Regulatory aspects for competitive Generic Therapies in USA

The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1) FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will Explain the process and criteria to request and designate a drug as a CGT. Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT. Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)

PAY-FOR-DELAY AGREEMENTS UNDER EU COMPETITION LAW – A COMMENT ON PAROXETINE

Summary The Court of Justice of the European Union (“Court of Justice”) issued its first ruling on pay-for-delay agreements, in reply to a reference for a preliminary ruling from the UK’s Competition Appeal Tribunal (“CAT”) during its review of the appeal of a Competition and Markets Authority (“CMA”) decision applying a fine to GlaxoSmithKline (“GSK”) and five generic manufacturers for having entered into agreements settling patent disputes relating to GSK’s antidepressant paroxetine, on the basis that such agreements infringed competition rules. In its Paroxetine ruling of 30 January 2020[1], the Court of Justice found that patent settlements are not, by their very nature, anticompetitive; however, generic manufacturers can be regarded as potential competitors to the originator manufacturers when they have announced their intention to compete in the same market as the originator and, as such, patent settlement agreements are to be reviewed as horizontal agreements between competitors. Finally, a payment from the originator to the generic manufacturer in a patent settlement agreement is not enough to qualify such an agreement as a restriction of competition by object (the agreement is not anticompetitive by its very nature), unless there is no other justification for the payment other than to compensate the generic manufacturer for accepting to delay its entry in the market. In those circumstances, the Court finds that such an agreement will constitute a restriction of competition by object[2]. In this comment, we review the Court’s findings in relation to the issue of potential competition between the originator and the generics manufacturers and the qualification of this agreement as a restriction of competition by object. Keywords: pay-for-delay; restriction; competition; agreement; settlement; patent

The Anticompetitive Effects of Common Ownership: The Case of Paragraph IV Generic Entry

Brand-name pharmaceutical companies often file lawsuits against generic drug manufacturers that challenge the monopoly status of patent-protected drugs. Institutional horizontal shareholdings, measured by the generic shareholders' ownership in the brand-name company relative to their ownership in the generic manufacturer, are significantly positively associated with the likelihood that the two parties enter into a settlement agreement in which the brand pays the generic manufacturer to stay out of the market.

Pay-for-Delay Agreements in the Pharmaceutical Sector: Towards a Coherent EU Approach?`

This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

What's in Your Bottle?: Shire US Inc. v. Barr Laboratories Inc. and Its Effect on Prescription Drug Trade Dress Protection in the Third Circuit

The pharmaceutical industry may have lost its ability to differentiate prescription drug tablets from generic imitations in light of the Third Circuit’s decision in Shire US Inc. v. Barr Laboratories Inc.1 Traditional trade dress jurisprudence has long recognized a cause of action whereby a national brand-name manufacturer can sue to protect its product’s identity from a generically manufactured facsimile. Such an action normally arises when a generic manufacturer copies the appearance of a brand-name product, thereby gaining instant product recognition based on the brand-name manufacturer’s established marketing and accumulated goodwill.2 Trademark common law and the Lanham Act protect brand-name manufacturers from such unfair trade practices.3 Over-the-counter drugs are packaged in containers bearing manufacturers’ names and markings, enabling consumers to differentiate between, for example, Ecotrin™ aspirin and generic CVS store brand aspirin.4 When a generic manufacturer’s label is sufficiently similar to that of an established product, the Lanham Act dictates that the generic manufacturer must cease selling its product.5 Even when products, i.e., tablets, are physically identical, packaging labels serve as sufficient identification of their source.