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Hedge funder Kyle Bass and his Coalition for Affordable Drugs has been somewhat successful at using a new type of patent challenge to push review of "questionable" drug patents. But Bass' partner in that effort now says he doesn't trust the Patent & Trademark Office to be impartial in making those decisions...Erich Spangenberg, in an article at IPWatchdog, says PTO chief Michelle Lee and her staff have favored pharma since Bass announced last year that he and his group would target pharma patents via the inter partes review process...according to the documents, Lee and other PTO officials sat down with the industry association BIO...Bass and Spangenberg themselves called and emailed repeatedly to request a similar meeting, and they're still waiting... It's an outrage that Ms. Lee is showing incredible bias by granting meetings to the people that are gouging American patients, consumers and taxpayers and denying the same access to the people who are attempting to end this abuse...Some analysts have criticized the coalition for targeting inconsequential patents that aren't likely to change the length of a company's monopoly hold on the market, while profiting from shorting the shares of the same company. In a PTO filing, the coalition has acknowledged that Bass and his group don't have altruistic motives, but maintains that his profit motives "do not change the social value of his activities."...

The nation's largest endoscope distributor will pay $623.2 million to resolve civil and criminal allegations that it paid kickbacks to hospitals and doctors in exchange for purchasing its devices, the Justice Department announced...Olympus Corporation of the Americas has agreed to pay a record-setting $310.8 million to settle civil claims that it violated the False Claims Act because its claims were tainted by illegal kickbacks. The sum is the largest ever paid by a medical-device company over violations related to the federal anti-kickback law...Olympus will also pay a $312.4 million criminal penalty over the allegations. The company admitted to paying doctors and hospitals in the form of consulting payments, travel, meals, grants and free endoscopes in exchange for their business...the kickbacks helped the company make more than $600 million in sales and gross profits of more than $230 million...The civil settlement resolves a lawsuit originally brought by whistle-blower John Slowik, a former chief compliance officer for the company. In successful False Claims Act cases, whistle-blowers are entitled to a portion of whatever money the government is able to recover. Slowik will receive $51 million...

A Los Angeles-area doctor convicted of murder for prescribing exorbitant amounts of painkillers that left a dozen patients dead was sentenced...to 30 years to life in prison...The conviction of Dr. Hsiu-Ying "Lisa" Tseng and her long prison sentence are rare for a doctor...Minutes before she was sentenced, Tseng apologized in court to the families of her dead patients and others who became addicted to prescription drugs under her care...In handing down the harsh sentence, Los Angeles County Superior Court Judge George Lomeli said he found it egregious that Tseng continued to write reckless prescriptions even after learning her patients were dying..."(She’s) a person who seemingly did not care about the lives of her patients in this case but rather appeared more concerned about distributing dangerous controlled substances in an assembly line fashion so as to collect payments which amounted to her amassing several million dollars," Lomeli said...

In the latest legal challenge to Gilead Sciences and its register-ringing strategy, the AIDS Healthcare Foundation has filed a lawsuit accusing the drug maker of manipulating the patent system in order to thwart competition to its HIV medicines. And the nonprofit alleged that countless HIV patients have been prevented from accessing treatment — and may have been harmed — as a result...At issue is tenofovir, or TDF, which is a cornerstone of the combination HIV treatments that Gilead sells. The patent on the TDF compound expires in December 2017 and Gilead hopes to replace it with a modified version known as TAF (Genvoya)....TAF is more potent and causes fewer side effects, notably bone damage and kidney toxicity. The foundation argued that Gilead knew of these differences thanks to animal testing dating back to 2001, but that the company delayed testing TAF in humans until 2011. In doing so, Gilead extended patent protection by a few years, the foundation charged in the lawsuit...the foundation argued that TAF is an obvious modification of TDF and, therefore, does not deserve patent protection... The nonprofit....seeks to have the TAF patents invalidated...Gilead’s refusal to make TAF available as a stand-alone drug appears to be a calculated, anticompetitive maneuver aimed at keeping competing TAF drugs off the market for years despite the weakness of Gilead’s patents covering TAF, the lawsuit claimed. The failure to make TAF available as a stand-alone drug highlights Gilead’s motive of avoiding competition at all costs...Gilead "reevaluated TAF as part of its ongoing R&D review process" and "decided to prioritize" TAF development...the company believes its patents are valid.

