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An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
Forcing Patent Claims, Tun-Jen Chiang
Forcing Patent Claims, Tun-Jen Chiang
Michigan Law Review
An enormous literature has criticized patent claims for being ambiguous. In this Article, I explain that this literature misunderstands the real problem: the fundamental concern is not that patent claims are ambiguous but that they are drafted by patentees with self-serving incentives to write claims in an overbroad manner. No one has asked why the patent system gives self-interested patentees the leading role in delineating the scope of their own patents. This Article makes two contributions to the literature. First, it explicitly frames the problem with patent claims as one of patentee self-interest rather than the intrinsic ambiguity of claim …
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Michigan Law Review
While many recognize the critical role that technology plays in modern life, few appreciate the role that standards play in contributing to its success. Devices as prevalent as the modern laptop computer for example, may be governed by over 500 interoperability standards, regulating everything from the USB drive to the memory chip. To facilitate adoption of such standards, firms are increasingly turning to standard-setting organizations. These organizations consist of members of an industry who agree to abide by the organization's bylaws, which typically regard topics such as patent disclosure and reasonable licensing. Problems arise, however, when members violate these bylaws …