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Big Pharma Fights Patent Disclosure Requests From Investors

Some of the world’s largest pharmaceutical companies will be forced to disclose information about their use of controversial patent strategies that could delay competitors launching cheaper versions of blockbuster drugs. We are fighting against shareholder proposals.

The Coalition of Ethical Investors has provided Johnson & Johnson, Merck, Pfizer, Eli Lilly, Gilead, Amgen, Regeneron, Bristol-Myers Squibb, and AbbVie with guidance on the process to follow when filing multiple patents for a single drug. I requested that the report be issued.

According to shareholders, including Mercy Investment Services and Trinity Health, the report reveals whether their patent strategy is designed to extend exclusivity of their top-selling drug and how this will affect patient access. You should provide details about what you might give.

Eight out of nine companies have opposed proposals with the Securities and Exchange Commission. Companies regularly challenge shareholder proposals with the SEC and often win. BMS is still involved in discussions with investors.

The shareholder proposal came amid public debate over the use of so-called “patent thickets” by pharmaceutical companies. This leads to multiple, sometimes hundreds, of patents being filed beyond the main patent covering a specific compound. Critics argue that the strategy will delay the launch of generic drugs by rivals, even after a 20-year monopoly on the blockbuster drug’s key patents has passed.

“Without competition, manufacturers can drive prices wild,” said Lydia Kaikendal, director of shareholder advocacy at Mercy Investments. It’s a thing,’ he said. service.

She said differences between the US and EU patent systems mean that European patients typically have access to generic drugs that are up to five years cheaper than American patients.

HumiraAbbVie’s world’s best-selling drug, with global sales reaching $200 billion, faced competition in Europe in 2018. release Rivals have blamed it on a large “patent bush” created around the drug in the United States this year.

“We can’t sue over 100 patents. It’s too expensive,” he said.

She said many branded pharmaceutical companies deploy so-called “double patenting” technology, whereby multiple patents claim the same or distinct variations of an invention. These aren’t incremental innovations that improve how patients are treated, she said, Goode.

At the request of the Biden Administration, the US Patent and Trademark Office and the Food and Drug Administration are reviewing their practices to ensure more timely access to the market for generic and biosimilar drugs. targeting drug price is high.

Large pharmaceutical companies defend their patent strategies, arguing that intellectual property protection is necessary to justify continued investment in existing drugs. These investments will drive innovation that benefits patients, such as new dosing regimens, delivery methods, and combinations with other drugs that offer real benefits to patients, they say.

Eight companies told the SEC that shareholder proposals are an attempt to “micromanage the business” and should be excluded for several reasons, including involving complex scientific and legal topics outside the shareholder’s expertise. says. Implementing the proposal could undermine the company’s core business model, Merck said in response to a proposal by the Capuchin Francisco Province of St. Joseph.

US Senator Elizabeth Warren

Senator Elizabeth Warren has asked the U.S. Patent Office to investigate a new patent application for Merck’s cancer drug Keytruda © Reuters

The Capuchin Order proposal cites a 2021 study by I-Mak, a research group focused on health inequalities, in which Merck has filed 95 secondary patents on its cancer drug Keytruda. It turns out that there is Two out of five of these patent applications relate to “manufacturing methods and processes that could be used to manufacture pharmaceuticals,” which could hinder competition even after key drug patents expire, the order said. said in the proposal.

Merck has filed up to 180 patents for Keytruda, which is expected to be the world’s best-selling drug this year, with sales of about $24 billion, according to I-Mak research. The drug is set to lose exclusivity provided by a key patent in 2028, but many analysts believe Merck could use its “patent thicket” to delay the introduction of competing drugs. I’m here.

Evercore ISI analyst Umer Raffat said: “They are innovating beyond existing drug compounds and this strategy should support Merck’s earnings over the next decade.”

Last week, US Senator Elizabeth Warren dispatched Kathy Vidal, Director of the US Patent Office. letter It urged Merck’s claims for new patents on Keytruda, including a new delivery method of injection under the skin, to scrutinize more closely.

“It’s not at all clear that Merck is doing anything other than extending its exclusivity over the drug,” Warren said.

A Merck spokesperson said the company has developed a number of innovations that enhance Keytruda’s benefits in order to reach more patients and increase treatment efficacy. We try to protect our innovations,” he added.

Merck said it continues to point to the second half of 2028 as the most likely time for biosimilars to enter the market.

https://www.ft.com/content/c5498e67-a48f-4adc-b85f-7bf1a0d400f6 Big Pharma Fights Patent Disclosure Requests From Investors

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