THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW:

  • USA Today Editorial Board: How Big Pharma Plays Games With Drug Patents And How To Combat It President Donald Trump came into office promising to do something about the inflated prices Americans pay for prescription drugs. He considered limiting rebates to the middlemen between insurance plans and drug companies but recently concluded that the complex plan was unworkable. This leaves policymakers back at square one. And it leaves Americans with a number of questions. Should they just resign themselves to paying more for their meds? Should they insist on price controls? Is there something in between?
  • CAPA Executive Director Matthew Lane pushed back on a Big Pharma-sponsored op-ed, writing in the Houston Chronicle: “When you lift the veil on Big Pharma’s rhetoric, you learn that patent abuse is a major contributing factor to skyrocketing drug costs. Drug companies have been manipulating the U.S. patent system for decades in order to prevent or delay generic medicines from coming to the market. Patients are denied affordable life-saving medications because there is little to no competition from generic brands. In fact, Americans currently pay up to 65 percent more for drugs than other Western countries. By exploiting legal loopholes, Big Pharma games the patent system to its advantage. Tactics like “patent thickets” which allow drug companies to file countless patents on a single drug or in which companies make small changes to their expensive brand name drug before a cheaper version can be approved, are purposefully used to drive out competition.”

WHAT WE SAID:

CAPA Statement: CAPA Blasts STRONGER Patents Act As A Massive Concession To Big Pharma

“This legislation is an inconceivable gift to Big Pharma and empowers them to continue abusing the patent system at the expense of American patients. If the public is prevented from challenging invalid patents, Big Pharma will be enabled to maintain and expand their drug monopolies and keep patients from accessing more affordable alternative medicines and treatments. “We strongly urge Congress to oppose this disastrous legislation. Our Coalition will continue working with members of both parties to enact responsible solutions that put American patients first, promote innovation and prevent Big Pharma from continuing to abuse the patent system.”

WHAT YOU SHOULD BE READING:

BIG PHARMA’S LATEST GAME OF PATENTS

Fortune: Protect At All Costs: How The Maker Of The World’s Bestselling Drug Keeps Prices Sky-High

Sy Mukherjee

According to advocacy and drug watchdog group Association for Accessible Medicines, the company applied for and won 75 Humira patents in the three years before its initial patent expired in 2016. AbbVie CEO Richard Gonzalez has said the company now holds approximately 136 Humira patents. How was the company able to rack up so many patents on a single product? Much of it has to do with the type of drug that Humira is—a “biologic.” Unlike chemically synthesized drugs, biologics derive from actual biological material, making them significantly more complex than standard chemical medicines. And therein lies the key to AbbVie’s IP strategy, explains Feldman. For instance, a company may be able to file patents on obscure steps in the production and manufacturing process, or adjustments in dosing.

Bloomberg Government: Curbs On Patent Challenges Sought In Revived Bill

Ian Lopez

Lawmakers are resurrecting legislation that would make it harder to challenge the validity of patents at the U.S. Patent and Trademark Office. Sen. Chris Coons (D-Del.) and Rep. Steve Stivers (R-Ohio) announced July 8 that they will reintroduce the “STRONGER Patents Act.” The bill would make changes to proceedings at the Patent Trial and Appeal Board, the agency administrative law body that handles patent challenges. The new bill will be largely similar to legislation introduced in the 115th Congress, with some changes, a Democratic aide said. One new provision in the bill, which a House aide said July 8 hadn’t been finalized, focuses on PTAB decisions about whether to accept a patent review request. The provision, according to an overview of the prospective bill from Stivers’ office, would clarify which parts of that decision could be reviewed by a court. It follows the U.S. Court of Appeals for the Federal Circuit 2018 ruling in WiFi One v. Broadcom, which specified that appeals are allowed if the PTAB rejects a request as late. The ruling overturned an earlier decision.

Bloomberg Law: Lawmakers Renew Bill To Help Patent Owners Fight Challenges

Malathi Nayak

The reintroduced bill also aims to restore a patent owner’s ability to get a permanent injunction after the patent board finds that a valid patent was infringed. Lawmakers are looking to undo the Supreme Court’s 2006 ruling in eBay Inc. v. MercExchange LLC which barred automatic injunctions for owners of infringed patents. The bill also would prohibit patent challenges in district courts if the PTAB has agreed to hear a challenge in an administrative review. Patent owners’ groups, including the Alliance of U.S. Startups and Inventors for Jobs and the Innovation Alliance, and the Biotechnology Innovation Organization are backing the bill. Allowing inventors to regain injunctive relief and making inter partes reviews more balanced “will have a dramatic and positive effect on patent-intensive startups,” the Alliance of U.S. Startups and Inventors for Jobs said in a statement.

