FTC cracks down on 100-plus ‘improper’ drug patents in comprehensive enforcement push

Under the leadership of Lina Khan, the Federal Trade Commission (FTC) has stepped up its enforcement actions, complicating its clearances of mergers, including Amgen’s acquisition of Horizon Therapeutics, which concluded in early October. Most recently, FTC has challenged what it deems are “improper” patent listings. At the receiving end of the FTC drug patent crackdown are Big Pharma companies such as AbbVie, AstraZeneca, and Boehringer Ingelheim. 

FTC drug patent crackdown targets 100+ patent listings

More than 100 patent listings are improper in the eyes of FTC because they do not meet the relevant statutory and regulatory requirements for inclusion in the FDA’s Orange Book, a publication of “Approved Drug Products with Therapeutic Equivalence Evaluations.” That is, FTC contends that the patents in question are either inaccurately listed or are not relevant to the approved drug products they are thought to cover. The agency notes a variety of reasons fo…

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From FTC’s tightened grip to PULSE Coalition: A timeline of the life science M&A landscape

The biopharma industry is pushing back against increased scrutiny of mergers and acquisitions from the Federal Trade Commission (FTC). More than 30 biopharma companies and industry associations announced the formation of the Partnership for the U.S. Life Science Ecosystem (PULSE) to advocate for the role of M&A activity in the biopharma sector.

The creation of PULSE comes in response to more aggressive enforcement against pharma mergers by the FTC under the Biden administration. Most recently, the FTC sued to block Amgen’s acquisition of Horizon Therapeutics, before ultimately settling to allow the deal to proceed with conditions.

Since June 2023, there has been a trend of falling M&A deal volume. Deal size has also dipped in recent months, but rising interest rates are another factor influencing that trend.

PULSE members, including Amgen, AbbVie, Gilead, and Merck, argue that M&A helps advance drug discovery and development.

A time…
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Resonetics closes $900M nitinol deal and rebrands Memry and Smart Materials

Nitinol is used for a variety of medtech applications. [Photo via Adobe Stock]

Resonetics has closed on its $900 million acquisition of the SAES Getters medical nitinol business.

Nashua, New Hampshire-based Resonetics said it will rebrand Memry Corporation and SAES Smart Materials as Resonetics.

The Smart Materials business creates raw nitinol alloy from nickel and titanium and produces nitinol wires, bars, ribbons and sheets. The Memry business offers electric discharge machining, laser processing, centerless grinding, and nitinol tubing, sheet, and wire fabrication. 

Those two companies have around 600 employees at facilities in Bethel, Connecticut, New Hartford, New York, and Menlo Park, California.

Nitinol has superelastic and shape memory properties that make it uniquely useful for a variety of medical applications. Medical device developers are finding new and improved ways to use nit…

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FTC concludes antitrust investigation of $900M SAES-Resonetics nitinol deal

Nitinol is used for a variety of medtech applications. [Photo via Adobe Stock]

The Federal Trade Commission has closed its antitrust investigation into Resonetics’ planned $900 million purchase of the SAES Getters medical nitinol business.

Milan, Italy-based SAES said it and Resonetics “will define the timing to finalize the closing of the transaction” in the coming days and will provide further updates.

The company did not say whether the FTC will allow the sale without conditions, but it doesn’t sound like the agency or the Department of Justice will sue over the transaction. More information was not immediately available.

Nashua, New Hampshire-based Resonetics signed a binding agreement in January 2023 to buy the medical nitinol division from SAES, including U.S. subsidiaries Memry Corp. and SAES Smart Materials. The business supplies medical device manufacturers with ra…

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Biden administration’s antitrust campaign a concern for pharma

Last year, the Biden administration drafted an executive order that promoted competition in the U.S. economy across several industries, including pharma and biotech. The focus on the pharma industry was not surprising, given Biden’s campaign pledge to curb drug pricing. To that end, the Biden administration has explored a variety of approaches, Robin Adelstein, the global head of antitrust and competition and co-head of commercial litigation, U.S. at Norton Rose Fulbright.

In November, the FTC signaled its intent to provide guidance for enforcement of the FTC Act, passed in 1914, to regulate monopolies and eliminate unfair competition and deceptive business practices.

Robin Adelstein

“For a long time, the FTC Act has been interpreted as being coextensive with the antitrust laws,” Adelstein said.

In 2015, FTC released the Statement of Enforcement Principles Regarding ‘Unf…

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FTC and DOJ staff eyes new ways to enforce antitrust laws in pharma

A two-day virtual workshop from the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) mulled the current state of antitrust law enforcement in the pharmaceutical industry, discussing the role of pharmacy benefit managers (PBMs) in driving up prices for consumers.

“A competitively vibrant market protects access to existing drugs and promotes new innovation, but access to medicine is already in peril by untenable costs,” said Rebecca Kelly Slaughter, an FDA commissioner in the workshop, which was held June 14–15.

M&A plays a role in driving up costs, Slaughter argued. “When mergers diminish competition in pharmaceutical markets, the result is higher prices, which can have a devastating effect for patients,” she said. “Enforcement action is necessary to prevent such harms.”

The workshop was organized by the Multilateral Pharmaceutical Merger Task Force, formed in March 2021 by then-Acting FTC Cha…

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 Department of Justice accuses Xlear of deceptive advertising; Xlear responds

Last month, the Federal Trade Commission (FTC) sued nasal spray company Xlear for claiming that its xylitol-containing saline nasal spray could help fight COVID-19. Specifically, the FTC alleged that Xlear had violated the COVID-19 Consumer Protection Act.

The Department of Justice also accused the company of violating the Federal Trade Commission Act.

American Fork, Utah–based Xlear released a statement denying the charges, arguing that federal authorities have violated its First Amendment right to free speech.

“Xlear’s response [to the allegations] outlines a series of studies, including two randomized clinical trials (RCTs) and other clinical and lab data, that more than substantiate Xlear’s statements regarding COVID-19,” said Nathan Jones, Xlear’s CEO, in a press release.

Jones cited an RCT that found that the Xlear nasal spray reduced the risk of hospitalization from COVID-19 by a factor of eight.

Xlear has also asserted that its nasa…

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Biden and Pelosi pursuing plans to cap drug prices

Joe Biden and Nancy Pelosi images from Wikipedia

President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days.

Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive products.

The proposals are included in a far-reaching executive order with several healthcare provisions. The main thrust of the order, however, is stimulating competition in the economy.

Earlier this year, Biden asked Congress to allow Medicare to negotiate drug prices, which was also a goal spelled out in the 2019 House Bill H.R. 3 that Democrats reintroduced in April.

Biden included the recent effort to give Medicare drug negotiation powers in an executive order intended to spur economic comp…

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