Tag Archives: pharmaceutical 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

Why pharma companies are fighting legal marijuana


There’s a body of research showing that painkiller abuse and overdose are lower in states with medical marijuana laws. These studies have generally assumed that when medical marijuana is available, pain patients are increasingly choosing pot over powerful and deadly prescription narcotics. But that’s always been just an assumption.

Now a new study, released in the journal Health Affairs, validates these findings by providing clear evidence of a missing link in the causal chain running from medical marijuana to falling overdoses. Ashley and W. David Bradford, a daughter-father pair of researchers at the University of Georgia, scoured the database of all prescription drugs paid for under Medicare Part D from 2010 to 2013.

They found that, in the 17 states with a medical-marijuana law in place by 2013, prescriptions for painkillers and other classes of drugs fell sharply compared with states that did not have a medical-marijuana law. The drops were quite significant: In medical-marijuana states, the average doctor prescribed 265 fewer doses of antidepressants each year, 486 fewer doses of seizure medication, 541 fewer anti-nausea doses and 562 fewer doses of anti-anxiety medication.

But most strikingly, the typical physician in a medical-marijuana state prescribed 1,826 fewer doses of painkillers in a given year.

These conditions are among those for which medical marijuana is most often approved under state laws. So as a sanity check, the Bradfords ran a similar analysis on drug categories that pot typically is not recommended for — blood thinners, anti-viral drugs and antibiotics. And on those drugs, they found no changes in prescribing patterns after the passage of marijuana laws.

“This provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws,” they write.

In a news release, lead author Ashley Bradford wrote, “The results suggest people are really using marijuana as medicine and not just using it for recreational purposes.”

One interesting wrinkle in the data is glaucoma, for which there was a small increase in demand for traditional drugs in medical-marijuana states. It’s routinely listed as an approved condition under medical-marijuana laws, and studies have shown that marijuana provides some degree of temporary relief for its symptoms.

The Bradfords hypothesize that the short duration of the glaucoma relief provided by marijuana — roughly an hour or so — may actually stimulate more demand in traditional glaucoma medications. Glaucoma patients may experience some short-term relief from marijuana, which may prompt them to seek other, robust treatment options from their doctors.

The tanking numbers for painkiller prescriptions in medical marijuana states are likely to cause some concern among pharmaceutical companies. These companies have long been at the forefront of opposition to marijuana reform, funding research by anti-pot academics and funneling dollars to groups, such as the Community Anti-Drug Coalitions of America, that oppose marijuana legalization.

Read Full Article – https://www.washingtonpost.com/news/wonk/wp/2016/07/13/one-striking-chart-shows-why-pharma-companies-are-fighting-legal-marijuana/