 95 30 5602.5: pages 30-55.

USPTO office action on January 6, 1997, and Myriad’s response on February 5, 1997: The USPTO requested that Myriad restrict its application to one invention and suggested ways to group claims into distinct inventions; Myriad responded with alternative combinations of claims into fewer new distinct inventions.

USPTO office action from March 27, 1997: The USPTO allowed some claims and denied others.

Amended claims submitted by inventors on June 7, 1995.

Cover letter from petitioner OncorMed to USPTO to access the application for US Patent 5,747,282.

Petition from OncorMed to USPTO to access the application for US Patent 5,747,282.

Letter from USPTO to OncorMed to grant petition to access the application for US Patent 5,747,282. Dated May 5, 1998.

Agreement between the University of Utah and the National Institutes of Health: Effective on February 10, 1995, this agreement grants the University of Utah “an exclusive license” to inventions including what would become US Patent 5,747,282. Portions of the agreement were redacted before it was released as part of the file wrapper.

Settlement between the University of Utah, Myriad Genetics and the National Institutes of Health: Dated February 10, 1995, this agreement resolves a dispute over who should be listed as an inventor on the ‘282 patent. Portions of the agreement were redacted before it was released as part of the file wrapper.

 

------------------Additional Resources-----------------
on Gene Patenting and the Myriad Case

     Introductions to Gene Patents

Cook-Deegan R: “Gene Patents.” In From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns. 2008.
A very brief introduction to gene patents in 2008, written for policy-makers and those without a formal legal or scientific background.

Cook-Deegan R, Heaney C. Patents in Genomics and Human Genetics. Annual Review of Genomics and Human Genetics. 2010. 11(17): 1-43. PMC2935940.
A longer, general introduction on gene patents intended for scientists interested in an overview and review of the material.

Short Summaries of the Myriad Case

Patently unpatentable: implications of the Myriad court decision on genetic diagnostics: Article by Mildred Cho summarizing the BRCA case.

Gene Patenting: Is the Pendulum Swinging Back?: Article by Aaron Kesselheim and Michelle Mello summarizing the BRCA case.

Case studies of Myriad Genetics

Holman, Christopher M., Will Gene Patents Impede Whole Genome Sequencing?: Deconstructing the Myth that Twenty Percent of the Human Genome is Patented (July 25, 2011). Available at SSRN: http://ssrn.com/abstract=1894715 or http://dx.doi.org/10.2139/ssrn.1894715A paper written to deconstruct Jensen and Murray's proposition (appearing in a 2005 "Science" article) that twenty percent of human genes are patented, and thus assumed to be unusable.

Gold ER, Carbone J. Myriad Genetics: In the eye of the policy storm. Genetics in Medicine. 2010 April Supplement 12(4): S39-S70. PMC3021512. Case study of Myriad Genetics’ business strategy and its communication difficulties, especially outside of the United States.

Cook-Deegan R, DeRienzo C, Carbone J, Chandrasekharan S, Heaney C, Conover C.  Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: comparing breast and ovarian cancers to colon cancers. Peer-reviewed case study commissioned by the SACGHS. Republished in Genetics in Medicine. 2010. April Supplement; 12(4): S15-S38. PMC304744.Case study comparing patient access to genetic tests for breast and ovarian cancers with patient access to genetic tests for colorectal cancers.

Cook-Deegan R, Chandrasekharan S, Angrist M. The dangers of diagnostic monopolies.  Nature. 2009 458(7237): 405-406. PMC2702156. Two-page summary of the Duke University researchers' empirical study of gene patents and licensing of ten clinical conditions, including breast and ovarian cancers.

Caulfield T, Bubela T, Murdoch C: Myriad and the Mass Media: The covering of a gene patent controversy. Genetics in Medicine 12(9):850-855, 2007. Article detailing the English language media coverage of the BRCA case.

Caulfield T, Cook-Deegan RM, Kieff FS, Walsh J. Evidence and anecdotes: analysis of human gene patenting controversies. Nature Biotechnology. 2006 24: 1091-4. PMC2701726. Article exploring the dominant policy concerns sparked by the issue of gene patenting more broadly.

Commentary on Gene Patenting and the Myriad Case

Cook-Deegan R, Conley J, Evans J, Vorhaus D. The next controversy in genetic testing: clinical data as trade secrets? European Journal of Human Genetics.November 2012. Article written about the data sharing climate in genetic diagnostics

Cook-Deegan R. Law and Science Collide over Human Gene Patents. Published in Science in November 2012. Article written about the Myriad case

Hal Wegner's Top Ten Patent Cases: This blog, posted by the Los Angeles Intellectual Property Association, listed the Myriad case in the Top Ten patent cases to watch

 

--------Other Media Coverage of the Myriad Case--------

CBS 60 Minutes: April 4, 2010 segment on the Myriad case

PBS Newshour: April 2, 2010 segment titled “Can genes be patented? Ruling reignites debate.”

The Colbert Report: April 5, 2010 segment on Judge Sweet’s March 29, 2010 Ruling.

NPR Science Friday: April 2, 2010 interview with Robert Cook-Deegan.

Duke University Online Office-Hours: April 2, 2010 interview with Robert Cook-Deegan.

The Mark: Canadian newsletter, "Should Human Genes Be Patented?" (May 26, 2010 interview with Robert Cook-Deegan)

Myriad Case in Australia

On February 15, 2013, the Federal Court of Australia affirmed the patent eligibility of isolated DNA molecules under Australian law. For more information, see the Court's complete decision.

 

------------Blogs to follow for BRCA updates------------

The Genomics Law Report:  A blog that provides ongoing news and analysis on issues at the intersection of genomics, medicine, and law. Edited by Dan Vorhaus, of Robinson, Bradshaw, & Hinson, P.A.

Patent Docs: A Biotech, Pharma Patent Law, and News blog maintained by Kevin Noonan, PhD., of McDonnell, Boehnen, Hubert, & Berghoff L.L.P.

Patently O: A patent blog authored by Dennis Crouch, of the University of Missouri School of Law, and Jason Rantanen, of the University of Iowa College of Law.

IP Watchdog: A blog focusing on patent and innovation news, business, and policy. Founded by Gene Quinn, a law professor and patent attorney with Zies, Widerman, & Malek. 

 

-----------------------------------------------------

This webpage developed by Jae Cheon, Lane Baldwin, Kathryn Maxson, and Robert Cook-Deegan for the Duke University Institute for Genome Sciences & Policy and the Duke/Georgetown Center for Public Genomics, funded by the U.S. National Human Genome Research Institute (P50 HG 003391).