Category Archives: Business Law

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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

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

Arizona Drug Firm Insys Makes Synthetic Pot Compound, Spends Big to Defeat Legal Pot

THURSDAY, SEPTEMBER 8, 2016 AT 2:53 P.M.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
Prop 205 “fails to protect the safety of Arizona’s citizens, and particularly its children,” according to a statement Insys provided to New Times on Thursday in response to a message left for CEO John Kapoor. “Our stance is consistent with our company’s goals. We strive to develop pharmaceutical products for the supportive care of patients while taking patient safety very seriously. To that end, we believe that all available medicines should meet the clinical standards set by the FDA.”
Yet while Insys holds itself out as the savior of Arizonans’ health, the company is reportedly under investigation in four states, including Arizona, for marketing practices related to Subsys that have allegedly resulted in patient deaths.

Airbnb threatens to sue New York if governor signs new law curtailing its service

Airbnb says a bill that would outlaw advertising short-term rentals on its platform in New York is unconstitutional and is threatening to sue the state if Governor Andrew Cuomo signs it into law.

Airbnb has been fighting an uphill battle for legal status in New York, which prohibits landlords and homeowners from renting out apartments for less than 30 days at a time. The bill to prevent advertising these rentals would essentially cripple the company’s operations in New York, which is among its most lucrative markets.

In a letter to Cuomo and other state leaders, Airbnb outlines the legal action it says it would be forced take should the governor sign the bill, AB 8704-C, into law. “As this unlawful bill would impose real harm on our community, out of respect for the process and to inform your considerations, we want to formally notify the State that if it is signed into law by Governor Cuomo, Airbnb would have no choice but to immediately file suit against the State of New York and ask a court to declare the statute invalid and unenforceable as well as to award any damages and fees as appropriate,” Rob Chesnut, general counsel of Airbnb, writes in the letter.

“AIRBNB WANTS TO BE CLEAR THAT IT DOES SO MORE IN SADNESS THAN IN ANGER”

Chesnut adds, “In making such a formal notification, Airbnb wants to be clear that it does so more in sadness than in anger, as the company believes that there are clearly available lawful alternative legislative options to meet legitimate policy objectives while still protecting the right of everyday New Yorkers to share the homes they live in order to help make ends meet.”

Airbnb has been accused of exacerbating New York’s housing crisis by housing advocates, the state’s powerful hotel union, and members of the state legislature and New York City Council. Some unscrupulous landlords have been known to push out their tenants, many of them low-income, so they can turn their apartments into illegal hotels, which they advertise on Airbnb.

Last year, the New York attorney general released a report that found that from 2010 through early June of 2014, $168.3 million, or 37 percent percent of revenue generated by Airbnb hosts, came from hosts with three or more listings.

Full Article – http://www.theverge.com/2016/9/7/12834606/airbnb-threatens-lawsuit-new-york-governor-cuomo-law

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/