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Sanofi Pasteur agreed to pay more than $19.8 million to settle allegations that it overcharged the Department of Veterans Affairs for its products...The French pharma’s vaccines unit voluntarily reported the "calculation and reporting error" with the VA in 2012, and has since "cooperated fully and negotiated in good faith with the government,"...Sanofi Pasteur based its first disclosure to the U.S. government on products sold to the VA from 2007 to 2011. A follow-up investigation by the VA's Office of Inspector General found the overcharging error dated back to 2002, the DOJ said…This is not the first settlement in a pharma overpricing case. A range of drugmakers have paid settlements to wrap up improper billing allegations, which often fall under the False Claims Act, which governs overcharging for Medicare, Medicaid and other government programs. The most prominent recent case was Mylan’s $465 million deal to settle allegations that it overcharged Medicaid for EpiPens...

National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...

• Disregarding federal laws
• Reliance on pharmaceuticals
• Lining up for the ‘T Train’

The state of California has filed a civil suit against units of drugmakers Teva and Allergan, for allegedly obstructing generic competition to Lidoderm transdermal patches...The suit...alleges a "pay-for-delay" deal between the companies and Endo Pharmaceuticals, which already had its Lidoderm product on the market and had made $825 million off of it in 2011...Allergan signed an agreement with Endo Pharmaceuticals, promising that the company would not face any generic competition for Lidoderm from units of Allergan from May 2012 through September 2013 and in turn that Allergan would not face any competition from Endo until May 2014...anticompetitive agreements...lead consumers, payors and the State to pay, directly or indirectly, monopoly prices for Lidoderm medications and deny them the lower prices that generic competition provides...  

The mental health system in Nevada has long been a lightning rod for criticism, with the Silver State consistently ranking at or near the bottom of most national rankings...But state legislators and health officials say a trio of bills now being drafted would make some small improvements by streamlining licensing of mental health professionals, updating the state’s definition of “mental illness” and making it easier to share information on individuals who have been deemed mentally ill with law enforcement...(Assemblyman James Oscarson)...proposed transferring “responsibility for regulating certain mental health-related professions to the State Board of Health...Another bill...would allow the state criminal record repository to more easily share information with local law enforcement officers. The idea is to help them identify an individual who has been “adjudicated as mentally ill or has been committed to any mental health facility” and is therefore barred from possessing firearms...A third proposal...aims to update the definition of “mental illness” in Nevada statutes...The bill would bring the state into line with the definitions in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders….

Novartis is embroiled in a soap opera in Greece, complete with bribery allegations and a suicide threat. Now the plot is thickening. The country’s chief corruption prosecutor, Eleni Raikou, has resigned—and she’s blaming the Swiss pharma giant’s legal issues for her decision...Raikou...sending a letter to Greece’s Supreme Court claiming she was targeted by "unofficial power centres" over her investigation of Novartis...Greek authorities raided Novartis’ offices...after one of the company’s local managers reportedly made a suicide threat...The executive was one of the employees the authorities were interviewing...The probe began after media reports appeared alleging that Novartis had paid bribes to local "functionaries,"…Raikou’s resignation letter said that the bribery probe turned up "substantial and crucial evidence" that doctors and some politicians in Greece had received €28 million ($30.4 million) worth of bribes from a Novartis bank account...some of the evidence was linked to the prosecution of a local businessman and former minister of defense Yiannos Papantoniou...

In a hotly anticipated judgment, the U.S. patent office...ruled that key patents held by the Broad Institute of MIT and Harvard on the gene-editing technology CRISPR-Cas9 do not overlap with competing claims from the University of California...UC may now receive a patent covering broader claims on the revolutionary tech...the Patent Trial and Appeal Board ruled the claims of UC and the Broad to be patentably distinct subject matter, leading the three judges to declare a judgment of non-interference...Put into layman's terms, the claims of the UC and the Broad are distinct enough so as to be separately patentable and therefore don't overlap with each other. This effectively supports the Broad's existing patents, while sending the UC's pending patent application back to the initial patent examiner...UC with a patent on use of CRISPR in all cells and the Broad with a patent for use of CRISPR specifically in eukaryotic cells...If that were to happen, biotechs operating in the space could end up having to license the tech from both UC and the Broad.

As Sanofi and Regeneron scramble to keep their PCSK9 cholesterol drug Praluent on the market, Amgen’s rival drug Repatha already appears to be chipping away at its market share...For the week of January 20, Repatha’s prescription total hit 3,231, ahead of Praluent’s 2,859...The Praluent partners are of course embroiled in a patent fight against Amgen, which claims that Sanofi and Regeneron knowingly stepped on its patents in developing Praluent. A district court jury sided with Amgen, and the judge in the case granted Amgen’s request for an injunction that would push Praluent off the market...Sanofi and Regeneron hope that the threat is short-lived; they’re trying to persuade the U.S. Circuit Court of Appeals in Washington, D.C., to put off the injunction while their patent appeal is heard. In their request for a stay, the two companies argued that they have a good chance of winning their appeal and that pulling Praluent in the meantime would do great damage to Regeneron.

Biogen's defense of its blockbuster multiple sclerosis treatment Tecfidera (dimethyl fumarate) got a lift...after the U.S. Patent Trial and Appeal Board rejected a patent challenge by a group affiliated with hedge fund manager Kyle Bass...The...Board upheld Biogen's '514 patent on the 480 mg dose of Tecfidera, boosting the chances Biogen will be able to maintain patent protection on the top-selling drug for longer...Despite the positive development, Biogen hasn't fully put to rest the patent challenges surrounding Tecfidera. So-called interference proceedings between the company and Forward Pharma are still ongoing at the Patent Trial and Appeal Board, which could force Biogen to pay Forward royalties on sales of Tecfidera.

The Federal Trade Commission...accused a Shire plc subsidiary of filing dozens of "sham" petitions with the Food and Drug Administration in an effort to delay generic competition to its branded prescription drug Vancocin HCI...the FTC alleged that Shire ViroPharma filed 43 citizen petitions with the FDA (along with 3 lawsuits) over a seven-year period, knowing that the FDA typically waited to approve generic drugs until it had resolved any outstanding citizen petitions...a deliberate attempt to maintain a monopoly...ViroPharma’s efforts led consumers and other purchasers to pay hundreds of millions of dollars more for the drug.

...Dr. Henri Wetselaar...his medical assistant (David Litwin) and a pharmacist (Jason Smith)...are accused of funneling large quantities of pills onto the streets of Las Vegas through an illegal prescription drug ring...the trial...has provided a window into the scope of the federal government’s crackdown on prescription drug abuse in Southern Nevada...One of the government’s star witnesses is a drug dealer who testified this week about an arrangement she had with Wetselaar and Litwin, who saw clients out of her home twice a week. Carolyn Allen said she would refer clients to Wetselaar, instruct them to complain about back pain, and provide them with the cash to pay for the prescription. Clients would return to her with the prescriptions...she would take the prescriptions to Lam’s Pharmacy, where Smith was the manager. She said Lam’s Pharmacy maintained an entire book dedicated only to her clients. Allen said her clients were prescribed — among other drugs — oxycodone, hydrocodone, Soma and Xanax.