Commil v. Cisco: Exploring the Relationship Between Patent Infringement and Validity

On Tuesday, the Supreme Court issued its opinion in Commil USA, LLC v. Cisco Systems, Inc., in which it held that a defendant’s belief that a patent is invalid is not a defense to induced infringement of that patent under 35 U.S.C. § 271(b).  Four years ago, in a case called Global-Tech, the Court had held that a defendant could not be liable for induced infringement unless it had knowledge not only of the patent’s existence but also that its behavior constituted patent infringement.  In Commil, six Justices clarified that a defendant who has knowledge of a patent’s existence but believes it to be invalid may still be held liable for inducing its infringement.  (Justice Scalia dissented and was joined by Chief Justice Roberts, with Justice Breyer recused.)

Commil raises several issues for discussion, but I want to talk about just one here: the majority’s fixation on the distinction between infringement and validity.  The key passages of Justice Kennedy’s opinion, on pages 9 through 11, seem to rest heavily on preserving the separation between these two issues.  Essentially, as Justice Kennedy puts it, “because infringement and validity are separate issues under the Act, belief regarding validity cannot negate the scienter required under §271(b).”  Justice Kennedy is clearly correct as a formal matter.  We ask different legal questions when adjudicating issues of infringement and validity, we apply different burdens of proof to the two questions, and we involve different parties in their resolution.

But Justice Kennedy’s opinion ignores the close practical relationship between the two issues.  By contrast, scholars and practitioners have long recognized the tension between infringement and validity as instantiated in patent litigation.  A patentee wants its patent to be construed broadly, to ensure that the defendant’s invention falls within its bounds.  Yet at the same time, the patentee must avoid claiming too broadly, or its patent may be invalidated on precisely those grounds.  (Defendants typically advocate the opposite positions.)

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New from Bioethicist Art Caplan: How State Right-To-Try Laws Create False Expectations

A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:

Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.

Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.

Read the full article here.

Recent Judicial Rulemaking Leaves Life Science Patents Hanging In The Balance

A new post by Claire Laporte of Foley Hoag LLP on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Do patents nurture or stifle innovation?

In a recent series of decisions, the Supreme Court has begun to express concern that some patents suppress innovation. And it has done so in a number of cases that turn on what used to be a sleepy backwater of the patent law: 35 U.S.C. § 101. This statute says, simply, that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, … may obtain a patent therefor, subject to the conditions and requirements of this title [i.e., the other requirements of the patent law].”

You might think that this language means that all you have to do is figure out whether an invention falls into one of the permitted categories. If it does, it’s something that can be patented (assuming you meet the other requirements — which are numerous). But no! Over the past few decades, the Supreme Court has engrafted a whole new set of judge-made requirements onto this statute: you cannot get a patent on something that is a “law of nature,” a “product of nature,” or an “abstract idea.” And starting in 2010, the Court put real teeth into these doctrines. […]

See the full post here.

2015 Broad Institute Innovation & Intellectual Property Symposium

2015 Broad Institute Innovation & Intellectual Property Symposium

Monday, April 13, 2015 – Wednesday, April 15, 2015

Broad Institute, 415 Main St., Cambridge, MA

This ​symposium ​will ​bring ​together ​Broad ​scientists, ​delegates ​from ​the ​European ​and ​U.S. ​Patent ​Offices, ​and ​global ​business ​and ​legal ​thought ​leaders ​for ​discussion ​and ​information ​exchange ​on ​topics ​related ​to ​innovation ​and ​intellectual ​property ​law ​of ​interest ​to ​the ​Cambridge ​and ​Boston ​scientific, ​business ​and ​legal ​communities. ​

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

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Monday 2/23: HLS Health Law Workshop with Amy Kapczynski

HLS Health Law Workshop: Amy Kapczynski

February 23, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Professor Kapczynski’s presentation, “Order Without Intellectual Property Law:  The Flu Network as a Case Study in Open Science,” is available upon request. Please contact Jennifer Minnich (jminnich@law.harvard.edu) if you would like a copy.

Amy Kapczynski is an Associate Professor of Law at Yale Law School and director of the Global Health Justice Partnership. She joined the Yale Law faculty in January 2012. Her areas of research including information policy, intellectual property law, international law, and global health. Prior to coming to Yale, she taught at the University of California, Berkeley, School of Law. She also served as a law clerk to Justices Sandra Day O’Connor and Stephen G. Breyer at the U.S. Supreme Court, and to Judge Guido Calabresi on the U.S. Court of Appeals for the Second Circuit. She received her A.B. from Princeton University, M. Phil. from Cambridge University, M.A. from Queen Mary and Westfield College at University of London, and J.D. from Yale Law School.

Synthetic biology and intellectual property rights: Six recommendations

On 26th November 2013, the Danish Agency for Science, Technology and Innovation organized an expert meeting on “Synthetic Biology & Intellectual Property Rights” in Copenhagen sponsored by the European Research Area Network in Synthetic Biology (ERASynBio). The meeting brought together ten experts from different countries with a variety of professional backgrounds to discuss emerging challenges and opportunities at the interface of synthetic biology and intellectual property rights. The aim of this article is to provide a summary of the major issues and recommendations discussed during the meeting.

The ERASynBio consortium consists of 16 governmental funding bodies from 12 EU Member States (Austria, Denmark, Finland, France, Germany, Greece, Latvia, Netherlands, Portugal, Spain, Slovenia, and UK) and two Associated Countries (Norway and Switzerland)

Timo Minssen, Berthold Rutz and Esther van Zimmeren: Synthetic biology and intellectual property rights: Six recommendations. (2015) Biotechnology Journal Special Issue: Synthetic Biology Volume 10, Issue 2, pages 236–241

Summary of the recommendations addressed in the publication: Continue reading

The Puzzle Of Antibiotic Innovation

A new post by Kevin Outterson on the Health Affairs Blog, as part of part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an antibiotic apocalypse. A former chief economist at Goldman Sachs estimates that unless dramatic action is taken now, antimicrobial resistance could kill 50 million people a year and cause $100 trillion in cumulative economic damages.

In the US, dire warnings have issued from the Centers for Disease Control and Prevention (CDC), the President’s Council of Advisors on Science and Technology, and the President himself through an Executive Order on Combating Antibiotic-Resistant Bacteria in September 2014 (summary here). The President’s new budget asks for $1.2 billion to be spent on antibiotic resistance. […]

Read the full post here.

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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Article III Standing in Patent Law May Be Before the Supreme Court Soon

Who has standing to challenge a patent’s validity? And under what circumstances can Congress define an injury for the purpose of creating Article III standing? Those questions underlie a new petition for certiorari filed by Consumer Watchdog, who is asking the Supreme Court to reverse a Federal Circuit opinion holding that Consumer Watchdog lacked Article III standing to challenge a patent on embryonic stem cells.

Consumer Watchdog, a non-profit consumer organization, requested an inter partes reexamination of a patent on embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF), alleging that the patent should be invalidated on several grounds. After a lengthy administrative process, the Patent Trial and Appeal Board (PTAB) upheld the patent as valid. Consumer Watchdog subsequently appealed, under sections of the Patent Act that expressly permit third-party requesters (like Consumer Watchdog) in inter partes reexamination proceedings to appeal to the Federal Circuit if they are “dissatisfied” with the PTAB’s decision or if any “final decision [is] favorable to the patentability” of the claims in question. The Federal Circuit held that Article III’s case or controversy requirement imposes a separate, irreducible constitutional minimum requirement on standing — and that Consumer Watchdog hadn’t met that requirement.  Continue reading

European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

Tomorrow: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave.
Cambridge, MA 02138

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Wasserstein Hall, Milstein East B, Harvard Law School, 1585 Massachusetts Ave.

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

The FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

[Note: I am very pleased to have had the opportunity to write a response to a recent commentary posted on the Hastings Center Bioethics Forum about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs), an issue I have previously written about for this blog. My response, which is posted here at the Bioethics Forum, is cross-posted below.]

Wendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care.

