On April 6, 2017, the Federal Circuit reversed-in-part and
affirmed-in-part the district court's judgment of infringement
and summary judgment for non-infringement of The Medicines
Company's ("MedCo") patents-in-suit. See The
Medicines Company v. Mylan, Inc., 2015-1113 (Fed. Cir. 2017).
The patents-in-suit were U.S. Patent Nos. 7,582,727 ("the
'727 Patent) and 7,598,343 ("the '343 Patent").
MedCo initiated a suit against Mylan, Inc. ("Mylan") in
response to Mylan submitting an Abbreviated New Drug Application
("ANDA"). Through submitting an ANDA request, Mylan
wished to obtain approval from the Food and Drug Administration
("FDA") for a generic drug that would directly compete
against MedCo's ANGIOMAX® product. To counter Mylan's
ANDA request, and keep their product exclusive, MedCo filed suit
alleging that Mylan's ANDA drug infringed claims in both the
'727 and '343 Patents.
The district court held on summary judgment that Mylan's
drug did not satisfy the "efficient mixing" limitation of
the '343 Patent; however, following a 6-day bench trial found
that Mylan's drug did infringe the '727 Patent because the
asserted claims did not include an "efficient mixing"
limitation. Mylan argued on appeal that the district court erred by
not including the "efficient mixing" limitation as part
of the "batches" limitation in the '727 Patent.
Claim 1 of the '727 Patent recites a "batches"
limitation, whereby both patents in suit share similar
specifications pointing to "efficient mixing" with regard
to "batches" of an active ingredient. The Federal Circuit
agreed with Mylan, that when properly construed, the
"batches" limitation requires the use of a compounding
process that achieves batch consistency, which "does not
impermissibly add a process limitation to a product claim."
See id. at 14. The Court reasoned that Example 5 in the
specification of the'727 Patent described the only clear
meaning of the "efficient mixing" process:
We conclude that one or ordinary
skill in the art would rely on Example 5 to ascertain the metes and
bounds of 'efficiently mixing.' As the only embodiment of
efficient mixing, Example 5 is 'highly indicative of the scope
of the claims.' Example 5, however, is not merely the only
disclosed embodiment of efficient mixing—it is the only
description of efficient mixing in the patents in suit that casts
light on what efficient mixing is and that enables one of ordinary
skill in the art to achieve the objects of the claimed
See id. at 22-23. Although the '727 patent
specification described Example 5 as "non-limiting," the
Court found it appropriate to limit "efficient mixing" to
the sole description in the patent because no other portion therein
otherwise taught what affirmative steps constitute efficient
After reviewing the District Court's factual findings and
legal conclusions de novo, the Court found that
Mylan's ANDA request did not infringe MedCo's asserted
patents. Upon reading the "efficient mixing" limitation
into the claims, the Court found for Mylan by finding that their
proposed generic drug did not infringe MedCo's asserted
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In Wasica Finance GmbH v. Continental Automotive Systems, Inc., No. 15-2078 (Fed. Cir. 2017), the patentee Wasica Finance discovered, among other things, the importance of using consistent terminology in the patent specification and claims.
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