warchi / iStockphoto.com
If enacted by Congress, the proposed amendment to the Hatch-Waxman Act would spell trouble for generic pharmaceutical companies seeking to take on brand competitors in patent litigation, says Janine Carlan of Arent Fox.
US Senator Orrin Hatch, co-author of the original Hatch-Waxman Act of 1984, has introduced a new bill seeking to dramatically change the current course of Hatch-Waxman litigation. On June 13, Hatch introduced an amendment, the Hatch-Waxman Integrity Act of 2018, that is designed “to restore the careful balance the Hatch-Waxman Act struck to incentivise generic drug development”.
According to Hatch, the amendment would restore the balance by outlawing the ability to use the inter partes review (IPR) process in the context of a Hatch-Waxman litigation.
Background
Start a subscription today to access the LSIPR website.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’.
Hatch-Waxman Act, Arent Fox, Janine Carlan, patent, Orrin Hatch, IPR, inter partes review, US Congress, Trial Appeal Board, generic
