FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic; CNBC, April 30, 2024

Annika Kim Constantino, CNBC; FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic

"Most top-selling medications are protected by dozens of patents covering various ingredients, manufacturing processes, and intellectual property. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

The FTC also notified the Food and Drug Administration about the challenges. The FDA manages patent listings for approved drugs on a document called the Orange Book.

The FTC first challenged dozens of branded drug patents last fall, leading three drugmakers to comply and delist their patents with the FDA. Five other companies did not. 

The Tuesday announcement expands the Biden administration’s effort to crack down on alleged patent abuses by the pharmaceutical industry. The FTC has argued that drugmakers are needlessly listing dozens of extra patents for branded medications to keep their drug prices high and stall generic competitors from entering the U.S. market."

How a Drug Maker Profited by Slow-Walking a Promising H.I.V. Therapy; The New York Times, July 22, 2023

 Rebecca Robbins and Sheryl Gay Stolberg, The New York Times; How a Drug Maker Profited by Slow-Walking a Promising H.I.V. Therapy

"Gilead, one of the world’s largest drugmakers, appeared to be embracing a well-worn industry tactic: gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs...

Gilead ended up introducing a version of the new treatment in 2015, nearly a decade after it might have become available if the company had not paused development in 2004. Its patents now extend until at least 2031.

The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V. drugs claim that the company unnecessarily exposed them to kidney and bone problems."

Big pharma executives mocked ‘pillbillies’ in emails, West Virginia opioid trial hears; The Guardian, May 16, 2021

 

Chris McGreal, The Guardian; Big pharma executives mocked ‘pillbillies’ in emails, West Virginia opioid trial hears

"Paul Farrell, a lawyer for a West Virginia county, put it to the executive that the emails reflected a culture of contempt."

Report – Patent Abuse A Leading Cause Of High Drug Prices In US; Intellectual Property Watch, August 3, 2018

David Branigan, Intellectual Property Watch; Report – Patent Abuse A Leading Cause Of High Drug Prices In US

"The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was produced by the New York-based Initiative for Medicines, Access & Knowledge (I-MAK)...

“Spanning twelve drugmakers and a range of conditions such as cancer, arthritis, stroke, and diabetes, the study captures an industry-wide trend of pharmaceuticals ‘evergreening’ their products with excessive patents so they can artificially extend monopolies and boost profits—at the expense of American families and the budgets of public and private payers around the country,” according to the press release."

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny; The New York Times, April 14, 2018

Robert Pear, The New York Times; Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny

"At a time when researchers are using sophisticated science to develop new treatments and cures, the fight over physical samples — a few thousand pills — sounds mundane. But it has huge implications for consumers’ access to affordable medicines.

The F.D.A. says it has received more than 150 inquiries from generic drug companies unable to obtain the samples needed to show that a generic product works the same as a brand-name medicine. Some of the disputes over samples involve drugs that are costly to patients and to the Medicare program and that have experienced sharp price increases in recent years.

“Without generic competition, there is no pressure to drive down the costs of these medications,” the food and drug agency said. Under current law, it said, it cannot compel a brand-name drug manufacturer to sell samples to a generic company."

Allergan is dealt another setback as patent board shoots down Mohawk patent deal; STAT, February 23, 2018

Ed Silverman, STAT; Allergan is dealt another setback as patent board shoots down Mohawk patent deal

"In a closely watched case, a U.S. patent appeals board ruled that a Native American tribe cannot claim sovereign immunity in order to avoid a certain type of patent challenge. The decision is a blow to Allergan (AGN), which last fall transferred patent rights to one of its biggest-selling medicines to the St. Regis Mohawk Tribe in hopes of thwarting generic competition.

Procedurally, Allergan sought to avoid inter partes reviews, a type of patent challenge that has vexed drug makers since going into effect six years ago, because these are easier and faster to file than patent lawsuits. At the time it transferred patent rights to its Restasis eye treatment, which last year generated more than $1.4 billion in sales, Allergan was facing a conventional patent challenge in a federal court."

Louisiana considers radical step to counter high drug prices: Federal intervention; Washington Post, July 3, 2017

Carolyn Y. Johnson, Washington Post; Louisiana considers radical step to counter high drug prices: Federal intervention

"Gilead, a company that has projected between $7.5 billion and $9 billion in sales for 2017 for its hepatitis C drugs, says federal intervention would threaten future progress.

