Pozen says Texas court upholds Treximet patents
Headline Legal News
Drug developer Pozen Inc. said Monday that a Texas court upheld three patents supporting its migraine drug Treximet.
Pozen said the U.S. District Court for the Eastern District of Texas ruled that the patents were valid. The court also found that generic versions of Treximet developed by Par Pharmaceutical Co. and Dr. Reddy's Laboratories Ltd. infringed on all three patents, while a version developed by Alphapharm Pty Ltd. infringed on two patents. Teva Pharmaceutical Industries Ltd. had also challenged the patents, but was dismissed from Pozen's lawsuit in April 2010 after it agreed to abide by the court's decision.
The court said the Food and Drug Administration cannot approve the generics made by Dr. Reddy's and Par until Feb. 2, 2025, and that the agency can't approve the Alphapharm generic until Aug. 14, 2017.
Treximet is a combination of GlaxoSmithKline PLC's drug Imitrex and an anti-inflammatory drug developed by Pozen. GlaxoSmithKline markets the drug and pays royalties to Pozen. In the second quarter, those royalty payments accounted for $4 million of Pozen's $4.6 million in total revenue.
The FDA approved Treximet in April 2008 after years of delays, and Par filed for approval of its generic in October of that year.
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USCIS Adjusting Premium Processing Fee
U.S. Citizenship and Immigration Services (USCIS) announced today it is adjusting the premium processing fee for Form I-129, Petition for a Nonimmigrant Worker and Form I-140, Immigrant Petition for Alien Workers beginning on Oct. 1, 2018 to more effectively adjudicate petitions and maintain effective service to petitioners.
The premium processing fee will increase to $1,410, a 14.92 percent increase (after rounding) from the current fee of $1,225. This increase, which is done in accordance with the Immigration and Nationality Act, represents the percentage change in inflation since the fee was last increased in 2010 based on the Consumer Price Index for all Urban Consumers.
“Because premium processing fees have not been adjusted since 2010, our ability to improve the adjudications and service processes for all petitioners has been hindered as we’ve experienced significantly higher demand for immigration benefits. Ultimately, adjusting the premium processing fee will allow us to continue making necessary investments in staff and technology to administer various immigration benefit requests more effectively and efficiently,” said Chief Financial Officer Joseph Moore. “USCIS will continue adjudicating all petitions on a case-by-case basis to determine if they meet all standards required under applicable law, policies, and regulations.”
Premium processing is an optional service that is currently authorized for certain petitioners filing Forms I-129 or I-140. The system allows petitioners to request 15-day processing of certain employment-based immigration benefit requests if they pay an extra fee. The premium processing fee is paid in addition to the base filing fee and any other applicable fees, which cannot be waived.