AIDS Healthcare Foundation v. Gilead Sciences et al 

 

Area: Pharmaceutical Patents & Antitrust

Court: Northern District of California Federal Court

Berger & Hipskind represents the largest non-profit provider of HIV and AIDS medical care in the United States in a suit to stop Gilead Sciences illegal business practices which prevent affordable access to important, lifesaving HIV and AIDS therapies.

Gilead, in concert with Japan Tobacco and Janssen Sciences undertook a monopolistic scheme that tied the sales of Tenofavir Alafenamide Fumarate (“TAF”) to the sale of other drug products used in the treatment of HIV and AIDS.  Defendants’ anticompetitive practices arose in response to the upcoming expiration of Gilead’s patents covering Tenofovir Disoproxil Fumarate (“TDF”) in 2017, which will lead to generic entry in the TDF market and cut into Gilead’s multi-billion dollar profits. TDF has been used by physicians to treat HIV and AIDS for the past 15 years in conjunction with a variety of other drugs in various combinations and dosages to form a variety of highly active antiretroviral therapies (“HAART”) tailored for individual patients.


Because TAF is as efficacious as TDF, but in significantly smaller dosages, thus making it much safer for patients, TAF is replacing TDF as the backbone of HAART therapies.  Concurrent to its development of TDF, Gilead identified TAF as offering superior benefits to those suffering from HIV/AIDS as compared to TDF. However, instead of promptly developing TAF, and to maximize its profits and extend its monopoly in the field of Tenofovir treatments, Gilead sought to delay the release of TAF to ensure that TAF exclusivity did not overlap with its TDF monopoly until generic entry in the TDF market was imminent.  

While Gilead sat on its research regarding the safety of TAF for over a decade, HIV patients were given TDF and exposed to potentially life threatening kidney damage and bone toxicity.  Gilead’s delay in making TAF available was directly related to gaming the patent system and regulatory regime so Gilead could profit while HIV patients were deprived a drug known by Gilead to be a safer alternative.

 News Coverage Of The Case 

 

 Selected Case Documents 

 

Sunday, May 29, 2016

FEATURED ARTICLE: LA Times Publishes Frontpage Investigative Report On Berger & Hipskind's Lawsuit Against Gilead For Blocking Affordable Access To Medicine

Earlier this year, the Los Angeles-based AIDS Healthcare Foundation, which operates clinics and pharmacies for AIDS patients, sued Gilead, contending that it delayed the less toxic form of tenofovir to manipulate the patent system and keep prices artificially high.  The foundation, which buys tenofovir-based medicines for many of its 600,000 patients worldwide, called Gilead’s moves “a calculated, anticompetitive maneuver” aimed at keeping lower-cost generics off the market. It is asking the court to toss out the patents on the new drug so that other companies can sell it for less.

Clinical trials of the new compound on HIV-positive patients in Los Angeles and several other cities seemed to support their optimism. Patients needed just a fraction of the dose, creating the chance of far fewer dangerous side effects.  But in 2004, just as the Foster City biotech firm was preparing for a second and larger round of patient studies, Gilead executives stopped the research. 

Thursday, June 16, 2016

News Story On Protests Of Gilead Relating To Berger & Hipskind's Lawsuit Against Gilead For Blocking Access To Affordable HIV Drugs

The Los Angeles-based AIDS Healthcare Foundation has already sued Gilead Sciences and asked lawmakers to investigate the company over its drug pricing. But it’s not stopping there.

The foundation has launched a “Gilead Greed Kills!” advocacy campaign and staged two protests, the latest of which took place Wednesday in front of the California company’s Foster City headquarters. Fifty AIDS advocates, bedecked in “Gilead Greed Kills!” t-shirts, carried banners and placards criticizing the company for high prices on its HIV and hepatitis C meds.

Thursday, June 09, 2016

AIDS Healthcare Foundation Zaps Gilead with AIDS Drug Protest During Goldman Sachs Conference

AIDS Healthcare Foundation spearheaded a rolling protest caravan targeting the drug maker and its investors during the annual Goldman Sachs Global Healthcare Conference.  The protest featured a hearse, a double-deck bus and 40+ cars outfitted with “Gilead Greed Kills” banners as well as a small plane towing a “Gilead Greed Kills” banner over the resort. 

In a lawsuit filed earlier this year, AHF alleges that Gilead halted its early research of TAF in order to extend its patent on its existing HIV medication, which yielded billions of dollars in annual sales.  Gilead lawyers maintain the company “had no duty to develop, test, seek approval of, or launch its new product on any particular timetable.”  Meanwhile, HIV patients only had access to the more-harmful version of Gilead’s drug, which had damaging effects on their kidneys and bones.

Tuesday, June 07, 2016

Yahoo Finance - AIDS Healthcare Foundation Launches "Gilead Scandal" National Advertising Campaign

AIDS Healthcare Foundation, the largest global AIDS organization, has launched a new advertising campaign to draw attention to Gilead Sciences, Inc. following a recent and blistering LA Times article that exposed the pharmaceutical giant’s patent manipulation of its best-selling HIV drug.

In a lawsuit filed earlier this year, AIDS Healthcare alleges that Gilead halted its early research of TAF in order to extend its patent on its existing HIV medication, which yielded billions of dollars in annual sales.  Meanwhile, HIV patients only had access to the more-harmful version of Gilead’s drug, which had damaging effects on their kidneys and bones.

Monday, June 06, 2016

Politico - Lawsuit Claims Gilead Deliberately Delayed Safer HIV Drug

Critics say Gilead Sciences — the drug company that raked in $11 billion in annual sales on its blockbuster HIV drug tenovir —deliberately stopped research on a safer new version of the drug to maintain market dominance and maximize profits under its patent. Melody Petersen for the Los Angeles Times reports company executives stopped research even after scientists discovered a newer version — Genvoya promised 1,000-fold “greater antiviral potency” at a fraction of the dose. More than six years later, the company restarted those trials.

Wednesday, June 01, 2016

AIDS Foundation Asks Congress, FDA To investigate Gilead Over HIV Patent

Gilead’s new HIV meds containing tenofovir alafenamide fumarate, or TAF, can work at a fraction of the dose of last-gen product Viread, significantly cutting down on side effects. But critics claim the TAF meds shouldn’t be so new--and they’re calling on Congress to back them up.

The Los Angeles-based AIDS Healthcare Foundation intends to ask lawmakers and the FDA to investigate Gilead for potential patent manipulation and antitrust violations, it said Tuesday, citing “bald-faced greed” and “disregard for patient safety” by the California company.

Saturday, April 16, 2016

Berger & Hipskind LLP Files Amended Federal Complaint against Gilead over Disputed AIDS Drug Patent

As part of its federal lawsuit filed against Gilead Sciences Inc. alleging drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug, AIDS Healthcare Foundation (AHF) last week filed an Amended Complaint in U.S. District Court, Northern District of California, bringing Odefsey and Descovy, two other Fixed Dose Combinations (FDC) of multiple drugs that each contain a form of tenofovir and that were recently approved by the FDA, into the claim.

Wednesday, April 06, 2016

Fortune Magazine Article On Berger & Hipskind LLP's Case Against Gilead Sciences

The AIDS Healthcare Foundation alleged that Genvoya’s approval amounted to an attempt by Gilead to evergreen its patents on the older HIV med Stribilid, since the two drugs are essentially identical other than Genvoya’s newer tenofovir formulation.  Between HIV/AIDS therapies and Gilead’s megablockbuster hepatitis C treatments Sovaldi and Harvoni, the firm’s antiviral franchise brought in more than $30 billion in global 2015 sales.

Monday, March 28, 2016

The Pharmaceutical Business Review Coverage Of Berger & Hipskind LLP's Suit On Behalf Of The AIDS Healthcare Foundation

Earlier this year, AHF filed a federal lawsuit against Gilead Sciences and two other defendants in U.S. District Court, Northern District of California. It alleged drug patent manipulation and anti-trust claims with respect to Genvoya, the company's new four-in-one Fixed Dose Combination (FDC) to treat HIV/AIDS patients.  AHF president Michael Weinstein said: "Instead, so they could continue to maximize profits -- and run the patent clock -- on its older, potentially more harmful Tenofovir formulation. Gilead delayed bringing TAF to market and has yet to do so for TAF as a standalone drug."

Friday, March 25, 2016

Berger & Hipskind LLP Client AIDS Healthcare Foundation On Gilead's Delay In Bringing Key HIV Drug To Market: An Indefensible Excuse By Gilead

Despite the fact that Gilead is now widely touting its updated formulation of Tenofovir’s reduced risk of causing kidney damage and bone loss, it doesn’t matter one bit legally if they purposely delay bringing it to market. Instead, so they could continue to maximize profits—and run the patent clock—on its older, potentially more harmful Tenofovir formulation. Gilead delayed bringing TAF to market and has yet to do so for TAF as a standalone drug.

Tuesday, February 02, 2016

Pharmalot Article On Berger & Hipskind LLP Attorneys' Case Against Gilead: Gilead Accused Of Manupulating HIV Patents

In the latest legal challenge to Gilead Sciences and its register-ringing strategy, the AIDS Healthcare Foundation has filed a lawsuit accusing the drug maker of manipulating the patent system in order to thwart competition to its HIV medicines. And the nonprofit alleged that countless HIV patients have been prevented from accessing treatment — and may have been harmed — as a result.

Wednesday, January 27, 2016

The New York Times Discusses The Work Of Berger & Hipskind LLP Attorneys On An Antitrust And Patent Case Relating To Access To H.I.V. Drugs

The AIDS Healthcare Foundation filed a lawsuit seeking to invalidatepatents covering the new version of Gilead’s mainstay H.I.V. drug, tenofovir.The lawsuit also says that Gilead, to maximize product life span but to thedetriment of patients, delayed the introduction of the new, safer version oftenofovir until the old version was about to lose patent protection.

Tuesday, January 26, 2016

Reuters: AHF Files Federal Lawuit Against Gilead To Invalidate Patents On Key AIDS Drug

A legal action, filed today in U.S. District Court, Northern District of California, asserts that, “…Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to…” Tenofovir, a key component in Genvoya, Gilead’s fourinone Fixed Dose Combination (FDC).  Gilead’s illegal acts prevent people living with HIV/AIDS from accessing lifesavingtreatment and cost the public billions of dollars because of Gilead’s unwarrantedmonopoly,” said Daniel Hipskind, AIDS Healthcare Foundation’s attorney.

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