THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • On Thursday, Patients for Affordable Drugs (P4AD) released a report “The Truth About Insulin Prices” as part of a campaign for World Diabetes Day. The report shows how pharmaceutical companies have kept the prices of insulin artificially high by manipulating the patent system. The report notes that, “… insulin manufacturers have manipulated the patent system to achieve protection until 2030 or later. They do this by applying for multiple, overlapping patents.” The tactics used by these companies block generic insulin from entering the market and lowering prices and highlights the urgent need for reforms to strengthen the Inter Partes Review (IPR) process, which can help the U.S. Patent and Trademark Office more efficiently invalidate bad patents.  
  • On Wednesday, the unanimous consent request to take up the Affordable Prescriptions for Patients Act sponsored by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), which would addressproduct-hopping and the creation of patent thickets by Big Pharma was blocked in the U.S. Senate. The bill, which was passed out of the Senate Judiciary Committee unanimously, would be an excellent first step towards combatting Big Pharma’s patent abuses and increasing Americans’ access to cheaper drugs. Given the bill’s bipartisan support, this represents a major setback for cash-strapped American patients who will be most impacted by this partisan gridlock. Senators from both sides of the aisle must come together and pass this bill.  
  • Last week, Inside Health Policy reported that Abbvie’s revenue from Humira fell by 33.5 percent internationally due to competition from biosimilar medicines. Comparatively, AbbVie’s revenue in the United States, where it is protected from generic competition by a patent thicket, increased by 9.6 percent. As the story notes, Abbvie has more than 100 different patents on Humira alone. This report underscores what the Coalition Against Patent Abuse (CAPA) has been saying for some time: patent abuse prevents competition and allows Big Pharma to keep prescription drug prices high, stifling innovation and medical advancements.

WHAT YOU SHOULD BE READING:

PATENT PROGRESS

The Hill: Schumer Blocks Measure That Would Lower Prescription Drug Prices
Zachary Stieber
Sen. John Cornyn (R-Texas) was seeking to pass by unanimous consent a bill he is co-sponsoring with Sen. Richard Blumenthal (D-Conn.), which would crack down on drug companies gaming the patent system to delay competition from makers of cheaper generic drugs.  But Schumer objected to the request, blocking the move. The New York Democrat said that while he did not oppose the bill on substantive grounds, he opposed Cornyn playing a “little game” to try to move only his bill forward without larger action to lower drug prices, which he said Republicans are blocking.  “We have a whole lot of legislative ideas, not just his,” Schumer said on the floor.  “His party blocks everything that would have far larger consequence,” Schumer added, speaking of Cornyn, who is up for reelection next year.

National Review: Senator John Cornyn Accuses Chuck Schumer of ‘Playing Partisan Games’ by Blocking Bipartisan Drug Prices Bill
Tobias Hoonhout
Senator John Cornyn (R., Texas) criticized Senate Minority Leader Chuck Schumer (D., N.Y.) on Wednesday for “playing partisan games” by “blocking” a bipartisan bill to lower drug prices, which unanimously passed the Senate Judiciary Committee. The “Affordable Prescriptions for Patients” Act, which was originally cosponsored by Senator Richard Blumenthal (D., Conn.), aims to even the patent playing field between drug companies and competitors that produce cheaper, generic drugs. “Senator Blumenthal and I introduced a noncontroversial, bipartisan bill that passed the Judiciary Committee unanimously. This bill is meant to lower drug prices, but Senator Schumer keeps playing partisan games and is blocking it. This needs to stop,” Cornyn tweeted.

AEI: Patent Quality Returns To The Fore
Michael Rosen
Late last year, Professors Michael Frakes of the Duke University School of Law and Melissa Wasserman of the University of Texas at Austin School of Law published a groundbreaking paper that reconsidered the costs and benefits of augmenting the resources provided to patent examiners.  In “Irrational Ignorance at the Patent Office,” Frakes and Wasserman argued that “the savings in future litigation and prosecution expenses associated with giving examiners additional time per application more than outweigh the costs of increasing examiner time allocations.”

Culpeper Star-Exponent: Spanberger Hopes Senate Will Act On Bill To Lower Patients’ Drug Costs
Clint Schemmer
For a while, lawmakers of both major parties have been getting an earful from Americans about the steeply rising cost of prescription drugs. But now, Congress is trying to shine a light on one factor in that situation: the middlemen that connect pharmaceutical manufacturers, insurers and patients. U.S. Rep. Abigail Spanberger, D-7th, sounds hopeful that a unanimously endorsed bill will provide insight into how pharmacy benefit managers’ actions could be driving up patient’s out-of-pocket costs for pharmaceuticals.

BIG PHARMA’S GAME OF PATENTS

The Hill: Senate Fight Derails Bipartisan Drug Pricing Bills
Peter Sullivan
Sen. John Cornyn (R-Texas) came to the Senate floor preparing to seek unanimous consent to pass a measure with Sen. Richard Blumenthal (D-Conn.) which is aimed at lowering drug prices by cracking down on drug companies gaming the patent system to delay cheaper competition.  But Cornyn eventually ran out of time. Senate Minority Leader Charles Schumer (D-N.Y.) was preparing to object to his measure, sources say, not wanting to pass one relatively incremental drug pricing measure when negotiations are still ongoing over a larger effort on the topic.  That did not sit well with Cornyn, though, who blasted Schumer, and plans to try again next week to ask for unanimous consent to pass the bill.

Pharmaceutical Technology: From Evergreening To Thicketing: Exploring The Manipulation Of Pharma Patents
Allie Nawrat
Drug research and development (R&D) “is a high-risk investment for the pharmaceutical company”, as barrister Dr Peter Feldschreiber explains. The pharma patent system was created and is used to help companies to protect that investment and recover costs spent in discovering, developing and marketing new drugs, and, therefore, encourage future drug R&D and innovation. Pharma companies file for a patent soon after the discovery of a drug and its novel mechanism of action. From that point the company has a 20-year patent for the product, but R&D can take up to 15 years, so by the time the products is approved and available on the market, the patent can be close to running out. Once the 20-year exclusivity period is up, generic competitors can enter the market and compete with the branded drug on price. To further protect their investment, companies often seek to extend their exclusivity period for a drug by filing secondary patents.

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