Generics, patient groups train ire on patent bills

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Sep 17, 2024 View in browser
 
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By Lauren Gardner and David Lim

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Express Scripts by Evernorth
Driving The Day

Sen. Dick Durbin makes his way to a vote at the U.S. Capitol.

Sen. Dick Durbin's bill that would overhaul the Patent Trial and Appeal Board's patent review process is set to be marked up this week. | Francis Chung/POLITICO

PATENT CONSTERNATION — The Senate Judiciary Committee is scheduled to mark up two bipartisan bills Thursday that affordable-drug proponents and generics makers say would make it easier for major pharma companies to game the patent system in favor of their products.

One measure, cosponsored by committee Chair Dick Durbin (D-Ill.), would overhaul the patent review process at the Patent Trial and Appeal Board to require petitioners to have standing — namely, to have been sued or charged with patent infringement before filing for a review.

The second bill would expand the universe of processes eligible for patents to include “a use, application, or method of manufacture of a known or naturally-occurring process.”

Generics against: The Association for Accessible Medicines, which represents manufacturers of generics and biosimilars, argues the first bill would diminish one of their industry’s chief tools to get their products to market faster. Without the ability to lodge early challenges, the group says, brand-name drugmakers would have the bandwidth to innovate around potentially wrongly issued patents for years.

“Long before generic and biosimilar companies seek FDA approval — and thus long before they are sued for infringement — they often know which patents they must clear to enter the market,” AAM interim president David Gaugh wrote to committee leaders earlier this year.

The organization maintains the second measure would allow brand-name manufacturers to build even larger patent thickets around their products, keeping prices high for consumers.

More opposition: Advocacy groups for patients, providers and hospitals also oppose the measures. 

Patients for Affordable Drugs’ David Mitchell said the bills would undermine the goals of the Inflation Reduction Act, which launched Medicare’s ability to negotiate some drug prices directly with manufacturers.

Lauren Aronson, executive director of the Campaign for Sustainable Rx Pricing, wrote to committee leaders that the bill “would only further tip the scales in favor of Big Pharma and its ability to establish and maintain patent thickets.”

Both AAM and P4AD argue the patent eligibility measure would make it easier for major pharma companies to build those thickets — webs of overlapping intellectual property rights on a single product — which can delay the entry of cheaper copies onto the market.

The other point of view: PhRMA spokesperson Megan Van Etten said the patent review bill “is a positive step that would provide needed reforms to PTAB proceedings to promote innovation across all technologies.”

A spokesperson for Delaware Sen. Chris Coons, the primary Democratic sponsor of both bills, argued they would “provide more speed and clarity to a dated patent system.”

“Claims that these bills hinder competition or delay approval of generic drugs have been repeatedly debunked,” Van Etten said.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re crushed that coffee is due to become more expensive.

Reach out with tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

 

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In Congress

Pharmacist Bill Mattson fills a prescription drug order at Ballin Pharmacy in Chicago, Illinois

The Senate Finance Committee is scheduled to review the IRA's impact on prescription drug costs today. | Tim Boyle/Getty Images

SENATE FINANCE IRA CHECKUP — Another Senate committee is convening a group of wonks from both sides of the political spectrum this morning to discuss the impact of the Inflation Reduction Act on health care costs, less than two months ahead of the general election.

Taylor Harvey, Democrat spokesperson for the Senate Finance Committee, said the hearing will focus on the law’s impact on prescription drug costs and the Affordable Care Act’s premium tax credits.

FLYING IN BEFORE THE FLYOUT — Two pharma-related fly-ins are on the docket this week before Congress skips town for the October campaign season: cancer patients and compounding pharmacists.

About 750 cancer survivors, patients and advocates with the American Cancer Society Cancer Action Network will lobby members and staff to boost funding to cancer research and prevention programs and to pass legislation allowing Medicare to cover multicancer early detection tests once they’re FDA-approved and demonstrate clinical benefit.

And more than 200 pharmacy compounders will advocate for legislation to broaden the pool of data the FDA can use to determine when drugs are in shortage. They’ll also push back against statements from branded pharma companies Eli Lilly and Novo Nordisk, which both make popular GLP-1 medicines, about their products’ quality and compounding’s role during a drug shortage.

LIVE EVENT ON WEDNESDAY:

THE FUTURE OF PATIENT CARE AND ACCESS

Join us on Wednesday, Sept. 18, starting at 8:30 a.m. ET, as we dive into how health care delivery innovations fueled by AI and tech are empowering providers to focus more time and resources on patients.

