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…competition in violation of the Unfair Competition Law (“UCL”) (Bus. & Prof. Code, § 17200 et seq.); and (3) the common law tort of monopolization. We previously reported on Judge…
…Access to Generic Drugs Act of 2012 a forfeiture-triggering event. H.R. 3995 has been referred to the House Judiciary and Energy and Commerce Committees. There, it will join a growing…
…drugs and biologics by authorizing the Federal Trade Commission to stop companies from entering into anti-competitive deals, known also as “pay for delay” agreements, intended to block consumer access to…
…claiming that these companies have been “taking advantage of a loophole that delays generic competition.” These companies have clapped back. In their responses, each company emphasized that none of the…
…of GlaxoSmithKline’s AVODART (dutasteride) Capsules, 0.5 mg. FDA’s decision on Dutasteride Capsules, 0.5 mg, 180-day exclusivity came about in the context of the most familiar type of punt: failure to…
…types of labels and labeling are generically approved and do not need specific FSIS approval. Under the final rule, companies need not submit the label for approval if the label…
…any approved methods of using the listed drug.” Second, “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative,”…
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous…
…heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated August 13, 2009 did not come until more than 6 years after the date of…
…metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses)….
…the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” Order at 22. As such, that…
…basics: As with subpoenas and CIDs, the recipient of a 6(b) order may file a petition to limit or quash, and the Commission may seek a court order requiring compliance….
…Division) ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed PUC for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on…
…how this will work. At a minimum, under the statute, FDA has authority to issue a classification order in response to an accessory classification request. We assume this order will…
…lawsuit dropped. Spectrum Pharmaceuticals, Inc. (“Spectrum”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction challenging FDA’s February 24, 2015 denial of a Citizen Petition (Docket…