MNTA: text of Amphastar's complaint alleging Federal anti-trust and CA state unfair business practice violations by MNTA and Sandoz against Amphastar. One reason I sold out my entire position in MNTA about 18 months ago was the never-ending litigation over enoxaparin. This latest lawsuit IMO confirms that the enoxaparin litigation could continue for years even if the Federal Circuit reverses its prior decision against MNTA in the next few months and the District Court in Massachusetts then upholds MNTA's patents, which may add another year or 2 to the original litigation.
COMPLAINT
JAN P. WEIR, State Bar No. 106652 jan.weir@klgates.com
JOSEPH J. MELLEMA, State Bar No. 248118 joseph.mellema@klgates.com
TAYLOR C. FOSS, State Bar No. 253486 taylor.foss@klgates.com
JENNIFER A. MAURI, State Bar No. 276522 jennifer.mauri@klgates.com
K&L GATES LLP
One Park Plaza, Twelfth Floor
Irvine, CA 92614
T: (949) 253-0900
F: (949) 623-4499
Attorneys for Plaintiff
AMPHASTAR PHARMACEUTICALS, INC.
UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA
AMPHASTAR PHARMACEUTICALS, INC., INTERNATIONAL MEDICATION SYSTEMS, LTD.,
Plaintiffs
vs.
MOMENTA PHARMACEUTICALS, INC., SANDOZ PHARMACEUTICALS, INC.,
Defendants.
Civil Action No. 5:15-CV-01914
COMPLAINT FOR VIOLATIONS OF THE SHERMAN ACT; VIOLATIONS OF THE CARTWRIGHT ACT;
UNFAIR BUSINESS PRACTICES
Judge:
Courtroom:
JURY TRIAL DEMANDED
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 1 of 26 Page ID #:1
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 2 of 26 Page ID #:2
1 Plaintiffs Amphastar Pharmaceuticals, Inc. and International Medication
2 Systems, Ltd. (collectively “Plaintiffs”) allege as follows:
3
4 THE PARTIES
5 1. Plaintiff Amphastar Pharmaceuticals, Inc. (“Amphastar”) is a specialty and
6 generic pharmaceutical company located in Rancho Cucamonga, California.
7 Amphastar develops, manufactures, and markets technically complex proprietary and
8 generic drug products and active pharmaceutical ingredients (“APIs”) at its state-of-
9 the-art facilities. Amphastar, either directly or through its distributors, has long-
10 standing relationships with all the major group purchasing organizations (“GPOs”) and
11 drug wholesalers in the United States, which enables Amphastar to rapidly introduce
12 new products and quickly establish significant market share. Amphastar currently
13 manufactures and sells a generic version of the drug enoxaparin.
14
15 2. Plaintiff International Medication Systems, Ltd. (“IMS”) is a wholly-owned
16 subsidiary of Amphastar with its principal place of business in South El Monte,
17 California. IMS manufactures sterile injectable products that are sold in a variety of
18 delivery systems, including pre-filled syringes and vials. IMS also manufactures the
19 API for Amphastar’s generic enoxaparin.
20
21 3. Defendant Momenta Pharmaceuticals, Inc. (“Momenta”) is a Delaware
22 corporation with a principal place of business at 675 West Kendall Street, Cambridge,
23 Massachusetts 02142. Momenta is the assignee of at least one United States patent
24 that Momenta alleges relate to methods of analyzing enoxaparin.
25
26 4. Defendant Sandoz, Inc. (“Sandoz”) is a Colorado corporation with a principal
27 place of business at 506 Carnegie Center, Princeton, New Jersey 08540. Sandoz is the
28 distributor of a generic enoxaparin product that it markets and sells throughout the
1
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 3 of 26 Page ID #:3
1 United States. Sandoz and Momenta have entered into a profit-sharing contractual
2 relationship, which includes an exclusive license of the Momenta patent as further
3 alleged herein. Defendants Momenta and Sandoz will be referred to collectively as
4 “Defendants.”
5
6 JURISDICTION AND VENUE
7 Subject Matter Jurisdiction
8 5. Plaintiffs and Defendants are engaged in interstate commerce and in activities
9 substantially affecting interstate commerce. They are engaged in a regular,
10 continuous, and substantial flow of interstate commerce. Defendants are competitors
11 of Plaintiffs in connection with the sale of generic enoxaparin in the United States.
12 The drug enoxaparin is sold in all fifty states and has a substantial effect upon
13 interstate commerce.
14
15 6. This Court has federal question subject matter jurisdiction over the claims of this
16 Complaint under the Sherman Act, 15 U.S.C. §§ 1-2, the Clayton Act, 15 U.S.C. §
17 15(a), 28 U.S.C. § 1331, and as a civil action relating to regulation of monopolies, 28
18 U.S.C. § 1337.
19
20 7. This Court has federal question subject matter jurisdiction over the claims of this
21 Complaint under the Clayton Act, 15 U.S.C. §§ 12–27, 29 U.S.C. §§ 52–53, as a
22 federal law, 28 U.S.C. § 1331, and as a civil action relating to regulation of
23 monopolies, 28 U.S.C. § 1337.
24
25 8. This Court further has subject matter jurisdiction because the parties are diverse
26 and the amount in controversy exceeds $75,000. 28 U.S.C. § 1332. Amphastar and
27 IMS are citizens of California; Momenta is a citizen of Massachusetts; Sandoz is a
28 citizen of New Jersey. 28 U.S.C. § 1332(c)(1).
