THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • According to recent reporting from Reuters, lawmakers are watching closely how Gilead will price their drug remdesivir. Remdesivir, which was developed in part through taxpayer funding, has been touted as a potential treatment for COVID-19.
  • “But it has sued Gilead over patents on two of its widely-used HIV drugs that received federal funding grants while in development….Katz, a former official at the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services, said the government could make similar arguments over remdesivir, which was originally developed to treat Ebola with federal funding, and is now being studied in a trial backed by the National Institutes of Health.  Democratic lawmaker Lloyd Doggett of Texas, chairman of the House Ways and Means Health Subcommittee, sent Gilead a letter this week demanding the company detail its plans for remdesivir, including supply issues, disclosure of taxpayer investment in the drug’s development, and purchase and pricing arrangements. “American taxpayers have made a big investment in remdesivir, but now in return, those who need treatment may get only a big bill while Gilead gets a big payoff,” Doggett warned.” – Reuters
  • A new study published in the Journal of General Internal Medicine highlights the growing number and cost of orphan drugs. Orphan drugs treat rare diseases that impact small numbers of the population. These results are further evidence of what CAPA Executive Director Matthew Lane previously noted in an op-ed for The Hill, that the “Congress must reexamine the Orphan Drug Act to ensure that it is not being abused for unintended purposes.

WHAT YOU SHOULD BE READING:

Slate: How Patent Abuse Could Hurt The Fight Against The Pandemic
Elliot Harmon

  • As researchers around the world work together to bring a coronavirus vaccine to market, the governments and institutions that fund them should adopt policies that prioritize access for everyone, not exclusive licenses for one manufacturer or country. But that’s not enough. This moment in history doesn’t just demand that a few new treatments be opened to generic manufacturers; it demands a major shift in how governments and other funders approach patents altogether.

MarketWatch: Opinion: Should Patents Come Before Patients? How Drug Monopolies Hamper The Fight Against Coronavirus
Joseph Stiglitz, Arjun Jayadev & Achal Prabhala

  • Some will argue that the COVID-19 crisis is sui generis, or that the threat of compulsory licenses offers sufficient means for pressuring drug companies to behave well. But, beyond front-line researchers who are not motivated solely by short-term profits, it is not clear that the big pharmaceutical companies understand their responsibilities. After all, Gilead GILD, -0.88% , the maker of remdesivir, initially reacted to the current crisis by applying for “orphan drug” status, which would have granted it a stronger monopoly position and multimillion-dollar tax breaks. For too long, we have bought into the myth that today’s IP regime is necessary. The proven success of GISRS and other applications of “open science” shows that it is not.

Vanity Fair: “I Take That As A Threat”: Big Pharma Is Meddling In The Race For A COVID-19 Treatment
Diana Falzone

  • Dr. Jennifer Bryan, a Mississippi-based doctor and chairman of the board of trustees for Mississippi State Medical Association, listed a myriad of problems with big pharma’s vice grip on the industry, such as overseas drug production, which in some cases has led to recall, and monopoly patents, meaning companies can ratchet up the prices of drugs for consumers. “It’s disheartening to learn that this disruptive influence may be happening at the level of trying to intimidate research and corner a market on potential COVID-19 therapies,” she said, “but it isn’t surprising.”

Bloomberg Law: Patent Office Unveils Database To Aid Virus Patent Licensing
Ian Lopez

  • The Patent and Trademark Office is providing a database for the public to find patents related to the new coronavirus pandemic that are available for licensing. The effort, dubbed Patents 4 Partnerships, will help “bring to the marketplace new products and technologies for the prevention, treatment, and diagnosis of COVID-19,” the agency said in an announcement. Users can peruse database information via criteria like inventor name, issue date, assignee and keyword, to search for patents that may be licensed for use in the pandemic fight.

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