Hetero’s Subsidiaries not infringing Roxane’s patent on PhosLo

In Roxane Laboratories, Inc. (hereinafter referred to be as “Roxane”) v. Camber Pharmaceuticals Inc., et al. (hereinafter referred to as “Camber”) decided by United States Court of Appeals for the Federal Circuit on November 17, 2016, Roxane had appealed against decision of district court in an infringement suit against Camber and Invagen Pharmaceuticals Inc (collectively referred to as “appellees”), both of which are subsidiaries of Hetero Drugs Ltd. (hereinafter referred to as “Hetero”). The infringement suit was in respect of US patent number 8563032 (hereinafter referred to be as “032” patent). This appeal was from  the  United  States  District  Court  for  the  District  of  New  Jersey  in  No.  2:14-cv-04042-SRC-CLW, Judge Stanley R. Chesler. In March, 2014 appellant i.e. Roxane had filed suit for infringement against the appellees in the district of Ohio. The case was later (in June 2014) transferred to state of New jersey on the basis of convenience of  the parties  and  witnesses  as  a  whole  and  the  balance  of public and private interests.

Appellees manufacture and  sell  calcium  acetate  products  in  elongated  size  00  (“size  00el”)  capsules which are same in diameter and but have a greater length and  a larger fill volume. Calcium acetate is used to treat patients suffering from end-stage kidney failure who have abnormally high serum phosphorous levels. When taken orally, calcium acetate binds to phosphorous in foods and prevents its absorption through the gastrointestinal tract.

Roxane filed a patent on 6 Dec, 2006, the ’032 patent, for a capsule formulation of calcium acetate granules. The ‘032 patent titled ‘Formulation and manufacturing process for calcium acetate capsules’ was asserted by Roxane. This patent has only one independent claim.

In July 2015, the district  court  in  New  Jersey  issued an order construing the claim limitation “size 00 or less.” In favor of appelles. The district court held that the ’032 patent does not clearly state that size 00 also includes family of size 00 including 00el.

Appellant not only challenged construction of claims by court of New Jersey but also challenged transfer of case from state of Ohio to the state of New Jersey.

Independent claim 1 has been reproduced below for the reference:

Claim 1:

A calcium acetate capsule formulation comprising flowable granules comprised of a pharmaceutically acceptable amount of calcium acetate along with other pharmaceutically acceptable adjuvants, wherein said granules are filled into and contained within a pharmaceutically acceptable capsule such that 667 mg of said calcium acetate on an anhydrous basis are present in said capsule that is size 00 or less.

Decision of the Federal Circuit on the transfer of case:

Federal circuit observed that district court had not abused the discretion while transferring the case from Ohio to New Jersey. Federal Circuit observed that district court has wide discretions on transferring the jurisdiction and in the current case, the transfer was well within the powers of the district court.

 Decision of the Federal Circuit on the construction of claim:

Roxane argued that the court made a mistake in interpreting claims as excluding size 00el capsules. According to Roxane, “size 00” refers to either non-elongated or elongated size 00. Roxane maintains that capsule “size” only designates capsule diameter, not length or volume. Hetero responded that court correctly construed “size 00” as designating a capsule of one specific size i.e., one specific diameter, length, and fill volume not a family of capsules and that the limitation “size 00 or less” thus excludes the larger elongated size 00 capsules from the scope of the claims and further the written description, examples and the prosecution history supports the fact that “size 00” refers to standard, non-elongated size 00 capsules as they clearly mention size 00 capsule containing 667 mg of calcium acetate, thus having particular fill capacity. Federal Circuit concluded that 032’ patent and its prosecution history clearly indicates that size 00 refers to standard, non-elongated capsules and Hetero manufacturing and selling calcium acetate size 00el capsules does not infringe Roxane’s patent for capsule formulation of calcium acetate granules.

Federal circuit thus not only rejected the Appellant’s arguments on the transfer of case but also affirmed the construction of the claims by the district court.

About the Author : Ms. Rashmi Goswami, intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

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