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    00  (“  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 “ 00 or less.” In favor of appelles. The district court held that the ’032 patent does not clearly state that 00 also includes family of 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 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 00el capsules. According to Roxane, “ 00” refers to either non-elongated or elongated 00. Roxane maintains that capsule “” only designates capsule diameter, not length or volume. Hetero responded that court correctly construed “ 00” as designating a capsule of one specific i.e., one specific diameter, length, and fill volume not a family of capsules and that the limitation “ 00 or less” thus excludes the larger elongated 00 capsules from the scope of the claims and further the written description, examples and the prosecution history supports the fact that “ 00” refers to standard, non-elongated 00 capsules as they clearly mention 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 00 refers to standard, non-elongated capsules and Hetero manufacturing and selling calcium acetate 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.

Leave a Reply

Archives

  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • September 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010