Could a patent get in between you and a Covid-19 test? Yes – The Guardian

Posted: May 21, 2020 at 4:43 pm

Imagine if one company held a patent covering all methods of testing for Covid-19 antibodies. The company could charge monopoly prices for its tests and prohibit competitors including non-profit and university labs from manufacturing or administering their own. If the company made itself the countrys sole supplier, it would struggle to meet demand. The company would profit, but Americans would face waiting lists, confusion and inequitable access and the virus would keep spreading.

Would a patent holder ever exploit an outbreak of life-threatening infectious disease in this way? Yes. In 2001, the United States faced a credible threat of an anthrax outbreak, yet Bayer refused to license its patents on ciprofloxacin (Cipro), the most effective antibiotic treatment for anthrax, to competitors, even as Bayer itself struggled to supply the nations antibiotic stockpile.

It may seem outlandish to imagine one patent creating a wide-ranging monopoly on diagnostic testing, but it happened. In the 1990s and 2000s, biotech companies obtained and enforced broad patents on medical diagnostics that gave them near-total control of testing for particular conditions. One company obtained patents on methods of diagnosing people at high risk of developing breast cancer and attempted to eliminate testing at competing laboratories by sending cease-and-desist letters; another became the sole provider of genetic testing for many neurological and endocrine conditions, including muscular dystrophy and Alzheimers disease.

By 2011, the American Medical Association submitted an alarmed amicus brief to the US supreme court, lamenting that [i]t is hard to imagine how the clinical diagnostic community will continue to provide quality patient care and how physicians will continue to practice medicine in an ethical and effective manner under a patent regime that permits broad patents on the bodys natural responses to illness and medical treatment.

The supreme court listened. Between 2012 and 2014, in a trio of important cases Mayo, Myriad and Alice it confirmed that if a patent is directed to an abstract idea, natural phenomenon or natural law, it must claim something new and attributable to the inventor an inventive concept to become eligible for patent protection. A patent cant broadly claim a fundamental building block of knowledge like the human bodys antibodies to Covid-19 and tack on ubiquitous, conventional technology like using a needle to draw a blood sample containing those antibodies. These supreme court decisions helped restore patent laws traditional balance between inventors incentives and public access to technology.

The United Statess innovation economy has grown under Mayo, Myriad and Alice, with benefits to healthcare and not just diagnostic testing. For example, in 2013, Justus Decher developed a telehealth product that enables patients to consult with doctors remotely. A few years later, Decher was accused of infringing an older patent so broad it covered the basic idea of remotely consulting patients even by telephone. Fortunately, a court invalidated the patent under the supreme courts Mayo and Alice precedents. Dechers and other telehealth technologies have provided an important lifeline in the Covid-19 pandemic.

Pro-patent voices are now using the Covid-19 crisis to push the Coons-Tillis bill

Freed from overbroad patents on fundamental knowledge, we see an explosion of efforts to build and disseminate new tools to fight Covid-19, including 3-D printed and open source masks and ventilators and clinical trials on dozens of potential treatments and vaccines. While the US lags on deploying diagnostic testing, inventors are busily inventing: the FDA has authorized dozens of different Covid-19 tests. Some inventors may be motivated by the patent incentive companies can still get patents, just within limits. But much is driven by altruism, love of science and the reputation that comes from inventing something that saves millions of lives. Today, no one company monopolizes Covid-19 testing, and all benefit.

Yet some patent holders and their allies are unwisely threatening this balance. Last year, with support from the largest pharmaceutical and biotech industry trade groups, Senators Chris Coons and Thom Tillis proposed a bill that would undo Mayo, Myriad, and Alice, expanding limits on patent eligibility. Pro-patent voices are now using the Covid-19 crisis to push the Coons-Tillis bill, asserting that broad patents on now-patent-ineligible subject matter are necessary to incentivize invention of anti-Covid technologies, especially diagnostic tests. That ignores evidence that the biggest problems we face are global shortages of unpatented basic supplies like nasal swabs and a failure of federal government coordination, not a shortage of inventive activity.

Congress should reject these efforts to undo the traditional balance and expand the scope of patent eligibility. The current legal standard may not be perfect, but it is working. In the Covid-19 crisis, Congress should focus instead on policies that give healthcare workers, other essential workers, patients, and all Americans the resources they need.

Chris Morten is the supervising attorney at NYU Laws Technology Law & Policy Clinic and a fellow at NYU and Yale Law Schools. Alex Moss is a staff attorney at the Electronic Frontier Foundation, specializing in intellectual property

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Could a patent get in between you and a Covid-19 test? Yes - The Guardian

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