Reuters Runs Akin Article on Inflation Reduction Act and Patent Litigation re: ‘Selected’ Drugs
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“Navigating the parallel path of patent litigation alongside the Inflation Reduction Act,” an article by Akin intellectual property partner Michael Kahn, health care & life sciences partner Craig Bleifer and intellectual property counsel Caitlin Olwell, has been published by Reuters.
Following on the Inflation Reduction Act (IRA), which requires manufacturers of “selected” drugs to participate in a price negotiation, the article provides background and insights regarding the new regime, including recent guidance documents from the Centers for Medicare & Medicaid Services (CMS). The first 10 selected were announced on August 29 by the White House, and the article notes that the manufacturers must now produce technical, sales and competitive information to CMS.
The authors write that there is “considerable substantive overlap” between the information required in the CMS price negotiation and that which would be produced during patent litigation discovery, noting the necessity of coordinating regulatory and litigation activities to ensure consistency across fora.
The article elaborates on the specific areas in which the paths are expected to overlap: procedural intersections, including documents for negotiation, confidentiality and preservation; and substantive intersections, including objective indicia of non-obviousness and remedies.
The authors conclude that it is “expected that the new IRA regulatory regime will be relevant to patent litigations concerning ‘selected’ drug products” and note that practitioners may want to “consider employing a coordinated approach involving regulatory, patent litigation and business teams—if possible, well before a drug product has been ‘selected’ for negotiation.”
To read the full article, click here.
Akin lawyers are working on part two of this two-part article series, which will look to explore the incentives created by the IRA regarding settling patent litigation or licensing rights to facilitate generic and biosimilar entry and their potential antitrust-related ramifications.
