Source: http://www.patentdocs.org/2013/07/hatch-waxman-watch-safe-harbor-edition.html
Timestamp: 2014-07-24 22:58:57
Document Index: 502444633

Matched Legal Cases: ['§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271']

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week, two district courts dispensed with lawsuits based on the
protections afforded by the safe harbor provision of the Hatch-Waxman
statute. Both of the cases relied
heavily on the Federal Circuit case Momenta
Pharm. v. Amphastar Pharm., 686 F.3d 1348 (2012). In fact, one of the cases was the Momenta
case back at the Massachusetts District Court. The other case was in the Southern District of New York, and in that
case, the dismissal occurred at the pleadings stage. Because both cases looked to 35 U.S.C. § 271(e)(1),
it is useful to review this provision, which reads:
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
of drugs or veterinary biological products.
Federal Circuit Momenta case
interpreted this language broadly, stating that the "language
unambiguously applies to submissions under any federal law, providing that the
law 'regulates the manufacture, use, or sale of drugs.'" Therefore, according to current Federal
Circuit jurisprudence, the safe harbor is not limited to pre-approval
activities (see Momenta); it is not
limited to information that is actually submitted to the FDA, provided the FDA
requires that records be maintained for possible inspection (see Momenta); and it is OK if the
information has alternative uses, such as for fund raising or other business
purposes (see Abtox, Inc. v. Exitron
Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997)). It is with this understanding that the lower
courts proceeded.
Pharma., Inc. v. Amphastar Pharma., Inc., C.A. No. 11-11681-NMG
week, the U.S. District Court for the District of Massachusetts granted a
summary judgment motion of non-infringement in favor of Amphastar (see Memorandum & Order). This case involved generic versions of
Aventis' product Lovenox (enoxaparin). However,
the patent-in-suit was owned by Momenta, another generic company, and related
to methods for comparing generic enoxaparin to the branded version. As a reminder, the procedural posture in front
of the Federal Circuit was as an appeal of a preliminary injunction. Because the Court found that the alleged
infringing activity was protected by 35 U.S.C. § 271(e)(1), it vacated the
injunction. In fact, the Federal Circuit
suggested that "the district court may want to consider whether Momenta's
admission . . . makes this case amenable to summary judgment of
non-infringement." Nevertheless,
the lower court stayed the case pending a petition for en banc appeal, and a petition for certiorari to the Supreme Court
in Classen Immunotherapies, Inc. v.
Biogen IDEC, another safe harbor case. After both of those petitions were denied, the District Court lifted the stay,
and Amphastar moved for summary judgment the next day.
Momenta's
position regarding whether the safe-harbor provision applied in this case
apparently did not change significantly. First, it argued that the FDA did not mandate the use of its patented
test, and therefore its use by Amphastar was entirely voluntary. However, as the District Court pointed out, the Federal
Circuit "explicitly" held that the safe harbor "'does not
mandate the use of a non-infringing alternative when one exists." Second, Momenta argued that the required
record-keeping was not a "submission," and therefore fell outside the
statute. However, again, the Court noted
the Federal Circuit's "express" holding that the FDA's requirement for
maintaining records that might be inspected was sufficient to satisfy this
requirement. Finally, Momenta alleged
that the use of this information during manufacturing was for commercial purposes,
and therefore not "solely" for uses related to satisfying Federal
Law. However, the Federal Circuit found
this argument to not be consistent with precedent, citing the Abtox case. Therefore, the Massachusetts court simply
applied the holding of Momenta to
grant the summary judgment motion.
also argued that Amphastar was liable under 35 U.S.C. § 271(g), which states in
part: "Whoever without authority imports into the United States or offers to sell,
sells, or uses within the United States a product which is made by a process
patented in the United States shall be liable as an infringer, if the
importation, offer to sell, sale, or use of the product occurs during the term
of such process patent." This
section of the statute is generally directed to importation of a product made
by a U.S. patented method practiced abroad, and in this case, there was no
allegation that Amphastar manufactured the drug product
outside the U.S. Instead, Momenta argued that the
language of the statute does not require that the patented process be practiced
inside or outside the U.S. This ignores,
however, another section of that provision that states it only applies when "there
is no adequate remedy under this title for infringement." Because 35 U.S.C. § 271(a) applies to the
making or use of a patented invention within the U.S., the Court reasoned that
35 U.S.C. § 271(g) does not apply in this case.
At about the same time that Amphastar
filed its Summary Judgment motion, Teva filed a motion to dismiss a similar action based
on the same patents. In almost an
identical opinion, the Massachusetts District Court also dismissed this
case (see Memoradum & Order).