It is a startling accusation...Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?...Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto (rivaroxaban) say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written...researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe...The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those of patients using warfarin. The concern is that the faulty results may have led doctors to give patients the wrong dose of warfarin, which could have favored Xarelto...Some experts say this case is reminiscent of other instances in which drug companies concealed or altered drug-trial data in medical journals...

On February 25...upon conclusion of the...criminal case...United States v. Vascular Solutions, Inc...Judge Lamberth charged the jury...The case involves allegations that...a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and committed four counts of selling misbranded medical devices...After deliberating for one day, the jury came back with a verdict of "not guilty" on all counts for both the company and its CEO...FDA’s ability to restrict speech that is truthful and not misleading is limited...FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines...promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act...given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating...an unapproved use does not violate the misbranding provisions...DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.

The ongoing outrage over the cost of hepatitis C treatments is, once again, prompting consumers to fight back against insurers that deny them access to the medicines. In the latest instance, a pair of lawsuits was filed that accuse two large insurers in the state of Washington of rationing...The lawsuits...seek class action status, charge that Group Health Cooperative and BridgeSpan restricted access to the medicines except to the "most severely ill" people, but not for a "clinical purpose." Instead, the consumers charge the insurers do so due to "financial concerns." And they want the insurers to provide coverage...BridgeSpan requires "infected individuals wait for treatment...until they demonstrate serious scarring or cirrhosis of the liver from hepatitis C infection," one lawsuit charges. Meanwhile, patients are "forced to live with…an increased risk of cancer or death."...The newest crop of hepatitis C medicines...boast cure rates exceeding 90 percent...Health care experts had predicted still more lawsuits would be filed while prices remain high. What remains to be seen is whether the arrival of a new Merck hepatitis C drug, which is priced at $54,600, will generate sufficient discounting so that insurers loosen restrictions.

States across the country have been chasing painkiller makers, alleging all kinds of bad behavior in the sales and marketing of opioids. Now one of those cases has stuck, with Endo agreeing to not soft-pedal the risks of taking Opana ER (oxymorphone),  or oversell its crush resistance as conditions of settling an investigation in New York...Endo Health Solutions also agreed to pay $200,000 and take a variety of steps to make sure doctors understand the addiction risks to their patients. The company will also stop marketing to and report any physicians they think might be improperly prescribing the opioid...the AG's (Attorney General Eric Schneiderman) investigation focused on Opana ER, which he said had become the drug of choice among many abusers...the investigation found that Endo "improperly marketed Opana ER as designed to be crush resistant," providing a "false sense of security to health care providers and their patients," even though Endo's own studies showed the drug could be crushed and ground up...

Eli Lilly suffered a crushing defeat in the U.K. over patents for its lung cancer blockbuster Alimta (pemetrexed) as the U.K. High Court ruled in favor of Actavis' plan to market copycat versions of the med...The High Court's decision also applies to Actavis' generics in France, Italy and Spain...The company has a separate compound patent for the drug that expires in 2017. But certain patents for Alimta expire in 2021, and the latest ruling could throw a wrench in Lilly's plans to hold on to sales...Lilly is not pleased with the High Court's decision. "We strongly disagree with the ruling by the U.K. High Court" and "we plan to seek permission to appeal this ruling,"…The company has fared better with Alimta in the U.S., though. In August, a federal court ruled in favor of Lilly and granted the company 5 more years of U.S. exclusivity for the med. The court found that generic meds proposed by Teva Pharmaceutical Industries would infringe on Lilly's method patent for Alimta in combination with vitamins, allowing Lilly to hold on to the patent until 2022...

Chinese Internet giant Alibaba suffered two blows this past week: the China Food and Drug Administration announced that it will no longer work with the company on an initiative to track medicines to ensure their authenticity, and a pharmacy chain has filed a lawsuit against the company saying the initiative gave it an unfair advantage over other drug sellers...CFDA Vice Director Sun Xianze held a confab with 20 pharmacy and drug companies and wholesalers on Jan. 27 at which the decision was announced to curtail the deal with Ali Health, a subsidiary of Alibaba...The original plan with Alibaba had its detractors early on who complained about the costs involved and said the plan would do little to stop fake drugs from getting into the hands of unsuspecting patients...CFDA officials said they would continue to push for the bar code tracking system, but would instead work with a nonprofit institution and not a commercial entity...Meanwhile, Alibaba found itself in the middle of a lawsuit filed...by Yangtianhe Pharmacy...The suit says the CFDA broke the law by partnering with a commercial entity to create the system, which is called the Product Identification, Authentication and Tracking System.