Biotech Values

[mouton29]

There have been a number of motions and answers and memos filed, but all sealed. However, Amphastar has just filed a motion for leave to file another replay, a "sur reply." Technically they have not filed this, what follows is just an exhibit to the motion asking for permission to file it. However, I doubt the court will deny them permission. The Amphastar sur reply is cut and pasted:

7519/12614-002 current/25530331v1 10/19/2011 4:35 pm
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
MOMENTA PHARMACEUTICALS, INC., et al.,
Plaintiffs,
v.
AMPHASTAR PHARMACEUTICALS, INC., et al.
Defendants.
)))))))))))
C.A. No. 1:11-cv-11681-NMG
DEFENDANTS’ SUR-REPLY TO PLAINTIFFS’ RESPONSE TO DEFENDANTS’
OPPOSITION TO PLAINTIFF’S MOTION FOR A PRELIMINARY INJUNCTION
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
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
Herman L. Goldsmith (admitted pro hac vice)
PROSKAUER ROSE LLP
Eleven Times Square
New York, NY 10036-8299
[e-mail]
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.
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 1 of 15
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Plaintiffs make new arguments and present new evidence by way of an additional expert
declaration in support of Plaintiffs’ Memorandum of Law In Response To Defendants’
Opposition To Plaintiffs’ Motion For A Preliminary Injunction. As demonstrated below,
Plaintiffs’ new arguments and evidence are without merit.
I. The ’886 Patent
A. The ’886 Patent Is Not Infringed
Plaintiffs contend that the “separation” step of claims 6, 15 and 53 covers the use of
HPLC or CE to determine the presence of the non-naturally occurring sugar associated with peak
9 of FIG. 1 of the ’886 patent. It is undisputed that peak 9 of FIG. 1 was obtained by CE. It is
also undisputed that HPLC would not yield FIG. 1 and thus would not yield peak 9. Further,
Plaintiffs do not dispute that if claims 6, 15 and 53 do not cover HPLC as the separation step
then there would be no infringement of the ’886 patent by Defendants.
1. The language of the ‘886 patent’s Claims requires Peak 9 of FIG.1 from the use of a
CE method.
Plaintiffs’ Response at page 2 lines 25-26, contends that “[T]he claim requires the use of
`a separation method,’ without further limitation or qualification.” This is not true. The ’886
patent clearly requires that the “separation method” in each of Claims 6, 15 and 53 is “to
determine …[the] presence of a structural signature associated with the non-naturally
occurring sugar associated with peak 9 of FIG. 1”. One can only determine the presence of
peak 9 of FIG. 1 using CE. As there is no other identification of what the sugar is at peak 9,
one must perform the CE that resulted in FIG. 1 to determine the presence of the sugar associated
with peak 9. (Azadi Supp. Decl., ¶ 4.)
Plaintiffs argue that a person of skill in the art using a separation method different than
CE “might” find the sugar associated with peak 9 of FIG. 1 under a different peak depending on
the method of separation conditions used. (Resp. p. 8.) Yet, Plaintiffs do not explain how a
person of skill in the art would be able to determine that what he/she found under a different
peak is the same sugar under peak 9 of FIG. 1. (Azadi Supp. Decl., ¶ 4.) It is well known by
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those skilled in the art that even when the same separation instrument, such as CE, is used, if the
control parameters (e.g., type of column, working conditions, etc.) are changed, then the peak
profile will be totally different. Not to mention, HPLC and CE are two completely different
separation technologies. Plaintiffs’ argument that as long as the conditions of the separation
method contain a parallel analysis the person of skill in the art “would find at least one unique
peak that would necessarily correspond to the non-naturally occurring sugar” does not answer
the question of how he/she would know that the one unique peak was the same as the sugar at
peak 9 of FIG. 1. Without any description as to how one skilled in the art could determine which
peak generated by a non-CE separation method corresponds to peak 9 of FIG. 1, claims 6, 15 and
53 would be non-enabled if read on HPLC. See e.g., AK Steel Corp. v. Sollac and Ugine, 344
F.3d 1234, 1244 (Fed. Cir. 2003) (“as part of the quid pro quo of the patent bargain, the
applicant's specification must enable one of ordinary skill in the art to practice the full scope of
the claimed invention.”); Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1380 (Fed. Cir.
2007) (“the asserted claims read on, and the full scope of the claimed invention includes, an
injector system with and without a pressure jacket. There must be ‘reasonable enablement of the
scope of the range’ which, in this case, includes both injector systems with and without a
pressure jacket.”)
