Monday, October 21, 2013

Acella Pamlab End Patent Suit over Generic Foltx

Case Filed: Nov 06, 2012

Case Closed: Oct 11, 2013

Court: Delaware District Court

Judge: Sue L. Robinson

Case Summary:
Pamlab, Breckenridge Pharmaceutical, Metabolite Laboratories jointly filed a patent infringement suit against Acella Pharmaceuticals claiming that their US patent US6528496 was infringed. The cause of the suit was of Acella manufacturing a generic version of the pharmaceutical product Foltx/Folbic before the expiration of the ‘496 patent covering Foltx/Folbic and its use.

The patent is entitled ‘Compositions treating, preventing or reducing elevated metabolic levels’ which was legally issued to Robert H. Allen and Sally P. Stabler on Mar 04, 2003 and expired[i] by Dec 29, 2012.  Metabolite was the last assignee[ii] of the ‘496 patent (source: MaxVal’s Assignment Database). Pamlab was the exclusive licensee and Breckenridge the sub-licensee of the ‘496 patent.

Pamlab manufactures and sells the product with the trademarked name Foltx® and Breckenridge sells under the name Folbic®.  The products contain three active ingredients, namely vitamin B12, vitamin B6, and folic acid. It is used as a supplement to prevent/treat vitamin deficiency and also is prescribed to treat certain heart and blood vessel diseases by reducing the level of homocysteine.

The complaint alleges that Acella had manufactured a product which it represents as containing 2 mg of vitamin B12, 25 mg. of vitamin B6, and 2.5 mg. of  folic acid, the same active ingredients in the same amounts as Foltx and Folbic, and which Acella markets under the name of Folastin.

It says “in offering its Folastin for sale, Acella has represented, explicitly or implicitly, that it’s Folastin is substitutable for Foltx/Folbic and quoted it as a “willful infringement”.

With its suit, plaintiffs sought the court to declare a permanent enjoinment of Acella from marketing and selling Acella's Folastin along with fees, costs and expenses.

Stipulated motion for dismissal was filed by Acella and the Court upon consideration granted the dismissal, thereby closing the case.

See 1:12-cv-01403 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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