Page 1
`Page 1
`
`
`
`THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK;
`THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK;
`NEW YORK UNIVERSITY; GALDERMA LABORATORIES, INC.; GALDERMA
`NEW YORK UNIVERSITY; GALDERMA LABORATORIES, INC.; GALDERMA
`LABORATORIES, L.P.; and SUPERNUS PHARMACEUTICALS, Plaintiffs v.
`LABORATORIES, L.P.; and SUPERNUS PHARMACEUTICALS, Plaintiffs v.
`MYLAN PHARMACEUTICALS INC., Defendants. MYLAN
`MYLAN PHARMACEUTICALS INC., Defendants. MYLAN
`PHARMACEUTICALS INC., Plaintiffs v. THE RESEARCH FOUNDATION OF
`PHARMACEUTICALS INC., Plaintiffs v. THE RESEARCH FOUNDATION OF
`STATE UNIVERSITY OF NEW YORK; NEW YORK UNIVERSITY;
`STATE UNIVERSITY OF NEW YORK; NEW YORK UNIVERSITY;
`GALDERMA LABORATORIES, INC.; GALDERMA LABORATORIES, L.P.; and
`GALDERMA LABORATORIES, INC.; GALDERMA LABORATORIES, L.P.; and
`SUPERNUS PHARMACEUTICALS, Defendants.
`SUPERNUS PHARMACEUTICALS, Defendants.
`
`Civ. No. 09-184-LPS,Civ. No. 10-892-LPS
`Civ. N0. 09-184-LPS,Civ. No. 10-892-LPS
`
`UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
`UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
`
`809 F. Supp. 2d 296; 2011 U.S. Dist. LEXIS 96181
`809 F. Supp. 2d 296; 2011 U.S. Dist. LEXIS 96181
`
`August 26, 2011, Decided
`August 26, 2011, Decided
`August 26, 2011, Filed
`August 26, 2011, Filed
`
`HISTORY:
`SUBSEQUENT
`of
`Findings
`of
`Findings
`HISTORY:
`SUBSEQUENT
`fact/conclusions of law at Research Found. of State Univ.
`fact/conclusions of law at Research Found. of State Univ.
`of N.Y. v. Mylan Pharms. Inc., 2012 U.S. Dist. LEXIS
`of NY. v. Mylan Pharms. Inc., 2012 U.S. Dist. LEXIS
`80737 (D. Del., May 16, 2012)
`80737 (D. Del., May 16, 2012)
`Affirmed in part and vacated in part by, Remanded by
`Affirmed in part and vacated in part by, Remanded by
`Research Found. of State Univ. of N.Y. v. Mylan Pharms.
`Research Found. of State Univ. of NY. v. Mylan Pharms.
`Inc., 2013 U.S. App. LEXIS 16284 (Fed. Cir., Aug. 7,
`Inc., 2013 U.S. App. LEXIS 16284 (Fed. Cir., Aug. 7,
`2013)
`2013)
`
`PRIOR HISTORY: Mylan Pharms., Inc. v. Galderma
`PRIOR HISTORY: Mylan Pharms., Inc. v. Galderma
`Labs., Inc., 2011 U.S. Dist. LEXIS 30555 (D. Del., Mar.
`Iabs., Inc., 2011 U.S. Dist. LEXIS 30555 (D. Del., Mar.
`24, 2011)
`24, 2011)
`
`[**1] For Research Foundation of State
`COUNSEL:
`[**1] For Research Foundation of State
`COUNSEL:
`University of New York, Galderma Laboratories Inc.
`University of New York, Galderma Laboratories Inc.
`(1:09-cv-00184-LPS), Plaintiffs: Jack B. Blumenfeld,
`(1:09—cV—00184—LPS), Plaintiffs: Jack B. Blumenfeld,
`LEAD ATTORNEY, Morris, Nichols, Arsht & Tunnell
`LEAD ATTORNEY, Morris, Nichols, Arsht & Tunnell
`LLP, Wilmington, DE; Gerald J. Flattmann , Jr., PRO
`LLP, Wilmington, DE; Gerald J. Flattmann , Jr., PRO
`HAC VICE.
`HAC VICE.
`
`For New York University, Galderma Laboratories LP,
`For New York University, Galderma Laboratories LP,
`Plaintiffs: Jack B. Blumenfeld, LEAD ATTORNEY,
`Plaintiffs: Jack B. Blumenfeld, LEAD ATTORNEY,
`Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
`Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
`
`For Mylan Pharmaceuticals Inc., Defendant: Richard L.
`For Mylan Pharmaceuticals Inc., Defendant: Richard L.
`Horwitz, LEAD ATTORNEY, David Ellis Moore, Potter
`Horwitz, LEAD ATTORNEY, David Ellis Moore, Potter
`Anderson & Corroon, LLP, Wilmington, DE; Lorelei
`Anderson & Corroon, LLP, Wilmington, DE; Lorelei
`Westin, Michael D Nguyen, PRO HAC VICE.
`Westin, Michael D Nguyen, PRO HAC VICE.
`
`For Mylan Pharmaceuticals Inc., Counter Claimant:
`For Mylan Pharmaceuticals Inc., Counter Claimant:
`Richard L. Horwitz, LEAD ATTORNEY, David Ellis
`Richard L. Horwitz, LEAD ATTORNEY, David Ellis
`Moore, Potter Anderson & Corroon, LLP, Wilmington,
`Moore, Potter Anderson & Corroon, LLP, Wilmington,
`DE.
`DE.
`
`For Mylan Pharmaceuticals Inc. (1:10-cv-00892-LPS),
`For Mylan Pharmaceuticals Inc.
`(1:10—cv—00892—LPS),
`Plaintiff: Richard L. Horwitz, LEAD ATTORNEY,
`Plaintiff: Richard L. Horwitz, LEAD ATTORNEY,
`David Ellis Moore, Potter Anderson & Corroon, LLP,
`David Ellis Moore, Potter Anderson & Corroon, LLP,
`Wilmington, DE; David S. Steuer, Kirin K. Gill, Lorelei
`Wilmington, DE; David S. Steuer, Kirin K. Gill, Lorelei
`P Westin, Matthew R. Reed, Michael D Nguyen,
`P Westin, Matthew R. Reed, Michael D Nguyen,
`Tung-On Kong, PRO HAC VICE.
`Tung-On Kong, PRO HAC VICE.
`
`For Galderma Laboratories Inc., Galderma Laboratories
`For Galderma Laboratories Inc., Galderma Laboratories
`LP, Supernus Pharmaceuticals Inc., Defendants: Jack B.
`LP, Supemus Pharmaceuticals Inc., Defendants: Jack B.
`Blumenfeld, Maryellen Noreika, Morris, Nichols, Arsht
`Blumenfeld, Maryellen Noreika, Morris, Nichols, Arsht
`& Tunnell, Wilmington, [**2] DE.
`& Tunnell, Wihnington, [**2] DE.
`
`For Galderma Laboratories LP, Galderma Laboratories
`For Galderma Laboratories LP, Galderma Laboratories
`Inc., Supernus Pharmaceuticals Inc., Counter Claimants:
`Inc., Supemus Pharmaceuticals Inc., Counter Claimants:
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`|PR2015-01777
`
`1
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`809 F. Supp. 2d 296, *; 2011 U.S. Dist. LEXIS 96181, **2
`809 F. Supp. 2d 296, *; 2011 U.S. Dist. LEXIS 96181, **2
`
`Page 2
`Page 2
`
`Maryellen Noreika, Morris, Nichols, Arsht & Tunnell,
`Maryellen Noreika, Morris, Nichols, Arsht & Tunnell,
`Wilmington, DE.
`Wilmington, DE.
`
`For Mylan Pharmaceuticals Inc., Counter Defendant:
`For Mylan Pharmaceuticals Inc., Counter Defendant:
`Richard L. Horwitz, LEAD ATTORNEY, David Ellis
`Richard L. Horwitz, LEAD ATTORNEY, David Ellis
`Moore, Potter Anderson & Corroon, LLP, Wilmington,
`Moore, Potter Anderson & Corroon, LLP, Wihnington,
`DE.
`DE.
`
`laws of the State of New York, having a principal place
`laws of the State of New York, having a principal place
`of business
`in Albany, New York.
`(Statement of
`of business
`in Albany, New York.
`(Statement of
`Uncontested Facts (C.A. 09-184-LPS D.I. 257-1 3)
`Uncontested Facts
`(C.A. 09-184—LPS D.I. 257-1 3)
`("SUF") ¶ 1)
`CSUF011)
`
`3 All citations to Docket Index ("D.I.") entries
`3 All citations to Docket Index ("D.I.") entries
`are to C.A. 09-184-LPS, unless otherwise noted.
`are to C.A. 09-184—LPS, unless otherwise noted.
`
`JUDGES: Leonard P. Stark, U.S. District Judge.
`JUDGES: Leonard P. Stark, U.S. District Judge.
`
`OPINION BY: Leonard P. Stark
`OPINION BY: Leonard P. Stark
`
`OPINION
`OPINION
`
`[*298] Stark, U.S. District Judge:
`[*298] Stark, U.S. District Judge:
`
`In July 2011, the Court held a four-day bench trial in
`In July 2011, the Court held a four—day bench trial in
`this patent infringement action brought pursuant to the
`this patent infringement action brought pursuant to the
`Hatch—Waxman Act. The case arises from Defendant's
`Hatch-Waxman Act. The case arises from Defendant's
`efforts to bring to market a generic version of Plaintiffs'
`efforts to bring to market a generic version of Plaintiffs’
`Oracea® drug product, a once-daily 40 milligram (mg)
`Oracea® drug product, a once-daily 40 milligram (mg)
`administration of doxycycline indicated for the treatment
`administration of doxycycline indicated for the treatment
`of acne rosacea. Plaintiffs assert
`that claims of five
`of acne rosacea. Plaintiffs assert
`that claims of five
`separate patents are infringed. Defendants contend that all
`separate patents are infringed. Defendants contend that all
`five patents are invalid. 1 As explained below, the Court
`five patents are invalid. 1 As explained below, the Court
`concludes that the asserted claims of one patent-in-suit
`concludes that the asserted claims of one patent—in—suit
`are infringed and valid. The preliminary injunction
`are infringed and valid. The preliminary injunction
`entered in July 2010 will remain in effect pending the
`entered in July 2010 will remain in effect pending the
`Court's receipt and review of supplemental briefing as to
`Court's receipt and review of supplemental briefing as to
`an appropriate permanent remedy. 2
`an appropriate permanent remedy. 2
`
`[**3] The
`There are five patents-in-suit.
`1
`[**3] The
`There are five patents—in—suit.
`1
`"Ashley Patents" are U.S. Patent No. 7,211,267
`"Ashley Patents" are U.S. Patent No. 7,211,267
`("the '267 patent") (PTX 1) and U.S. Patent No.
`("the ’267 patent") (PTX 1) and U.S. Patent No.
`7,232,572 ("the '572 patent") (PTX 2). The "Amin
`7,232,572 ("the '572 patent") (PTX 2). The "Amin
`Patents" are U.S. Patent No. 5,789,395 ("the '395
`Patents" are U.S. Patent No. 5,789,395 ("the ’395
`patent") (PTX 3) and U.S. Patent No. 5,919,775
`patent") (PTX 3) and U.S. Patent No. 5,919,775
`("the '775 patent") (PTX 4). Finally, the "Chang
`("the ’775 patent") (PTX 4). Finally, the "Chang
`Patent" is U.S. Patent No. 7,749,532 ("the '532
`Patent" is U.S. Patent No. 7,749,532 ("the ’532
`patent"). (PTX 5)
`patent"). (PTX 5)
`2 This opinion constitutes the Court's findings of
`2 This opinion constitutes the Court's findings of
`fact and conclusions of law pursuant to Fed. R.
`fact and conclusions of law pursuant to Fed. R.
`Civ. Proc. 52(a).
`Civ. Proc. 52(a).
`
`FINDINGS OF FACT
`FINDINGS OF FACT
`
`I. PARTIES
`I. PARTIES
`
`1. Plaintiff The Research Foundation of State
`1. Plaintiff The Research Foundation of State
`University of New York ("RF SUNY") is a private,
`University of New York ("RF SUNY") is a private,
`non-profit corporation organized and existing under the
`non—profit corporation organized and existing under the
`
`2. Plaintiff New York University ("NYU") is a
`2. Plaintiff New York University ("NYU")
`is a
`private, non-profit corporation organized and existing
`private, non—profit corporation organized and existing
`under the laws of the State of New York, having a place
`under the laws of the State of New York, having a place
`of business in New York, New York. (SUF ¶ 2)
`of business in New York, New York. (SUF ‘H 2)
`
`3. Plaintiff Galderma Laboratories Inc. ("GLI") is a
`3. Plaintiff Galderma Laboratories Inc. ("GLI") is a
`corporation organized and existing [*299] under [**4]
`corporation organized and existing [*299] under
`[**4]
`the laws of the State of Delaware, having a principal
`the laws of the State of Delaware, having a principal
`place of business in Fort Worth, Texas. (SUF ¶ 3)
`place of business in Fort Worth, Texas. (SUF ‘H 3)
`
`4. Plaintiff Galderma Laboratories, L.P. ("GLLP") is
`4. Plaintiff Galderma Laboratories, L.P. ("GLLP") is
`a privately held partnership registered in the State of
`a privately held partnership registered in the State of
`Texas, having a principal place of business in Fort Worth,
`Texas, having a principal place of business in Fort Worth,
`Texas. (SUF ¶ 4)
`Texas. (SUF ‘H 4)
`
`Inc.
`Pharmaceuticals,
`Supernus
`Plaintiff
`5.
`Inc.
`Pharmaceuticals,
`Supemus
`Plaintiff
`5.
`("Supernus") is a corporation organized and existing
`("Supemus")
`is a corporation organized and existing
`under the laws of the State of Delaware, having a
`under the laws of the State of Delaware, having a
`principal place of business in Rockville, Maryland. (SUF
`principal place of business in Rockville, Maryland. (SUF
`¶ 5) 4
`15)"
`
`4 Plaintiffs RF, SUNY, NYU, GLI, GLLP, and
`4 Plaintiffs RF, SUNY, NYU, GLI, GLLP, and
`Supernus are referred to collectively throughout
`Supemus are referred to collectively throughout
`this Opinion as "Plaintiffs" or "Galderma."
`this Opinion as "Plaintiffs" or "Galderma."
`
`6. Defendant Mylan Pharmaceuticals Inc. ("Mylan")
`6. Defendant Mylan Pharmaceuticals Inc. ("Mylan")
`is a corporation organized and existing under the laws of
`is a corporation organized and existing under the laws of
`the State of West Virginia, having a principal place of
`the State of West Virginia, having a principal place of
`business in Morgantown, West Virginia. (SUF ¶ 6)
`business in Morgantown, West Virginia. (SUF ‘H 6)
`
`H. DOXYCYCLINE
`II. DOXYCYCLINE
`
`The
`7.
`The
`7.
`monohydrate is:
`monohydrate is:
`
`structural
`structural
`
`formula
`formula
`
`of
`of
`
`doxycycline
`doxycycline
`
`
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`|PR2015-01777
`
`2
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`809 F. Supp. 2d 296, *299; 2011 U.S. Dist. LEXIS 96181, **4
`809 F. Supp. 2d 296, *299; 2011 U.S. Dist. LEXIS 96181, **4
`
`Page 3
`Page 3
`
`(SUF ¶ 41)
`(SUF‘][41)
`
`8. Doxycycline is a member of the tetracycline class
`8. Doxycycline is a member of the tetracycline class
`of antibacterial drugs. (SUF ¶ 42)
`of antibacterial drugs. (SUF ‘H 42)
`
`9. Doxycycline
`9. Doxycycline
`compound. (SUF ¶ 44)
`compound. (SUF ‘H 44)
`
`is
`is
`
`an
`an
`
`antibiotic
`antibiotic
`
`tetracycline
`tetracycline
`
`10. There are two general categories of antibiotics:
`10. There are two general categories of antibiotics:
`bacteriostatic agents, which inhibit bacterial growth; and
`bacteriostatic agents, which inhibit bacterial growth; and
`bactericidal [**5] agents, which kill bacteria. (SUF ¶ 45)
`bactericidal [**5] agents, which kill bacteria. (SUF ‘H 45)
`
`19. The active ingredient in Oracea® is doxycycline
`19. The active ingredient in Oracea® is doxycycline
`monohydrate. (SUF ¶ 51)
`monohydrate. (SUF ‘H 51)
`
`20. Oracea® is a capsule dosage form for oral
`20. Oracea® is a capsule dosage form for oral
`administration. (SUF ¶ 52)
`administration. (SUF ‘H 52)
`
`21. The dosage strength of Oracea® is 40 mg. (SUF
`21. The dosage strength of Oracea® is 40 mg. (SUF
`¶ 53)
`‘ll 53)
`
`22. Oracea® is an oral pharmaceutical composition
`22. Oracea® is an oral pharmaceutical composition
`of doxycycline to be administered once-daily. (SUF ¶ 54)
`of doxycycline to be administered once-daily. (SUF ‘H 54)
`
`11. Generic doxycycline is commercially available in
`11. Generic doxycycline is commercially available in
`at least 50 mg, 75 mg, 100 mg, 150 mg, and 200 mg
`at least 50 mg, 75 mg, 100 mg, 150 mg, and 200 mg
`dosage forms. (SUF ¶ 46)
`dosage forms. (SUF ‘H 46)
`
`23. Oracea® is indicated for the treatment of only
`23. Oracea® is indicated for the treatment of only
`inflammatory lesions (papules and pustules) of rosacea in
`inflammatory lesions (papules and pustules) of rosacea in
`adult patients. (SUF ¶ 56)
`adult patients. (SUF ‘H 56)
`
`12. Periostat® is a 20 mg dose of doxycycline
`12. Periostat® is a 20 mg dose of doxycycline
`administered twice-daily to a human and is indicated for
`administered twice-daily to a human and is indicated for
`treatment of periodontal disease. (SUF ¶ 47)
`treatment of periodontal disease. (SUF ‘H 47)
`
`13. According to its approved label, Periostat® has a
`13. According to its approved label, Periostat® has a
`steady state Cmax of 0.790 µg/ml. (SUF ¶ 48)
`steady state Cmax of 0.790 pg/ml. (SUF ‘H 48)
`HI. ROSACEA AND ITS TREATMENT
`III. ROSACEA AND ITS TREATMENT
`
`24. Oracea® is a hard shell gelatin capsule filled
`24. Oracea® is a hard shell gelatin capsule filled
`two
`types
`of
`doxycycline
`beads,
`30 mg
`with
`two
`types
`of
`doxycycline
`beads,
`30 mg
`with
`immediate-release
`("IR")
`beads
`and
`10 mg
`immediate-release
`("IR")
`beads
`and
`10 mg
`delayed-release ("DR") beads (coated with an enteric
`delayed—release ("DR") beads (coated with an enteric
`polymer). (SUF ¶¶ 57-58)
`polymer). (SUF M 57-58)
`
`25. Oracea® does not contain a bisphosphonate
`25. Oracea® does not contain a bisphosphonate
`compound. (SUF ¶ 59)
`compound. (SUF ‘H 59)
`
`14. Rosacea is a long-lasting, chronic inflammatory
`14. Rosacea is a long—lasting, chronic inflammatory
`disorder. (Tr. 71) 5
`disorder. (Tr. 71) 5
`
`26. Oracea® contains one or more pharmaceutical
`26. Oracea® contains one or more pharmaceutical
`excipients. (SUF ¶ 60)
`excipients. (SUF ‘H 60)
`
`The trial transcript is docketed at D.I. 270,
`5
`The trial transcript is docketed at D.I. 270,
`5
`271, 272, and 273. All references to the trial
`271, 272, and 273. All references to the trial
`transcript are in the format "Tr." followed by the
`transcript are in the format "Tr." followed by the
`page number.
`page number.
`
`27. Oracea® is the first and only orally administered,
`27. Oracea® is the first and only orally administered,
`systemically delivered drug approved by the FDA for the
`systemically delivered drug approved by the FDA for the
`treatment of rosacea. (PTX 426 at GAL 0229992; Tr.
