THE REFILL: Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW
- This month, The Hill published a timely op-ed by Matthew Lane, executive director of the Coalition Against Patent Abuse. Lane penned this piece amidst the COVID-19 pandemic to highlight the need to make sure our drug laws are working to encourage innovation and public-private partnerships for the development of needed drugs while preventing the misuse of laws for things other than what Congress intended.
- “Last month it was revealed that Gilead sought orphan drug designation under the ODA for its promising drug Remdesivir, which could be a treatment for those suffering from COVID-19. The ODA was enacted in 1983 with the intention to increase the development and deployment of drugs which treat rare diseases that impact small numbers of the population, those under 200,000 total patients in the United States. The intent was to incentivize the development of treatments that would otherwise lack commercial viability due to a lack of patients. It seems unusual that such a designation would be sought for a disease that is currently approaching 800,000 cases… Regardless of whether Gilead sought an ODA designation to speed up development or for financial reasons, this event shows that the ODA is not functioning as intended. The ODA was enacted for a noble cause: to help those suffering from rare diseases get the treatments they need.”
- An article by Valerie Bauman in Bloomberg Law highlighted how the coronavirus pandemic has resulted in patent court delays which could prevent substantial savings to American patients and taxpayers that comes from generic competition. At least six patent infringement cases related to brand-name drugs are at risk of exceeding the Food and Drug Administration’s timeline for approving generic versions of these drugs, and this list could grow longer as the public health crisis continues.
WHAT YOU SHOULD BE READING:
The Guardian: Opinion: Could A Patent Get In Between You And A Covid-19 Test? Yes
Chris Morten and Alex Moss
- 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.
- Today it’s estimated that billions in value are lost when a company simply abandons their patents before they expire. Money spent on research and filing for patents is lost if companies can’t utilize new technologies or find a buyer for them. Some organizations have entire departments for licensing patents, but most don’t have those types of resources. A robust marketplace for patent licensing, purchasing, and exchange could change the game for groups looking to recover their investment in technology development. On May 4, the United States Patent and Trademark Office (USPTO) announced the availability of a new web-based intellectual property (IP) marketplace platform called Patents 4 Partnerships.
- 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.”
- The CARES Act authorized the U.S. Patent and Trademark Office (USPTO) to temporarily modify statutory deadlines and it has done so. The USPTO has revised the deadline for responding to some Patent and Trademark matters to June 1, 2020, if the filing delay was due to COVID-19 related circumstances. The party requesting the extension must include a statement that: A practitioner, applicant, patent owner, petitioner, third-party requester, inventor, or other person associated with the filing or fee was personally affected by the COVID-19 outbreak, including, without limitation, through office closures, cash flow interruptions, inaccessibility of files or other materials, travel delays, personal or family illness, or similar circumstances, such that the outbreak materially interfered with timely filing or payment.
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