BRCA

News & Analysis as of

Myriad Set for Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

Patent Protection for Isolated Genetic Sequences Upheld in Australia

Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...more

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

A five-judge bench of the Full Court of the Federal Court of Australia (Full Court) has today unanimously decided that Myriad Genetics Inc's (Myriad) patent covering the isolated BRCA1 gene (Patent) is patentable subject...more

Myriad Appeals Adverse Preliminary Injunction Decision

On March 13, Myriad Genetics filed a Notice of (interlocutory) Appeal with the Federal Circuit. Myriad is seeking to have the Court review and reverse the District Court's denial of the company's preliminary jnjunction...more

Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court

The old adage "Be careful what you wish for" comes to mind regarding Myriad Genetics' motion to the Judicial Panel on Multidistrict Litigation under 28 U.S.C. § 1407, that cases relating to the company's BRCA gene patents be...more

District Court Doubts Patent Eligibility of Myriad BRCA Claims

In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of...more

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics'...more

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women...more

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

Myriad Genetics Sues LabCorp over BRCA Gene Testing

The very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina. ...more

Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back

The latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is Invitae Corp. located in San Francisco. Myriad sued Invitae on Monday in the District of...more

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

After a brief hiatus that saw Counsyl and Quest Diagnostics file declaratory judgment actions in alternate venues, Myriad has filed yet another lawsuit against a genetic diagnostics company that brought its own BRCA gene...more

Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics

Myriad is facing yet another challenge to its remaining BRCA gene testing franchise, this time from Quest Diagnostics joined by its R&D arm, Nichols Institute. Quest is "the world's leading provider of diagnostic information...more

Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics

Whether relying on Carl von Clausewitz or Jack Dempsey for the sentiment, Counsyl, Inc., a genetic diagnostic testing company has decided that the best defense against Myriad Genetics is a good offense and, accordingly, has...more

Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies

Not to be outdone by defendants Ambry Genetics and Gene-by-Gene's 109-page brief in opposition to Myriad's Preliminary Injunction Motion, Myriad has now filed a Reply Brief weighing in at 140 pages (page limits in briefs...more

Why Does Myriad Think It Can Win BRCA Gene Lawsuits?

Earlier this month, Myriad Genetics filed patent infringement lawsuits against Ambry Genetics (on July 9th) and Gene-by-Gene (on July 10th). Filed with the complaint in the Ambry lawsuit was a Motion for Preliminary...more

Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure...more

Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes Hidden Field

A day after Myriad Genetics sued Ambry Genetics for patent infringement, the company filed suit in the District of Utah, Central Divisions against Gene by Gene Ltd. (Case No. 2:13-cv-00643-EJF; complaint). The complaint is...more

Myriad Sues Ambry for Offering BRCA1/BRCA2 Breast Cancer Genetic Testing

On July 9, 2013, Myriad Genetics, Inc. brought suit against Ambry Genetics Corporation, alleging that Ambry is infringing ten (10) patents by offering breast cancer genetic testing for the BRCA1 and/or BRCA2 mutations...more

Consortium Launches Public Database of BRCA Data

On June 13, the Genetic Alliance announced the launch of an initiative to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes. ...more

Supreme Court Rules on Validity of Patents for Genetic Information

On June 13, the U.S. Supreme Court handed down a ruling in Association for Molecular Pathology et. al. v. Myriad Genetics, the outcome of which was considered crucial in the development of genetic research....more

How Will U.S. Supreme Court Decision That Naturally Occurring DNA Is Not Patentable Impact Future Technology Patents?

On June 13, 2013, the United States Supreme Court unanimously agreed to end the three-decade-old practice of awarding patents based on human genes. In Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398...more

Patent Watch: Ass'n for Molecular Pathology v. Myriad Genetics, Inc.

A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring....more

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