THE REFILL: Latest Dosage of Rx Patent Abuse


  • This Wednesday, the Senate Judiciary Subcommittee on Intellectual Property held a hearing on the need to strengthen patent quality and prevent the spread of low-quality and invalid patents, which have contributed in part to high drug prices. CAPA released a statement commending Sen. Tillis (R-NC) for holding this hearing and called on Congress to reform the patent system by strengthening the inter partes review (IPR) process. Read the full statement here
  • Last week, U.S. Representatives Spanberger (D-VA) and Reed (R-NY) introduced the Biologic Transparency Act in the U.S. House of Representatives. The bill would bring transparency to Big Pharma’s use of patent thickets to prevent or delay competition from biosimilars. CAPA released a statement supporting this bipartisan legislation and thanking Reps. Spanberger and Reed for their leadership. Read the full statement here
  • Also last week, the Kaiser Family Foundation (KFF) released a report that examined the rising cost of Medicare Part D drugs and found that Big Pharma has increased the price of key prescription drugs well above the rate of inflation between 2016 and 2017. The report reinforces what CAPA has been tellinglawmakers, that Big Pharma’s rampant abuse is hurting Americans and must be stopped. Read KFF’s full analysis here.



Bloomberg Law: Discretionary Denials At Patent Court Thwart Generic Drugmakers
Valerie Bauman
The decline in patent challenge institutions has frustrated patent lawyers representing clients from all industries, including pharmaceutical companies. “We’re generally concerned,” said Karin Hessler, general counsel for the Association for Accessible Medicines, which lobbies on behalf of generic drugmakers. “We want to see a significant decrease in prescription drug pricing and IPR has traditionally been a tool that generics have used,” she added. “We’re concerned that the door to IPRs may be closing due to circumstances outside their control.” Denials can happen even when a patent challenge establishes a reasonable likelihood that at least one claim is unpatentable or, in some cases, without a substantial analysis of the petition. “For a denial to institute there’s no right to appeal, so you may be spending a lot of money on an IPR and not get a hearing,” Hessler said.

Politico: ‘Patent Thicket’ Bill Caught In Tug-Of-War Over Drug Pricing Reforms
Susannah Luthi & Sarah Owermohle
A bipartisan Senate effort to crack down on drug companies that game the patent system to shut out cheaper competitors has become a bargaining chip in the roiling debate over pharmaceutical prices. The bill, S. 1416 (116), by Sens. John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.) would authorize the Federal Trade Commission to sue drug companies if they use tactics like obtaining duplicative patents or push patients onto similar new therapies just as old products are running off patent, in order to delay cheaper copies of the medication from reaching the market. The Congressional Budget Office has projected the measure would lower federal spending by $507 million over a decade.

The Hill: Drug Companies Spend Millions On Lobbying As Congress Tries To Rein In High Drug Prices
Jessie Hellmann
Prescription drug companies and trade groups shelled out millions of dollars to lobby Congress as it considered legislation aimed at reining in skyrocketing drug prices, according to new lobbying disclosure reports.  The Pharmaceutical Research and Manufacturers of America (PhRMA) — the trade group representing branded drug companies — spent $6.2 million on lobbying in the third quarter of 2019, which ran from July through the end of September. That’s $240,000 more than it spent during the same time frame last year.


Longview News Journal: Letter: Taking Action On Prescription Costs
U.S. Senator John Cornyn
The Affordable Prescriptions for Patients Act encourages price competition among drug companies by defining anti-competitive patent abuse. The Second Look at Drug Patents Act shines a light on anti-competitive behavior by publishing new drug patents for the public — and other drug companies — to see. I also supported a bill to increase transparency for the costs charged by pharmacy benefit managers (PBMs). Drug companies that abuse the system to make a profit have run unchecked for too long. By targeting these anti-competitive practices, we can stop bad actors and lower Texans’ cost at the pharmacy.

Office of U.S. Representative Abigail Spanberger: Spanberger, Reed Introduce Bipartisan Bill to Increase Access to Lower-Cost Prescription Drugs, Encourage Biosimilar Competition
Rep. Spanberger (D-VA)
Spanberger’s Biologic Patent Transparency Act would take a first step in stopping this practice of “patent gaming” and would seek to level the playing field for biosimilar drugs. By increasing patent transparency in the prescription drug market, their legislation would promote competition between biosimilars and established biologic medicines—and these provisions would deliver biosimilar treatments to patients faster and help lower drug prices for American consumers.

The Center For Biosimilars: Bipartisan Patent Transparency Bill Introduced In House Of Representatives
Allison Inserro
A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drug prices has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March. The Biologic Patent Transparency Act aims to end patenting practices that make it difficult for biosimilars to enter the market by increasing transparency in the prescription drug market and promoting competition. The act would require companies to publicly disclose the patents that protect their originator biologics, thus making it easier for competitors to evaluate and plan for the development of biosimilars.