2
COMPLAINT
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1
2 9. This Court further has supplemental jurisdiction under 28 U.S.C. § 1367 on
3 Plaintiffs’ claim for violations of the Cartwright Act, found at California Business and
4 Professions Code § 16720 et seq., because the claim is “so related to claims in the
5 action within such original jurisdiction that [it] form[s] part of the same case or
6 controversy under Article III of the United States Constitution.”
7
8 10. Further still, this Court has supplemental jurisdiction under 28 U.S.C. § 1367 on
9 Plaintiffs’ claim for violations of California Business and Professions Code § 17200,
10 because the claim is “so related to claims in the action within such original jurisdiction
11 that [it] form[s] part of the same case or controversy under Article III of the United
12 States Constitution.”
13
14 Personal jurisdiction
15 11. This Court has personal jurisdiction over Defendants because Defendants
16 knowingly transact a large volume of business in California in the form of sales of
17 pharmaceuticals, including generic enoxaparin. Further, Defendants directed their
18 actions toward Plaintiffs in this district and succeeded in causing competitive injury to
19 Plaintiffs in this district.
20
21 Venue
22 12. Venue is proper in this Court because this Court has personal jurisdiction over
23 Defendants. 28 U.S.C. § 1391(b). Further, Defendants directed their actions toward
24 Plaintiffs in this district and succeeded in causing competitive injury to Plaintiffs in
25 this district.
26
27 13. Venue is further appropriate in this Court because Defendants conduct a
28 substantial amount of business in this judicial district. 28 U.S.C. § 1391(b).
3
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 5 of 26 Page ID #:5
1
2 14. Venue is further appropriate in this Court because Plaintiffs’ principal place of
3 business is located within this judicial district. 28 U.S.C. § 1391(c).
4
5 FACTS COMMON TO ALL CLAIMS
6 The Market for Enoxaparin Prior to Generic Entry
7
8 15. This case involves the anticoagulant drug “enoxaparin.” Enoxaparin is a low
9 molecular weight heparin (“LMWH”). In medicine, enoxaparin is used in the
10 prevention and treatment of deep vein thrombosis (including inpatient treatment of
11 acute deep vein thrombosis with or without pulmonary embolism, and outpatient
12 treatment of acute deep vein thrombosis without pulmonary embolism), and in the
13 treatment of myocardial infarction, including certain specific myocardial infarction
14 treatments (e.g., acute ST-segment elevation myocardial infarction). Other LMWHs
15 are prepared by different processes than enoxaparin and have distinct physical,
16 chemical, and biological properties, and they are not considered as clinically
17 equivalent to enoxaparin. Enoxaparin is the most popular and widely prescribed
18 LMWH due mainly to its physical, chemical, and biological properties and it generates
19 the largest sales. No other anticoagulant drug is a close substitute for enoxaparin.
20
21 16. Sanofi-Aventis (“Aventis”) originally introduced enoxaparin to the United
22 States in 1995 under the brand name Lovenox®, after obtaining approval from the
23 Food and Drug Administration (“FDA”). Lovenox® became a huge commercial
24 success for Aventis, generating billions in revenue in the United States. Prior to
25 entering the United States market, Aventis filed an application on June 26, 1991, for a
26 United States patent purporting to cover Aventis’s Lovenox® product. Aventis’s
27 patent eventually issued on February 14, 1995 as United States Patent No. 5,389,618
28
4
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 6 of 26 Page ID #:6
1 (the “’618 patent”). Aventis listed the ’618 patent in the FDA’s Orange Book as being
2 applicable to its Lovenox® product.
3
17. An applicant seeking the right to market a generic drug in the United States may
4
file an Abbreviated New Drug Application (“ANDA”) with the FDA. An ANDA
5
applicant must establish to the FDA’s satisfaction that the generic drug meets the
6
FDA’s “sameness” standard as compared to the brand drug. Compliance with FDA
7
rules, regulations and requirements is mandatory for the sale of drug products in the
8
United States.
9
10 18. Amphastar filed an ANDA to sell a generic version of enoxaparin in the United
11 States on March 4, 2003. In its ANDA, Amphastar contended that Aventis’s ’618
12 patent was invalid and unenforceable. Amphastar was the first to file with the FDA for
13 the FDA’s approval to sell a generic version of enoxaparin in the United States, and
14 Amphastar was the first generic applicant to receive acknowledgement of “sameness”
15 by the FDA for generic enoxaparin, dated November 2, 2007. Amphastar received
16 FDA approval to sell enoxaparin on September 19, 2011.
17
19. Teva Pharmaceuticals, Inc. followed Amphastar, and on June 24, 2003, filed an
18
ANDA seeking FDA approval to sell generic enoxaparin in the United States. Teva
19
was the second filer to seek FDA approval to sell a generic version of enoxaparin.
20
Teva received FDA approval to sell enoxaparin on June 23, 2014.
21
22
20. Defendant Sandoz filed an ANDA on August 26, 2005, two and a half years
23
after Amphastar’s filing. Sandoz was the third filer for a generic version of
24
enoxaparin. Sandoz received FDA approval to sell enoxaparin on July 23, 2010.
