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 Will Begin Accepting CW-1 Petitions for Fiscal Year 2019
On April 2, 2018, U.S. Citizenship and Immigration Services (USCIS) will begin accepting petitions under the Commonwealth of the Northern Mariana Islands (CNMI)-Only Transitional Worker (CW-1) program subject to the fiscal year (FY) 2019 cap. Employers in the CNMI use the CW-1 program to employ foreign workers who are ineligible for other nonimmigrant worker categories. The cap for CW-1 visas for FY 2019 is 4,999.
For the FY 2019 cap, USCIS encourages employers to file a petition for a CW-1 nonimmigrant worker up to six months in advance of the proposed start date of employment and as early as possible within that timeframe. USCIS will reject a petition if it is filed more than six months in advance. An extension petition may request a start date of Oct. 1, 2018, even if that worker’s current status will not expire by that date.
Since USCIS expects to receive more petitions than the number of CW-1 visas available for FY 2019, USCIS may conduct a lottery to randomly select petitions and associated beneficiaries so that the cap is not exceeded. The lottery would give employers the fairest opportunity to request workers, particularly with the possibility of mail delays from the CNMI.
USCIS will count the total number of beneficiaries in the petitions received after 10 business days to determine if a lottery is needed. If the cap is met after those initial 10 days, a lottery may still need to be conducted with only the petitions received on the last day before the cap was met. USCIS will announce when the cap is met and whether a lottery has been conducted.