Biotech Values

[mouton29]

Amphastar Motion to Dismiss

I am cutting and pasting the memo in support of the motion below. I will do in two parts, in reverse order because the second argument will at least be more interesting intellectually to this board. The first and longer argument is that the case should be dismissed for lack of jurisdiction or transferred to California. Here is the more substantive portion of the memo:

III. Plaintiffs Have Failed to State a Claim Upon Which Relief Can Be Granted
Plaintiffs’ Complaint fails to state a claim upon which relief can be granted and must be
dismissed. The Complaint boils down a claim that Defendants are infringing the Momenta
patents because the FDA allegedly requires the testing methods described by the patents. See
Cmplt. ¶¶ 22, 24. By statute, what Plaintiffs allege is not patent infringement.
A. Plaintiffs’ Claims Must Be Plausible
In order to survive a motion to dismiss under Rule 12(b)(6), a complaint’s factual
allegations “must be enough to raise a right to relief above the speculative level.” See, e.g.,
Gorelik v. Costin, 605 F.3d 118, 121 (1st Cir. 2010). In addition, a complaint must state a
plausible claim in order to survive a motion to dismiss. See Ashcroft v. Iqbal, 129 S. Ct. 1937,
1949-50 (2009). Determining plausibility is a “context-specific task that requires the reviewing
court to draw on its judicial experience and common sense.” Id. “But where the well-pleaded
facts do not permit the court to infer more than the mere possibility of misconduct, the complaint
has alleged—but it has not ‘show[n]’—that the pleader is entitled to relief.” Id. (quoting Fed. R.
Civ. P. 8(a)(2)).
The plausibility standard articulated by the Supreme Court applies and is particularly
well-suited to patent infringement cases, in light of the vast expenses that are required to defend
against these claims. See Twombly, 550 U.S. at 558-59; see also Realtime Data, LLC v. Stanley,
721 F. Supp. 2d 538, 545 (E.D. Tex. 2010) (Seagate [a case involving the standard for willful
infringement] clearly requires a patentee to do more than suggest that more definite allegations
are to follow once discovery is underway.”). A complaint that falls short of the plausibility
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standard must be dismissed under Rule 12(b)(6) “at the point of minimum expenditure of time
and money by the parties and the court.” Twombly, 550 U.S. at 558 (citations omitted).
B. The FDA Reporting Safe Harbor Bars Plaintiffs’ Claims
Plaintiffs assert that this case is about patents that purport to claim quality control testing
methods used during the manufacture of generic enoxaparin sodium. See Cmplt. ¶¶ 22, 24.
Even assuming Plaintiffs are correct in their characterization of the Momenta patents, it is
undisputed that Defendants’ activities have been conducted to obtain FDA approval and to
manufacture generic copies of patented inventions of the innovator, and that these activities have
been in conformity with the applicable FDA regulations. As such, Defendants’ activities fall
squarely within the safe harbor of 35 U.S.C. § 271(e)(1), and cannot be liable for patent
infringement.
Generally, an act of patent infringement occurs when one “makes, uses, offers to sell, or
sells any patented invention . . . during the term of the patent therefor.” See 35 U.S.C. § 271(a).
Nearly thirty years ago, however, Congress first enacted an exemption to this general rule:
It shall not be an act of infringement to make, use, offer to sell, or sell within the
United States or import into the United States a patented invention … solely for
uses reasonably related to the development and submission of information under a
Federal law which regulates the manufacture, use, or sale of drugs or veterinary
biological products.
35 U.S.C. § 271(e)(1).8 The Federal Food, Drug, and Cosmetic Act (“FDCA”) is such “a Federal
law which regulates the manufacture, use, or sale of drugs.” See, e.g., 21 U.S.C. § 355(a).
Under the FDCA, a drugmaker that intends to seek approval to market a generic drug
may file an Abbreviated New Drug Application (“ANDA”) with the FDA. See 21 U.S.C.
8 Importantly, “n any action for patent infringement …, no injunctive or other relief
may be granted which would prohibit the making, using, offering to sell, or selling within the
United States … of a patented invention under [35 U.S.C. § 271(e)(1).]” See 35 U.S.C.
§ 271(e)(3).
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§ 355(j). The ANDA filer need not make an independent showing that the drug covered by the
ANDA is safe and effective, as must be done by the filer of a New Drug Application (“NDA”)
but it must show that the drug includes the same active ingredient as, and is bioequivalent to, the
reference drug that has previously been approved by the FDA. See generally 21 U.S.C. §
355(j)(2)(A), § 355(j)(8)(b). Thus, Section 271(e)(1) provides a safe harbor for these activities
that must be undertaken by an ANDA filer, thereby mandating that any such activity “shall not be
an act of infringement.”
The Supreme Court described the expansive scope of this safe harbor exception to
infringement in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005). The Court
said:
[T]he statutory text [of 35 U.S.C. § 271(e)(1)] makes clear that it provides a wide
berth for the use of patented drugs in activities related to the federal regulatory
process. As an initial matter, we think it is apparent from the statutory text that
§ 271(e)(1)’s exemption from infringement extends to all uses of patented
inventions that are reasonably related to the development and submission of any
information under the FDCA.
Merck, 545 U.S. at 202 (emphasis in original). The Court further explained its views regarding
the “wide berth” of the safe harbor, noting that “[t]here is simply no room in the statute for
excluding certain information from the exemption on the basis of the phase of research in which
it is developed or the particular submission in which it could be included.” Id. To emphasize the
scope of the safe harbor, the Court stated that “[Congress] exempted from infringement all uses
of patented compounds ‘reasonably related’ to the process of developing information for
submission under any federal law regulating the manufacture, use, or distribution of drugs.” Id.
at 206 (emphases in original). Thus, the Supreme Court expressly acknowledged the broad
scope of the safe harbor extends to information that must be submitted to FDA in regards to the
manufacture of drugs, including generic drugs.
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In this case, Plaintiffs are the assignees of two patents, U.S. Patent No. 7,790,466 (the
“’466 patent”) and U.S. Patent No. 7,575,886 (the “’886 patent”). Plaintiffs claim the patents-insuit
cover specific quality control tests that are identified and described in the FDA’s Response to
the Citizen’s Petition dated July 23, 2010. See, e.g., Mem. in Supp. Prelim. Relief at 12.
Notably, these tests purportedly described in the patents-in-suit are not necessary to manufacture
of the generic drug; instead, as acknowledged by Plaintiffs, these tests merely perform quality
control of the generic drug at various stages during its manufacturing process to ensure
“sameness” with the reference drug. See id. According to Plaintiffs, these quality control tests
must be performed pursuant to FDA’s regulations. See id.
Thus, even assuming that Defendants practice the patents-in-suit during the
manufacturing process for their approved version of generic enoxaparin – and Defendants do not
– it is undisputed that the results of any tests performed by Defendants during the manufacture of
its generic drug are performed and reported in accordance with the FDA’s regulations. This
scenario is more than “reasonably related” to government regulatory requirements; it is directly
related to those requirements.
As such, the safe harbor of Section 271(e)(1) applies to the Defendants’ activities that are
specifically required by the FDA, particularly since FDA’s regulations require Defendants
generate and maintain reports based on its manufacturing practices.9 The safe harbor of Section
9 Section 501(a)(2)(B) of the FDCA requires that all drugs be manufactured in
accordance with Current Good Manufacturing Practice (“CGMP”). See 21 U.S.C. § 351. The
approval process for generic drug marketing applications includes a plenary review of the
manufacturer’s compliance with CGMP. Decisions regarding compliance with CGMP
regulations are based upon inspection of the facilities, sample analyses, and compliance history
of the firm, and are summarized in reports that represent several years of inspection history. The
records and reports requirements of CGMP for drug manufacturers extend to various records
related to the manufacture of the drug, including equipment, cleaning, and use logs, see 21
C.F.R. § 211.186; component, drug product container, closure, and labeling records, see 21
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271(e)(1) precludes a finding of infringement by Defendants for manufacturing their generic
drug in accordance with FDA regulations.
CONCLUSION
Plaintiffs have failed to establish that jurisdiction and venue are proper before this Court.
Even if they had established these things, however, the Complaint fails to state a claim upon
which relief can be granted. Accordingly, the Court should dismiss the Complaint in its entirety,
or, in the alternative, transfer this case to the Central District of California.
Dated: October 12, 2011 Respectfully submitted,
/s/ Steven M. Bauer
Steven M. Bauer (BBO No. 542531)
[e-mail]
Isaac A. Hubner (BBO No. 677719)
[e-mail]
PROSKAUER ROSE LLP
One International Place
Boston, MA 02110
Telephone: [phone]
Facsimile: 617.526.9899
Anthony T. Pierce (admitted pro hac vice)
[e-mail]
Mark Mansour (admitted pro hac vice)
[e-mail]
Jonathan P. Robell (admitted pro hac vice)
[e-mail]
AKIN GUMP STRAUSS HAUER & FELD LLP
1333 New Hampshire Avenue NW
Washington, DC 20036
Telephone: [phone]
Facsimile: 202.887.4288
Jan P. Weir (admitted pro hac vice)
[e-mail]
STRADLING YOCCA CARLSON & RAUTH
660 Newport Center Drive, Suite 1600
Newport Beach, CA 92660
Telephone: [phone]
Facsimile: 949.725.4100
Counsel for Defendants Amphastar Pharmaceuticals, Inc., International Medication Systems,
Ltd., and Watson Pharmaceuticals, Inc.
C.F.R. § 211.184; master production and control records, see 21 C.F.R. § 211.186; batch
production and control records, see 21 C.F.R. § 211.188; laboratory records, see 21 C.F.R. §
211.194; and distribution records, see 21 C.F.R. § 211.196.
Case 1:11-cv-11681-NMG Document 49-1 Filed 10/12/11 Page 18 of 19
CERTIFICATE OF SERVICE
I hereby certify that on the 12th day of October, 2011, I caused a copy of the foregoing
Motion to Dismiss or Transfer to be electronically filed using the CM/ECF system, which will
then send a notification of such filing (NEF) to the following:
Courtney M. Schou
Eric J. Marandett
Jessica Gan Lee
Robert S. Frank , Jr.
CHOATE, HALL & STEWART LLP
Two International Place
100-150 Oliver Street
Boston, MA 02110
Telephone: [phone]
Facsimile: 617.248.4000
Counsel for Plaintiffs Momenta
Pharmaceuticals, Inc. and Sandoz, Inc.
Melissa Nott Davis
Sarah Chapin Columbia
Thomas P. Steindler
MCDERMOTT, WILL & EMERY LLP
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