25
Among other collaborative aspects of their relationship in connection with their
26
generic enoxaparin product, Sandoz is the ANDA owner and Momenta is Sandoz’s
27
contract laboratory.
28
5
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 7 of 26 Page ID #:7
1 21. On August 4, 2003, Aventis sued Amphastar and Teva, alleging infringement of
2 the ’618 patent. On February 8, 2007, Amphastar cleared the way for generic
3 competition by successfully establishing that Aventis’s ’618 patent was unenforceable
4 due to inequitable conduct. The Federal Circuit affirmed that decision on May 14,
5 2008.
6
7 22. From the time Aventis began selling Lovenox® in the United States until
8 approximately late July 2010, Aventis was the sole source for enoxaparin in the United
9 States because the FDA had not approved a generic version of Lovenox®.
10
11 Defendants’ Intent to Be the Sole Source of Generic Enoxaparin in the United States
12
13 23. For purposes of the claims alleged herein, the relevant product market was—and
14 is—the market for generic enoxaparin, or in the alternative, enoxaparin. Between
15 generic and brand enoxaparin, consumers who are price-sensitive primarily purchase
16 generic enoxaparin, and would view another generic, as opposed to the brand, as a
17 reasonable substitute. Generic manufacturers primarily compete against each other for
18 sales. Due to purchasing structures in different channels of trade, if a generic is
19 commercially available, some distributors will purchase and supply only generic
20 enoxaparin. Generic manufacturers regard the pricing of other generic manufactures
21 as directly affecting their pricing. The relevant geographic market was—and is—the
22 United States.
23
24 24. On or about November 1, 2003, Defendants entered into a Collaboration and
25 License Agreement (“Collaboration Agreement”) for the development and
26 commercialization of enoxaparin sodium injection in the United States. The
27 Collaboration Agreement heavily incentivized Defendants to obtain and maintain
28 themselves as the sole source of generic enoxaparin in the United States.
6
COMPLAINT
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1
2 25. The Collaboration Agreement contained financial incentives, which included
3 among other things, certain milestone payments for Defendants to be the sole provider
4 of generic enoxaparin in the United States. Momenta’s President and CEO, Craig
5 Wheeler, publicly stated regarding the Collaboration Agreement that “if you look at
6 the structure of the deal, the company is heavily, heavily incentivized to be a sole
7 generic in the marketplace.”
8
9 26. Under the terms of the Collaboration Agreement, Sandoz was obligated to pay
10 higher amounts of profit share or royalty payments to Momenta so long as there were
11 no third-party competitors marketing a generic enoxaparin. As contemplated by the
12 Collaboration Agreement, provided that a generic monopoly existed, Momenta would
13 receive a profit share payment from Sandoz significantly higher than a royalty
14 payment. The Collaboration Agreement also provided that Momenta would receive no
15 less than a 45% share of all profits earned by Sandoz’s sales of its generic enoxaparin
16 so long as Defendants were the sole source of generic enoxaparin in the United States.
17
18 27. The Collaboration Agreement also obligated Sandoz to make various milestone
19 payments, which were contingent upon no other generic enoxaparin products entering
20 the market (i.e., contingent upon developing and maintaining a generic monopoly).
21 For example, on or about July 23, 2011, Momenta received a $10 million milestone
22 payment from Sandoz in recognition of completing a full year of sales without an
23 additional generic enoxaparin product entering the market.
24
25 28. Further, the compensation from Sandoz to Momenta would be substantially
26 higher so long as Defendants’ generic enoxaparin remained the sole generic
27 enoxaparin product available. For example, because there were no competing generic
28 enoxaparin products on the market for at least one year following Defendants’ launch
7
COMPLAINT
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1 of their generic enoxaparin, the compensation from Sandoz to Momenta was double or
2 triple that which Momenta would receive if there had been market entry by a
3 competitor.
4
5 29. Sandoz, for its part, also enjoyed significantly higher revenues and profits under
6 a profit sharing arrangement rather than a royalty payment for the simple reasons that
7 during the time there were no other generic enoxaparin competitors on the market,
8 Sandoz commanded a much higher price for its generic enoxaparin, and no competing
9 sales were diverted to any competitors. Sandoz, in fact, did maintain a high price for
10 Defendants’ generic enoxaparin product—a price that was very close to Aventis’s
11 price for its Lovenox® brand product—for the entire duration of time that Defendants
12 marketed the sole generic enoxaparin product. During the first year, sales of
13 Defendants’ generic enoxaparin product exceeded one billion dollars. Sandoz’s ability
14 to maintain a high price for Defendants’ generic enoxaparin was of paramount
15 importance to Sandoz, and it was critical to Sandoz to ensure generic competitors were
16 blocked from entering the market.
17
18 30. The terms of the Collaboration Agreement created a strong financial incentive
19 for Defendants to obtain and maintain a monopoly in the relevant market for as long as
20 possible.
21
22 31. The Collaboration Agreement also exclusively licensed Momenta’s patents to
23 Sandoz, which were intended to be used by Defendants to exclude competition.
24 Among the licensed patents was United States Patent No. 7,575,866 (the “’886
25 patent”). Momenta filed the application that matured into the ’886 patent on March
26 11, 2003, and the ’886 patent issued on August 18, 2009. Among the named inventors
27 was Momenta’s Dr. Zachary Shriver.
