Secondary patents in the pharmaceutical industry: missing the wood for the trees?

ABSTRACT

Introduction: The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products.

Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data.

Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI’s) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI’s shows that the term of the primary patent is not extended by the secondary patents.

KEYWORDS:

• Secondary patents
• Proton pump inhibitor
• product lifecycle management
• innovators
• generics

Article Highlights

• Identifying NME and market entry entails huge investments, fraught and risk.

• Secondary patents (SP’s) result of continued R & D to exploit NME characteristics.

• SP’s do not extend exclusivities of earlier patents, create new narrower exclusivities.

• Exploiting SP’s to create new markets, exclude other innovators, strategic decisions.

• Generic market entry following patent expiry also a strategic decision.

This box summarizes key points contained in the article.

Declaration of interest

M Kulkarni has received funds from EMR, CSIR-HRDG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper has not been funded.