Showing posts with label Big Pharma. Show all posts
Showing posts with label Big Pharma. Show all posts

Wednesday, May 1, 2024

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."

Saturday, July 22, 2023

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

Rebecca Robbins and 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."

Monday, March 13, 2023

The top 10 drugs losing US exclusivity in 2023; Fierce Pharma, March 13, 2023

Fraiser Kansteiner, Eric Sagonowsky, Zoey Becker, Kevin Dunleavy, Angus Liu, Fierce Pharma; The top 10 drugs losing US exclusivity in 2023

"Across the industry this year, big-selling drugs from Johnson & Johnson, Takeda, AstraZeneca, Roche and other companies are set to face their first generic or biosimilar challengers in the U.S. As always, the patent expirations should create quite a shake-up for many of the industry’s top players."

Friday, October 5, 2018

Drugmakers play the patent game to ward off competitors; Kaiser Health News via NBC News, October 2, 2018

Sarah Jane Tribble, Kaiser Health News via NBC News; Drugmakers play the patent game to ward off competitors

"Yet the patenting of a small change in how an existing drug is made or taken by patients is part of a tried-and-true pharmaceutical industry strategy of enveloping products with a series of protective patents.
Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents, using tactics critics call “evergreening” or “product hopping.”
Lisa Larrimore Ouellette, a patent law expert at Stanford University, said the pharmaceutical industry gets a greater financial return from its patent strategy than any other industry does."

Saturday, August 4, 2018

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."

Sunday, April 15, 2018

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."

Saturday, February 24, 2018

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."

Tuesday, July 11, 2017

Why drugmakers aren’t sweating the next wave of patent losses; Bloomberg News via News Chief, July 10, 2017

Bloomberg News via News Chief; Why drugmakers aren’t sweating the next wave of patent losses

"Drugmakers plunged off a patent cliff earlier this decade, losing billions in sales as lucrative branded drugs lost exclusivity. An expensive lobbying effort aimed at preventing a repeat is paying off.
The loss of a series of key patents for cholesterol fighters and other widely used medicines cost big-name drug companies about $82 billion in sales between 2011 and 2013, according to life-sciences data company Evaluate Ltd., forcing large-scale job cuts and a wave of deals to make up for lost revenue...
By the time lawmakers passed a path to market for biosimilars as part of the Affordable Care Act in 2010, the industry had assured that competition would come much more slowly, making the resulting sales decline look less like a precipice and more like a gentle hill."

Tuesday, July 4, 2017

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

"At [Louisiana’s health secretary Rebekah] Gee’s urging, Joshua Sharfstein, a professor of public health at Johns Hopkins University and a former Food and Drug Administration deputy commissioner, convened a meeting of health-policy specialists and economists. They advised that the state ask the federal government to intervene in a two-pronged approach: Gee should first ask the government to negotiate with a drug company and license a medication, in line with a recent recommendation by a committee from the National Academies.

At the same time, they advised Gee to pursue a harder-edged tactic, in case the voluntary approach did not work: Gee should ask the secretary of health and human services to invoke a century-old law that allows the government to use patents at a reasonable cost. The panel recommended a price as low as $1,000 per patient.

The law was used routinely in the 1950s and 1960s to make medicines available at lower prices. It was considered but not used during the anthrax attacks in 2001. It has been used by more than 10 government agencies or departments to lower the prices for patented inventions, including night-vision goggles for the Defense Department.

“The drug has been out for years, and we’re failing to provide it to the majority of people who have this infection,” Gee said. “We’re failing at our mission to improve the public health, and so just doing what we’re doing is not an option and we have to do better.”"

Monday, July 3, 2017

‘Bombshell’ Canadian Patent Ruling Seen Favoring Foreign Companies; Bloomberg, June 30, 2017

Josh Wingrove, Bloomberg; ‘Bombshell’ Canadian Patent Ruling Seen Favoring Foreign Companies

"“It’s a bombshell of a decision,” said Richard Gold, a law professor at Montreal’s McGill University who studies intellectual property. He’s a member of the university’s Centre For Intellectual Property Policy, which intervened in the case. “We’re now the only country in the developed world that when an inventor says, ‘my invention does X,’ it doesn’t actually have to do X.”
The Supreme Court ruled that a current standard, known as the “promise doctrine,” goes too far, because it allows for patents to be invalidated if an invention doesn’t do any of the things it promised."

Monday, May 22, 2017

The World’s Best-Selling Drug Just Lost a Key Patent Battle; Fortune, May 18, 2017

Sy Mukherjee, Fortune; 

The World’s Best-Selling Drug Just Lost a Key Patent Battle


"The rheumatoid arthritis and psoriasis medicine has recently been a target of biopharma companies that are trying to make generic Humira copycats called "biosimilars."...

Once the drug does fall off the patent cliff, however, AbbVie could be in for some rough times. Humira sales make up more than 60% of its revenues."

Wednesday, November 2, 2016

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."

Tuesday, October 11, 2016

The government and the courts are finally getting fed up with patent trolls — and stupid patents; Los Angeles Times, 10/11/16

Michael Hiltzik, Los Angeles Times; The government and the courts are finally getting fed up with patent trolls — and stupid patents:
"Almost nobody disputes that America’s patent system is a mess, or that it’s been that way for an unconscionably long time.
Overworked and misguided patent examiners issue patents for manifestly undeserving claims. An entire industry of patent trolls has sprung up to assemble patent rights and exploit them, not to make products or develop services, but to harass other businesses into paying them off to avoid costlier litigation.
Efforts to reform patenting tend to run into resistance from big businesses, such as the pharmaceutical industry, that long ago figured out how to game the process and are disinclined to give up their advantage. As a result, a system that was written into the U.S. Constitution to encourage invention and innovation has been turned into a “dead weight … on the nation’s economy.”"

Monday, August 29, 2016

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."

Friday, August 19, 2016

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."

Thursday, June 16, 2016

Mr. Modi, Don't Patent Cow Urine; New York Times, 6/16/16

Achal Prabhala and Sudhir Krishnaswamy, New York Times; Mr. Modi, Don't Patent Cow Urine:
"The B.J.P. government released India’s first National Intellectual Property Rights Policy last month, and it is dangerously misguided. Although the paper reaffirms the basic tenets of India’s admirably farsighted patent laws, it also calls for protecting traditional remedies like cow urine. Taken to its logical conclusion, this policy could open the door to many more exceptions, playing into the hands of patent-happy international pharmaceutical companies.
Big Pharma justifies aggressive patenting by claiming that profit-making drives invention by giving labs and companies an incentive to invest in research. Indian law takes the opposite view: Higher standards for legal protection leave more room for innovation. Unlike many other countries, India does not allow patents for natural substances, traditional remedies, frivolous inventions or marginal innovations.
This is a good thing — a great thing, in fact. Having fewer patents means more competition for more generic drugs, which means more affordable medicine for more people. Imatinib, a drug used to treat a form of leukemia, is available in India at about one-tenth the price it costs in much of the world. In 2000, when the only anti-retroviral drugs for HIV/AIDS available were produced by Western companies, the annual cost of treatment was about $10,000. The price has dropped to about $350, at least in the developing world, thanks to generic equivalents that were developed in India.
Naturally, all this drives Big Pharma mad. Its business model relies largely on patenting small tweaks to existing technologies, which multiplies financial returns with only minimal investment in research."

Wednesday, April 13, 2016

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?"