KEI will host a two hour virtual roundtable on march-in rights in U.S. government-funded inventions on Wednesday October 6, 2021 from 2pm to 4pm EDT. This will take place via Zoom, so if you would like to take part in the discussion or listen in, please reply to march-in@keionline.org. The main objective of the roundtable is to discuss both the history of and the prospects going forward for march-in requests.
The history of march-in requests, while fairly bleak so far, is probably not as bleak as some may think, with a few examples of concessions, settlements and partial remedies that are often overlooked. But the prospects going forward are the most important topic, given the combination of President Biden’s competition executive order and the HHS report on drug pricing, both of which rejected efforts to eliminate unreasonable pricing as a ground and signaled a new openness to considering cases based upon pricing issues.
Beyond the legal issues, the roundtable will discuss practical issues for march-in requests, including specifically the following:
Grounds. Will a federal department or agency be comfortable deciding a case based upon a ground that will be seen as a precedent for other similar cases? In other words, will the ground for the march-in request scale?
Patent landscape. Does the federal government have sufficient rights in relevant patented inventions to achieve a beneficial outcome? If not, will a government department or agency consider using another statute, 28 USC § 1498(a), to overcome patents that do not have federal rights in the inventions?
Timeliness. Will the remaining time in the life of the patent be sufficient to merit a march-in?
Appeals. Will the provision in 35 USC 203(b) (which states that if a march-in request is granted, the patent holder is given a stay “pending the exhaustion of appeals”) unduly delay the benefits of a march-in right remedy? Or, does the federal government’s potential use of a royalty-free license to practice the patent provide sufficient additional leverage that can overcome such delays if the government finds such an action appropriate?
Non-patent regulatory exclusivities. If the product is regulated by the FDA, will entry of competitors to the product or service be frustrated by a regulatory exclusivity, such the FDA’s exclusive rights in test data, or Orphan Drug exclusivity?
Likelihood of entry by a competitor. Assuming that patent and regulatory exclusivities can be overcome, are there firms that are likely to provide timely entry, given the challenges of acquiring manufacturing know-how, and time and cost of obtaining regulatory approval, and other economic barriers to entry?
This will be a moderated informal discussion.