Ferric carboxymaltose – USA

Ferric carboxymaltose – USA

VIFOR (INTERNATIONAL) AG et al v. MYLAN LABORATORIES LTD  

Case No. 19-13955

Judge: Chief Judge Freda L. Wolfson

Date: 06/28/2021

Court: District of New Jersey – OPINION – Claim construction

 

Plaintiffs Vifor (International) AG and American Regent, Inc. (collectively, “Plaintiffs”) brought the instant Hatch-Waxman patent infringement suit against Defendants Mylan Laboratories Ltd.  and Sandoz Inc. (collectively “Defendants”).  At issue in this claim construction dispute are five patents which share a common specification: US 7,612,109; US 7,754,702; US 8,895,612; US 9,376,505; and 10,519,252. The patents-in-suit are listed in Orange Book for Injectafer (ferric carboxymaltose injection), and they cover an iron replacement product suggested for the treatment of iron deficiency anemia in adult patients.

 

Construction of disputed terms:

1. “Maltodextrin”: (’109 Patent, Claims 1-16, 19-21, 23-27 ’505 Patent, Claims 1-6, 8-24, 26-36 ’252 Patent, Claims 1-4, 6-8, 10-16, 18- 26)

Plaintiffs’ Construction – “starch hydrolysate composed of a mixture of saccharides of variable length consisting of chains of D-glucose units connected primarily by α- (1→4) glycosidic bonds”

Defendants’ Construction – “saccharide(s) of variable length composed of chains of D-glucose units connected primarily by α-(1→4) glycosidic bonds”

Court’s Construction –  “a mixture of saccharides of variable length composed of chains of D-glucose units connected primarily by α-(1→4) glycosidic bonds”

 

2. “one maltodextrin” / “each individual maltodextrin”: (’109 Patent, Claims 1-16, 19-21, 23-27 ’505 Patent, Claims 1-6, 8-24, 26-36 ’252 Patent, Claims 1-4, 6-8, 10-16, 18- 26)

Plaintiffs’ Construction – one/each “maltodextrin,” as that term is defined above

Defendants’ Construction – Indefinite under 35 U.S.C. § 112

Court’s Construction – one/each “maltodextrin,” as that term is defined by this Opinion, i.e., one mixture of saccharides of variable length composed of chains of D-glucose units connected primarily by α-(1→4) glycosidic bonds

 

3. “the iron carbohydrate complex has a substantially nonimmunogenic carbohydrate component”: (’702 Patent, Claims 4-6, 17-19, 21-22, 24, 31-38, 44-47, 53-54 ’612 Patent, Claims 1-5, 10-11, 15-18)

Plaintiffs’ Construction – “the iron carbohydrate complex has a carbohydrate component resulting in a low risk of anaphylactoid/hypersensitivity reactions, wherein a low risk is an incidence of adverse events associated with the iron carbohydrate complex lower than iron dextran”

Defendants’ Construction – “Indefinite under § 112.  To the extent a construction is possible, it should be construed as a carbohydrate component resulting in a low risk of anaphylactoid/ hypersensitivity reactions, wherein a low risk is an incidence of adverse events lower than dextran”

Court’s Construction – “a carbohydrate component resulting in a low risk of anaphylactoid/ hypersensitivity reactions, wherein a low risk is an incidence of adverse events lower than dextran”

 

4. “the iron carbohydrate complex has […] substantially no cross reactivity with antidextran antibodies”: (’702 Patent, Claims 4-6, 17-19, 21-22, 24, 31-38, 44-47, 53-54 ’612 Patent, Claim 2)

Plaintiffs’ Construction – “the iron carbohydrate complex … does not exhibit a substantial antibody/antigen immune response with antidextran antibodies in a clinical setting”

Defendants’ Construction – Indefinite under § 112.  To the extent a construction may be possible, it must be construed as not limited to requiring cross reactivity with anti-dextran antibodies in a clinical setting

Court’s Construction – “the iron carbohydrate complex … does not exhibit a substantial antibody/antigen immune response with antidextran antibodies”

 

5. “subject”: (’702 Patent, Claims 4-6, 17-19, 21-22, 24, 31-38, 44-47, 53-54 ’612 Patent, Claims 1-5, 10-11, 15-18)

Plaintiffs’ Construction – “human”

Defendants’ Construction – “Mammal to whom the carbohydrate complex is administered”

Court’s Construction – “Mammal to whom the carbohydrate complex is administered”

 

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