THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW:

  • USPTO Director Nominee Kathi Vidal Addresses Need to Improve Patent Quality During Senate Hearing 
    During the hearing, Senator Leahy asked USPTO nominee Vidal about patent thickets.  Read the exchange below:  

As America Invents Act Reaches its 10th Anniversary, Lawmakers and Regulators Focus on Preventing Patent Abuse to Lower Drug Prices

On Wednesday, the Senate Judiciary Committee held its nomination hearing with Katherine Vidal, nominee to be Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO).  During the hearing, Vidal and Senator Patrick Leahy (D-VT) shared an exchange regarding patent abuse as a contributor to high drug costs. 

“For years, many major pharmaceutical companies have been using anticompetitive tactics to extend market exclusivity and increase profits.  While the American Invents Act of 2011 created processes such as inter partes review to resolve patent disputes and reduce the number of low-quality patents, reforms are needed to improve the system,” stated CAPA Executive Director Matthew Lane. “It is encouraging to hear USPTO Director nominee Vidal address these concerns and CAPA looks forward to working with regulators and lawmakers to strengthen the U.S. patent system and balance the interests of both patients and the industry.”

During the hearing, Senator Leahy asked USPTO nominee Vidal about patent thickets.  Read the exchange below:  

  • Senator Patrick Leahy: “The Food and Drug Administration has been raising the alarm about the ways in which the patent system is being abused by brand drug manufacturers to shut out competitors. Certainly we’ve been concerned about this in my state of Vermont when we can drive a few miles across the Canadian border and see what happens when competition is allowed and prices come down. President Trump’s FDA commissioner Dr. Scott Gottlieb referred to patent thickets built up around biologics as purely designed to deter the entry of approved biosimilars. In September of this year, President Biden’s FDA wrote to the PTO raising several areas of concern. The end result is the practices that were identified by both the Biden and Trump FDA as causing higher prices for American consumers, again as I said if you’re in Vermont and drive a few miles across the Canadian border and see the difference. So do you agree with the recent bipartisan consensus at the FDA that certain abuses of the patent system contribute to the high cost of prescription drugs by preventing competitors from entering the market?”  
  • Katherine Vidal, nominee to be Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office: “Thank you Senator Leahy for raising that very important issue. I’m aware of all of the concerns about patent abuses and potential patent abuses. I do think that one thing the patent office can do is to make sure the patent office is always issuing the highest quality patents. I think to your point about patent thickets the conversation that I’ve heard is that there are follow on patents that add marginal value that have additions to the original patent. For example, changing the color of a particular drug. So, certainly I would work, if I am fortunate enough to be confirmed, on strengthening the value of IP.” 

Click here to watch a video of today’s hearing

WHAT YOU SHOULD BE READING:

The Washington Post: The Early 202: Big Pharma Isn’t The Only Player In The Prescription Drug Pricing Fight
Theodoric Meyer & Jacqueline Alemany

  • …The Campaign for Sustainable Rx Pricing, meanwhile, says PhRMA is pointing at others “to deflect accountability.” “The fact is, brand name drug companies are solely responsible for setting and hiking list prices on their products and Congress must remain focused on solutions that hold Big Pharma accountable to lower drug prices for the American people,” executive director Lauren Aronson said in a statement.

Bloomberg Law: PTO Pick Vidal Promises Fresh Look at Rule on Patent Reviews
Stephanie Handler

  • President Joe Biden’s nominee to lead the U.S. Patent and Trademark Officel told lawmakers she would look into the agency’s practice of discretionary denials at the Patent Trial and Appeal Board. Kathi Vidal, a litigator in Winston & Strawn LLP’s Silicon Valley office, would be the second woman to lead the agency if confirmed. She spoke at a Senate Judiciary Committee hearing on Wednesday.

The Hill: Patent trolls kill startups, but the Biden administration has the power to help
Abby Rives                                                                                                      

  • … Without going through standard rulemaking processes, the agency made new policies to deny IPR petitions that challenged likely-invalid patents. For purely procedural reasons that conflicted with the AIA, the PTAB started leaving more questionable patents in force, and those patents in turn continue to work their way through the courts. This cuts against the fact that Congress created IPR to be a backstop against frivolous litigation over patents that should never have been granted in the first place.

Forbes: The BBB’s Threat To Biosimilar Drug Development  
Ike Brannon  

  • In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that the U.S. should throw in the towel on copycat versions of the nation’s highest priced specialty drugs in favor of government price controls. The recommendation was rightly maligned by those who recognize the undeniable role drug competition plays in driving down medicine costs for patients and taxpayers, alike. Yet, two years later, Congressional Democrats, perhaps unwittingly, appear poised to incarnate the Bach proposal.  

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