`treatment of rosacea.
`(P'TX 426 at GAL 0229992; Tr.
`540)
`540)
`
`15. Historically, rosacea has been treated by oral
`15. Historically, rosacea has been treated by oral
`administration of antibiotics in antibiotic dosages and/or
`administration of antibiotics in antibiotic dosages and/or
`administration of topical gels and creams to treat the
`administration of topical gels and creams to treat the
`signs and symptoms of the disease. (PTX 209 at 1249;
`signs and symptoms of the disease. (P'TX 209 at 1249;
`Tr. 75, 534-36)
`Tr. 75, 534-36)
`
`16. The most common oral treatments for rosacea
`16. The most common oral treatments for rosacea
`prior to the launch of Oracea® were antibiotic doses of
`prior to the launch of Oracea® were antibiotic doses of
`tetracyclines. (PTX 209 at 1249; Tr. 534-36)
`tetracyclines. (P'TX 209 at 1249; Tr. 534-36)
`
`[*300] IV. Oracea®
`[*300] IV. Oracea®
`
`17. Plaintiff GLLP currently holds New Drug
`17. Plaintiff GLLP currently holds New Drug
`Application
`("NDA")
`50-805
`on Oracea® brand
`Application
`("NDA")
`50-805
`on Oracea® brand
`doxycycline capsules ("Oracea®"), which was approved
`doxycycline capsules ("Oracea®"), which was approved
`[**6] by the U.S. Food and Drug Administration
`[**6] by the U.S. Food and Drug Administration
`("FDA") on May 26, 2006. (SUF ¶ 49)
`("FDA") on May 26, 2006. (SUF ‘H 49)
`
`18. GLLP is the exclusive distributor of Oracea® in
`18. GLLP is the exclusive distributor of Oracea® in
`the United States. (SUF ¶ 50)
`the United States. (SUF ‘H 50)
`
`28. Oracea® treats rosacea in a human. (PTX 426 at
`28. Oracea® treats rosacea in a human. (P'TX 426 at
`GAL 0229992; PTX 381 at GAL 0240969-70; [**7] Tr.
`GAL 0229992; PTX 381 at GAL 0240969-70;
`[**7] Tr.
`73, 129-30)
`73, 129-30)
`
`is
`29. Oracea®, when administered once-daily,
`is
`29. Oracea®, when administered once-daily,
`administered in an amount that reduces lesion count and
`administered in an amount that reduces lesion count and
`an amount
`that
`is effective to treat
`the papules and
`an amount
`that
`is effective to treat
`the papules and
`pustules of rosacea. (PTX 426 at GAL 0229996-97; PTX
`pustules of rosacea. (P'TX 426 at GAL 0229996-97; PTX
`381 at GAL 0240969-70; Tr. 73, 287-88, 727)
`381 at GAL 0240969-70; Tr. 73, 287-88, 727)
`
`30. Oracea® is administered long-term, i.e., over a
`30. Oracea® is administered long-term, i.e., over a
`period of time longer than eight to ten days. (PTX 426 at
`period of time longer than eight to ten days. (P'TX 426 at
`GAL 0229993, -96-97; SUF ¶ 38)
`GAL 0229993, -96-97; SUF ‘H 38)
`
`31. Oracea® is administered by "sustained release,"
`31. Oracea® is administered by "sustained release,"
`i.e., a method of drug delivery to achieve a certain level
`i.e., a method of drug delivery to achieve a certain level
`of the drug over a particular period of time. (PTX 426 at
`of the drug over a particular period of time. (P'TX 426 at
`GAL 0229993, - 95, -96)
`GAL 0229993, - 95, -96)
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`|PR2015-01777
`
`3
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`809 F. Supp. 2d 296, *300; 2011 U.S. Dist. LEXIS 96181, **7
`809 F. Supp. 2d 296, *300; 2011 U.S. Dist. LEXIS 96181, **7
`
`Page 4
`Page 4
`
`is
`32. Oracea®, when administered once daily,
`is
`32. Oracea®, when administered once daily,
`administered in an amount that results in no reduction of
`administered in an amount that results in no reduction of
`skin microflora during a six-month treatment. (PTX 426
`skin microflora during a six-month treatment. (PTX 426
`at GAL 0229996; PTX 394; 459, 612-15)
`at GAL 0229996; PTX 394; 459, 612-15)
`
`33. In vivo microbiological studies utilizing a similar
`33. In vivo microbiological studies utilizing a similar
`drug exposure to Oracea® for up to 18 months
`drug exposure to Oracea® for up to 18 months
`demonstrated no detectable long-term effects on bacterial
`demonstrated no detectable long—term effects on bacterial
`flora of the oral cavity, skin, intestinal tract, and vagina.
`flora of the oral cavity, skin, intestinal tract, and vagina.