Plaintiffs contend that claim 54 of the ’886 patent “expressly identifies HPLC as a type of
separation method” (Resp. 3:9-10). Plaintiffs misconstrue the language of claim 54. Claim 54
provides:
54. The method of claims 1, 3, 6, 7, 8, 10, 11, 14, 20 or 43, wherein the
structural signature is determined using high performance liquid
chromatography (HPLC).
(Schou Decl., Exh. B, Col. 70:30-32. Emphasis added.) Plaintiffs contend that claim 54 is
directed to a separation method using HPLC. Claim 54 does not contain the phrase “the
separation method” with HPLC. Claim 54, states instead a method of “determining” “the
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 3 of 15
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structural signature” of the sugar associated with peak 9 of FIG. 1 (See Schou Decl., Exh. B,
Cols. 6:57-7:60.), which can only occur after the “separation”.
The fact that the dependent claim 54’s “determining” step is a different additional step
from the independent claim 6’s separation step is apparent from related dependent claims 55, 57,
58, 59 and 60. Dependant claims 55, 57, 58, 59 and 60 contain the exact same language as claim
54 with the exception that the particular method for “determining” the structural signature is
changed—NMR for claim 55, MALID-MS claim 57, ESI-MS claim 58, and ELISA claim 60.
Importantly, neither NMR or MALID-MS, ESI-MS ELISA are separation techniques. (Azadi
Supp. Decl., ¶ 11.) Further, Example 1 of the ’886 patent provides that after separation,
individual peak “was collected”, then “their mass was measured by offline MALDI Mass
Spectrometer” (Col 48:65 –Col. 49:2). Using a non-separated sample in any one of these
systems, one would not provide a meaningful result for a mixture of oligosaccharide like this
case. (Id.) Since NMR or MALID-MS, ESI-MS, or ELISA are not separation methods, the step
of “determining” the structural signature is a different step than the separating step. Thus, as all
of claims 54-60 are identical except for use as the particular method of determining, claims 54
and 56 cannot be construed differently and thus are not separation steps.
2. The Specification Supports Defendants’ Claim Construction
Plaintiffs make the same mistake of conflating the step of determining the actual
structural signature from the separation step in their citation to the Specification. (Resp. 3-4.)
Plaintiffs quote a portion of the Specification refers to “determining” the structural signature, not
separating out a particular sugar component. The portion of the specification was cited in
Defendants’ opposition, however, the `886 patent describes the separation step and states that
HPLC is not sufficient whereas CE is the method of the invention Col. 47:54-Col.48:1.
The ’886 patent repeatedly distinguishes and differentiates its invention as being different
from the HPLC separation method, especially from SAX-HPLC separation. “SAX-HPLC … is
often insufficiently sensitive for detecting small amount of structurally important heparin-
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 4 of 15
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derived oligosaccharide” (Col. 4:40-44, emphasis added); and “CE is superior to SAX HPLC
in oligosaccharide analysis …” (Col. 33:55-56, emphasis added).
It should be noted that the ’886 patent acknowledges that SAX-HPLC is prior art
technology “HPLC (SAX) have previously been used for the qualitative and quantitative
analysis of heparin preparations” (Col. 47:42-44, emphasis added). However, in contrast to the
claims of ’886 patent regarding the inferiority of SAX-HPLC, both the USP method <207> and
Amphastar’s release testing for 1,6-anhydro ring are conducted with the SAX-HPLC method.
3. The Prosecution History Supports Plaintiffs’ Claim Construction
It is beyond dispute that Plaintiffs then amended the pending claims to add the peak 9 of
FIG. 1 limitation. It is also undisputed that the Examiner initially rejected claim 331 (the basis of
claims 6, 15, and 53) as anticipated by Desai et al. and Linhardt et al. Plaintiffs contend that in
addition of the “peak 9 of FIG 1” limitation does not create an estoppel because Momenta added
the “exhaustively digested” limitation at the same time. The fact that the patentee made more
than one amendment does not mean that there is no prosecution history estoppel.
