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New Jersey...accused Insys Therapeutics Inc of engaging in a fraudulent scheme to boost sales of a fentanyl-based cancer pain drug, as Massachusetts announced a $500,000 settlement with the drugmaker to resolve similar allegations...The lawsuit by New Jersey Attorney General Christopher Porrino accused Insys of illegally directing its sales force to push prescriptions of Subsys for a broader range of patients than the opioid drug was approved for, and at higher doses...The lawsuit...alleged Insys also paid kickbacks, including sham speaker fees to medical practitioners to prescribe Subsys and defrauded insurers into paying for it...The lawsuit said Insys’ greed put hundreds of lives in jeopardy and led to the 2016 overdose death of a New Jersey woman who was prescribed Subsys to treat fibromyalgia.

Allergan Plc’s decision to pay a Native American tribe $15 million a year rather than let one of its blockbuster drugs be scrutinized by the U.S. Patent & Trademark Office is part of a backlash against an agency review panel that has been dubbed a “death squad.”...The drugmaker earlier this month transferred ownership of patents protecting a medicine with $1.49 billion in sales last year to the Saint Regis Mohawk Tribe of upstate New York. The tribe, which will receive royalties every year, says that as a sovereign entity it is immune from such civil patent challenges....The creative -- and untested -- maneuver is designed to circumvent the Patent Trial and Appeal Board...critics say the board has made it too easy for rivals to attack patents and they’re pressing Congress, the courts and the patent office for changes...companies such as Google or Apple Inc., which are among the biggest users of the review board to fend off what they consider nuisance lawsuits from companies looking for a quick payday...the Supreme Court agreed to take a case to determine if the reviews are constitutional -- critics of the reviews say a patent is a property right that only federal courts can revoke. But even those who want to see the system dismantled say that case is a long shot...The patent office has been considering changes to its procedures...

In a word: patents...The Biologics Price Competition and Innovation Act (2010) was...part of the Affordable Care Act. Its essential goal was to infuse competition and lower the prices of drugs that were made from living cells -- so-called biologics...Until the 2010 law, biologics had no fear of competition -- there was no legal way to introduce generic versions into the market -- so they were able to maintain their monopoly price even after their patents expired. The BPCIA was intended to establish mechanisms within the Food and Drug Administration, the Patent and Trademark Office, and the courts that would allow the introduction of "biosimilars." These drugs weren't exact replicas of biologics, but were similar enough, and safe enough, to be used instead of the brand-name drugs...Here we are seven years later. Guess how many biosimilars have made it to market?..Two...companies are forced to fight through thickets of patents to get a biosimilar to market, a law that was supposed to save the U.S. billions will continue to do just the opposite: make it easy for biologic makers to maintain unwarranted monopolies...

Arizona sued Insys Therapeutics Inc...accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine called Subsys...The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on Insys’ drug Subsys amid a national opioid addiction epidemic...The lawsuit accused Arizona-based Insys of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys and of misleading insurers into believing patients who were prescribed the opioid had cancer when they actually did not...The lawsuit seeks an injunction, restitution for customers and the disgorgement of any illegally earned profits…

The Nevada Legislature has filed a motion to intervene as a defendant in a federal lawsuit that challenges a state law that requires disclosure of how insulin is priced...Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization say the Nevada law passed this year is unconstitutional. The groups maintain the legislation improperly interferes with federal patent law because the disclosure requirements it imposes penalize pricing decisions that are consistent with the patent rights granted by Congress...Gov. Brian Sandoval and Department of Health and Human Services Director Richard Whitley are named as defendants in the lawsuit. The Legislature on Tuesday filed its motion to defend the law.

Drug pricing regulation hasn't gained much ground on a national level, but in Nevada, there's a fierce fight over pricing and transparency for diabetes medications. In the latest twist, the industry lost its bid to stall a new law that's designed to shine light on pricing practices...Industry groups PhRMA and BIO filed for a temporary restraining order and preliminary injunction against officials in Nevada, contending that the state's Senate Bill 539 will "impose irreparable injury" against drugmakers...The bill mandates that the state gather a list of essential diabetes medicines and as well as detailed pricing information from companies that sell those drugs. The reports would include costs, profits, rebates and other details, in addition to pricing numbers...And then that information would go public: Under the law, the state would publish the reported info online.

The Pharmaceutical Research and Manufacturers of America the Biotechnology Innovation Organization today initiated litigation in the United States District Court for the District of Nevada challenging provisions of SB 539, a Nevada law that would violate patent rights and negate trade secret protection for designated diabetes medicines in a way that would harm patients and chill future biomedical innovation...PhRMA and BIO seek a declaration from the Court that the challenged provisions of SB 539 are preempted by federal law and violate several provisions of the United States Constitution...also seek an injunction prohibiting the implementation or enforcement of these challenged provisions...The Complaint alleges that provisions of SB 539 violate the Constitution in at least four ways:

1. by interfering with federal patent law;
2. by interfering with federal trade secret law;
3. by violating the Takings Clause of the Fifth Amendment of the United States Constitution which prohibits government from taking property without just compensation; and
4. by violating the dormant Commerce Clause of the United States Constitution, which prohibits Nevada from impeding commerce in other states.

A Native American tribe holding patents for drugmaker Allergan Plc...moved to dismiss a case brought by generic drug company Mylan NV challenging the patents...In a filing to the U.S. Patent Trial and Appeal Board, the Saint Regis Mohawk Tribe asked that Mylan’s case seeking to invalidate Allergan’s patents on dry-eye medicine Restasis be thrown out on the grounds that the board has no jurisdiction over the tribe...The move was expected after Allergan announced on Sept. 8 that it had transferred Restasis patents to the tribe in order to protect them from administrative challenges...the tribe said it is sovereign government that cannot face litigation in an administrative court unless it expressly waives its immunity or the U.S. Congress abrogates immunity...(Allergan) has said the transfer is only intended to shield the patents from review at the patent board, which it has called a flawed forum for patent disputes. Allergan has said it will not invoke tribal immunity in federal courts

Shkreli is expected to be locked up...for four months...Martin Shkreli's new home in a Brooklyn, New York, federal jail is definitely not the kind of place "where you want to be,"…Metropolitan Detention Center Brooklyn...Shkreli...was thrown into the MDC...after a Brooklyn federal court judge revoked his $5 million release bond...Judge Kiyo Matsumoto ruled that Shkreli represented a danger to the community because of a bizarre $5,000 bounty he offered to Facebook followers who grabbed samples of Hillary Clinton's hair for him...Shkreli, who previously ran two pharmaceutical companies and several hedge funds...A jury convicted him in August of three securities fraud charges...

The plaintiff in a proposed class action lawsuit against CVS dropped her claims...After making a series of allegations that pharmacy giant CVS was gouging generic drug consumers who paid with insurance, the plaintiff in a proposed class action lawsuit dropped her claims...Megan Schulz alleged she paid more through insurance to get a generic drug than if she’d just paid cash. The suit also alleged pharmacy "copays" were really payments to pharmacy benefit managers, set up by confidential deals. CVS refuted the allegations and said in a statement...that it’s pleased the suit has been dismissed..."The complaint contained numerous demonstrably false assertions that a reasonable pre-filing investigation by the law firm would have discovered,"..."As such, we are pleased that the suit has been voluntarily dismissed.",,,"We plan to refile the lawsuit against CVS related to its generic drug pricing scheme promptly,"..."Our case against Walgreens was not dismissed and will remain on file until we achieve a just outcome for consumers."