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Full-Text Articles in Law
Comparative Patent Quality, Colleen Chien
Comparative Patent Quality, Colleen Chien
Faculty Publications
One of the most urgent problems with the US patent system is that there are too many patents of poor quality. Most blame the US Patent and Trademark Office (USPTO) – its mistakes, overly generous grant rate, and lack of consistency. But, the quality and quantity of patents in force is the product of three sets of decisions: to submit an application of certain quality (by the applicant), to grant the patent (by the patent office), and to renew a patent and keep it in force (by the applicant/patentee). Startling, there is no consensus way to measure patent quality. This …
Recalibrarting Patent Venue, Colleen V. Chien, Michael Risch
Recalibrarting Patent Venue, Colleen V. Chien, Michael Risch
Faculty Publications
For most of patent law’s 200-year plus history, the rule has been that patentholders are permitted to sue defendants only in the district they inhabit. In 1990, the Federal Circuit changed this by enlarging the scope of permissible venue to all districts with personal jurisdiction over the defendant. Since then, patentees have flocked to fewer districts, and in 2015, brought more than 40% of their cases in a single rural district with 1% of the US population, the Eastern District of Texas. Fueled in particular by concerns that non-practicing entities (NPEs), who bring the majority of cases in the Eastern …
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
Faculty Publications
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …
The Myths Of Data Exclusivity, Erika Lietzan
The Myths Of Data Exclusivity, Erika Lietzan
Faculty Publications
This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …