Ex-Parte Interim Injunction Passed against Symed Laboratories Ltd. for Infringement of Vifor (International) Ltd.’s Patent

An Ex-Parte Interim Injunction was recently passed against Symed Laboratories Ltd. (a Hyderabad based Pharmaceutical Company) by Delhi High Court in a patent infringement suit filed by Vifor (International) AG (a Swiss Pharmaceutical Company). The lawsuit was filed by Vifor against Symed Labs for the infringement of one of Vifor’s Indian granted Patents: IN 221536.

Vifor is a specialty pharmaceutical company focused on the treatment of iron deficiency and offers a number of prescription as well as over-the-counter products and has an iron replacement product portfolio consisting of its products Ferinject®, Venofer®, and Maltofer®. Vifor has about 7 granted patents published at the Indian Patent Office. The Patent in question is on a water-soluble Iron Carbohydrate complex for the treatment of iron deficiency anemia and a process for producing the same. The first claim of the Patent is as follows:

“Water-soluble iron carbohydrate complexes obtainable from an aqueous solution of iron (III) salt and an aqueous solution of the oxidation product of one or more maltodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, wherein the obtained iron complexes have an average molecular weight of 80 kDa to 400 kDa.”

Symed is involved in the manufacture and marketing of bulk pharmaceuticals products, and has launched an alleged infringing product iron carboxymaltose (ferric carboxymaltose) and is also advertising the same at its website. The product of the Vifor’s said patented invention is Ferinject®, an iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, allows for controlled delivery of the iron to target tissues.

The major novelty of the claimed invention seems to lie in average molecular weight of 80 kDa to 400 kDa which has not been disclosed before the priority date of the invention as argued by Vifor’s counsel (as understood from a cursory look of the cited prior arts in the prosecution history of the patent published at the Indian Patent Office). The closest prior art as cited by the examiner disclosed the average molecular weight range of 300-5000. The defendant can study the complete prosecution history of the patent and can try to conduct a strong prior art search especially which covers this molecular range to invalidate the subject patent. The defendant can also study the prosecution history of the family patent applications to see for example, whether or not the same has been granted or not, the kind of prior art references cited therein, the objections made by the examiners, and so forth. This article is being written only to provide information on the passing of this order and not to evaluate whether the patent in question is valid or not and therefore detailed search & analysis on the patent in question is not carried out.

Further, there is an ongoing discussion (for example at Spicy IP) whether the Indian Courts should grant ex-parte injunctions in the patent infringement matters especially where most Indian Judges are not that technically capable to comprehend on their own (they mostly need the assistance of expert witnesses to assess the patent infringement and validity matters). For example, in this order, the Judge did not discuss how denial of an ex-parte order would cause irreparable injury to the Plaintiff and further did not discuss the claims at once.

The complete Order of the Justice Sistani is available here.

About the Author: Ms. Meenakshi Khurana, Patent Specialist at Khurana & Khurana and can be reached at [email protected]