Issue:
May a violation of 35 U.S.C. 112, 4th paragraph, render a patent
invalid?
Answer:
Yes. Failure to comply with any requirement of 35 U.S.C. 112, including
paragraph 4, renders a patent invalid, even if the same violation would have
been simply objected to by the USPTO.
Background:
Pfizer sued Ranbaxy alleging that a product described in one of Ranbaxy’s
Abbreviated New Drug Applications infringed two of Pfizer’s patents related
to the prescription drug Lipitor. The District Court concluded that both
patents were infringed, not invalid and not unenforceable.
Arguments: On appeal, Ranbaxy argued that the
patents were not infringed, and furthermore, that the supposedly infringed
claim of one of the patents was invalid for failure to comply with 35 U.S.C.
112, ¶ 4. The claim at issue, claim 6, recites “the hemicalcium salt of
claim 2.” Claim 2, which depends on claim 1, recites only an acid and not a
salt of the acid. Claim 1 recites acids or salts. Ranbaxy alleged that the
claim at issue failed to further limit the subject matter of the claim(s) on
which it depended, as required by paragraph 4 of § 112, since claim 6 is
completely outside the scope of claim 2.
Reasoning:
The Court of Appeals for the Federal Circuit held that a violation of 35
U.S.C. 112, ¶ 4, renders a patent invalid just as violations of other
paragraphs of § 112 would. The CAFC noted that invalidation of a claim for a
§112, 4th paragraph, violation does not “exalt form over
substance” but rather is consistent with the overall statutory scheme by
requiring patent applicants to satisfy certain requirements before obtaining
a patent, “some of which are more procedural or technical than others.”
Although the Court of Appeals recognized that the patentee was attempting to
claim “patentable subject matter” and noted that the claim at issue could
have been properly drafted as an independent claim or dependent from claim
1, it nonetheless ruled that claims cannot be re-written in order to
preserve validity. A claim which violates §112, ¶ 4, is invalid even if the
PTO treats non-compliance as “a matter to be addressed through an objection”
rather than a rejection. Furthermore, the Court reiterated that invalidity
of a claim for failure to comply with any requirement of Section 112
is a defense to an infringement suit.
Conclusion:
A violation of any section of 35 U.S.C. 112 renders a patent invalid and is
a viable defense to an infringement suit.
Summary supplied by Vanessa Perez. Edited by
Nicholas P. Godici.
