Teva drops lawsuit with Amicus over Creates Act dispute
Teva Pharmaceuticals has abandoned its lawsuit against Amicus Therapeutics, which it had accused of contravening a US federal law designed to help generic makers bring cost-effective biosimilars to market.
The Israel-based drugmaker filed its voluntary dismissal at the US District Court for the Eastern District of Pennsylvania on September 2.
The “Creates” law, enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, opened a new pathway for developers of potential drug and biological products to obtain samples of brand products that they need to support their applications to produce generics.
In July 2021, Teva filed a complaint in Pennsylvania contending that Amicus had refused to supply the necessary samples of Galafold, (migalastat hydrochloride). The drug treats Fabry disease, also known as Anderson–Fabry disease, a rare genetic disorder that can affect many parts of the body, including the kidneys, heart, and skin.
According to the filing, Teva’s affiliate, Tusa, sent Amicus a Creates Act request in August 2020 seeking to buy two wallet packs of the drug so it could file an abbreviated new drug application (ANDA) at the US Food and Drug Administration to unveil a generic version.
Under the act, Amicus was required to deliver these packs within 31 days after receiving the request but Teva did not receive them until April 27, 2021, “far beyond the timeline prescribed by the Creates Act”.
On March 29, 2021, Teva sent Amicus a second request under the act, seeking to purchase twenty-five additional wallet packs of Galafold.
In that request, Teva explained that it needed these 25 additional wallet packs to conduct testing in support of its planned ANDA, including analytical and bioequivalence testing. Teva also noted in the filing that it had attempted to obtain Galafold samples through normal commercial channels, but the product was simply unavailable.
The complaint accused Amicus of deliberately delaying fulfilling its legal obligations, stating that the company had “failed to provide sufficient quantities of Galafold to Teva, and in fact has refused to do so, apparently in an effort to delay potential generic competition….”
But on Thursday, Teva dismissed this action with prejudice under Federal Rule of Civil Procedure 41(a)(1)(A)(i), confirming that each party would bear its own costs and attorneys’ fees.
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