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Sepracor's Ship Almost Gets In

Executive Summary

How much better can it get for Sepracor Inc.? Even with a $2.6 billion market cap (and a likely annual loss of $100-plus million for the next few years) Wall Street can't get enough of the company. The biggest piece of recent good news: the signing of the long-expected {Prozac} deal. Eli Lilly is paying for rights to Sepracor's {Prozac} isomer, R-fluoxetine.

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Sepracor's Primary Care Ambitions

With the exception of Forest Labs, small companies haven't been able to build sustainable businesses in primary care because they can't generate enough returns (generally from expensive-to-acquire marketable products) to both restock a pipeline and drop requisite profits to the bottom line. Now Sepracor aims to be the first to do so, thanks to a research shortcut. Investors, hungry for a successful biopharma business model, are watching closely.

The Battle for IP

Generic firms are increasingly attacking innovators' drug patents before they expire--even, in some cases, the previously invulnerable active ingredient patents--and courts are supporting some of their tactics. The primary means used by generic firms for mounting this offensive campaign: Paragraph IV filings, which claim that the innovator's patent is invalid or won't be infringed. It's a tactic that generic firms are relying on more heavily. While the details of each patent dispute differ widely, one thing is clear: generic firms are finding successful ways to maneuver around existing innovator patents. They are winning in court almost 75% of the time after litigating Paragraph IV challenges. In particular, the Pfizer/Reddy case exposes how generic firms can and will poke holes in an innovator's intellectual property. Notwithstanding that Pfizer had explored and patented the derivative salts of Norvasc, this case highlights how the timing of certain types of patents may be crucial. In addition, it may motivate pharmaceuticals to more comprehensively explore alternative forms and formulations of their compounds. Besides building a portfolio of strong patents, fully exploring the form and formulation space could result in a secondary benefit: discovering a superior product.

Health And Wellness Trademark Review 14 January, 2020

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

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