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Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio

Copyright © DrugPatentWatch. Originally published at

Kenneth L. Dorsney, Editor-in-Chief

1,035 pages

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Pre-ANDA litigation is the companion to ANDA Litigation, which I recommend for its guidance on all matters occuring after a drug company decides to launch a generic version of a drug. In contrast,
Pre-ANDA litigation addresses important topics which precede ANDA litigation, such as the vital considerations in launching innovative new drugs, developing and protecting patents and other intellectual property relating to novel drugs, developing generic drug portfolios, and general management of pre- and post-launch of branded, generic, and biologic drugs in the United States and Beyond.

The book can be roughly divided into four segments. The first 14 chapters focus on issues important to branded conmpanies, from drug development and approval through pre-litigation preparation. Chapters 15 through 28 cover topics primarily of interest to generic entrants (though both parties would be well-advised to at least appreciate both sections). The last two segments, chapter 29 and 30, focus on novel and ‘follow-on’ biologic drug approvals, and on drug regulation and approval outside the United States.

The first two chapters of Pre-ANDA Litigation introduce the regulatory system controlling drug approval and marketing, and the R&D process through which drugs are discovered and developed. With this essential background covered, the third chapter shifts the tone and focuses on patent considerations. The timing of patent filings is critical in drug development, as disclosure of inventions in publications, in conference or poster sessions, or in clinical trials, can render them unpatentable.

Raising company-wide awareness of at least the fundamental aspects of IP law can be critical to success … In many instances an inventors own publication has undermined the patent ability of her or his invention.

Subsequent chapters provide details on FDA submissions for new drugs, generic drugs, and 505(b)(2) drugs (a hybrid between a generic drug and a novel drug), along with common challenges to the approval process or regulatory protections for each.

The chapter on patent portfolio strategies is superb. It can be difficult to appreciate the rationale for strategies presented by patent counsel, and this chapter helps explain the the basis of common strategies which aid in resource allocation and in patent portfolio development decisions. It contains critical guidance on topics such as how to craft initial patents so as not to preclude the opportunity for secondary patents, the benefits of continuing patent applications, and expedited application processes.

Given the frequency of patent licensing in the pharmaceutical industry, the chapter on due diligence (covering patents, trademarks, trade secrets, and regulatory issues) is extremely useful. While attorneys can use this chapter as a broad checklist, the elements described within are useful not only to business executives in advance of elevation to legal due diligence, but also for those seeking to license their intellectual property who want to increase the likelihood of successful execution.

Covering the broad field of branded and generic drug launches, and the strategic considerations in advance of defending or challenging generic entry is a monumental task. Pre-ANDA Litigation accomplishes through a balance of strategically-focused chapters primarily addressing regulatory or established case law, and tactically-focused chapters written in consideration of the perpetually-changing dynamics of the industry.

Overall, I would recommend Pre-ANDA Litigation for readers seeking high-level coverage of the branded and generic interplay, and the companion book, ANDA Litigation, for those more interested in specific strategic guidance after a generic company has initiated a drug launch.

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