Plaintiffs also contend that for prosecution history estoppel to apply, Momenta had to
make a “clear and unmistakable” disclaimer of HPLC. (P’s. Resp. p. 5, lines 1-2, citing Martek
Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1377 (Fed. Cir. 2009).) Martek is a
prosecution disclaimer case. Prosecution disclaimer cases arise where there is no corresponding
amendment to a patent’s claims. When there is no amendment, the courts require a “clear and
unmistakable disclaimer.” Id. However, when there is an amendment to the claims, as in this
case, there is no requirement for a “clear and unmistakable” disclaimer. Rather, in the case of an
amendment the courts place the burden on the patentee to show that there was no
waiver/disclaimer of all the subject matter removed by the amendment. Festo Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., Ltd. 535 U.S. 722, 739-40 (2002) (citing Warner-Jenkinson v.
Hilton Davis Chemical Co., 520 U.S. 17, 33 (1997)):
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When the patentee is unable to explain the reason for amendment, estoppel not
only applies but also “bars the application of the doctrine of equivalents as to that
element.” Ibid. These words do not mandate a complete bar; they are limited to
the circumstance where "no explanation is established." They do provide,
however, that when the court is unable to determine the purpose underlying a
narrowing amendment—and hence a rationale for limiting the estoppel to the
surrender of particular equivalents—the court should presume that the patentee
surrendered all subject matter between the broader and the narrower language.
Id. at 740.
The Federal Circuit has recently affirmed this doctrine. See, e.g., Duramed Pharms., Inc. v.
Paddock Labs., Inc., 644 F.3d 1376, 1380 (Fed. Cir. 2011) (holding that “ecause during
prosecution [the patentee] narrowed the scope of the [its] patent’s claims in response to a prior
art rejection, a presumption of prosecution history estoppel applies.”)
The direction that the prosecution moves in after an amendment is made is irrelevant to
whether that amendment supports a finding of prosecution history estoppel. See Springs Window
Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed. Cir. 2003) (quoting Desper Products,
Inc. v. QSound Labs, Inc., 157 F.3d 1325, 1336 (Fed. Cir. 1998)) (stating that “when the
applicant amended the claims and made accompanying remarks to overcome a rejection based on
another patent, we stated [in the Desper Products case] that the fact that ‘the prosecution shifted
to a difference focus does not blunt the impact of those remarks made to overcome prior
rejections.’”). Where, as in this case, the patentee was faced with a rejection, amended its claims
and made new arguments, and then the examiner withdrew its rejection, the reliance by the
patent office is clear. Lifestream Diagnostics, Inc. v. Polymer Tech. Sys., Inc., 109 Fed. Appx.
411, 413-415 (Fed. Cir. 2004) (“A patentee may not state during prosecution that the claims do
not cover a particular device and then change position and later sue a party who makes that same
device for infringement.”).
Thus, the ’886 patent’s written description which states that HPLC is not good enough for
separation (Col. 4:40-44; Col. 33:55-56, Col. 47:49-53), the patent’s claims that refer to the peak
of a CE derived FIG. 1 and the prosecution history in which Momenta added the peak 9
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 6 of 15
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limitation to overcome the prior art are all consistent and do not support a reading of claims 6, 15
and 53 as using HPLC for the separation step.
B. The Asserted Claims Of The ’886 Patent Are Invalid
1. Claims 6, 15 and 53 Claim An Obvious Use Of A Known Method
Plaintiffs incorrectly suggest that Defendants bear the burden of proving invalidity on this
motion. The burden of establishing a likelihood of success on the merits is on Plaintiffs and that
burden includes the burden of showing that the patent will withstand a validity challenge.
Plaintiffs’ argument that Defendants’ invalidity position is based on nothing but lawyer
argument is incorrect. Defendants presented undisputable evidence of the invalidity of the ’886
patent from the prosecution history for the ’886 patent. There can be no dispute that original
claim 331 was rejected in its entirety as anticipated by Desai et al. (Hubner Decl., Exh. F. p. 12.)
The Examiner rejected every one of Momenta’s arguments including the declaration of Dr.
