Degarelix – USA

Degarelix – USA

Ferring Pharmaceuticals Inc. et al v. Fresenius Kabi USA, LLC

Case: No. 20-431

Judge: Maryellen Noreika

Date: 06/14/2021

Court: District of Delaware – Claim construction

 

This case is related to plaintiffs (Ferring pharma) drug product, Firmagon®, which is used to treat treat the symptoms of Hormone-​dependent Advanced Prostate Carcinoma. Plaintiffs asserted following patents against defendant (Fresenius Kabi). U.S. Patents Nos. 9,579,359 (“the ’359 Patent”), 10,729,739 (“the ’739 Patent”), 9,415,085 (“the ’085 Patent”), 10,695,398 (“the ’398 Patent”), 8,841,081 (“the ’081 Patent”), 9,877,999 (“the ’999 Patent”), 8,828,938 (“the ’938 Patent”), and 10,973,870.

 

Agreed-upon constructions:

1. “prostate cancer” means “any cancer of the prostate gland in which cells of the prostate mutate and begin to multiply out of control” (’359 Patent cl. 1; ’739 Patent cl. 1, 14, 27; ’085 Patent cl. 1; ’398 Patent cl. 1, 8);

2. “monthly” means “about once every 28 days” (’359 Patent cl. 2; ’739 Patent cl. 2, 15, 28; ’085 Patent cl. 3, 5, 9; ’398 Patent cl. 3, 5);

3. “IUIL” means “IU/L” (’081 Patent cl. 16–18); and

4. “having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP” means “having a S-ALP level above 147 IU/L” (’999 Patent cl. 1, 12–15, 17, 24).

 

Disputed term constructions:

1. “in a subject with a reduced likelihood of causing a testosterone spike or other gonadotrophin releasing hormone (GnRH) agonist side-effect” shall have its plain and ordinary meaning (’359 Patent cl. 1; ’739 Patent cl. 1, 14, 27);

2. “the [treated] subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with [the] gonadotrophin releasing hormone (GnRH) agonist leuprolide” shall have its plain and ordinary meaning (’359 Patent cl. 3; ’739 Patent cl. 3, 16);

3. “wherein administration of degarelix to the subject decreases the frequency of an additional cardiovascular event in the subject as compared to the frequency of an additional cardiovascular event upon treatment with a gonadotrophin releasing hormone (GnRH) agonist in a subject with a history of at least one cardiovascular event” shall have its plain and ordinary meaning (’085 Patent cl. 1);

4. “wherein a risk of developing or experiencing an additional cardiovascular event upon treatment with degarelix is diminished compared to a risk of developing or experiencing an additional cardiovascular event upon treatment with a GnRH agonist” shall have its plain and ordinary meaning (’398 Patent cl. 1);

5. “metastatic stage prostate cancer” and “metastatic prostate cancer” mean “a cancer that has spread to distant organs from the original tumour site, e.g., the prostate gland” (’081 Patent cl. 1, 15; ’999 Patent cl. 1, 15, 17, 18, 19, 24)

6. “[a] method of manufacture of degarelix . . . containing 0.3% by weight or less of Ac-D-2Nal-D-Phe(4Cl)-D-3Pal-Ser-X-D-4Aph(Cbm)-Leu-ILysPro-D-Ala-NH2, wherein X is 4-([2-(5-hydantoyl)]acetylamino)- phenylalanine” means “[a] method of manufacture of degarelix . . . containing 0.3% by weight or less of [-D-2Nal-D-Phe(4Cl)-D-3Pal-Ser-XD-4Aph(Cbm)-Leu-ILys-Pro-D-Ala-NH2, wherein X is 4-([2-(5- hydantoyl)]acetylamino)-phenylalanine using the claimed method and prior to purification steps directed at removing other impurities” (’938 Patent cl. 1);

7. “[a] method of manufacture of degarelix . . . comprising step-wise providing a solution of an amino acid or peptide in which an α-amino group is protected by Fmoc” shall have its plain and ordinary meaning.

 

Leave a Reply

Leave a Reply

Your email address will not be published.

Disclaimer
All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2022 Pharma IP Circle. All Rights Reserved