THE REFILL: Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW
- TUESDAY, JULY 20: The Coalition Against Patent Abuse (CAPA) is hosting a panel with the Public Interest Patent Law Institute highlighting how patent law can impact every American, particularly when it comes to high drug prices. The event will feature a discussion moderated by CAPA Executive Director Matthew Lane and include the following panelists:
- Tahir Amin, I-MAK
- Alex Moss, Public Interest Patent Law Institute
- Jef Pearlman, USC Gould School of Law
- Kate Ruane, American Civil Liberties Union
Register HERE to learn more about the intersection of patents and our everyday lives—whether it be access to genetic testing, affordable drug prices, podcasting, or open source development.
- CAPA Concludes “Spot-On Savings” Mini-Series Showing How The IPR Process Can Generate Savings For Millions Of Patients & The U.S. Healthcare System
Part VI: IPR & Anemia – An Effective, Low-Cost Tool for Resolving Patent Disputes.
Read the full story below:
- The IPR process resolved a patent challenge around the dosing regimen for erythropoietin, a biologic compound used in the treatment of anemia.
- Janssen Pharmaceuticals held a patent claiming the wait time between doses of erythropoietin, which was 5-30 days. Hospira petitioned for IPR on the grounds that this dosing regimen was already revealed in an earlier patent filing from two years earlier.
- Had Hospira not pressed this issue through the IPR process, Janssen would have benefited from an extra two years of exclusivity.
- Because IPR resulted in the cancellation of claims of the patent, a erythropoietin biosimilar was able to enter the marketplace, saving patients money at the pharmacy counter.
It is clear that the IPR process generates savings for patients and the entire U.S. healthcare system as a cost-effective tool for knocking down erroneously issued patents. IPR should be strengthened, but repeated legal challenges have weakened its ability to correct erroneously issued patents.
- ICYMI: Senate Judiciary Subcommittee Addresses Anticompetitive Tactics Used by Big Pharma to Thwart Competition, Keep Prices High
This week, the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights held a hearing to examine anticompetitive tactics used by many major pharmaceutical companies to extend market exclusivity and increase profits.
Senators on both sides of the aisle, as well as industry experts, pointed to much-needed patent reform as one way to address high drug prices.
Key Quotes From The Hearing Include:
- Amy Klobuchar (D-MN): “We’ve got problems of product hopping in which brand name pharmaceuticals force patients with an established drug within an expiring patent to a new drug with a new patent, often with little or no therapeutic difference, just to avoid competition from generics. That’s a bill our friends Senator Cornyn and Senator Blumenthal have that could get at that.”
- Rachel Moodie (VP, Head of Legal and Intellectual Property, Biosimilars for Fresenius Kabi): “Because of the misuse of patent thickets and rebates as marketing tools and product hopping as another tool to thwart competition, the U.S. branded pharmaceutical industry is not currently operating as a true free market system with downward pressure at an appropriate time.”
- Richard Durbin (D-IL): “The top-12 best-selling drugs in America each have an average of 71 patents and 78 percent of all new patents are for drugs that are already on the market.
CAPA Executive Director Matthew Lane Stated: “Practices such as patent thicketing are often used by Big Pharma to maintain their drug monopolies while preventing American patients from accessing more affordable generic drugs and treatment alternatives… Moving forward, passing long overdue patent reforms and strengthening low-cost tools such as the inter partes review (IPR) process should remain a top priority.”
WHAT YOU SHOULD BE READING:
- Lawmakers will have a hard time objecting to legislation aimed at lowering prescription drug prices by limiting deals between name brand and generic manufacturers, Sen. Amy Klobuchar said Tuesday. “The stakes could not be higher,” Klobuchar (D-Minn.), chair of the Senate Judiciary Committee’s antitrust panel, said at a hearing. Klobuchar is sponsor of a bill (S. 1428) that would limit arrangements in which brand drugmakers compensate generics for waiting before they enter the market.
The Wall Street Journal: Drug Prices Are One Focus Of Biden’s Push To Boost Competition
- President Biden’s executive order to promote business competition lays out a series of steps to lower prices for prescription drugs, including taking legal action against companies that cooperate to keep generic medicines off the market… The administration also is calling for measures to increase the use of generic drugs and other medicines known as biosimilars, which are essentially generic versions of expensive biological drugs already on the market. Most of the ideas have been urged in the past, primarily by Democrats but also by the Trump administration.
- A pricey new Alzheimer’s drug already mired in controversy could cost Medicaid anywhere from $720 million to nearly $2.2 billion each year depending on the number of patients treated, according to a new analysis. The medication, which is called Aduhelm and carries a $56,000 price tag, is generating concern over its potential impact on the overall health care system.
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