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TransForm, J&J and topiramate: New life, old products

Executive Summary

In May, the US Patent Office granted TransForm its first patent on topiramate sodium trihydrate-an alternate salt form of J&J's $700 million epilepsy drug Topamax. J&J found itself with an interesting complement to Alza reformulation efforts on the drug--which were gearing it for alternative indications like obesity and migraine--and a potential IP complication. The business-like result: a broad licensing agreement under which TransForm assigns all its topiramate patent rights to J&J in exchange for up-front money, an equity investment, milestones, and future royalties.

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The Search for Defensible IP in Older Drugs

The jumpstart model reduces drug development risk by starting with existing drugs which are then reformulated or repurposed for new or expanded indications. In every case, the parent drug either already belongs to somebody else or has lost patent protection, or soon will, and is therefore freely available for others to exploit. As such, early competition is a significant risk for any jumpstart product. Devising an IP fence high enough to protect a new product could determine a company's success going forward.

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.

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