`(PTX 426 at GAL 0229996; PTX 394; PTX 413; PTX
`(PTX 426 at GAL 0229996; PTX 394; PTX 413; PTX
`200; PTX 201)
`200; PTX 201)
`
`34. Oracea® should not be used for treating bacterial
`34. Oracea® should not be used for treating bacterial
`infections,
`providing
`antibacterial
`prophylaxis,
`or
`infections,
`providing
`antibacterial
`prophylaxis,
`or
`[**8]
`reducing
`the
`numbers
`or
`eliminating
`reducing
`the
`numbers
`[**8]
`or
`eliminating
`microorganisms associated with any bacterial disease.
`microorganisms associated with any bacterial disease.
`(PTX 426 at GAL 0229996)
`(PTX 426 at GAL 0229996)
`
`take Oracea® to treat
`35. Patients
`should not
`take Oracea® to treat
`35. Patients should not
`infections caused by bacteria germs or viruses. (PTX 426
`infections caused by bacteria germs or viruses. (PTX 426
`at GAL 0229998)
`at GAL 0229998)
`
`V. MYLAN'S GENERIC PRODUCT
`V. MYLAN'S GENERIC PRODUCT
`
`36. Defendant Mylan submitted Abbreviated New
`36. Defendant Mylan submitted Abbreviated New
`Drug Application ("ANDA") 90-855 to the FDA under §
`Drug Application ("ANDA") 90-855 to the FDA under §
`505(j) of the Federal Food, Drug and Cosmetic Act
`505(j) of the Federal Food, Drug and Cosmetic Act
`("FFDCA"), seeking FDA approval for the commercial
`("FFDCA"), seeking FDA approval for the commercial
`manufacture, use, and sale of a [*301] generic version
`manufacture, use, and sale of a [*301] generic version
`of Oracea® ("Mylan's Generic Product" or "Mylan's
`of Oracea® ("Mylan's Generic Product" or "Mylan's
`ANDA Product") before the expiration of the '267 patent,
`ANDA Product") before the expiration of the '267 patent,
`the '572 patent, the '395 patent, and the '775 patent. (SUF
`the ’572 patent, the ’395 patent, and the ’775 patent. (SUF
`¶ 61)
`‘ll 61)
`
`as
`identifies Mylan
`37. ANDA 90-855
`as
`identifies Mylan
`37. ANDA 90-855
`manufacturer of Mylan's Generic Product. (SUF ¶ 62)
`manufacturer of Mylan's Generic Product. (SUF ‘H 62)
`
`the
`the
`
`38. The FDA approved ANDA 90-855 on July 1,
`38. The FDA approved ANDA 90-855 on July 1,
`2010. (SUF ¶ 63)
`2010. (SUF ‘H 63)
`
`39. Mylan's Generic Product will contain the
`39. Mylan's Generic Product will contain the
`package insert approved by the FDA for Mylan's Generic
`package insert approved by the FDA for Mylan's Generic
`Product ("Mylan's Label," "Mylan Label," or "Label").
`Product ("Mylan's Label," "Mylan Label," or "Label").
`(SUF ¶ 64)
`(SUF ‘H 64)
`
`40. The active ingredient in Mylan's Generic Product
`40. The active ingredient in Mylan's Generic Product
`is doxycycline. (SUF ¶ 65)
`is doxycycline. (SUF ‘H 65)
`
`41. The dosage strength of Mylan's Generic Product
`41. The dosage strength of Mylan's Generic Product
`is 40 mg. (SUF ¶ 66)
`is 40 mg. (SUF ‘H 66)
`
`capsule filled with two types [**9] of doxycycline beads,
`capsule filled with two types [**9] of doxycycline beads,
`30 mg IR and 10 mg DR. (SUF ¶ 67)
`30 mg IR and 10 mg DR. (SUF ‘H 67)
`
`43. Mylan's Generic Product does not contain a
`43. Mylan's Generic Product does not contain a
`bisphosphonate compound. (SUF ¶ 68)
`bisphosphonate compound. (SUF ‘H 68)
`
`44. FDA has found Mylan's Generic Product to be
`44. FDA has found Mylan's Generic Product to be
`bioequivalent to Oracea®. (SUF ¶ 69)
`bioequivalent to Oracea®. (SUF ‘H 69)
`
`45. The statements in the approved package insert for
`45. The statements in the approved package insert for
`Mylan's Generic Product
`are
`true.
`(Memorandum
`Mylan's Generic Product
`are
`true.
`(Memorandum
`Opinion granting Preliminary Injunction (D.I. 177) at 9;
`Opinion granting Preliminary Injunction (D.I. 177) at 9;
`see also 18 U.S.C. § 1001; 21 U.S.C. §§ 355b(a)(1),
`see also 18 U.S.C. § 1001; 21 U.S.C. §§ 355b(a)(I),
`355c(a); Tr. 323)
`355c(a); Tr. 323)
`
`46. The doxycycline in Mylan's Generic Product is
`46. The doxycycline in Mylan's Generic Product is
`doxycycline
`monohydrate.
`(DTX
`2091
`at
`doxycycline
`monohydrate.
`(DTX
`2091
`at
`MYL-D118692-93; DTX 2267 at MYL-D000206; Tr.
`MYL-D118692-93; DTX 2267 at MYL-D000206; Tr.
