Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Galderma Laboratories L.P. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

August 21, 2019

GALDERMA LABORATORIES L.P., GALDERMA S.A. and NESTLE SKIN HEALTH S.A., Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.

          John W. Shaw, Karen E. Keller, Nathan R. Hoeschen, SHAW KELLER LLP, Wilmington, DE; Leora Ben-Ami, Thomas F. Fleming, Justin Bova, Ashley Ross, Christopher T. Jagoe, KIRKLAND & ELLIS LLP, New York, NY; Kristen Reichenbach, KIRKLAND & ELLIS LLP, San Francisco, CA; Noah Frank, KIRKLAND & ELLIS LLP, Washington, D.C. Attorneys for Plaintiffs.

          Jack B. Blumenfeld, Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Jamil N. Alibhai, Michael C. Wilson, Daniel E. Venglarik, Kelly P. Chen, Chad J. Ray, Jordan C. Strauss, Chase A. Cobern, MUNCK WILSON MANDALA, LLP, Dallas, TX. Attorneys for Defendant.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE:

         On April 21, 2017, Galderma Laboratories L.P., Galderma S.A., and Nestle Skin Health S.A. (collectively, "Galderma") brought this action against Teva Pharmaceuticals USA, Inc. for infringement of several patents under 35 U.S.C. § 271(d)(2)(A). (D.I. 1). I held a bench trial from June 10 to 12, 2019. (D.I. 253-56).[1] By trial the parties had narrowed the case to three patents-U.S. Patent Nos. 9, 089, 587 ("the '587 patent"), 9, 233, 117 ("the '117 patent"), and 9, 233, 118 ("the '118 patent") (collectively, "the asserted patents").[2]

         Presently before the Court are the issues of validity and infringement of the asserted patents. Galderma asserts infringement of claim 12 of the '587 patent, claims 2, 3, and 6 of the '117 patent, and claims 6, 7, 10, and 11 of the '118 patent. (D.I. 241). The parties stipulated to infringement of claim 6 of the' 118 patent, assuming the claim is valid and enforceable. (D.I. 230, Ex. B). Teva argues, however, that each of the asserted claims are invalid for lack of written description, anticipation, and obviousness. (D.I. 240). I have considered the parties' post-trial briefing. (D.I. 240, 241, 244, 245, 248, 249).

         For the following reasons, I find each of the asserted claims invalid for anticipation.

         I. BACKGROUND

         The asserted patents are directed to methods of treating papulopustular rosacea. I have construed "papulopustular rosacea" as a "chronic inflammatory disorder characterized by facial papules, pustules, persistent erythema, and the presence of inflammatory infiltrates that accompany flares." (D.I. 126 at 2). I also adopted the parties' agreed-upon construction of "inflammatory lesions of [papulopustular] rosacea" as "papules and/or pustules." (Id. at 3).

         Galderma owns NDA No. 206255 for Soolantra (ivermectin) Cream 1% for the treatment of inflammatory lesions of rosacea. (D.I. 228 ¶¶ 5-6). Ivermectin is an anti-parasitic drug derivative that has been approved for human use since 1996. PX-1 at 1:50-54. All the asserted patents are listed in the Orange Book for Soolantra. (D.I. 228 ¶ 7). Teva filed ANDA No. 210019 on December 30, 2016 seeking FDA approval for the commercial manufacture, use, and sale of a generic 1% ivermectin cream ("Teva's ANDA product"). (Id. ¶¶ 17, 20). Teva's ANDA label states that the product is "indicated for the treatment of inflammatory lesions of rosacea." (Id. ¶ 25). Teva sent its Paragraph IV certification to Galderma on March 10, 2017 stating that the asserted patents are "invalid, unenforceable, and/or will not be infringed" by its ANDA product. (Id. ¶ 20). Galderma then filed this action alleging infringement by Teva's ANDA submission. (D.I. 1); 35 U.S.C. § 271(d)(2)(A).

         II. ASSERTED CLAIMS

         All of the asserted claims require (1) topically administering, (2) once daily, (3) to a skin area affected by the inflammatory lesions of rosacea, (4) a pharmaceutical composition comprising 1% by weight ivermectin and a pharmaceutically acceptable carrier. E.g., PX-3 at 24:20-23. In addition, some claims require certain efficacies based on reduction in lesion count, improvement in Investigator's Global Assessment (IGA) score, [3] delayed time to first relapse, [4]and/or comparison to a second pharmaceutical composition comprising 0.75% by weight metronidazole.[5]

         Galderma asserts dependent claim 12 of the '587 patent. The relevant claims provide:

8. A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea or the inflammatory lesions of rosacea a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a significant reduction in inflammatory lesion count in the subject, and a significant improvement in at least one selected from the group consisting of a higher investigator's global assessment success rate and a delayed time to first relapse in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second pharmaceutical composition comprising 0.75% by weight metronidazole.
11. The method of claim 8, wherein the pharmaceutical composition comprises about 0.5% to about 1% by weight ivermectin.
12. The method of claim 11, wherein the pharmaceutical composition comprises about 1 % by weight ivermectin.

PX-1 at 24:19-44.

         Galderma asserts dependent claims 2, 3, and 6 of the' 117 patent. The relevant claims provide:

1. A method of treating inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of rosacea a pharmaceutical composition comprising 1% by weight ivermectin and a pharmaceutically acceptable carrier, wherein as early as 2 weeks after the initial administration of the pharmaceutical composition, a significant reduction in inflammatory lesion count is observed.
2. The method of claim 1, wherein the treatment results in more reduction in inflammatory lesion count in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second pharmaceutical composition comprising 0.75% by weight metronidazole.
3. The method of claim 1, wherein the treatment results in longer relapse-free time of the inflammatory lesions of rosacea in the subject in comparison to that achieved by twice daily topically administering to the subject a second pharmaceutical composition comprising 0.75% by weight metronidazole.
5. The method of claim 1, wherein the subject has moderate to severe papulopustular rosacea before the treatment.
6. The method of claim 5, wherein the subject has 15 or more of the inflammatory lesions before the treatment.

PX-2 at 28:43-67.

         Galderma asserts independent claim 6 and dependent claims 7, 10, and 11 of the '118 patent. The parties have stipulated to infringement of claim 6. (D.I. 230, Ex. B). The relevant claims provide:

6. A method of treating inflammatory lesions of papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of papulopustular rosacea a pharmaceutical composition comprising about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a significant reduction in inflammatory lesion count in the subject.
7. The method of claim 6, wherein as early as 2 weeks after the initial administration of the pharmaceutical composition, the significant reduction in inflammatory lesion count is observed.
8. The method of claim 6, wherein the pharmaceutical composition is administered once daily to the skin area.
10. The method of claim 8, wherein the once daily topical administration to the subject the pharmaceutical composition results in more reduction in inflammatory lesion count in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second pharmaceutical composition comprising 0.75% by weight metronidazole.
11. The method of claim 8, wherein the once daily topical administration to the subject the pharmaceutical composition results in longer relapse-free time of the inflammatory lesions in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.