But the FDA’s proposal seems designed to address precisely these two consequences. The proposal could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA’s disclosure to Congress is critical to a full policy discussion of the situation.  Continue reading

DARPA Announces Disease Forecasting Prize

On Friday, the Defense Advanced Research Projects Agency (DARPA) announced a challenge to the public: provide the most accurate forecast of the spread of chikungunya virus in each of the countries in the Pan American Health Organization, win $150,000. Innovation prizes like DARPA’s are increasing in popularity, with public and private entities alike issuing challenges across a variety of subjects and methodologies. DARPA isn’t the first to announce a disease forecasting prize, either – the Centers for Disease Control (CDC) recently awarded a prize for predicting the timing and intensity of last winter’s flu season. But the choices both to focus on chikungunya and to do so using a prize fund are interesting ones that deserve further discussion.

Chikungunya is a viral disease spread by infected mosquitoes, much like the better-known malaria and dengue fever. Its symptoms often resemble those of dengue, whose other common name – breakbone fever – is telling. Chikungunya is rarely fatal, but it is often temporarily disabling, until the disease has run its course. And unfortunately, also like dengue, there is no specific treatment for chikungunya, although recent Phase I trials of a candidate vaccine appear to have been successful. But perhaps most importantly for DARPA’s purposes, chikungunya is also experiencing a resurgence in the Americas, including in the United States.

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Ebola, Ethics, and the WHO Getting to Yes

Earlier this week, the World Health Organization, responding both to the international outcry over the rapidly rising number of Ebola cases and deaths across sub-Saharan Africa (and critiques of the speed of their action), and the news that western health care workers and ministry had found ways to get access to the untested-in-humans Ebola drug ZMapp, convened a panel of ethicists to offer recommendations on more widespread use of experimental Ebola treatments.

The issues considered by the ethicists included:

1) Whether it is ethical to use unregistered interventions with unknown adverse effects for possible treatment or prophylaxis. If it is, what criteria and conditions need to be satisfied before they can be used?

2) If it is ethical to use these unregistered interventions in the circumstances mentioned above, then what criteria should guide the choice of the intervention and who should receive priority for treatment or prevention?

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Art Caplan: Why do two white Americans get the Ebola serum while hundreds of Africans die?

As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental serum. Caplan argues that the decision was a question of economics:

The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”

But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. […]

But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. […]

To get Caplan’s full perspective, read the full article.

The Revival of Phage Therapy to Fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives?

In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).

Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.

One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.

Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives?

Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized”  by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.

Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013)  and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.

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The FDA Takes Steps Toward Regulating Laboratory-Developed Tests

On Thursday, the FDA finally began to take an action that it had been publicly contemplating for over four years: the regulation of laboratory-developed tests (LDTs). In the FDA’s words, LDTs are diagnostic tests which are “designed, manufactured and used within a single laboratory.” There are thousands of LDTs, including very high-profile ones, such as Myriad Genetics’ test for assessing breast cancer risk. Although these diagnostic tests fall under the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of “medical device,” the FDA has for decades stated it was exercising its enforcement discretion in declining to regulate LDTs. (The FDA has exercised its regulatory powers over diagnostic tests that are designed and manufactured by one laboratory and sold to another for use.)  Although the official draft guidelines have not yet been released, the FDA’s report regarding their anticipated contents suggests that regulation of LDTs will follow a risk-based framework similar to the one in place now for other medical devices.

Much (though not all) of the relevant industry opposes the FDA’s actions here, and it’s easy to see why. Many of these LDTs would now be subject to premarket review, or at the very least additional reporting requirements, which make the development of these tests both riskier and more expensive.  Some firms argue that the FDA lacks jurisdiction to regulate LDTs, but they also argue that their LDTs are already sufficiently regulated by the Clinical Laboratory Improvement Amendments (CLIA), under the auspices of the Centers for Medicare and Medicaid Services. But here’s the problem: CLIA and the FDCA regulate different aspects of LDTs. And it can be detrimental to patient health to leave the FDCA aspects of LDTs unregulated.

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