28
8
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 10 of 26 Page ID #:10
1 Defendants’ Deception of the USP Standards
Setting Organization to Obtain a Generic Monopoly
2
3 32. At least by 2007, Aventis had requested that the United States Pharmacopeial
4 Convention (“USP”) adopt criteria for enoxaparin that included a standardized test that
5 Aventis had developed for determining such criteria, namely that 15 to 25% of the
6 carbohydrate chains in enoxaparin had a 1,6-anhydro ring structure on one of their
7 terminal ends. In or around February 2007, or at least by that time, the USP had begun
8 work on a proposed standard for enoxaparin, including work on a test method
9 proposed by Aventis. Aventis’s proposed standard became known as USP Method
10 <207>.
11
12 33. The USP is a scientific nonprofit organization that sets standards for identity,
13 strength, quality, and purity of medicines, food ingredients, and dietary supplements
14 that are manufactured, distributed and consumed worldwide. USP’s drug standards are
15 enforceable in the United States by the FDA. USP standards are recognized and
16 required under federal law. For example, the FDA enforces USP standards by
17 requiring that any pharmaceutical product comply with the USP monograph for that
18 drug product. See 21 U.S.C. § 351(b). Further, “[c]ompliance with a USP-NF
19 monograph, if available, is mandatory.”
20
21 34. As a public standards-setting organization, the USP has an express policy of
22 impartiality and of not favoring one manufacturer over another in setting its standards.
23 “USP will hold open meetings and publish standards impartially. USP will not provide
24 . . . standards-setting activities, in a manner that will allow any stakeholder to have an
25 undue advantage over another stakeholder.” “Consistent with and in furtherance of
26 this mission, USP is committed to doing all it reasonably can to assure that USP-NF
27 standards and related methods are developed through an objective, independent,
28 science-based process, and that the resulting official compendial standards not have the
9
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 11 of 26 Page ID #:11
1 effect of favoring any manufacturer over others or putting any FDA-approved product
2 out of compliance. The USP attempts to maintain independence and impartiality, as it
3 is critical to the integrity and credibility of its standard-setting activities.”
4
5 35. To ensure impartiality and its policy of not favoring any one manufacturer over
6 another, the USP maintains a strict Code of Ethics that applies to all members and
7 participants of USP committees. The USP develops these standards through
8 “members” or “participants” of various expert panels and committees, often scientists
9 in the field relevant to the standard being developed. Each member and participant
10 agrees to the USP’s Rules and Procedures of the Council of Experts, which include
11 specific rules on conflicts of interest. Each individual or entity involved in the
12 standard-setting process has a duty to ensure that they remain free of any actual or
13 perceived conflicts of interest in the performance of their duties. The conflict-of-
14 interest rules place a duty on each member to submit to the USP a statement disclosing
15 all interests that could result in a conflict of interest, including intellectual property
16 rights. In the event that a conflict of interest arises, it is the duty of the member to
17 disclose the conflict of interest to the USP. The USP will not permit a member to be
18 present for the final discussion, deliberation, or vote on the issue on which he or she
19 has a conflict of interest.
20
21 36. It is common practice for USP Staff to review USP conflict of interest policies at
22 the beginning of USP panel meetings.
23
24 37. Zachary Shriver, who was an employee and director at Momenta during the
25 relevant time period, served as Momenta’s representative on USP’s Heparin Ad Hoc
26 Advisory Panel and Low Molecular Weight Heparins Expert Panel, which oversaw the
27 development and approval of USP’s enoxaparin standard. In spite of his association
28 with Momenta at the time, Dr. Shriver—and Momenta whom he represented on the
10
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 12 of 26 Page ID #:12
1 panel—owed the USP a duty to disclose any and all information relevant to the USP’s
2 adoption of the enoxaparin standard. Dr. Shriver and Momenta were well aware of
3 their duty to the USP and the USP’s policy not to favor one manufacturer over another.
4 In fact, Dr. Shriver who was Senior Director of Research Analytics at Momenta,
5 concurrently and simultaneously represented both Momenta as well as USP (and thus
6 the public interest) during the time that Dr. Shriver participated in the USP panel
7 discussions and the ultimate adoption of USP Method <207>.
8
9 38. Sandoz also participated in panel discussions and owed the USP a duty to
10 disclose any and all information relevant to the USP’s adoption of USP Method
11 <207>.
12
39. During the USP’s consideration of USP Method <207>, Defendants and Dr.
13
Shriver learned that Aventis had a pending patent application, the claims of which, if
14
issued, would read on USP Method <207>. Defendants objected to Aventis having a
15
patent that covered a standardized USP test, contending that the test, once adopted,
16
should be free for anyone to use. Defendants insisted that the USP require Aventis to
17
expressly abandon the patent application so that there would be no doubt that any
18
member of the public could practice USP Method <207>. Defendants were aware at
19
the time that the USP had a policy of not favoring one manufacturer over another.
20
Defendants were aware at the time that the USP would be disinclined to adopt a
21
standard test method that was covered by one company’s patent, which could prohibit
22
the free public use of the USP’s adopted standard and method.