In a statement, the company said the proposal “puts in jeopardy further medical innovation by undermining the patent system and de-incentivizing research and development.” Gilead said that the state’s predictions of the budget impact are unrealistic, based on the idea that the entire infected population could be screened, treated and connected to treatment in a year. Gilead offers states that do not restrict access to treatments deep discounts — less than $30,000 for a 12-week treatment...

Gee said that she is not wedded to one approach and that she simply thinks the equity and access problems that are an outgrowth of high drug prices need to be tackled. After receiving the expert panel’s recommendation, Gee put out the proposal for public comment and received 102, a majority of which were in favor of taking some action. She expects to make a decision soon about a strategy to try to eliminate hepatitis C in Louisiana."

The Real Reason Drugs Cost Too Much; Bloomberg View, 8/23/16

Editorial Board, Bloomberg View; The Real Reason Drugs Cost Too Much:

"The problem would not be nearly so severe if the drugs' government-granted monopolies were shorter. Once generic versions are allowed to compete, a medicine's price often drops by almost half, sometimes more than 85 percent, if enough competitors jump into the market.

Yet the government tends to do the opposite, the Brigham and Women's researchers found, by extending market exclusivity via additional patents for trivial alterations -- a new coating on a pill, for example. This is nonsensical: Unless a drug is transformed in a way that affects its therapeutic value, it should not qualify for an extended patent.

Drug makers often stretch their own market exclusivity by paying generics companies to delay introducing competitive medicines.

The government, which is protecting these companies' monopoly rights, should demand an end to this tactic."

In Washington’s Drug Price Fight, Plenty of Blame to Go Around; Bloomberg, 10/27/16

Anna Edney, Robert Langreth, Bloomberg; In Washington’s Drug Price Fight, Plenty of Blame to Go Around:

"AARP, which represents seniors, is part of the Campaign for Sustainable Rx Pricing, along with Anthem Inc., one of the U.S.’s biggest health insurers, Wal-Mart Stores Inc. and the Blue Cross Blue Shield Association. The coalition has proposed having drugmakers submit for government review any price increases over 10 percent, and making it easier for generics to come to market.

Health insurers, who just six years ago were painted as villains during the passage of Obamacare, are relishing the turnabout now that drugmakers are the focus.

“These increases have got to stop,” said John Bennett, chief executive officer of Capital District Physicians’ Health Plan Inc., or CDPHP, a not-for-profit health insurer in Albany, New York. Last year, 22 percent of the premiums Capital took in for its commercial plans was spent on drugs.

“They are unsustainable for us as a society and they are morally wrong,” Bennett said in a telephone interview. “They are extracting profit out of a scarce resource that people need to survive.”

Members Of Congress Rip Into Mylan CEO; Huffington Post, 9/21/16

Lauren Weber, Huffington Post; Members Of Congress Rip Into Mylan CEO:

"“To have companies like yours take advantage of the situation, take advantage of these people who are really in need of this medication, I think it speaks to something that we are better than that,” Rep. Lacy Clay (D-Mo.) said. “How did we get to this point that we have a culture like this in corporate America that wants to stick it to consumers?”...

Cummings emphasized his disgust that pharmaceutical companies would continue to ratchet up drug prices for life-saving medication and said he hoped Bresch would apologize. She did not.

“After Mylan takes our punches, they’ll fly back to their mansions in their private jets and laugh all the way to the bank while our constituents suffer, file for bankruptcy, and watch their children get sicker and die,” Cummings said. “It’s time for Congress to act.”"

Drugs And Privilege: Big Business, Congress And The EpiPen; Huffington Post, 8/31/16

Michael Winship, Huffington Post; Drugs And Privilege: Big Business, Congress And The EpiPen:

"[Mylan CEO Heather Bresch] should resign for price gouging rather than get a raise, but like so many of her fellow executives Bresch sails serenely on as her fellow Americans drown in health care debt. Her career and the success of her company epitomize everything that so enrages every voter who believes that the fix is in and that the system is weighted in favor of those with big money and serious connections...

And even at half-price, the cost of an EpiPen remains an outrage. In fact, some estimate that the dose of epinephrine used in the injector may really cost as little as a dollar.

In other words, this is one more, big old scam — yet another case of big business trying to pull the wool over the citizens’ eyes and pick our pockets while the government and our politicians mostly look the other way.

The Mylan mess is the cozy relationship between regulators and the regulated in a nutshell. Throughout government, politics and business, cash contributions are made, connections are used, strings are pulled and favors are requested and returned. So the system wins again, corrupt as hell.

But take notice. Realize that the rest of us are more and more aware of how we’re being had — and that we truly must be heard and heeded. Unless the tiny-hearted, gold-digging CEOs of America’s corporations and our leaders get the dollar signs out of their eyes and come to their senses, they are writing a prescription for an angry public response that not even their bought-and-paid-for Congress can hold at bay."

Who is to blame for the EpiPen hike? Drug monopolies – not evil CEOs; Guardian, 8/29/16

Colin Holtz, Guardian; Who is to blame for the EpiPen hike? Drug monopolies – not evil CEOs:

"Instead of playing whack-a-mole, we need to break the monopolies themselves.

Many companies have effectively outsourced their R&D to federally funded academic research. Under existing law, federal funding of R&D requires companies to offer the medicine on “reasonable terms”. If they do not, we can demand generic versions for federal programs like VA hospitals, and pay a royalty in return. Or, we can simply break the patent for everyone.

In fact, we may not be limited to publicly funded pharmaceuticals. The federal government technically has the power to suspend a patent altogether. In 2003, the Bush administration threatened the maker of anthrax medicine Cipro with exactly that power.

Moving forward, all new patents could include far-stricter cost protections that link prices to median income. Or, if you prefer a more flexible system, you could incentivize innovation with hefty cash prizes, but place the resulting drugs in the public domain."

The Downfall Of Invention: A Broken Patent System; Huffington Post, 8/16/16

Tahir Amin, Huffington Post; The Downfall Of Invention: A Broken Patent System:

"The cost of dozens of brand-name drugs have nearly doubled in just the past five years. Public outrage over drug prices extends from Capitol Hill to the presidential candidates to patients. In response, pharmaceutical executives are spending more on lobbying and marketing. Yet for all this attention, most of the proposed solutions for reducing prescription drug costs—tougher negotiations, appeals for transparent R&D costs or investigations into insurers—miss one of the primary sources of the problem: the way we award patents.

Today, too many drug makers receive patents for unmerited and unjust reasons...

Not surprisingly, the pharma industry employs a variety of stall tactics that make it virtually impossible for affordable, generic drugs to enter the U.S. market. In what’s called “pay-for-delay,” for example, patent owners pay off generic manufacturers to wait before entering the market, a practice that could violate antitrust laws...

It’s time to restore the U.S. patent system to its original purpose – to protect and incentivize invention, not innovation."

Lifting the Patent Barrier to New Drugs and Energy Sources; New York Times, 4/12/16

Eduardo Porter, New York Times; Lifting the Patent Barrier to New Drugs and Energy Sources:

"Malaria has preyed on humans for centuries. Hundreds of thousands of children die each year from the disease. Considering the market’s size, why haven’t pharmaceutical companies rushed to develop a vaccine against the deadly parasite that causes it?

The answer is easy: There is no money to be made from a vaccine for poor children who could not possibly pay for inoculation.

Last year, GlaxoSmithKline finally introduced the world’s first malaria vaccine for large pilot tests among African children. The move, however, is not an endorsement of the profit motive as a spur for innovation. The Bill and Melinda Gates Foundation picked up much of the tab. And Glaxo does not expect to make money on its investment.

The lack of interest of the pharmaceutical industry, which generates huge profits protected by a web of patents enforced around the world, raises an important question.

Do we need a different way to spur innovation and disseminate new technologies quickly around the world? Are patents, which reward inventors by providing them with a government-guaranteed monopoly over their inventions for many years, the best way to encourage new inventions?"

Document Claims Drug Makers Deceived a Top Medical Journal; New York Times, 3/1/16

Katie Thomas, New York Time; Document Claims Drug Makers Deceived a Top Medical Journal:

"It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.

Duke and Johnson & Johnson contend that they worked independently of each other. Bayer declined to comment. And top editors at The New England Journal of Medicine said they did not know that separate laboratory data existed until a reporter contacted them last week, but they dismissed its relevance and said they stood by the article’s analysis.

But the claim — that industry influence led to the concealing of data — carries echoes, some experts said, of an earlier era of drug marketing, when crucial clinical data went missing from journal articles, leading to high-profile corrections and a wave of ethics policies to limit the influence of drug companies on medical literature."