Go

Breaking News on Pharmaceutical Technology

All feeds

News headlines > Industry Drivers

Text size Print Email this page

Pharmaceutical patent round-up

By Staff Reporter, 25-Oct-2007

Related topics: Industry Drivers, Ingredients, excipients and raw materials

In-PharmaTechnologist.com brings you an update of pharmaceutical patent litigations.

A jury in the US Federal District Court in Boston has ruled that Roche's pegylated-erythropoietin (peg-EPO) product Mircera infringes 11 Amgen EPO patent claims.

In a statement, Amgen said the biotechnology company was "pleased with the jury's verdict" and would now be seeking an injunction to prevent Roche from commercialising its product in the US in violation of Amgen's affirmed patent rights.

The US Food and Drug Administration (FDA) is expected to make a decision on November 14 on whether it will approve Mircera, which was approved in the EU in July.

The injunction hearing is scheduled for November 15.

In a separate statement, Roche said it was "currently evaluating its legal options including the possibility of an appeal".

"The verdict is disappointing because in the end, it is US patients with chronic kidney disease who lose. Amgen has had an extended monopoly for the last 20 years in the US blocking new therapeutic options to treat anaemia from being introduced," Roche pharma division chief executive William Burns said.

The ruling should block competition against Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) until 2012. The drugs have worldwide sales of $6.6bn (€4.6bn).

The Court of Appeal of Barcelona has upheld Pfizer's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Pfizer's blockbuster cholesterol drug Lipitor, which is sold in Spain under the brand names Zarator and Cardyl.

The ruling reverses a lower court decision.

The patent was originally challenged by Novartis' generics unit Lek Pharmaceuticals, and the challenge is one of four separate patent challenges on the calcium salt by generic companies in Spain.

"This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those disorders," Pfizer general counsel Allen Waxman said.

Lek can seek to appeal the decision.

Mylan and GlaxoSmithKline (GSK) have entered into a patent license and settlement agreement relating to Paroxetine Hydrochloride Extended-release Tablets, the generic version of GSK's antidepressant Paxil CR.

All litigation between Mylan and GSK relating to Paroxetine Hydrochloride Extended-release Tablets has been dismissed.

According to Mylan, under the agreement with GSK, Mylan is provided patent licenses and the right to market all three strengths of its generic version - 12.5mg, 25mg, and 37.5mg - beginning no later than October 1, 2008.

The Novartis Indian patent case has been adjourned to November 6.

The Swiss pharmaceutical company is embroiled in a case to exclude the Technical Member from the bench of the Intellectual Property Appellate Board in its Glivec (imatinib mesylate) patent case.

Novartis has objected to S Chandrasekaran sitting on the bench as Technical Member as he had been on the original panel which had refused Novartis' patent application in Indian in 2006.

On October 8, the government informed the Madras High Court that Chandrasekaran would be excluded.

Natco Pharma has objected to this exclusion.

Related Products, Brochures, Web links

Product presentations