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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

By

NOEMIE BISSERBE and
INTI LANDAURO

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

Blog, Business Law, Drug Companies, Legal News

Drug makers spend big to fight California price control referendum

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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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Blog, Business Law, Drug Companies, Personal Injury

Texas Law Firm Investigating Potential For Talc Lawsuits Against Johnson & Johnson

Baron & Budd: “Seemingly Benign Product” Could Lead to Severe Health Complications Including Ovarian Cancer

ARTICLE | | BY DAVE SCHATZ

NEW BRUNSWICK, NJ–A Dallas-based law firm apparently wants to get in on the opportunity to represent women harmed by Johnson & Johnson’s (J&J’s) talcum-based products.

The law firm, Baron & Budd, says it is investigating potential legal action against Hub City-based pharmaceutical giant Johnson & Johnson (J&J) regarding a possible link between its talcum-based products and ovarian cancer, according to a press release issued by the firm on the last day of February.

Talc, a mineral, is contained in J&J products including baby powder.  It is imported from China, according to package labels.

The “national” law firm cites the recent $72 million verdict in Missouri, one that many media outlets have picked-up on.

The family of Jackie Fox will receive $62 million in a punishment award, plus $10 million in compensatory damages, as we reported.  J&J is expected to appeal the decision.

The release mentions that more than 1,000 other suits are pending against the company, but does not mention the 130 additional cases in the Garden State, consolidated in Atlantic County. The first New Jersey case is set to go to trial in July.

“It is extremely disturbing that such seemingly benign products could be linked to a devastating disease,” said Russell Budd, president and managing shareholder of Baron & Budd.

“We will thoroughly investigate this matter and make sure the rights of anyone harmed by talc-based products are protected.”

“Plaintiffs in the cases are claiming that [J&J] failed for decades to warn consumers that talc-based products such as Shower to Shower and baby powder posed a risk for ovarian cancer,” says the release, citing a report from Reuters highlighting the concern that women who use talcum powder on their genitals are at a higher risk for developing the disease.

Reuters also reported that many women traditionally, “spread talcum powder in the genital areas to help eliminate vaginal odors and keep the area comfortable and cool,” reads the release.

An epidemiologist at a Cancer Center in St. Louis is quoted in the Reuters Report as saying that inflammation increases the risk of a woman developing Ovarian Cancer, and it is a known fact that talcum powder increases inflammation, according to the release.

“The Reuters article also reported that a Harvard University doctor who testified in the Missouri trial has published several studies since 1982 linking talc-based products and ovarian cancer. According to the doctor, exposure to talc can increase a woman’s risk of developing the disease by as much as 30 percent,” says the release.

In 2011, J&J responded to consumer pressure concerning two harmful chemicals used to make its famous “No More Tears” baby shampoo: formaldehyde and 1,4-dioxane.

J&J ultimately reformulated the product, moving to its current hypoallergenic version, which is available on store shelves around the world. It looks and smells the same as the original formula. But, according to media reports it still contains very small amounts of formaldehyde.

J&J has said it was very costly to make the change. Now other makers of look-alike, golden-hued baby shampoos, including Wal-Mart Stores Inc., “Equate” label are also paraben, phthalate and quatemium 15 free.

Sourced From –http://newbrunswicktoday.com/article/texas-law-firm-investigating-potential-talc-lawsuits-against-johnson-johnson