Patent Litigation

Allergan Assigns Patents to Native American Tribe to Avoid Validity Challenge

What will those lawyers think of next? In one of the most surprising patent strategies ever, the Irish drug company Allergan has assigned six patents on its top-selling dry eye drug Restasis to the Saint Regis Mohawk Tribe of upstate New York, which is one of the colonial-era Iroquois Nations. The federally recognized tribe is now the owner of the patents, with Allergan having taken back a license to exploit them. The purpose of the transfer is to take advantage of the tribe’s claim to “sovereign immunity,” under which an Indian tribe (the usual legal term), as a sovereign nation, is immune from being sued unless it consents or Congress abrogates its immunity. Allergan’s hope is that would-be generic competitors will be prevented from challenging the validity of the patents either in federal court or through the U.S. Patent & Trademark Office’s inter partes review process.

The idea apparently had its genesis in a decision by the USPTO’s Patent Trial and Appeal Board in a case involving an information technology patent held by the University of Florida. The PTAB held that the university, as an agency of the sovereign state of Florida, was immune to an inter partes challenge to the patent’s validity. Although the PTAB is an administrative body rather than a court, sovereign immunity is usually deemed to extend to “quasi-judicial proceedings,” which accounts for its application in the Florida case.


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Filed under Patent Litigation, Patents & IP, Pending Regulation

More Bad Legal News for Athena Diagnostics: Don’t Mess with Mayo

We have been reporting for more than a year about the case of Williams v. Quest Diagnostics (the parent company of Athena Diagnostics), in which the plaintiff has sued Athena and Quest for causing the death of her son by misclassifying a genetic variant when testing the boy’s DNA. That case is now on  hold in a South Carolina federal court until the state’s Supreme Court resolves the question of whether a genetic testing lab is a licensed healthcare provider under South Carolina law. If it is, then the case will be governed by the state’s malpractice statute of limitations and will probably be dismissed as having been filed too late. If it’s not, then the ordinary negligence statute of limitations will apply and the case will probably be allowed to proceed.

But now Athena faces an adverse ruling from another court—a Massachusetts federal district court—in a patent infringement suit that Athena and two co-plaintiffs brought against Mayo Collaborative Services and the Mayo Clinic: Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC. In an August 4, 2017 decision, Judge Indira Talwani invalidated Athena’s patent on a method for diagnosing myasthenia gravis (MG), an autoimmune disease that depletes muscle strength. Previous tests detected what are called AChR autoantibodies (antibodies that attack antigens originating in the patient’s own body as if they were foreign substances) to diagnose MG.

But 20% of MG patients don’t have AChR autoantibodies, so the earlier tests yield false negatives. The inventors of the Athena patent discovered that the 20% do have another kind of autoantibody that attacks a neuromuscular protein receptor called MuSK. The patented method calls for making a version of MuSK with a radioactive label (125I-MuSK) and then introducing the 125I-MuSK to a bodily fluid (blood) sample from the patient. If MuSK autoantibodies are detected, the patient is diagnosed with MG.


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Filed under Genomics & Medicine, Patent Litigation, Pending Litigation

Disputes Continue over Foundational Patents for Gene Editing

CRISPR-Cas9 editing of the genome

As we noted early last year, a major dispute over patent rights to CRISPR-Cas systems broke out in January 2016 between Feng Zhang, the Broad Institute, and MIT on one side and Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna on the other. CRISPR-Cas systems are powerful tools for genome editing that allow researchers to activate or deactivate target genes. As a reminder of this patent dispute, at issue is whether Zhang was first to invent the application of CRISPR-Cas9 in mammalian and human cells or whether Doudna’s invention of CRISPR-Cas9 was broad enough to encompass application in both prokaryotic and eukaryotic cells (including mammalian and human cells).

A few noteworthy events have occurred since our last coverage in February 2016. The two sides are engaged in what is called an interference proceeding. The U.S. Patent and Trademark Office (USPTO) determined preliminarily that the two sides were claiming patent rights to the same technology and initiated the interference to let them fight over who had priority. Under the pre-2013 version of the Patent Act that applies here, the key question would be who invented first.
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Filed under General Interest, Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP

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.
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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.
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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.
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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.
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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.
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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.


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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.
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Filed under Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation