Tag Archives: drug company legal news

Sanofi Files Suit Against Merck, Claiming Patent Infringements

French drugs firm takes legal steps to prevent the launch of rival versions of its diabetes treatment

A packet of diabetes drug Lantus SoloStar on the production line at a manufacturing site of French drugmaker Sanofi in Frankfurt, Germany. The French company has filed a lawsuit against U.S. peer Merck & Co. to prevent it from launching a rival version of its diabetes treatment. PHOTO: REUTERS

PARIS— Sanofi SA said it filed a lawsuit against Merck & Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant’s best-selling diabetes treatment Lantus.

In the filing in the U.S. District Court of Delaware, Sanofi said on Monday it claims that Merck Sharp & Dohme Corp., Merck & Co.’s international division, violated as many as 10 patents held by the French company, including ones for its insulin Lantus and its insulin delivery device soloSTAR.

The Paris-based drugs company said it started the legal proceedings against Merck after the U.S. firm’s filing for new drugs applications with the U.S. Food & Drug Administration.

A spokeswoman for Merck said the company’s product “doesn’t infringe Sanofi’s patents.”

Sanofi shares were 1.3% higher at €69.91 in midday trading.

The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue.

In the first six months of the year, diabetes revenue fell by 6% to €2.9 billion ($3.2 billion), hit by a 15% drop in Lantus sales to €2.38 billion. The company has said it expects revenue from diabetes drugs to continue to decline this as competition among insulin makers intensifies.

In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi.

In a bid to replenish its new drugs pipeline and revive growth, Sanofifor months had pursued U.S. biotech Medivation—a Nasdaq-listed company that focuses on hard-to-treat cancers, markets one prostate-cancer therapy, Xtandi, and has two other oncology assets in clinical development.

But U.S. pharma giant Pfizer Inc. beat out Sanofi grabbing Medivation for $14 billion in August.

Sourced From  – http://www.wsj.com/articles/sanofi-files-suit-against-merck-on-patent-infringements-1474285467

Has Charitable Giving Become A Profitable Form Of Investing For Pharmaceutical Companies?

Martin Shkreli, the notorious ex-CEO of Turing Pharmaceuticals, made waves last summer when he purchased the rights to Daraprim and raised its price more than 5,000 percent. Physicians use the drug to treat toxoplasmosis, a life-threatening condition that affects those with weakened immune systems (due to HIV/AIDS, etc.).

Days after Shkreli’s purchase, he contacted Patient Services Inc., a charity committed to making medical care more affordable. Shkreli wanted to create a fund for – you guessed it – patients who suffer from toxoplasmosis.

Patient Services Inc., or PSI, jumped at the opportunity, suggesting an initial donation of $22 million, including $1.6 million of its operational costs. Shkreli countered with an offer of $1 million and $80,000 of the company’s costs. This was a paltry offer, considering that Daraprim now costs $60,000 to $90,000 for six-week treatment in light of Shkreli’s price hike.

And that isn’t the worst of it.

Finding A Loophole

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PSI is a copay charity, one of seven large ones in the U.S. health care system. It exists to offer payment assistance to the 40 million Americans who qualify for Medicare, helping them to a smaller copay and smaller up-front costs. Even with the help of copay charities, Medicare recipients were still paying around $3,000 for their Daraprim prescriptions.

American taxpayers shoulder the difference. This is where the controversy of “charitable giving” comes into play. By donating a paltry $1 million to a copay charity, Shkreli was able to collect millions more from Medicare, thanks to his own drug price hike. “Big pharma” benefits, while taxpayers and patients suffer.

The Great Charitable Giving Illusion

Many pharmaceutical companies give the illusion that they participate in charity copay for altruistic reasons. Congress recently released an internal case study of Turing Pharmaceuticals, suggesting that its patient payment programs should be “repeatedly referenced” to promote public relations. Experts explain that giving millions to these copay charities makes pharmaceutical companies look altruistic, when the opposite is actually true.

The real intent of these donations is often to deflect criticism when they hike drug prices, leaving the health care system to pick up the broken pieces.

A History Of Deceit

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Daraprim may be the most high-profile example of this charitable funding phenomenon, but it’s certainly not the first. Retrophin, another drug company run by the now-infamous Shkreli, hiked the price on Thiola, a drug intended to treat recurring kidney stones, nearly 2,000 percent. At the same time, his company gave a donation to PSI for kidney stone patient copays.

Read Full Article – https://www.summitbehavioralhealth.com/blog/charitable-giving-profitable-investing-pharmaceutical-companies/

Big Pharma Promotes Legal Drug Addiction

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Big Pharma Promotes Legal Drug Addiction

Many of us believe that Big Pharma must be held accountable for this dangerous opioid trend, especially since several have been caught lying about the benefits and risks of their drugs.

As noted by the Organic Consumers Association (OCA), the drug industry has “fostered the opioid addiction epidemic” in several ways, by:

  1. Introducing long-acting opioid painkillers like OxyContin, which prior to reformulation in 2010 could be snorted or shot. Many addicts claimed the high from OxyContin was better than heroin. In fact, from a chemical standpoint, OxyContin is nearly identical to heroin, and has been identified as a major gateway drug to heroin.
  2. Changing pain prescription guidelines to make opioids the first choice for lower back and other pain conditions that previously did not qualify for these types of drugs. Even the World Health Organization (WHO) has had a hand in this problem, although it restricted its promotion of narcotic painkillers to cancer patients.
  3. Promoting long-term use of opioids, even though there’s no evidence that using these drugs long term is safe and effective
  4. Downplaying and misinforming doctors and patients about the addictive nature of opioid drugs. OxyContin, for example, became a blockbuster drug mainly through misleading claims, which Purdue Pharma knew were false from the start. The basic promise was that it provided pain relief for a full 12 hours, twice as long as generic drugs, giving patients “smooth and sustained pain control all day and all night.”However, for many the effects do not last anywhere near 12 hours, and once the drug wears off, painful withdrawal symptoms set in, including body aches, nausea and anxiety. These symptoms, in addition to the return of the original pain, quickly begin to feed the cycle of addiction.7

A 2015 article in The Week does a great job revealing the promotional strategy developed by Purdue, and backed by the US Food and Drug Administration (FDA), that has led to such enormous personal tragedy.

As noted in this article: “The time-release conceit even worked on the FDA, which stated that ‘Delayed absorption, as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.’”

Other recent research has found that medical marijuana lowers prescription drug use.

The Big Q: Could that be why it hasn’t been rescheduled?

There are no other truly compelling reasons why addictive narcotics like OxyContin are legal, while marijuana, which is extremely unlikely to kill even if one take very high amounts is not.

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Read Full Article – http://www.livetradingnews.com/big-pharma-promotes-legal-drug-addiction-10406.html#.V6F8KZMrKRs

Merck’s patent win over Gilead reversed over false testimony

Merck & Co.’s $200 million jury verdict against Gilead Sciences Inc. was voided in a patent dispute over a breakthrough for hepatitis C because of misconduct by a witness at the companies’ trial.

A federal judge concluded Monday that dishonest and duplicitous testimony by a retired Merck scientist before and during a March trial played into the jury’s finding that the company was responsible for early discoveries that led to the development of Gilead’s Sovaldi and Harvoni medicines.

The scientist “intentionally fabricated testimony” and Merck supported his “bad faith conduct,” U.S. District Judge Beth Labson Freeman in San Jose, California, said in her ruling.

The reversal of the fifth-largest U.S. verdict this year vindicates Gilead in its refusal to share royalties with Merck on the more than $20 billion revenue the hepatitis C drugs generated from 2013 through 2015 in the U.S. The Foster City, California-based company’s sales have started to slow this year as competition for the liver disease market intensifies among drugmakers.

“This is a nice little bump for Gilead who’d already accounted for the $200 million,” said Bloomberg Intelligence analyst Asthika Goonewardene. “But of course, this is a big win and will be beneficial to Gilead and how they can claim ownership of the drug in the long run.”

