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A federal appeals court ruled Monday that four patents related to Purdue Pharma's painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug...Purdue had sued Teva, Amneal Pharmaceuticals, Epic Pharma and a U.S. arm of Mylan NV after they sought approval from the Food and Drug Administration to make generic OxyContin...Despite the court's ruling, Purdue has several other patents protecting OxyContin, and we do not anticipate generic manufacturers selling the product in the near future...Three of the patents Purdue sought to enforce in its lawsuits are related to an improved formulation of oxycodone, the active ingredient in OxyContin...The other patent describes technology designed to prevent abuse of the drug by making it difficult to crush and causing it to form a gel when dissolved in water so that it cannot be injected...Purdue appealed all four cases to the Federal Circuit...

In a split decision for the pharmaceutical industry, the Arizona Supreme Court issued an opinion that has drug makers both encouraged and worried as they track the progress of a case that may have an outsized impact on consumer lawsuits filed in the state...The case was brought by Amanda Watts, a young woman who claimed she developed lupus and hepatitis after taking an acne treatment made by Medicis Pharmaceutical...She contended the company failed to provide proper side effect warnings. A state appeals court sided with Watts, which prompted Medicis to try to have the decision overturned...Watts has argued over two points that alarm drug makers...The loss of uniformity in liability standards for prescription medicines will subject pharmaceutical manufacturers to fundamentally different standards of liability in each state...(1) A key argument Watts made is that a long-standing industry defense against consumer lawsuits conflicted with another state law about deciding who may be at fault when there is harm. Known as the learned intermediary, this defense says drug makers cannot be held liable if a consumer suffers harm from a medicine — so long as all risk information was appropriately conveyed to the patient’s physician...The state Supreme Court gave drug makers a lift by deciding that the learned intermediary is a legitimate defense...(2) Meanwhile, the pharmaceutical industry will be watching whether Watts wins her argument over consumer fraud violations. Although drug makers argue their customers are actually physicians, the state Supreme Court opined that a direct transaction between a drug maker and a patient is not required for a consumer to claim fraud in the event that misrepresentation resulted in injury...It could be a game changer...

Federal prosecutors in Philadelphia said on Wednesday that they had indicted five people, including two research scientists, on charges of stealing trade secrets about drugs to treat cancer and other diseases from GlaxoSmithKline...the two scientists, Yu Xue and Lucy Xi, worked at Glaxo’s research facility in Upper Merion, Pa., and emailed and downloaded confidential data about a dozen or more company products to associates who planned to sell and market the trade secrets through a company they set up in China, called Renopharma...to conceal their crime, Ms. Xue and two other associates, Tao Li and Yan Mei, agreed to put the proceeds in the name of Ms. Xue’s twin sister...who was also charged. Ms. Xi worked with Ms. Xue at Glaxo and was married to Mr. Mei...the defendants boasted that their company, based in Nanjing, had received some financial support and free laboratory space from the government and that its ultimate goal was to develop its own antibody drugs.

U.S. patent officials...denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine...In June, Amgen...asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion...In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."...Amgen said it still plans to challenge the legality of the patents.

Attorneys are urging caution in evaluating the strength of a U.S. trade secrets case against two GlaxoSmithKline scientists who were accused last week of transferring trade secrets to China. The case bears some similarities, they say, to other recent cases involving Chinese American or Chinese defendants in which federal prosecutors abruptly dropped charges because of improper analysis or insufficient evidence...Last week, federal prosecutors in Philadelphia...announced the indictments of biomedical researchers Yu Xue and Lucy Xi, as well as three associates, for trade secrets theft, wire fraud, and other charges. The scientists stand accused of emailing and downloading proprietary data about GSK products and sending it to contacts working for the Chinese startup Renopharma, which provides contract research services for early drug discovery...The case comes on the heels of several high-profile investigations into Chinese or Chinese American scientists in which prosecutors have abruptly dropped charges, sparking accusations of racial profiling. This past September, prosecutors dropped charges against Xiaoxing Xi, the interim chair of Temple University’s physics department, after experts submitted affidavits suggesting that his alleged crimes were merely standard scientific collaborations.

Martin Shkreli appears to be a big step closer to testifying before a congressional committee...US Department of Justice wrote a letter Sunday to a federal judge overseeing a securities fraud case against Shkreli to say “the government does not object to (Shkreli) traveling to Washington, D.C., to comply with the House Committee’s subpoena” to testify at a hearing on prescription drug pricing. As part of his $5 million bail order, Shkreli is prevented from traveling outside parts of New York City and nearby Long Island...The letter paves the way for Shkreli to appear before the House Oversight and Government Reform Committee, which wants to explore the rising cost of medicines. A hearing had been scheduled for Tuesday, but it has been postponed to Feb. 4 due to the recent blizzard.

For the second time since Express Scripts began blocking coverage of hundreds of ingredients used to make compounded medicines, several compounding pharmacies have filed a lawsuit accusing the pharmacy benefits manager of using illegal tactics...In the latest instance, a half-dozen compounding pharmacies have charged Express Scripts with violating antitrust laws and is attempting to force them out of business...Express Scripts has taken “a series of unreasonable restrictions and rules that would make it impossible for [the compounding pharmacies] to fill prescriptions” for patients “and obtain reimbursements that would cover their costs,”...The company and the other benefits managers “employed tactics designed to ensure that the compounding pharmacy industry …cannot survive.”...The move to cut back on covered ingredients has riled compounding pharmacies...the Food and Drug Administration has cracked down on compounding pharmacies by increasing the number of inspections, and, in rare cases, taking legal action to halt allegedly unsafe practices. The justifiable emphasis on safety has forced many compounding pharmacies to enhance operations...The compounding pharmacies are striking back. In November 2014, three others filed a lawsuit claiming Express Scripts illegally blocked legitimate prescriptions and unfairly forced patients to seek more expensive medicines or simply not seek treatment. The pharmacies maintained the benefits manager violated federal law because it lacks authority to essentially alter terms of health plans.

Massachusetts Attorney General...opening a new front in the push to boost access to life-saving drugs, has warned the country’s biggest biotech company that it faces possible legal action unless it lowers the price of two popular hepatitis C medicines...In a letter to Gilead Sciences Inc., made public Wednesday, the attorney general wrote that the high price of the company’s Sovaldi drug, which costs $84,000 for a full 12-week course of treatment, and its Harvoni regimen, at $94,500, "may constitute an unfair trade practice in violation of Massachusetts law" because they are too expensive for many patients...While other state attorneys general have sued drug makers seeking larger Medicaid rebates or discounts, her office is believed to be the first to consider using a state consumer protection law to charge a company with overpricing its products...

Johnson & Johnson is facing yet another lawsuit over its antibiotic Levaquin from people who claim that the company hid serious side effects. The latest legal action comes a couple of months after an FDA panel flagged serious problems associated with the entire class of antibiotics and voted to change the meds' labels...Five plaintiffs allege in a new suit that J&J and its Janssen unit deliberately mislabeled and misbranded Levaquin (levofloxacin), playing down harmful side effects for its own financial gain. The plaintiffs sued J&J and others--including former FDA commissioner Margaret Hamburg--under the federal Racketeer Influenced and Corrupt Organizations act, a law typically used to prosecute organized crime. "These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs," according to the suit...The plaintiffs are seeking more than $120 million in compensatory damages and more than $750 million in punitive damages to drive home "the seriousness of their egregious conduct and to deter similar conduct in the future."...The latest suit marks another chapter in J&J's Levaquin saga. The company has encountered thousands of lawsuits over the past several years from plaintiffs claiming that it did not adequately warn patients about the drug's dangers.

In a setback to the pharmaceutical industry, the US Supreme Court declined on Tuesday to hear an appeal sought by Johnson & Johnson of a $63 million verdict that found the company failed to properly warn consumers about the risks of its Children’s Motrin painkiller...At issue was whether J&J should have upgraded its product labeling to reflect the risk that a patient may develop toxic epidermal necrolysis, which can lead to a rare disease called Stevens-Johnson syndrome...J&J sought to convince the Supreme Court that federal law preempted the state court verdict. In response to a citizen’s petition seeking upgraded labeling, the Food and Drug Administration had agreed that an increased warning about skin reactions — such as rashes and blisters — was warranted. But the agency did not agree to add the names of the skin diseases…the company maintained it would have violated federal law if the Motrin labeling was updated with the sort of specific language the family believed should have been used, according to its filing with the Supreme Court...J&J complained it was in an untenable bind…J&J, which now faces a $140 million payout when including interest...is “disappointed the Supreme Court declined to hear this case because we believe it raises important and unsettled preemption issues.”