`98-99)
`98-99)
`
`47. Mylan's Label instructs doctors and patients that
`47. Mylan's Label instructs doctors and patients that
`one doxycycline capsule (40 mg) of Mylan's Generic
`one doxycycline capsule (40 mg) of Mylan's Generic
`Product
`should
`be
`taken
`once-daily
`by
`oral
`Product
`should
`be
`taken
`once-daily
`by
`oral
`administration. (DTX 2091 at MYL-D118686-87; DTX
`administration. (DTX 2091 at MYL-D118686-87; DTX
`2267 at MYL-D000220; Tr. 83, 100-01)
`2267 at MYL-D000220; Tr. 83, 100-01)
`
`is indicated for the
`48. Mylan's Generic Product
`is indicated for the
`48. Mylan's Generic Product
`treatment of only inflammatory lesions (papules and
`treatment of only inflammatory lesions (papules and
`pustules) of rosacea in adult patients. (DTX 2091 at
`pustules) of rosacea in adult patients.
`(DTX 2091 at
`MYL-D118686-87; Tr. 82)
`MYL-D118686-87; Tr. 82)
`
`49. Mylan's Label instructs doctors and patients to
`49. Mylan's Label instructs doctors and patients to
`use Mylan's Generic Product to treat rosacea in a human.
`use Mylan's Generic Product to treat rosacea in a human.
`(DTX 2091 at MYL-D118686-87, -97; Tr. 82)
`(DTX 2091 at MYL-D118686-87, -97; Tr. 82)
`
`50. Mylan's Generic Product, when administered
`50. Mylan's Generic Product, when administered
`once-daily [**10] in accordance with Mylan's Label, is
`once-daily [**10] in accordance with Mylan's Label, is
`administered in an amount that reduces lesion count and
`administered in an amount that reduces lesion count and
`that
`is effective to treat
`the papules and pustules of
`that
`is effective to treat
`the papules and pustules of
`rosacea. (DTX 2091 at MYL-D118695-96; Tr. 82-83)
`rosacea. (DTX 2091 at MYL-D118695-96; Tr. 82-83)
`
`administered
`is
`51. Mylan's Generic Product
`administered
`is
`51. Mylan's Generic Product
`long-term, i.e., over a period of time longer than eight to
`long—term, i.e., over a period of time longer than eight to
`ten days. (DTX 2091 at MYL-D118687, -95-96; Tr. 84)
`ten days. (DTX 2091 at MYL-D118687, -95-96; Tr. 84)
`
`VI. PATENTS-IN-SUIT
`VI. PATENTS-IN-SUIT
`
`A. The Ashley Patents
`A. The Ashley Patents
`
`1. Ashley '267 Patent
`1. Ashley '267 Patent
`
`42. Mylan's Generic Product is a hard shell gelatin
`42. Mylan's Generic Product is a hard shell gelatin
`
`52. U.S. Application Number 10/117,709, from
`52. U.S. Application Number 10/117,709, from
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`|PR2015-01777
`
`4
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`809 F. Supp. 2d 296, *301; 2011 U.S. Dist. LEXIS 96181, **10
`809 F. Supp. 2d 296, *301; 2011 U.S. Dist. LEXIS 96181, **10
`
`Page 5
`Page 5
`
`which the '267 patent issued, was filed on April 5, 2002.
`which the ’267 patent issued, was filed on April 5, 2002.
`(SUF ¶ 7)
`(SUF ‘ll 7)
`
`53. The '267 patent issued on May 1, 2007, naming
`53. The ’267 patent issued on May 1, 2007, naming
`Robert A. Ashley as the sole inventor and listing
`Robert A. Ashley as
`the sole inventor and listing
`CollaGenex Pharmaceuticals, Inc. as assignee. (SUF ¶ 8)
`CollaGenex Pharmaceuticals, Inc. as assignee. (SUF ‘H 8)
`The '267 patent is entitled "Methods of Treating Acne."
`The ’267 patent is entitled "Methods of Treating Acne."
`(PTX 1)
`(PTX 1)
`
`54. GLI is the current assignee of the '267 patent.
`54. GLI is the current assignee of the ’267 patent.
`(SUF ¶ 9)
`(SUF ‘ll 9)
`
`55. The '267 patent claims priority from provisional
`55. The ’267 patent claims priority from provisional
`application no. 60/325,489, filed September 26, 2001 and
`application no. 60/325,489, filed September 26, 2001 and
`provisional application no. 60/281,916, filed April 5,
`provisional application no. 60/281,916,
`filed April 5,
`2001. (SUF ¶ 10)
`2001. (SUF ‘H 10)
`
`[*302] 56. The '267 patent is set to expire on April
`[*302] 56. The ’267 patent is set to expire on April
`5, 2022. (SUF ¶ 11)
`5, 2022. (SUF ‘H 11)
`
`2 Ashley '572 Patent
`2 Ashley '572 Patent
`
`from
`57. U.S. Application Number 11/061,866,
`from
`57. U.S. Application Number 11/061,866,
`which the '572 patent issued, was filed on February 18,
`which the '572 patent issued, was filed on February 18,
`2005. (SUF ¶ 12)
`2005. (SUF ‘H 12)
`
`58. The '572 patent [**11] issued on June 19, 2007,
`58. The '572 patent [**11] issued on June 19, 2007,
`naming Robert A. Ashley as the sole inventor and listing
`naming Robert A. Ashley as the sole inventor and listing
`CollaGenex Pharmaceuticals, Inc. as assignee. (SUF ¶
`CollaGenex Pharmaceuticals, Inc. as assignee. (SUF ‘H
`13) The '572 patent is entitled, "Methods of Treating
`13) The '572 patent is entitled, "Methods of Treating
`Rosacea." (PTX 2)
`Rosacea." (PTX 2)
`
`trial by
`63. Dr. Webster, who was called at
`trial by
`63. Dr. Webster, who was called at
`Galderma, is an expert in the field of clinical dermatology
`Galderma, is an expert in the field of clinical dermatology
`and microbiology. (Tr. 70; PTX 248) 6
`and microbiology. (Tr. 70; PTX 248) 6
`
`There is no dispute that each of the experts
`6
`There is no dispute that each of the experts
`6
`who testified at trial is a person having at least
`who testified at trial is a person having at least
`ordinary skill in the art with respect to the patents
`ordinary skill in the art with respect to the patents
`about which that expert testified.
`about which that expert testified.
`
`64. Dr. Chambers, who was called at trial by Mylan,
`64. Dr. Chambers, who was called at trial by Mylan,
`is an expert [**12] in the field of infectious diseases and
`is an expert [**12] in the field of infectious diseases and
`antimicrobial agents, including antibiotic resistance and
`antimicrobial agents, including antibiotic resistance and
`the
`pharmacokinetics
`and
`pharmacodynamics
`of
`the
`pharmacokinetics
`and
`pharmacodynarnics
`of
`antimicrobial agents. (Tr. 552; DTX 2102)
`antimicrobial agents. (Tr. 552; DTX 2102)
`
`65. Dr. Randall Stafford, who was called at trial by
`65. Dr. Randall Stafford, who was called at trial by
`Mylan, is an expert in the field of clinical epidemiology,
`Mylan, is an expert in the field of clinical epidemiology,
`including the use prescription patterns generated by IMS
`including the use prescription patterns generated by IMS
`Health. (Tr. 416; DTX 2208)
`Health. (Tr. 416; DTX 2208)
`
`66. Dr. Barbara Gilchrest, who was called at trial by
`66. Dr. Barbara Gilchrest, who was called at trial by
`Mylan, is an expert in the field of clinical dermatology
`Mylan, is an expert in the field of clinical dermatology
`with a specific focus in the treatment of acne and rosacea.
`with a specific focus in the treatment of acne and rosacea.
`(Tr. 449; DTX 2135)
`(Tr. 449; DTX 2135)
`
`67. A microorganism is a single cellular life form or
`67. A microorganism is a single cellular life form or
`sub-life form, including a bacterium, a virus, a yeast, or
`sub—life form, including a bacterium, a virus, a yeast, or
`protozoan. (Tr. 557)
`protozoan. (Tr. 557)
`
`68. Microorganisms live everywhere on and in our
`68. Microorganisms live everywhere on and in our
`bodies. (Tr. 557)
`bodies. (Tr. 557)
`
`59. GLI is the current assignee of the '572 patent.
`59. GLI is the current assignee of the '572 patent.
`(SUF ¶ 14)
`(SUF ‘H 14)
`
`69. Approximately 100,000,000,000,000 bacterial
`69. Approximately 100,000,000,000,000 bacterial
`cells inhabit the human body. (Tr. 149-50, 557)
`cells inhabit the human body. (Tr. 149-50, 557)
`
`60. The '572 patent is a continuation of application
`60. The '572 patent is a continuation of application
`no. 10/272,499, filed on October 15, 2002, and issued as
`no. 10/272,499, filed on October 15, 2002, and issued as
`U.S. Patent No. 7,014,858, which is a continuation of
`U.S. Patent No. 7,014,858, which is a continuation of
`application no. 10/117,709, which issued as the '267
`application no. 10/117,709, which issued as the ’267
`patent. (SUF ¶ 15)
`patent. (SUF ‘H 15)
`
`61. The '572 patent claims priority from provisional
`61. The '572 patent claims priority from provisional
`application no. 60/281,916, filed April 5, 2001 and
`application no. 60/281,916,
`filed April 5, 2001 and
`provisional application no. 60/325,489, filed September
`provisional application no. 60/325,489, filed September
`26, 2001. (SUF ¶ 16)
`26, 2001. (SUF‘][ 16)
`
`62. The '572 patent is set to expire on April 5, 2022.
`62. The '572 patent is set to expire on April 5, 2022.
`(SUF ¶ 17)
`(SUF ‘H 17)
`
`3. Facts relating to infringement and validity of
`3. Facts relating to infringement and validity of
`Ashley Patents
`Ashley Patents
`
`70. In our bodies, the number of bacterial cells is
`70. In our bodies, the number of bacterial cells is
`greater than the number of human cells by a factor of 10.
`greater than the number of human cells by a factor of 10.
`(Tr. 557)
`(Tr. 557)
`
`71. Doxycycline is among the most potent known
`71. Doxycycline is among the most potent known
`antimicrobial agents. (Tr. 558)
`antimicrobial agents