Combination Products

News & Analysis as of

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

FDA to Give 5 Year NCE Exclusivity to Combinations

In a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new...more

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2013)

When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability? The Supreme Court answered this question in KSR Int'l Co. v....more

Patent Watch: Allergan, Inc. v. Sandoz Inc.

On May 1, 2013, in Allergan, Inc. v. Sandoz Inc., the U.S. Court of Appeals for the Federal Circuit (Dyk, Prost,* O'Malley) affirmed-in-part and reversed-in-part the district court's judgment that U.S. Patents No. 7,642,258,...more

Federal Circuit Upholds One Claim Covering Combigan

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

6 Results
|
View per page
Page: of 1