23
24
40. Defendants were very familiar with USP Method <207> and the USP’s conflict
25
of interest policies. On or about November 14, 2008, USP held a meeting of the
26
Heparin Ad Hoc Advisory Panel that was considering the USP’s adoption of USP
27
Method <207>. At the beginning of the meeting USP Staff member, Mr. Van Hook,
28
gave a presentation to those in attendance of USP’s rules of conflict of interests. The
11
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 13 of 26 Page ID #:13
1 attendees were specifically advised that their “[p]osition as a member should not be
2 used to benefit one’s own interest, or the interest of his or here company.” Defendant
3 Momenta presented a detailed analysis of USP Method <207> including commenting
4 on specific enzymes, columns, reagents and procedures used in the method. Dr.
5 Shriver was in attendance during the November 14, 2008 USP meeting.
6
41. Also during the November 14, 2008 Heparin Ad Hoc Advisory Panel meeting,
7
the USP Staff reported: “USP has had successful correspondence with the company
8
[Sanofi-Aventis] that may have patents that may pertain to the test or related tests. The
9
company has reported that it will allow the one patent that may cover the method to
10
lapse. As such USP is not aware of any patent issue that may cover the test. The AP
11
may proceed with the use of the test as planned.”
12
13 42. Though in attendance at the November 14, 2008 Heparin Ad Hoc Advisory
14 Panel meeting, neither Momenta nor Dr. Shriver advised the USP of Defendants’
15 pending patent application. Other than Defendants’ Dr. Shriver, no one else serving on
16 the USP panel for setting standards for enoxaparin knew that Defendants had a patent
17 application that they would use to block the use of USP Method <207> after the ’866
18 patent issued.
19
20 43. Having obtained Aventis’s abandonment of Aventis’ pending patent
21 application—and being unaware of Momenta’s pending application due to its non-
22 disclosure by Defendants— in December 2009, the USP approved and adopted USP
23 Method <207>. Once the USP adopted USP Method <207>, it became the official test
24 method that the FDA required of Amphastar to test for its enoxaparin in order to obtain
25 and maintain its generic enoxaparin approval.
26
27 44. On or about March 4, 2011, the USP held a meeting of the USP Low Molecular
28 Weight Heparins Expert Panel. Dr. Ishan Capila appeared on behalf of Momenta as an
12
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 14 of 26 Page ID #:14
1 Expert Panel member. Dr. Shriver also attended as an Expert Panel member. The
2 USP staff once again reviewed USP’s conflict of interest policy and informed the panel
3 members that conflicts of interest must be disclosed. Again, neither Momenta, Dr.
4 Capila, nor Dr. Shriver disclosed their then issued ’886 patent.
5
6 45. On or about April 20-21, 2011 the USP held another meeting of the USP Low
7 Molecular Weight Heparins Expert Panel. Again Dr. Capila and Dr. Shriver attended
8 as Expert Panel members. Again, USP Staff reviewed the USP conflicts of interest
9 policy including the requirement that Expert Panel members disclose any conflicts of
10 interest. The USP Staff advised the Expert Panel members: “All Counsel of Expert
11 members, those on either the EC or EP, must declare their conflicts of interest and
12 must sign a confidentiality agreement. Due to the nature of work of the Council of
13 Experts, especially in the biologics and biotechnology area there are potential
14 antitrust and biosimilar issues that the EP should keep in mind throughout its
15 work.” Again, despite this warning, neither Momenta, Dr. Capila, nor Dr. Shriver
16 advised the USP of Momenta’s then-issued ’886 patent.
17
18 Defendants’ Wrongful Enforcement Of Their
Patent Against Use Of The USP Standard Method
19
20 46. Defendants were the first to obtain FDA approval for a generic version of
21 enoxaparin. The FDA granted final approval for Defendants’ ANDA on or about July
22 23, 2010, and immediately thereafter, Defendants began selling and shipping generic
23 enoxaparin to customers in the United States. At the time, and until Amphastar
24 received FDA approval, Defendants were the sole source of generic enoxaparin in the
25 United States and held a monopoly in the relevant market. Alternatively, Defendants
26 obtained a dangerous probability of monopolizing the relevant market.
27
28
13
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 15 of 26 Page ID #:15
1 47. According to the FDA, on average, the first generic competitor prices its product
2 only slightly lower (about 94%) than the brand name manufacturer. However, market
3 entry by a second generic manufacturer reduces the average generic price to nearly half
4 the brand name price (about 52%). As additional generic manufacturers enter the
5 market with their competing products, prices continue to fall, but more slowly. For
6 products that garner a large number of generic market entrants, the average generic
7 price falls to 20% (and sometimes even lower) of the branded price. These marketing
8 trends are based upon a well established study conducted by the FDA derived from an
9 extensive IMS Health retail sales database and demonstrate why the Defendants sought
10 to wrongfully maintain a monopoly. Defendants’ conduct kept the price of enoxaparin
11 artificially high, which cost the consumers, including the state and federal
12 governments, billions of dollars in overcharges.
13
14 48. Beginning in July 2010 and continuing until some time into 2012, Aventis and
15 Defendants each had some degree of market power. That is, Aventis was able to
16 charge a higher price for branded Lovenox®, and Defendants were able to charge a
17 higher price for its generic enoxaparin, than either of them would have been able to
18 charge had there been additional sellers of generic enoxaparin.
19
20 49. On September 19, 2011, the FDA approved Amphastar’s ANDA to sell generic
21 enoxaparin in the United States. As a condition for approval, the FDA specified that
22 Amphastar needed to establish on a batch-by-batch basis that its generic enoxaparin
23 contains between 15 and 25 percent of the 1,6-AS. Upon approval, the FDA instructed
24 Amphastar to comply with the USP compendium for enoxaparin, including USP
25 Method <207>. In particular, as required by the USP Monograph for enoxaparin,
26 Amphastar was required to establish that: “About 20 percent of the material contains a
27 1,6-anhydro derivative on the reducing end of the chain, the range being between 15
28 and 25 percent.”
14
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 16 of 26 Page ID #:16
1
2 50. On September 21, 2011, two days after Amphastar received FDA approval to
3 market generic enoxaparin in the United States, and in direct conflict with the position
4 that USP Method <207> should be free to be used by anyone, Defendants sued
5 Amphastar, wrongfully enforcing their patent against Amphastar’s use of USP Method
6 <207>. Notably, Defendants enforced their patent and sued Amphastar, despite the
7 fact that Momenta was the third generic filer, and despite the fact that the first filer
8 (Amphastar) already had invalidated Aventis’s Orange Book patent.
9
10 51. In their Complaint, Defendants represented to the court: “The FDA requires a
11 generic manufacturer to include in its manufacturing process the analysis of each batch
12 of its enoxaparin drug substance to confirm that its manufacturing process results in
13 the production of oligosaccharides that include defined relative amounts of a non-
14 naturally occurring sugar that includes a 1,6-anhydro ring structure.”
15
16 52. Defendants represented in other pleadings that the FDA also requires generic
17 manufacturers of enoxaparin to ensure that each batch complies with the standards for
18 identity enumerated in the USP Monograph for enoxaparin.
19
20 53. Defendants further represented that the USP Monograph for enoxaparin is an
21 official written standard that provides the definition of enoxaparin and the
22 requirements that a maker of enoxaparin must satisfy in order to ensure the drug
23 product’s quality, strength, and purity.
24
25 54. Still further, Defendants represented that the United States Pharmacopeia is the
26 standard-setting body for drugs sold in the United States and that the USP monographs
27 are enforced by the FDA.
28
15
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 17 of 26 Page ID #:17
1 55. Defendants further contended that the claims of the ’886 patent covered the USP
2 Method <207>.
3
56. Defendants admitted that Amphastar’s market entry is certain to cause an
4
immediate and substantial reduction in Sandoz’s price for enoxaparin and Sandoz’s
5
market share.
6
7
57. Upon filing their complaint against Amphastar, Defendants moved for a TRO
8
and preliminary injunction.
9
10
58. On October 7, 2011, the District of Massachusetts court issued a temporary
11
restraining order (“TRO”) enjoining Amphastar from selling enoxaparin pending a
12
hearing on the motion for preliminary injunction. The court required Defendants to
13
post a $50,000 bond for the TRO.
14
15 59. On October 28, 2011, the court issued a preliminary injunction to the same
16 effect. The court required the Defendants to post a $100,000,000 bond for the
17 preliminary injunction.
18
19 60. The Federal Circuit stayed the preliminary injunction on January 25, 2012 and
20 vacated the wrongfully obtained preliminary injunction on August 3, 2012.
21
22 61. Defendants’ lawsuit prevented Amphastar from selling generic enoxaparin in the
23 relevant market. From the issuance of the TRO until the Federal Circuit stayed the
24 preliminary injunction on January 25, 2012, Amphastar was completely prevented
25 from selling the drug enoxaparin. Even after the Federal Circuit vacated the
26 preliminary injunction on August 3, 2012, Amphastar’s sales were considered “at risk”
27 since final judgment based on the safe harbor provision of 35 U.S.C. § 271(e)(1) had
28
16
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 18 of 26 Page ID #:18
1 not yet happened, which prevented or impeded Amphastar from obtaining sales
2 contracts it would have otherwise obtained.
3
4 62. During the time period in which Defendants wrongfully enforced the ’886 patent
5 against Plaintiffs, obtaining first a TRO and then a preliminary injunction against the
6 sale of enoxaparin by Plaintiffs, Defendants exercised extreme market power in the
7 relevant market in the United States.
8
9 63. On July 19, 2013, the District Court of Massachusetts granted Amphastar’s
10 motion for summary judgment, finding that Amphastar did not infringe the asserted
11 claims of the ’886 patent under the Patent Act’s safe harbor provision, 35 U.S.C. §
12 271(e)(1). As a result of the judgment in the patent litigation against Defendants based
13 on the safe harbor provision of 35 U.S.C. § 271(e)(1), Amphastar and a subsequent
14 ANDA applicant, Teva, now have the ability to freely use the USP Method <207> for
15 batch release testing for their generic enoxaparin. The price of generic enoxaparin has
16 dropped as the result of natural competition, and to the benefit of consumers, including
17 the state and federal governments.
18
19 COUNT 1
20 Violation of Section 1 of the Sherman Act
21 64. Each of the numerical paragraphs both above and in the following counts is
22 incorporated herein by reference.
23
24 65. Defendants’ anticompetitive conduct set forth in this Complaint has violated
25 Section 1 of the Sherman Act. See 15 U.S.C. § 1.
26
27
28
17
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 19 of 26 Page ID #:19
1 66. Defendants are separate and distinct entities; neither is a subsidiary or agent of
2 the other. Apart from their agreement discussed herein, Defendants are economically
3 independent from each other.
