Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries; The New York Times, October 2, 2024

Stephanie Nolen , The New York Times; Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries

"The drugmaker Gilead Sciences on Wednesday announced a plan to allow six generic pharmaceutical companies in Asia and North Africa to make and sell at a lower price its groundbreaking drug lenacapavir, a twice-yearly injection that provides near-total protection from infection with H.I.V.

Those companies will be permitted to sell the drug in 120 countries, including all the countries with the highest rates of H.I.V., which are in sub-Saharan Africa. Gilead will not charge the generic drugmakers for the licenses.

Gilead says the deal, made just weeks after clinical trial results showed how well the drug works, will provide rapid and broad access to a medication that has the potential to end the decades-long H.I.V. pandemic.

But the deal leaves out most middle- and high-income countries — including Brazil, Colombia, Mexico, China and Russia — that together account for about 20 percent of new H.I.V. infections. Gilead will sell its version of the drug in those countries at higher prices. The omission reflects a widening gulf in health care access that is increasingly isolating the people in the middle."

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."

'Could You Patent The Sun?'; New York Times, January 2017

Video, New York Times; 'Could You Patent The Sun?'

"Decades after Dr. Jonas Salk opposed patenting the polio vaccine, the pharmaceutical industry has changed. What does that mean for the development of innovative drugs and for people whose lives depend on them?"

The Strange Case of Off-Patent Drug Price Gougers; Bloomberg, 9/9/16

Justin Fox, Bloomberg; The Strange Case of Off-Patent Drug Price Gougers:

"There’s a conflict at the heart of pharmaceutical pricing in the U.S.: On the one hand, it’s in the public’s interest for pharma companies to get a good return on the huge investments they often make in developing new drugs. On the other, it’s in the public’s interest to be able to afford those drugs.

We try to resolve this by granting companies temporary monopolies (aka patents) on the drugs they develop -- letting them effectively set the price unilaterally -- but then allowing competition from generic substitutes once the patents expire...

What’s going on, basically, is that a new breed of pharmaceutical company has emerged (Valeant is, or at least was, the archetype) that doesn’t develop drugs but identifies business opportunities in existing drugs --many of them with expired patents -- that the previous owners were too lazy or timid or decent to fully exploit. So they acquire them, and jack up the prices."