CSRXP APPLAUDS USPTO EFFORTS TO CRACK DOWN ON BIG PHARMA’S PATENT ABUSE AND SUPPORTS ADDITIONAL SOLUTIONS TO BOOST COMPETITION TO HELP LOWER DRUG PRICES

Comment Letters Highlight Key Agency Initiatives Targeting Brand Name Drug Companies’ Anti-Competitive Tactics, Outline Areas for Further Action and Collaboration

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) submitted two letters to the United States Patent and Trademark Office (USPTO) this week in response to requests for comment on efforts the agency can take to improve the U.S. patent system, increase competition from more affordable alternatives in the prescription drug market and increase collaboration with U.S. Food and Drug Administration (FDA).

“Big Pharma games the patent system to extend monopolies, boost profits and keep prescription drug prices high,” said Lauren Aronson, executive director of the Campaign for Sustainable Rx Pricing. “CSRxP applauds and supports action from the U.S. Patent and Trademark Office (USPTO) and increased collaboration between the USPTO and U.S. Food and Drug Administration (FDA) to crack down on brand name drug companies’ anti-competitive tactics that block access to more affordable alternatives for patients.”

“Both Congress and the Administration have a critical role to play in holding Big Pharma accountable for the industry’s egregious abuse of the patent system and tactics like patent-thicketing and product-hopping, that distort the market and contribute to out-of-control prices,” Aronson continued. “We look forward to continuing our work with both agencies to crack down on Big Pharma’s anti-competitive practices and boost competition to help lower prices for patients.”

Voters Support Regulatory Solutions to Boost Competition and Prioritize Clinical Value

A recent CSRxP national survey conducted by Morning Consult found U.S. voters overwhelmingly support regulatory action to boost competition and prioritize clinical value.

• 81 percent of voters consider it important federal agencies like the U.S. Patent and Trade Office (USPTO) and U.S. Food and Drug Administration (FDA) encourage greater competition in the prescription drug marketplace — including 80 percent of Democrats, 76 percent of Republicans and 72 percent of independents.
• 80 percent of voters agree that federal regulators at the FDA and U.S. Centers for Medicare and Medicaid Services (CMS) should consider both a medication’s effectiveness for patients and its likely cost to patients and the U.S. health system in their decision-making.

USPTO Solutions to Strengthen U.S. Patents and Hold Big Pharma Accountable

CSRxP’s comments underscore support for several existing USPTO efforts and outline additional regulatory solutions and potential areas of focus to further crack down on Big Pharma’s egregious anti-competitive practices:

• Extend patent examination time: CSRxP supports giving patent examiners more time during the patent examination period to examine patents. With additional time, patent examiners will be able to better evaluate whether applicants are seeking patents that are novel and non-obvious versus merely duplicative and obvious.
• Provide enhanced training and resources for patent examiners: CSRxP supports the provision of additional training and resources for patent examiners. We applaud the new collaboration between the USPTO and FDA to improve the robustness and reliability of drug and biological patents and particularly urge USPTO examiners to work with FDA officials to better distinguish between patents for drugs and biologics that are unique, novel, and non-obvious versus those that are duplicative and obvious.
• Improve communication between patent examiners and the PTAB: CSRxP supports initiatives to enable enhanced communication between patent examiners and the Patent Trial and Appeal Board (PTAB). With improved information sharing, patent examiners and members of the PTAB should be able to more efficiently and appropriately implement processes that lead to the issuance of patents that are truly innovative.
• Apply enhanced scrutiny to continuation patents: CSRxP urges USPTO to implement procedures that apply greater scrutiny to continuation patents particularly in large patent families. Continuation patents in large families especially can enable brand patent holders to develop even more extensive patent thickets and estates for their brand products, enabling them to delay competition from lower cost biosimilar therapies.
• Prohibit obviousness-type double patenting: As detailed above, obviousness-type double patenting arises through use of “terminal disclaimers” in the patent issuance process. Given this abuse of the patent system and its adverse impact on consumers and taxpayers, CSRxP urges USPTO to update regulations to reform the “terminal disclaimer” process and prohibit obviousness-type double patenting.
• Conduct a comparative analysis of patent examination and issuance: CSRxP strongly supports efforts by the USPTO to conduct a comparative analysis of the examination and issuance of pharmaceutical and biological patents in the U.S. patent system compared to the intellectual property systems of other countries. Lessons learned from other countries will help USPTO and other policymakers implement bipartisan solutions that combat abuses of the intellectual property system by big pharma, which drive up costs for consumers and taxpayers.
• Return to the “broadest reasonable interpretation” (BRI) standard within the USPTO PTAB inter partes review (IPR) process to foster increased generic and biosimilar competition in the drug market.
• Implement automatic review of secondary patents in order to limit inappropriate patent thickets and estates that inappropriately extend market exclusivity for brand products.
• Require drug manufacturers to demonstrate greater clinical benefit, or other higher standards, to receive new formulation patents to limit anti-competitive “evergreening” and “product hopping” practices.
• Raise patent standards for additional uses of existing compounds.

Support for Increased Collaboration Between USPTO and FDA on Patent Abuse

CSRxP also provides support for greater collaboration between USPTO and FDA to combat anti-competitive intellectual property abuses from Big Pharma. In its comments, CSRxP outlines several areas for collaboration between the agencies to hold Big Pharma accountable:

• CSRxP suggests that the USPTO work with the FDA to apply heightened scrutiny to patent “use codes” to ensure the descriptions are accurate and within the patent scope so they cannot effectively block or delay generic competition.
• CSRxP urges that the USPTO work with the FDA to apply increased scrutiny to listed patents in FDA’s “Orange Book” to help limit the number of listed invalid patents or valid patents inappropriately applied.
• CSRxP urges that FDA and USPTO implement automatic review of secondary patents.
• CSRxP urges the USPTO to collaborate with the FDA to require drug manufacturers to demonstrate greater clinical benefit, or other higher standards, to receive new formulation patents. 
• And CSRxP urges the USPTO to work with the FDA to increase standards for patent approval for additional uses of existing compounds in order to avoid unfair extensions of market monopolies.

Read CSRxP’s Final Comment Letter on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights HERE.

Read CSRxP’s Final Comment Letter on Joint USPTO-FDA Collaboration Initiatives HERE.

Learn more about U.S. voters overwhelming support for USPTO and FDA actions to support competition and hold Big Pharma accountable HERE.

Learn more about bipartisan, market-based solutions to hold Big Pharma accountable HERE.