Watch our keynote conversation with HHS’ Micky Tripathi, assistant secretary for technology policy and acting chief artificial intelligence officer. Stick around for a panel conversation with Nancy Howell Agee, CEO of Carilion Clinic; Andrea Downing, president and co-founder of The Light Collective; Kolaleh Eskandanian, VP and CIO of Children’s National Hospital; and Hafeezah Muhammad, founder and CEO of Backpack Healthcare.

RSVP to attend and watch here.

Eye on the FDA

KIDS’ DRUG SAFETY IN FOCUS — The FDA’s pediatric advisory committee meets Wednesday to discuss postmarketing safety reviews of dozens of medical products used by children.

The reviews, required by law and conducted by the FDA’s drug and device centers, focus on a diverse range of products from the smoking-cessation tablet Chantix to the ADHD drug Vyvanse.

The panel will vote, but the FDA had not posted the voting question as of Monday afternoon.

WOODCOCK MAKES AN APPEARANCE — Dr. Janet Woodcock, former FDA principal deputy commissioner, touted platform clinical trials and master protocols Monday.

The longtime FDA leader — who left the agency earlier this year after decades of service — acknowledged that randomized controlled trials are “a wonderful thing” but argued that “times change, things can be improved” at a National Press Club event on a breast cancer clinical trial known as the I-SPY 2.2 trial. The remarks from one of the FDA’s most consequential leaders come as the agency is under scrutiny for the evidence it requires for gene therapies and other innovative treatments.

Platform clinical trials compare multiple drug candidates against a single control group. Woodcock asserted that designing clinical trials so multiple types of interventions can be evaluated simultaneously would benefit patients by allowing them to switch to a different arm of a study if a trial therapy is not working.

“Anything that’s new and revolutionary causes a lot of discomfort, and you don’t maybe get it completely right, but I would say to those critics, look at all the people who are suffering during the traditional trial durations waiting for that evidence,” Woodcock said.

MEDICAL DEVICES

CHECKING IN ON TARIFFS — The medical device industry is not weighing in on a decision by the Office of the U.S. Trade Representative to hike tariffs in the coming years more than initially planned on products including face masks, medical gloves and needles and syringes.

The new rates are part of an effort to boost domestic manufacturing of medical supplies that were critical during the height of the Covid-19 pandemic — but tariffs continue to be a sticky policy for business groups to navigate, especially publicly. Debate over the taxing of imports has taken center stage in the general election — former President Donald Trump is campaigning on imposing up to a 20 percent tariff on most imports.

The Advanced Medical Technology Association declined to comment on the decision to impose face-mask duties to 50 percent starting Jan. 1, 2026; rates on medical gloves to 50 percent in 2025 and 100 percent in 2026; and tariffs on some needles and syringes to 100 percent this year.

 

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Drug Pricing

KFF: MOST VOTERS STILL UNAWARE OF IRA — Only 35 percent of voters are aware that a federal law requires the government to negotiate the prices of some prescription drugs for people on Medicare, according to a recent KFF survey.

The latest tracking poll, conducted from Aug. 26 to Sept. 4, demonstrates that despite President Joe Biden’s and Vice President Kamala Harris’ repeated touting of the Inflation Reduction Act, awareness of its impact on prescription drugs continues to lag.

Pharma Moves

Deirdre P. Connelly has been appointed to Sarepta Therapeutics’ board of directors. She retired as president of GSK’s North American drugs branch in 2015.

Document Drawer

The FDA will hold a Digital Health Advisory Committee meeting on Nov. 20-21 to discuss total product life-cycle considerations for generative artificial intelligence-enabled devices.

The FDA issued draft guidance for cancer-drug sponsors planning global clinical development programs to improve evidence generated from trials that span geographic regions.

Apple received 510(k) clearance on Friday for its over-the-counter sleep apnea feature for certain Apple Watches.

WHAT WE'RE READING

A senior Democratic staffer on the Senate Finance Committee who helped write the Inflation Reduction Act and portions of the Affordable Care Act will leave the panel next month, Stat’s John Wilkerson and Rachel Cohrs Zhang report.

Doctors are giving nearly twice as much to Democrats as Republicans this cycle, reversing contribution trends from the mid-2000s when physicians donated more to conservatives, POLITICO’s Daniel Payne reports.

 

A message from Express Scripts by Evernorth:

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