In This Issue
· Federal
Circuit Affirms District Court Finding That Lilly’s Alimta® Patent
Is Not Invalid For Obviousness-Type Double Patenting
· DC
District Court Orders FDA To Approve Watson’s Actos® ANDA
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Federal Circuit Affirms District Court Finding
That Lilly’s Alimta® Patent Is Not Invalid For Obviousness-Type Double Patenting
In Eli Lilly & Co. v. Teva Parenteral Medicines, the Federal
Circuit affirmed the U.S. District Court for the District of Delaware’s
ruling that Lilly's anticancer drug Alimta® (pemetrexed) was not
invalid for obviousness-type double patenting. Alimta® is approved for the
treatment of mesothelioma and non-small cell lung cancer, and U.S. Patent No.
5,344,932 (the ‘932 patent), which is owned by Princeton University and licensed
exclusively to Lilly, is listed in the Orange Book for the drug.
In 2008, Teva, Barr and APP
filed ANDAs asserting that the ‘932 patent was invalid, and seeking approval
to market generic versions of Alimta®. Specifically, Defendants alleged that
asserted claim 3 of the '932 patent was invalid for obviousness-type double
patenting over two patents in the patent family; namely, expired U.S. Patent
Nos. 5,028,608 (the ‘608 patent) and 5,248,775 (the ‘775 patent). The '932 patent, however, does not expire
until July 24, 2016.
Defendants first argued,
based upon Amgen Inc. v. Hoffman
La-Roche, that only the differences between the claims at-issue were
relevant to the analysis, such that any common features between the claims
should be ignored. The Federal Circuit
rejected this argument noting that in Amgen,
the Court merely held that, once the differences between claims were established,
an obviousness-type double patenting analysis required considering
"whether the differences in subject matter between the claims render the
claims patentably distinct," but that the claims must be viewed in the
context of the patent - not in the abstract.
The Federal Circuit further
noted that, in chemical cases, obviousness-type double patenting requires a
motivating reason to modify the earlier claimed compound into the
subsequently claimed compound with a reasonable expectation of success, and
that the Delaware district court correctly considered both parties’ expert
testimony in accepting Lilly’s expert testimony in ruling that "the ways
in which a person of ordinary skill in the art would modify [the compound
claimed in the '608 patent] would not result in pemetrexed."
The second argument was that
pemetrexed is not patentably distinct from a compound claimed in the '775
patent. Specifically, Defendants
argued that the '775 patent disclosed a pemetrexed intermediate thereby
rendering claim 3 of the ‘932 patent invalid for obviousness-type double
patenting based upon Sun Pharm. Indus.
v. Eli Lilly & Co. and Pfizer
v. Teva. The Federal Circuit again
rejected this argument noting that Defendants’ cases were an exception to the
rule, not the rule. That is, the cases
"address the situation in which an earlier patent claims a compound,
disclosing the utility of that compound in the specification, and a later
patent claims a method of using that compound for a particular use described
in the specification of the earlier patent [and that] in each of those cases,
the claims held to be patentably indistinct had in common the same compound
or composition." The Federal
Circuit then explained that the instant fact pattern was different in that
the claims at-issue were directed to separate and distinct chemical
compounds; namely the '775 patent claimed an intermediate, whereas the ‘932
patent claimed, a different compound, pemetrexed itself.
DC District Court Orders FDA To Approve Watson’s Actos® ANDA
In a matter that has been
on-going for nearly a decade, the U.S. District Court for the District of DC
recently ordered the FDA, for the first time, to approve an ANDA product for
marketing despite extant first-to-file market exclusivity.
The first ANDAs for Actos® (pioglitazone HCl) tablets were submitted by Watson, Mylan, and Ranbaxy on
July 15, 2003, and were thus subject to the pre-Medicare Modernization Act,
which provided for market exclusivity on
a patent-by-patent basis that could be shared by respective ANDA filers. Thereafter, the FDA required Watson to amend
its Paragraph IV certification to include “section viii” statements to
certain patents-in-suit. The NDA
holder Takeda then filed a patent infringement litigation, which was ultimately
settled. Under the settlement, Watson
and Mylan received a non-exclusive license to the Takeda Orange Book
patents-in-suit effective August 17, 2012. (See G&B Updates, March 2007, July and December 2008 and October
2010).
As the license effective date
approached, Watson and Mylan were required to amend the ANDAs to replace the
section viii statements with Paragraph IV certifications. Mylan did so first and was awarded the
first-to-file exclusivity by the FDA resulting in the instant case, which Watson
filed on August 15, 2012. Watson
sought an injunction to prevent the FDA from granting final approval to any
other ANDA, including Mylan, prior to granting such approval to Watson’s
ANDA. The DC District Court denied
Watson’s request for an injunction, and the FDA granted final approval to
Mylan on August 17 as well as awarded the 180-day exclusivity.
Watson then filed an Amended
Complaint, accompanied by a summary judgment motion seeking a court order directing
the FDA to ignore Mylan’s the 180-day market exclusivity and approve Watson’s ANDA. The FDA, in response, argued that “Watson filed certifications to the
relevant patents and patent claims two years after Mylan filed its
certifications, and it is Watson’s own delay that led to its loss of a right
to exclusivity.”
The DC District Court was not
persuaded by the FDA’s argument and concluded, based upon the plain language
of the statute, that the FDA’s decision was arbitrary, capricious and
contrary to the statute. The Court
specifically noted that the statute provides that “if the application
contains a paragraph IV certification and it is for a drug for which there
was a previous application containing such a certification, approval of the
application is delayed for 180 days. Here, when Watson filed its application containing a paragraph IV
certification for the drug composition/use patents on July 15, 2003, there
was no previous application containing such a certification on file for that
drug. Mylan’s application came in on
the same day.” The DC District Court
further observed that “FDA’s decision to deny Watson shared exclusivity in
this circumstance is arbitrary and capricious because it produces absurd
results that are contrary to the purpose of the Hatch-Waxman Amendments and
the exclusivity provision in particular. . . . Here, although denial of shared exclusivity
to Watson does not mean that generic pioglitazone cannot be marketed at all .
. . the result is still at odds with the sole purpose of the exclusivity
provision: to encourage generic applicants to file paragraph IV
certifications and incur the risks and costs of patent litigation necessary
to clear the patents out of the way and facilitate the entry of generics into
the market.”
Although the ruling is under
appeal and may be factually limited, it will be interesting to see how this
long-running dispute is finally resolved, and how it impacts (if at all) any current
approval/market exclusivity issues after appellate review. |
