Patent Litigation

New Federal Trade Secret Act and Its Impact on Life Sciences

918333_u_s__capitol_buildingOn May 11, 2016, a new federal trade secrets law called the Defend Trade Secrets Act (DTSA) took effect. Its primary impact is to allow the victims of trade secret misappropriation to sue in federal court. It also provides some new civil remedies that exceed what is usually available under state law. The DTSA will be slotted into the U.S. Criminal Code (chapter 90 of Title 18), which already makes industrial espionage and trade secret theft a federal crime. In terms of what companies have to do to comply, the answer is almost nothing—the sole exception being a change in future employee contracts that is discussed below. In this post I’ll describe and analyze the new law and offer some thoughts about its potential impact on the life sciences industry.

Until now, civil trade secret protection has been entirely a matter of state law. The law is very consistent from state to state, as 47 states have enacted the Uniform Trade Secrets Act (UTSA). The exceptions are New York, Massachusetts, and North Carolina, though the North Carolina statute is generally similar to UTSA. Enforcement actions must usually be brought in state court, though federal courts can take jurisdiction if the plaintiff and defendant are citizens of different states. Even then, however, the federal court must apply state law in deciding the case.
Read the rest of this entry »

Comments Off on New Federal Trade Secret Act and Its Impact on Life Sciences
Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Patent Litigation, Patents & IP

ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance

MyriadJust about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.

The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
Read the rest of this entry »

Comments Off on ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance
Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California

CRISPR-Cas9 editing of the genomeThe patent dispute already called “the biggest in biotech history” is only getting started. On January 11, 2016, Administrative Law Judge (ALJ) Deborah Katz officially declared an interference over patents for the CRISPR-Cas gene editing technologies. An interference is a U.S. Patent and Trademark Office (USPTO) administrative proceeding conducted to determine which of multiple claimants to a particular invention has priority rights. Since the patents in question were filed before the March 2013 effective date of the America Invents Act, priority will be awarded to the claimant who was the first to invent the technology in question. This dispute pits Feng Zhang, the Broad Institute, and MIT against Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna. Law professor Jacob S. Sherkow has followed the case closely and has provided useful background information on Stanford’s Law and Biosciences Blog.
Read the rest of this entry »

Comments Off on The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California
Filed under Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP, Pending Litigation

Australia revokes Myriad’s three patent claims on isolated BRCA1 DNA

genome sequenceIn a decision issued on October 7, 2015, the High Court of Australia (High Court) ruled unanimously in D’Arcy v. Myriad Genetics Inc., [2015] HCA 35, that three BRCA1 patent claims held by Myriad Genetics, Inc. under Australian Patent 686,004 were invalid. While Myriad’s patent had actually expired on August 11, 2015, the court decision set important precedent relevant to intellectual property in genetics/omics and precision medicine.

The D’Arcy case itself, along with other litigation in the U.S. involving Myriad’s gene patents, has been discussed previously on Genomics Law Report (See generally here). Mutations in the BRCA1 gene confer increased risk of breast and ovarian cancer. The Myriad scientists were first to clone and sequence BRCA1, the gene that Mary-Claire King had linked to cancer susceptibility in a landmark paper in Science in 1990. Myriad identified several BRCA1 mutations. Myriad’s Australian Patent 686,004 contains 30 separate claims. Yvonne D’Arcy challenged the validity of the first three claims in Myriad’s patent, which claimed the isolated BRCA1 sequences with mutations conferring increased risk of breast and ovarian cancer.
Read the rest of this entry »

Comments Off on Australia revokes Myriad’s three patent claims on isolated BRCA1 DNA
Filed under Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP

Are Software Patents Dead?—Alice’s Implications for Life Sciences

Not too long ago, getting patents on software and business methods was all the rage. And concern about their effects was profound. In fact, in 2003 I spoke at a Federal Reserve Bank conference devoted to the question of whether such patents were an existential threat to the financial industry. Now, after a series of Supreme Court cases that brought about a dramatic shift in the approach taken by the lower courts and the Patent Office, the question is whether those patents are still alive. The answer is that they are, but barely, and their prognosis is bad.

Do these developments matter to people in the life sciences? The answer is a resounding yes. If we then ask why software patentability matters, the answer is that life sciences are increasingly focused on software-dependent data analysis.

These points were brought home to me when I spoke at another, more recent conference—the Bio-IT World Conference in Boston this past April.
Read the rest of this entry »

Comments Off on Are Software Patents Dead?—Alice’s Implications for Life Sciences
Filed under Bioinformatics/IT, Industry News, Legal & Regulatory, Patent Litigation, Patents & IP