Merck vowed to appeal Monday’s ruling, saying it “does not reflect the facts of the case.”

“In its decision, the jury recognized that patent protections are essential to the development of new medical treatments,” the company said in an email. “The compounds and methods at issue in this case facilitated significant advances in the treatment of patients with HCV infection, and achieving these advancements required many years of research and significant investment by Merck and its partners.”

Gilead said it “has always believed Merck’s patents are invalid and unenforceable.”

“We are pleased the court has ruled in Gilead’s favor and determined that Merck’s patents are unenforceable against Gilead, and therefore, Merck is not entitled to recover any damages,” the company said in an email.

Labson Freeman re-opened the case in April after Gilead alleged that ex-Merck scientist Phil Durette gave conflicting statements about his participation in a key phone call some 15 years earlier when the drug’s basic composition was first presented to Merck.

Durette initially said in a pretrial deposition he wasn’t on a phone call in which secrets about the compound’s basic chemistry were discussed while Merck was exploring a take-over of Pharmasset Inc., a company that was later acquired by Gilead. When testifying to the jury after checking his notes, Durette admitted to playing a role in the meeting.

“Dr. Durette’s lying at his deposition, recanting that testimony at trial without proper prior notice to Gilead, and further untruthful testimony at trial all support the court’s conclusion that Merck did intend to deceive Gilead and the court,” the judge wrote.

She said Merck’s actions were “even more egregious” because Durette was acting as the company’s patent attorney.

Merck’s victory at trial had set the stage for it to seek future royalty payments from Harvoni and Sovaldi, which sells for $1,000-a-pill in the U.S., before discounts and rebates.

While Gilead continues to dominate the market, the lull in its hepatitis C treatment revenue opened the door to Amgen Inc. retaking its place as the world’s top biotech firm by market capitalization.

The case is Gilead Sciences Inc. v. Merck & Co., 13-cv-04057, U.S. District Court, Northern District of California (San Jose).

Full Article – http://www.theindianalawyer.com/mercks-patent-win-over-gilead-reversed-over-false-testimony/PARAMS/article/40559

Drug makers spend big to fight California price control referendum

Drug Companies To Pour $100M Into Battle Against California’s Price Control Ballot Initiative

The initiative, likened by one lobbyist to a “grenade being rolled into the conversation,” would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs, and the industry is gearing up to fight back. In other news, Novartis’ heart-failure drug is getting a warmer welcome in Europe than America, and the company is considering its options in selling its stake in Roche.

Politico: Drug Makers Spend Big To Fight California Price Control Referendum

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state. That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C. (Cook and Karlin-Smith, 4/25)

The industry is expected to pour $100 million into an effort to squash the November ballot initiative.

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state.

That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C.

Drug companies are expected to pour $100 million into an effort to squash the referendum in what will be a test of the industry’s strength at a time of growing consumer backlash against drug prices. The initiative would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs — one of the few federal agencies allowed to negotiate drug prices.

From the industry’s perspective, California could set a dangerous precedent. Besides having an economy the size of many small countries, the liberal bastion is often a laboratory for new ideas that take root and then spread east. That’s even more likely given that the presidential front-runners are pushing the federal government to negotiate drug prices for Medicare.

“This is the crack in the door” on drug pricing, said Jamie Court, president of Consumer Watchdog, a California nonprofit devoted to consumer protection issues. “If any Democrat in America wants bulk purchasing in Medicare, it will start with bulk purchasing for the most liberal state government in America.”

Which is precisely the intention of the initiative’s sponsor, Michael Weinstein, CEO of the Los Angeles-based AIDS Healthcare Foundation. “If we win, we hope it will start a national prairie fire,” he said.

Weinstein pursued the ballot measure after years of in-your-face activism on AIDS and after watching the California state legislature fail to do anything about drug prices — a big concern to people with HIV/AIDS who may be taking costly drugs for the rest of their lives.

Read more: http://www.politico.com/story/2016/04/drug-makers-california-referendum-222334#ixzz471Q9mg4k
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