Financial Times: US Reform Plan For Patents Raises Innovation Concerns

Bruce Love

The bill is the bipartisan brainchild of Republican Thom Tillis and Democrat Chris Coons, who head the Senate judiciary committee’s intellectual property subcommittee. The panel believes a section of the US Patent Act, which defines and limits what ideas and inventions can be patented, does not incentivise innovation. Their aim is to restore predictability and stability to patent eligibility, according to a note accompanying the proposed amendment. Yet in three days of testimony last month, industry experts and lobbyists could not even seem to agree on whether patent eligibility rules should be reformed at all, let alone how they should be modified, says Michael Borella, partner at McDonnell Boehnen Hulbert & Berghoff. Most life science innovators in particular want a more “open” or permissive system, making it easier to lodge patents, Mr Borella says.

San Antonio Express News: Drug Bill Carries Serious Side-Effects, No Benefits

Peter Pitts

Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) claim that their new bill — the Affordable Prescriptions for Patients Act — will expand access to needed medicines for American patients. But in reality, the bill is poised to do the exact opposite. The bill is premised on the idea that drug companies are gaming the IP system by making incremental changes to drugs they have already patented. Sens. Cornyn and Blumenthal believe such behavior is merely a way of driving off competition from less-expensive generics, thereby inflating drug costs for patients. The Affordable Prescriptions for Patients Act addresses this perceived abuse by empowering the Federal Trade Commission (FTC) to bring antitrust suits against pharmaceutical companies who engage in this practice. But nearly every assumption behind the bill is flawed. For starters, the reform takes for granted that any alterations or refinements to an existing medicine automatically amounts to an anti-competitive ploy, when in fact there are countless reasons to engage in such work.

POLICY PROGRESS

Houston Chronicle: In Defense Of The Drug Bill

U.S. Senator John Cornyn

In Houston, one man wrote to me that he gave up taking his Crohn’s disease medication because he can’t afford to spend $1,800 for a 90-day supply. I also heard from a woman named Agatha that her prescription recently increased to more than five times the cost. She can’t afford it, but she continues to take it so she can see her newborn grandchild grow up. The arthritis drug Humira has been on the market for 15 years, and thanks to hundreds of patent applications, three lower-cost, competing drugs that are sold outside the U.S. won’t be available to American patients until 2023. That’s not innovation. That’s taking advantage of the system to keep prices high. The Affordable Prescriptions for Patients Act won’t threaten pharmaceutical companies that act fairly. It will limit the number of patents these companies can use to keep competition off the market, and empower the Federal Trade Commission to challenge anti-competitive behavior. By cracking down on monopolies and bad actors, we can encourage price competition and lower drug prices for Texans at the pharmacy.

The Hill: Advocates Frustrated Over Pace Of Drug Price Reform

Alex Gangitano

Matthew Lane, director of the Coalition Against Patent Abuse (CAPA), which includes health care providers and consumer groups seeking drug patent reforms, said the White House was also likely to raise pressure on lawmakers in the weeks ahead. “I know from what we have been hearing, the president’s very upset about not having enough movement on drug prices, which was a big issue for him and they want something through,” he said. “I think a lot of this is going to depend on continued pressure from the White House into the Senate that this is something they want on his [Trump’s] desk to run for re-election,” said Joshua Lamel, a spokesperson for CAPA. Lane, from CAPA, struck a more optimistic note, arguing that the attention on the issue would not fade. “We’re not especially concerned about the time pressure because I know that there’s a lot of attention on the drug pricing right now but we don’t see that changing anytime soon,” Lane said. “This is very much about starting the process and getting the wins on the board as we lead to a bigger solution.”

Coalition For Affordable Prescription Drugs: New Report Uncovers Big Pharma’s Abuses Cost U.S. Health Care System $31.7 Billion

CAPD Staff

The Coalition for Affordable Prescription Drugs (CAPD) released a new report from Matrix Global Advisors, “Gamesmanship and Other Barriers to Drug Competition.” The report shows how brand drug companies have used anticompetitive tactics to delay the entry of generic competition and sustain monopolies. According to the report, stopping this gamesmanship could save U.S. patients and taxpayers over $30 billion. Key takeaways of the report include: • Brand drug companies use a wide array of anticompetitive tactics to delay competition for their products, including strategies not yet widely discussed and addressed by policymakers. • The average exclusivity period for large-market brand drugs has increased by 2.2 years since the mid-1990s. • The U.S. health system would stand to gain $31.7 billion in savings if brand drug gamesmanship was prohibited and generic drugs came to market 2.2 years faster.

WSHU Public Radio: Blumenthal Bill Targets Pharma’s Manipulation Of Patent System

Christian Carter

ABOUT COALITION AGAINST PATENT ABUSE (CAPA)

The Coalition Against Patent Abuse are healthcare providers, consumer groups, patient advocacy organizations, free market advocates, employers, and others fighting abuses of the patent system that can extend government-granted monopolies that illegitimately keep drug prices high for years, or even decades. Our members include the following groups and organizations: America’s Health Insurance Plans, Association for Accessible Medicines, Blue Cross Blue Shield, Campaign for Sustainable Rx Pricing, Citizen Outreach, Consumer Action, Innovation Defense Fund, Institute for Liberty, Kaiser Permanente, Knowledge Ecology International, Lincoln Network, R Street Institute, Society for Patient Centered Orthopedics, and U.S. Public Interest Research Group.