4
5 67. Defendants acted in concert during the proceedings before the USP.
6
7 68. On information and belief, Defendants entered into an agreement in restraint of
8 trade in the United States.
9
10 69. On information and belief, Defendants conspired together to restrain trade in the
11 United States.
12
13 70. Defendants behaved in a manner that unreasonably restrained trade in the United
14 States.
15
16 71. Defendants affected interstate commerce by keeping the price of enoxaparin
17 unreasonably high due to their wrongful restraint of trade.
18
19 72. As a result of being blocked from selling generic enoxaparin by Defendants’
20 wrongful enforcement of their patent and TRO and preliminary injunction, Plaintiffs
21 suffered antitrust injury. During the time Plaintiffs were blocked from selling
22 enoxaparin to purchasers of enoxaparin and the general consuming public, including
23 the state and federal governments, paid significantly higher prices than they would
24 have paid had Plaintiffs not been blocked. As a result, Plaintiffs suffered numerous
25 and significant damages, including but not limited to damaged reputation, reduced
26 financing upon IPO, and lost profits on sales that they would have made but for the
27 TRO and preliminary injunction.
28
18
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 20 of 26 Page ID #:20
1 73. As a result of Defendants’ actions complained of herein, Amphastar has been
2 damaged in an amount exceeding $75,000, the full amount of which remains to be
3 determined.
4
5 COUNT 2
6 Violation of Section 2 of the Sherman Act
7 74. Each of the numerical paragraphs both above and in the following counts is
8 incorporated herein by reference.
9
10 75. Defendants’ anticompetitive conduct set forth in this Complaint has violated
11 Section 2 of the Sherman Act. See 15 U.S.C. § 2.
12
13 76. Defendants wrongfully acquired monopoly power in the relevant market by
14 deceiving the USP into adopting a standard test method that Defendants contended is
15 covered by Defendants’ patent rights. At the time of the anticompetitive acts
16 complained of herein, the relevant product market was the market for generic
17 enoxaparin, or in the alternative enoxaparin, and the relevant geographic market was
18 the United States.
19
20 77. Defendants then used the wrongfully obtained monopoly to exclude Amphastar
21 from the relevant market.
22
23 78. As a result of being blocked from selling generic enoxaparin by Defendants’
24 wrongful enforcement of their patent and TRO and preliminary injunction, Plaintiffs
25 suffered antitrust injury. During the time Plaintiffs were blocked from selling
26 enoxaparin purchasers of enoxaparin and the general consuming public, including the
27 state and federal governments, paid significantly higher prices than they would have
28 paid had Plaintiffs not been blocked. As a result, Plaintiffs suffered numerous and
19
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 21 of 26 Page ID #:21
1 significant damages including but not limited to damaged reputation, reduced
2 financing upon IPO and lost profits on sales that they would have made but for the
3 TRO and preliminary injunction.
4
5 79. As a result of Defendants’ actions complained of herein, Amphastar has been
6 damaged in an amount exceeding $75,000, the full amount of which remains to be
7 determined.
8
9 COUNT 3
10 Violation of Section 2 of the Sherman Act
11
12 80. Each of the numerical paragraphs both above and in the following counts is
13 incorporated herein by reference.
14
15 81. Defendants conspired to monopolize in violation of 15 U.S.C. § 2.
16
17 82. Defendants are separate and distinct entities; neither is a subsidiary or agent of
18 the other. Apart from their agreement discussed herein, Defendants are economically
19 independent from each other.
20
21 83. Defendants had a specific intent to monopolize. Defendants specifically
22 intended and effected through their willful deception of the USP to bar Plaintiffs from
23 selling generic enoxaparin and did so by wrongfully pursuing a patent infringement
24 action against Plaintiffs use of USP Method <207>.
25
26 84. Defendants made a conspiratorial agreement or overt act in furtherance of the
27 ongoing conspiracy to monopolize through their patent infringement lawsuit filed on
28
20
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 22 of 26 Page ID #:22
1 September 21, 2011, which Defendants agreed to bring together as co-Plaintiffs, and
2 did bring together as co-Plaintiffs.
3
4 85. Defendants committed further overt acts in furtherance of the conspiracy by
5 seeking a TRO and a preliminary injunction in its lawsuit against Plaintiffs, both of
6 which resulted in court orders that barred Plaintiffs from selling generic enoxaparin in
7 the United States.
8
9 86. Defendants brought the patent infringement lawsuit and sought the TRO and the
10 preliminary injunction with the specific intent to unlawfully maintain their monopoly.
11 They intended these actions to result in court orders barring Plaintiffs from selling
12 generic enoxaparin in the United States, with the result that Defendants would be the
13 sole seller of generic enoxaparin in the United States.
14
15 87. As a result of being blocked from selling generic enoxaparin by Defendants’
16 wrongful TRO and preliminary injunction, Plaintiffs suffered antitrust injury. During
17 the time Plaintiffs were blocked from selling enoxaparin, purchasers of enoxaparin and
18 the general consuming public, including the state and federal governments, paid
19 significantly higher prices than they would have paid had Plaintiffs not been blocked.
20 As a result, Plaintiffs suffered numerous and significant damages including but not
21 limited to damaged reputation, reduced financing upon IPO, and lost profits on sales
22 that they would have made but for the TRO and preliminary injunction.
23
24 88. As a result of Defendants’ actions complained of herein, Amphastar has been
25 damaged in an amount exceeding $75,000, the full amount of which remains to be
26 determined.
27
28
21
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 23 of 26 Page ID #:23
1 COUNT 4
2 Violation of Section 2 of the Sherman Act
3
4 89. Each of the numerical paragraphs both above and in the following counts is
5 incorporated herein by reference.
6
7 90. Defendants have attempted to monopolize the relevant market in violation of
8 Section 2 of the Sherman Act based on the anticompetitive conduct described herein.
9
10 91. Defendants had a specific intent to monopolize the relevant market. As
11 discussed in more detail above, Defendants specifically conspired to wrongfully block
12 anyone else from selling generic enoxaparin in the United States. Defendants also
13 specifically intended to monopolize the relevant market by barring Plaintiffs from
14 selling generic enoxaparin through its wrongful lawsuit and injunction, which
15 prevented Plaintiffs’ sale of generic enoxaparin. In doing so, Defendants attempted to
16 control high prices in the relevant market, and to exclude competition.
17
18 92. Through the anticompetitive and exclusionary acts described above, Defendants
19 achieved a dangerous probability of success of monopolizing the relevant market. By
20 excluding Plaintiffs, Defendants maintained their monopoly over generic enoxaparin in
21 the United States. As a result, Defendants were able to charge a higher price for
22 generic enoxaparin than if Defendants had not blocked Plaintiffs from selling generic
23 enoxaparin.
24
25 93. The structure of the market in September 2011 created a dangerous probability
26 of success for Defendants. In order to obtain FDA approval, any ANDA applicant
27 would have to perform tests that Defendants said were covered by the ’886 patent.
28
22
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 24 of 26 Page ID #:24
1 94. As a result of being blocked from selling generic enoxaparin by Defendants’
2 wrongful TRO and preliminary injunction, Plaintiffs suffered antitrust injury. During
3 the time Plaintiffs were blocked from selling enoxaparin, purchasers of enoxaparin and
4 the general consuming public, including the state and federal governments, paid
5 significantly higher prices than they would have paid had Plaintiffs not been blocked.
6
7 95. As complained of herein, Defendants’ actions have damaged Plaintiffs in an
8 amount exceeding $75,000, the full amount of which remains to be determined.
9
10 COUNT 5
11 Unfair Business Practices: Violation of CAL. BUS. & PROF. CODE § 17200
12 96. Each of the numerical paragraphs both above and in the following counts is
13 incorporated herein by reference.
14
15 97. Defendants’ actions as described in this Complaint constitute a violation of CAL.
16 BUS. & PROF. CODE § 17200 because they are business practices that threaten to violate
17 an antitrust law, violate the policy and spirit of an antitrust law, and otherwise
18 significantly threaten or harm competition.
19
20 98. The preliminary injunction precluded Plaintiffs from advertising, offering for
21 sale, or selling any of Plaintiffs’ generic enoxaparin in the State of California.
22
23 99. As a direct result of Defendants’ unfair business practices as stated herein,
24 Plaintiffs have suffered injury in fact, including lost profits and other monetary
25 damages, in excess of $75,000.
26
27
28
23
COMPLAINT
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 25 of 26 Page ID #:25
1 COUNT 6
2 Violations of the Cartwright Act, CAL. BUS. & PROF. CODE § 16700
3 100. Each of the numerical paragraphs both above and in the following counts is
4 incorporated herein by reference.
5
6 101. Defendants acted as a trust pursuant to Section 16720 of the Cartwright Act,
7 which defines “trusts” as a “combination of capital, skill or acts by two or more
8 persons” for certain enumerated purposes.
9
10 102. Defendants created or carried out restrictions in trade or commerce to limit or
11 reduce the sale of generic enoxaparin within the State of California.
12
13 103. Defendants prevented competition in the manufacturing, making, transportation,
14 sale or purchase of generic enoxaparin within the State of California.
15
16 104. The actions of Defendants stated in the preceding paragraphs affected generic
17 enoxaparin intended for sale, barter, use or consumption in the State of California.
18
19 105. As a direct result of Defendants’ acts, Plaintiffs suffered injury in fact, including
20 lost profits and other monetary damages, in excess of $75,000.
21
22 PRAYER FOR RELIEF
23 Wherefore Plaintiffs pray for the following:
24 A. Antitrust damages;
25 B. Punitive damages;
26 C. Treble damages;
27 D. Exemplary damages;
28 E. Unjust enrichment;
24
COMPLAINT
25
COMPLAINT
F. Lost profits;
G. Prospective damages; H. Interest and costs;
I. Attorneys’ fees; and
J. Such further relief as this Court may deem just and equitable.
DEMAND FOR JURY TRIAL
Pursuant to FED. R. CIV. P. 38, Plaintiffs hereby demand a trial by jury on its
claims.
K&L GATES, LLP
Dated: September 17, 2015 By: /S/ Jan P. Weir Jan P. Weir
Joseph J. Mellema
Taylor C. Foss Jennifer A. Mauri Attorneys for Amphastar
Pharmaceuticals, Inc. & International
Medication Systems, Inc.
Case 5:15-cv-01914-RGK-SP Document 1 Filed 09/17/15 Page 26 of 26 Page ID #:26