Pharma. USA, Inc. v. Sandoz Inc., Case No. 09 Civ. 10112 (KBF)
U.S. District Court for the Southern District of New York also dispensed of two
cases last week because of the Hatch-Waxman safe harbor provision (Mylan was
defendant in the second case), but this time both cases were at the pleading
stage. Interestingly, Momenta was a
co-defendant with Sandoz. Therefore, the
parties of this case were basically a mirror image of the Momenta v. Teva
litigation that was dismissed in Massachusetts. In
other words, both parties were able to take advantage of the safe-harbor
provision in the different litigations (or both parties were burned by it).
products in question were generic versions of glatiramer acetate, which is sold
under the name Copaxone to reduce the frequency of relapses in patients with
relapsing-remitting multiple sclerosis. Glatiramer acetate is a mixture of polypeptides, and much like with
Lovenox/enoxaparin in the Momenta
case, the ANDA filers needed to demonstrate that their active ingredient was
the same as the branded product. Specifically, the ANDA filers needed to show that the polypeptides in
their products have the same molecular weight characteristics as those in
Copaxone. Teva is the exclusive licensee
to four patents that claim polypeptide markers and methods for using these
markers to measure these molecular weight characteristics.
the fact pattern was so similar to Momenta,
the defendants moved to dismiss for failure to state a claim. The District Court did not, however, start
with Momenta, but rather it underwent
a similar analysis as the Momenta court. First, it started with the text of statute,
and it found the meaning to be plain and unambiguous. As a result, the District Court did not need to
consult the legislative history. If it
did, it might have discovered that the intent of Congress was that the statute
was only meant to apply to pre-approval activity, as Chief Judge Radar
explained in detail in the Momenta
District Court then compared the case to Momenta,
and found that the two cases had "striking similarities." The Court concluded that the holding of Momenta and its fact pattern support
dismissal in this case. "Momenta allows for the elective use of
patented technology as long as it serves to produce information required under
federal law." Teva had not alleged
that Sandoz or Mylan activity was any different.
Teva attempted to differentiate this case by relying on another Federal Circuit
case, Proveris Scientific Corp. v.
Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008). In that case, Innovasystems was making and
selling a product that could be used by generic drug manufactures to calibrate
drug delivery devices. Innovasystems had
argued that when its product was used by its customers (the generic drug
manufacturers), they were protected by the safe harbor provision, and therefore
Innovasystems should also be protected. The Federal Circuit rejected this argument, and pointed out that the "patented
invention" of Innovasystems was not the type of "patented invention"
to which § 271(e)(1) refers. It was important
that Innovasystems was selling the patented invention to others, and not
developing information for submission to the FDA. The District Court concluded that the present case was
analogous to Momenta, and that Proveris was inapposite to the present facts. Therefore, the Court held, "without an exclusion for
plaintiffs' patented product not being the type of "invention" that
can fall within § 271(e)(1), plaintiffs failed to state a claim" for the relevant
counts in the complaints (see Opinion & Order).
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Judge Moore's opinion in Momenta Pharmaceuticals is really bad, and these two district court cases may be the "tip of iceberg" on how problematic the Momenta Pharmaceuticals opinion is with regard to applying the Hatch-Waxman "safe harbor" to post-FDA approval activity. As Chief Judge Rader correctly pointed out in his dissent in Momenta Pharmaceuticals, Judge Moore’s opinion reads 35 U.S.C. § 271(e)(1) in a manner contrary to the statutory language, and more importantly, completely inconsistent with the legislative intent for when this “safe harbor” provision was to apply. Even more troubling, Judge Moore’s opinion in Momenta Pharmaceuticals cannot be easily squared with the earlier Federal Circuit case of Classen Immunotherapies, Inc. v. Biogen IDEC (where Judge Moore dissented from the Federal Circuit’s majority opinion written by Judge Newman and joined by Chief Judge Rader). In other words, we've got jurisprudential "mess" in terms of the Hatch-Waxman "safe harbor" which only an en banc ruling by the Federal Circuit can fix. Posted by:
It is not clear that an en banc CAFC will fix the mess. They have been sparring with the supreme court and themselves for years. This mess requires a congressional fix. To fix it, references to "congressional intent" have to go away and the statute replaced with language that, despite the court's finding that it is clear and unambiguous, is in fact clear and unambiguous. Any time judges have to resort to reading legislative intent tea leaves, you know you are in real trouble. With clean language, congress (and the rest of us) will finally come to know what it is that they really did intend those many years ago.
Anyone out there any good at statute drafting? Seriously. Posted by:
Maybe the English language will never be up to the task of being truly clear and unambiguous when it comes to patents. I just think that some of the wheels have come off the cart and some more are about ready to fly off. I very much hope that I am wrong and that everything is going in the right direction. My instinct just says otherwise. Posted by: