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Oklahoma Supreme Court overturns $465 million opioid ruling against Johnson & Johnson

JURIST

In 2017, Oklahoma sued J&J, Purdue Pharma and Teva Pharmaceuticals under the state’s public nuisance statute alleging that the drug manufacturers deceptively marketed opioids within the state. But that conduct has been criminal or property-based conflict.

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District Court Finds Use of a Method to Manufacture a Product Does Not Indirectly Infringe a Patented Method to Design A Product

The IP Law Blog

Plaintiff had argued that using the patented methods in the design process, which guides the subsequent manufacturing process, is sufficient to state a claim. In other words, Defendant argued that alleging a method is used in the design of a product is distinct from alleging that the method is used in the manufacture of the product.

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US Supreme Court: Hearing in Smith & Wesson Brands, Inc. et al. v. Estados Unidos Mexicanos (Mexico). Selling guns comparable to selling beer to teenagers?

Conflict of Laws

As previously indicated, this is a much-politicized case brought by Mexico against US gun manufacturers. The US District Court for the District of Massachusetts dismissed the case under the Protection of Lawful Commerce in Arms Act (PLCAA). We have previously reported on this case here and here. No judgment has yet been rendered.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.

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D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case

FDA Law Blog

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

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Supreme Court likely to let vape company’s FDA challenge proceed

SCOTUSBlog

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gives the FDA the power to regulate tobacco products and requires manufacturers to obtain the FDAs permission before putting a new tobacco product on the market. In 2016, the FDA issued a rule indicating that the law applies to e-cigarettes and e-liquids.

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Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).