Shriver. (Id., at 3.) Momenta acquiesced and abandoned the prosecution of claim 331. This is
strong, clear and convincing, impartial evidence upon which this Court and a trier of fact can rely
that the fundamental steps in claims 6, 15 and 53 of providing, separating and making a
determination were known in the art and not an invention of Momenta. The only reason that
claims 6, 15 and 53 were allowed was because of the inclusion of added limitations of using the
otherwise anticipated test of claim 331 to determine the “quality” of the sample (claim 6),
determine the level of one or more structural signatures (claim 15) and to select a batch base
upon use of the otherwise anticipated test (claim 53.) Thus, the test was known and the claims
allowed because of how the known test is used. Drawing a conclusion as to the quality of a test
sample based upon a comparison with a reference standard is a well known quality control
procedure. Further, selecting a batch based upon a quality control test involving the comparison
of a test sample to a reference standard is a basic known FDA procedure. Lastly, determining the
level of the structural signature is inherent in the anticipated test. (Azadi Supp. Decl., ¶¶ 13-15)
Finally, Plaintiffs contend that the PTO Examiner allowed claim 331 and that Defendant’s
evidence to the contrary is misleading. As evidence, Plaintiffs cite the Court to claim 1 of the
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 7 of 15
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’886 patent which Plaintiffs contend is claim 331 “with only minor amendment.” (Ps. Resp. at
7.) However, like asserted claims 6, 15, and 53, claim 1 of the ’886 patent contains an additional
limitation beyond the original limitations of claim 331. Claim 1 has the added limitation of:
“determining the presence of the structural signature associated with the non naturally occurring
sugar associated with peak 9 of FIG. 1 in a second batch of enoxaparin”. (Schou Decl., Exh. B,
Col. 64:3-5, emphasis added.) Plaintiffs are right this is a minor amendment. As such, claim 331
was never allowed without further amendment.
2. Claims 6, 15 and 53 Are Indefinite
Dr. Shriver contends in his declaration that claims 6, 15 and 53 are sufficiently definite
because they reference a non-naturally occurring sugar. However, enoxaparin is entirely made
up of non-naturally occurring sugars because their chains are cut from a naturally occurring
sugar, which is heparin. The depolymerization of heparin by use of “alkaline depolymerization
of heparin benzyl ester” (USP monograph of Enoxaparin Sodium) does not occur in nature and
thus all of the depolymerized sugar sequences of enoxaparin are non-naturally occurring.
Further, enoxaparin has several types of special signature structures of non-naturally occurring
sugars, including sugars that do not have the 1,6-anhydro ring structure, such as odd
oligiosaccharides. Thus, merely stating that the claimed test is looking for a non-naturally
occurring sugar provides no information regarding which of many are the subject of the claim.
Likewise, merely stating that the sugar results from the method of making enoxaparin does not
distinguish between the many possible sugars.
Dr. Shriver further contends that while the sugar that is being tested for in claims 6, 15
and 53 “bears a relationship to peak 9 of FIG. 1” one of skill in the art “might” find the same
sugar under a different peak, depending on the separation method and the conditions used.”
Shriver Decl., ¶ 30. The argument proves Defendants’ point. The fact that someone skilled in
the art “might” find the same sugar under a different peak means that they might not and without
direction from the patent as to how, the patent is not enabled and indefinite. Dr. Shriver does not
explain how someone skilled in the art would even know he/she found the same sugar without
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 8 of 15
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any identification of the sugar other than the reference to peak 9 in the CE derived FIG. 1. There
is, for example, no mention whatsoever in the ’886 patent that peak 9 relates to a sugar that has a
1, 6 anhydro ring structure. (Azadi Supp. Decl., ¶ 3.) Indeed there is no mention of a 1, 6
anhydro ring structure in the `886 patent at all. (Id.)
Dr. Shriver further contends that the ’886 patent provides a sufficient disclosure to enable
one skilled in the art to perform specific CE test that resulted in FIG. 1. Dr. Shriver contends that
the CE analysis that resulted in FIG. 1 came from the Rhomberg et al. publication, cited at Col.
33:9-17 of the ’886 patent. The Rhomberg publications are cited for determining the molecular
weight of polysaccharide fragments. There is no statement in the patent that the CE process
disclosed in Rhomberg is the same process disclosed in Example 1. Dr. Shriver does not say that
Rhomberg discloses the CE conditions used to generate FIG. 1. Dr. Shriver further contends that
the ’886 patent’s specification discloses “most” of the key parameters of the Rhomber procedure.
Dr. Shriver cites to Col. 27, lines 26-31 which is merely a summary description of the Figures.
No information is provided about the CE conditions, such as temperature, pressure, type and
length of column, pH, voltage, etc. Dr. Shriver cites Col. 47:54-65. Again there is no statement
relating to the CE conditions of Example 1. Cols. 48:56-49:20 relate to Example 1, but the cited
text merely describes the use of CE and not the CE conditions that generated FIG. 1. Cols.
48:56-49:20 describe the heparinase step, but provide none of the conditions for the CE. Lastly,
Col. 62:47-60 relates to an entirely different example and FIG 10, not FIG 1. Thus, Dr. Shriver
was unable to point to any disclosure in the ’886 patent of the CE conditions that generated FIG.
1. (Azadi Supp. Decl., ¶¶ 6-9.)
Since one of skill in the art cannot reproduce FIG. 1 one cannot determine what nonnaturally
occurring is allegedly present at peak 9 from the information provided in the patent
claims 6, 15 and 53 are invalid for indefiniteness. Howmedica Osteonics Corp. v. Tranquil
Prospects, Ltd., 401 F.3d 1367, 1371 (Fed. Cir. 2005) (“The perspective of a person of ordinary
skill in the art at the time of the patent application governs the definiteness analysis.”); Geneva
Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003) (“A claim is
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indefinite if its legal scope is not clear enough that a person of ordinary skill in the art could
determine whether a particular composition infringes or not.”) Further, each of all thirteen (13)
independent claims of the ’886 patent contains the associated with peak 9 of CE obtained FIG. 1
limitation, Patent ’886 termed peak 9 as an unknown substance, “a non naturally occurring
sugar” not a sugar having a 1,6-anhydro ring structure. USP’s drug standards are required by the
FDA and therefore are the industry standard for the pharmaceutical field. All USP standard
methods were carefully developed and validated by USP experts. Before a USP standard method
becomes effective, it must be published for comments from the public.
USP standard Method <207> is the “test for 1,6-anhydro derivative for enoxaparin
sodium” (USP method <207>) It utilizes a SAX-HPLC methodology. USP Method <207>
observes four (4) types of 1,6-anhydro structures. However, Plaintiffs are contending that peak 9
contains the 1,6-anhydro structure which means that peak 9 did not separate out the four sugars
and thus does not represent “a” sugar. Thus, the ’886 CE method is not capable of
distinguishing these 4 types; it reported only one peak, “peak 9 in FIG. 1”. Therefore, the
conclusion that peak 9 or the “non naturally occurring sugar” is the 1,6-anhydro ring structure is
scientifically unsupported when compared to the USP standard method <207>.
II. Defendants Do Not Infringe The ’466 Patent And It Is Invalid
A. Plaintiffs Have No Evidence Of Infringement
In spite of having moved for a TRO/preliminary injunction on the ground that Defendants
are infringing the ’466 patent, Plaintiffs have not responded at all to Defendants arguments and
evidence that there is no infringement of the ’466 patent based on a fundamental fact that the
FDA never asked Amphastar to perform any release testing for sequencing of tetrasaccharides.
Significantly, Plaintiffs have not responded to Defendants’ point that Plaintiffs have not
presented evidence that there is an actual FDA requirement for tetrasaccharide sequencing.
B. The ’466 Patent Is Invalid
Dr. Shriver contends that the prior art Sasisekharan ’642 patent did not disclose (a)
analyzing an isolated tetrasaccharide fraction from a size fraction enoxaparin preparation,” and
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 10 of 15
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(b) the requirement that a particular tetrasaccharide sequence be present in a defined relative
amount. Dr. Shriver’s arguments illustrate just how little alleged innovation there was to the
’466 patent. As Dr. Shriver acknowledges claim 1 was allowed over Sasisekharan because of the
step of first “isolating” the tetrasaccharides and claim 8 was allowed because of the added step of
determining the “amount” of the tetrasaccharide. Both steps were, however, disclosed in the
prior art patent to Linhardt et al., United States Patent No. 4,847,338 (’338 patent). At Col. 4:10-
30, Linhardt discloses the isolation of fragments for heparinase digested “depolymerized
heparin” (Claim 1 of `338 patent), including the isolation of “tetrasaccharides,” before further
processing the tetrasaccharides with “SAX-HPLC” to obtain “individual components” (Example
II of ’338 patent), just as claimed in claim 1 of the ’466 patent.
The fragments thus obtained are redissolved in a suitable aqueous solution
. . . and applied to a gel column . . .
The column effects separation of the fragments on the basis of size. . .
.Further fractionation of the sized fragment mixtures is accomplished on the basis
of charge using an anion exchanger, such as by high performance liquid
chromatography on a column packed with strong anion exchanger.
(See also, Example II, Col. 5:54-59 of ’338 patent: “Six distinct peaks were observed
representing, from last to first eluted, disaccharide, mixed tetrasaccharide fragments, missed
hexasaccharide fragments, mixed octasaccharide fragments, mixed decasaccharide fragments.”
Thus, Linhardt teaches the step of first isolating tetrasaccharides prior to further sequencing.
(Azadi Supp. Decl., ¶ 16.)
Linhardt then sequenced the isolated tetrasaccharides as described in Example II. (Col.
6:29-41. The Figure 2A represents the results of the further separation of the tetrasaccharides.
One of ordinary skill in the art would know that the area under the curve represents the amount
of the tetrasaccharide represented by the peaks in Figure 2A. (Azadi Supp. Decl., ¶ 17.) Thus,
Linhardt disclosed the only alleged points of novelty for claims 1 and 8, the only two
independent claims of the ’466 patent. It would have been obvious to any one skilled in the art
Case 1:11-cv-11681-NMG Document 77-1 Filed 10/19/11 Page 11 of 15
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to combine the teachings of Sasisekharan ’642 and Linhardt ’338 and thus, claims 1 and 8 of the
’466 patent are invalid.
III. The Safe Harbor Provision Of The Hatch-Waxman Act Applies In This Case
The Hatch-Waxman Act’s safe harbor provision plainly applies to the methods of testing
allegedly covered by the Plaintiffs’ patents. Plaintiffs’ argument to the contrary is out of step
with the text of the statute and Supreme Court precedent.
Section 271(e)(1) itself says nothing about pre- or post-FDA approval activities. Instead,
the statute simply states that “t 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 . . . .” 35 U.S.C. § 271(e)(1). Although
the Federal Circuit’s Classen decision,1 cited by Plaintiffs, plumbed the depths of Section
271(e)(1)’s legislative history to divine the purpose of the statute, the plain language speaks for
itself. This Court need go no further.
The Supreme Court has squarely addressed the breadth of Section 271(e)(1)’s plain
terms. In Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 193, 202 (2005), the Court
held that the statutory language “makes clear” that Section 271(e)(1) “provides a wide berth for
the use of patented drugs in activities related to the federal regulatory process. . . . [I]t 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.” Id. at 202. The Court continued, “[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 (emphasis in original) (citation omitted). There is “simply no room in the
statute,” the Court wrote, “for excluding certain information from the exemption on the basis of
1 Classen Immunotherapies, Inc. v. Biogen IDEC, No. 2006-1634, 1649, 2011 U.S. App.
LEXIS 18126 (Fed. Cir. Aug. 31, 2011).
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the phase of research in which it is developed or the particular submission in which it could be
included the ground that the allegedly infringing acts occurred.” Id. at 202.
The broad language of the statute and Supreme Court precedent should doom Plaintiffs’
attempt to limit Section 271(e)(1)’s safe harbor only to pre-approval testing. The dispute in
Classen involved the administration of drugs and vaccines and FDA reporting ancillary to that
administration. The Classen majority did not decide whether FDA-required testing constitutes
infringement if done after FDA approval. Indeed, the majority noted “[t]here is no issue in this
case of submissions for regulatory approval of generic products or like policy considerations.”
Classen, 2011 U.S. App. LEXIS 18126, at *36. The dissent disagreed with the majority and
concluded that “the safe harbor extends to all uses that are reasonably related to submitting any
information under the FDCA, including information regarding post-approval uses. Id. at 74.
Here, there is no reason to conduct the allegedly patented tests except to report the results to the
FDA. Any such testing therefore falls squarely within the ambit of Section 271(e)(1)’s safe
harbor.
CONCLUSION
Plaintiffs have not met their burden of establishing a likelihood of success on the merits,
irreparable harm or any public interest. Accordingly, Plaintiffs’ motion for preliminary
injunction should be denied.
Dated: October 19, 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
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Herman L. Goldsmith (admitted pro hac vice)
PROSKAUER ROSE LLP
Eleven Times Square
New York, NY 10036-8299
[e-mail]
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
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
Counsel for Defendants Amphastar Pharmaceuticals, Inc., International Medication Systems,
Ltd., and Watson Pharmaceuticals, Inc.
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7519/12614-002 current/25530331v1 10/19/2011 4:35 pm
CERTIFICATE OF SERVICE
I hereby certify that on the 19th day of October, 2011, I caused a copy of the foregoing
Opposition to Plaintiffs’ Motion for a Temporary Restraining Order and Preliminary Injunction
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
28 State Street
Boston, MA 02109
Telephone: [phone]
Fax: [phone]
Counsel for Plaintiff Sandoz, Inc.
/s/ Steven M. Bauer
Steven M. Bauer (BBO No. 542531)
[e-mail]
PROSKAUER ROSE LLP
One International Place
Boston, MA 02110
Telephone: [phone]
Facsimile: 617.526.9899
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