Australian appeals court upholds patents on isolated BRCA1 DNA

Robert Cook-Deegan, MD

Bob Cook-Deegan 0546.05 © Duke University Photography Jim WallaceOn September 5, the Federal Court of Australia (the appeals court) upheld a claim on isolated DNA from the BRCA1 gene. It dismissed Yvonne D’Arcy’s appeal of a case that has attracted international attention. Australian patent 686,004 has never been enforced, so the court decision has little real-world concrete impact. As Richard Gold and Julia Carbone explained in their classic case study, “Myriad Genetics: In the Eye of the Policy Storm,” the patent rights on BRCA1 and BRCA2 were exclusively licensed for use in Australia and New Zealand to Genetic Technologies, Ltd. (GTG), which in turn made them a “gift to the people of Australia.” When the CEO of GTG proposed taking back that gift in the summer of 2008, he provoked a firestorm and the company backed down in October, restating that it would not enforce its patent rights against laboratories offering BRCA testing. The Australian Senate held a series of hearings, and a bill proscribing DNA sequence patents was proposed, but the new government opposed it, and it lapsed. Instead, Australia enacted patent reforms in 2012 that raised the bar for utility and clarified the Australian law’s exemption from infringement liability for research and regulatory approval. Most of the provisions of that law took effect on April 15, 2013, the very day Association for Molecular Pathology v Myriad Genetics (AMP v Myriad) was argued before the U.S. Supreme Court.


Read the rest of this entry »

Comments Off on Australian appeals court upholds patents on isolated BRCA1 DNA
Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP

District Court Denies Myriad’s Preliminary Injunction Against Ambry

MyriadIn a 106-page opinion issued on March 10, 2014, Judge Robert Shelby of the federal district court in Salt Lake City denied Myriad Genetics’ Motion for Preliminary Injunction in its lawsuit against Ambry Genetics Corporation. For reasons I’ll try to explain, this is a significant development from a practical standpoint, but not earth-shaking from a legal point of view. Above all, it is not surprising. Reluctant as I am to say “I told you so,” well, I told you so.

As we previously reported, after the Supreme Court decided AMP v. Myriad Genetics, a number of competitors, including Ambry, jumped into the BRCA testing market. Myriad started suing them in the Utah federal district court, beginning with Ambry (filed July 9, 2013) and Gene by Gene (July 10). The cases were soon consolidated, to be handled together by Judge Shelby. In both cases, Myriad alleged that the defendant’s testing would infringe patent claims that had not been struck down by the Supreme Court’s AMP decision, which had held that DNA that had merely been isolated from the body was not patentable subject matter. In both cases, Myriad sought a preliminary injunction: a pre-trial order that the defendant must cease its testing activity for the duration of the case. If Myriad then prevailed at trial, the injunction would become permanent. The defendants denied Myriad’s allegations, opposed the preliminary injunction, and filed massive antitrust counterclaims alleging that Myriad has used its patents in unlawful ways to monopolize the BRCA testing market.
Read the rest of this entry »

Comments Off on District Court Denies Myriad’s Preliminary Injunction Against Ambry
Filed under Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Myriad Back in Court Again — This Time as a Defendant

MyriadMyriad Genetics is once again embroiled in litigation over its BRCA-related patents. But this time Myriad is the defendant. Counsyl, Inc., a San Francisco-based company that focuses on genetic carrier testing, sued Myriad in U.S. District Court for the Northern District of California on September 20, 2013. As we noted in an earlier post, Myriad — as a plaintiffhas recently sued two small companies, Ambry and Gene By Gene, that have entered the BRCA testing market in response to the Supreme Court decision invalidating Myriad’s gDNA patent. Myriad presumably filed those suits — against vulnerable defendants — to send a message that it would maintain its testing monopoly by enforcing patent claims that had survived the earlier litigation. But it took the risk that the defendants might succeed in invalidating those surviving claims. Now, with the Counsyl suit, the BRCA controversy has entered a new stage, with a prospective competitor launching a preemptive strike against Myriad and its patents.


Read the rest of this entry »

Comments Off on Myriad Back in Court Again — This Time as a Defendant
Filed under Genetic Testing/Screening, Genomics & Medicine, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Undeterred by the Supreme Court, Myriad Starts Suing

GLR-HandAs soon as the Supreme Court issued its decision in AMP v. Myriad Genetics, Myriad issued public statements saying that it had many surviving patents that would perpetuate its BRCA testing monopoly. We may now find out if that’s true.
Read the rest of this entry »

Comments Off on Undeterred by the Supreme Court, Myriad Starts Suing
Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP

Looking Back at Myriad: A User’s Guide

MyriadThe Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful.

When Where Action Citation
1997 USPTO US Patent 5693473 issued to Myriad Genetics Inc.
March 2010 SDNY US Patent 5693473 invalidated AMP v. USPTO, 702 F.Supp.2d 181
July 2011 Fed Cir NY SDNY decision affirmed in part, reversed in part AMP v. USPTO, 653 F.3d 1329.
March 2012 SCOTUS Certiorari granted, Fed Cir NY judgment vacated, case remanded to Fed Cir NY AMP v. Myriad, 132 S.Ct. 1794
August 2012 FedCir NY Subsequent determination made (in light of Mayo v. Prometheus) AMP v. USPTO, 689 F.3d 1303
November 2012 SCOTUS Certiorari granted AMP v. Myriad, 133 S.Ct. 694
April 2013 SCOTUS Heard oral arguments
June 2013 SCOTUS Fed Cir decision affirmed in part, reversed in part AMP v. Myriad, 569 US —


Read the rest of this entry »

Comments Off on Looking Back at Myriad: A User’s Guide
Filed under Badges, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation