28 Schering v. Geneva Pharma

(#28) PATENT || AFH
Schering Corp. v. Geneva Secondly, the court noted that the case could be one of first
impression, such that patent ‘233 did not disclose any
Pharmaceuticals compound that is identifiable as DCL. As such, what the court
339 F.3d 1373 (2003) | 1 August 2003 | Judge Rader was to determine in this case was to find anticipation when
Standard for Anticipation; Accidental and Unknown the entire structure of the claimed subject matter is inherent
Anticipations and the Doctrine of Inherecy in the prior art.
Loratadine, DCL
FACTS Nevertheless, patent law establishes that a prior art reference
Petitioner owns two patents (’233 and ‘716) on which expressly or inherently contains each and every
antihistamines (medicines that inhibit allergic symptoms). limitation of the claimed subject matter anticipates and
‘233 covers the prior art patent of the antihistamine invalidates.
loratadine, which is the active drug that petitioner markets as
Claritin. At that time, unlike conventional antihistamines, “Because inherency places subject matter in the public
loratadine did not cause drowsiness. domain as well as an express disclosure, the inherent
disclosure of the entire claimed subject matter anticipates as
‘716, which is at issue, covers a metabolite of loratadine called well as inherent disclosure of a single feature of the claimed
descarboethoxyloratadine (DCL). To put simply, when a subject matter. The extent of the inherent disclosure does not
pharmaceutical is ingested, a chemical process occurs in the limit its anticipatory effect. In general, a limitation or the
patient’s body that forms the new metabolite. Like loratadine, entire invention is inherent and in the public domain if it is
DCL is also non-drowsy. the "natural result flowing from" the explicit disclosure of the
prior art.”
Loratadine and DCL differ in structure. Claim 1 of the ‘716
patent covers DCL, its fluorine analog, and their salts; claim 3 “[T]he use of loratadine would infringe claims 1 and 3 of the
covers DCL only and its salts. '716 patent covering the metabolite DCL. This court has
recognized that a person may infringe a claim to a metabolite
Since the ‘233 patent was a prior art, the several respondents if the person ingests a compound that metabolizes to form the
sought to market generic versions of loratadine once the metabolite. … An identical metabolite must then anticipate if
patent expired and filed applications with the US FDA. earlier in time than the claimed compound.”
Because petitioner added the ‘716 patent in the Orange Book
listing for loratadine, the applications also contained a “The record shows that the metabolite of the prior art
certification that the ‘716 patent was invalid. loratadine is the same compound as the claimed invention.
Claims 1 and 3 are compound claims in which individual
After receiving notice of the FDA filings, Schering filed a suit compounds are claimed in the alternative in Markush format.
for infringement. The District Court found that the ‘233 patent DCL is within the scope of claims 1 and 3. Because the prior
anticipated claims 1 and 3 of the ‘716 patent. art metabolite inherently disclosed DCL, claims 1 and 3 are
anticipated and invalid. In other words, the record shows that
ISSUE a patient ingesting loratadine would necessarily metabolize
W/N patent ‘233 anticipated patent ‘716 that compound to DCL. That later act would thus infringe
claims 1 and 3. Thus, a prior art reference showing
HELD administration of loratadine to a patient anticipates claims 1
YES and 3.”
Firstly, the appellate court rejected the contention that
inherent anticipation requires recognition in the prior art,
citing several cases to that fact. This is the same with cases DISPOSITIVE
dealing with “accidental, unwitting, and underappreciated” The district court did not err in finding that the '233
anticipation, citing the Eibel Process Co. v. Minn. & Ontario patent discloses administering loratadine to a patient,
Paper and Tilghman v. Proctor cases. To contrast, however, and that DCL forms as a natural result of that
those cases did not show that the prior art produced the administration. The district court correctly concluded
claimed subject matter. “In those cases, the product sold or that DCL is inherent in the prior art. Without any genuine
offered for sale had an inherent, but unrecognized, feature issues of material fact, the district court correctly granted
that was a limitation of the asserted claims. [ ] Thus, this court summary judgment that claims 1 and 3 are invalid as
has distinguished Eibel and Tilghman, which therefore do not anticipated by the '233 patent.
bind this court to find no anticipation because skilled artisans
did not recognize that the prior art '233 patent inherently
produced the claimed invention, DCL.”
“In the context of accidental anticipation, DCL is not formed

accidentally or under unusual conditions when loratadine is
ingested. The record shows that DCL necessarily and
inevitably forms from loratadine under normal conditions.
DCL is a necessary consequence of administering loratadine
to patients. The record also shows that DCL provides a useful
result, because it serves as an active nondrowsy
antihistamine. In sum, this court's precedent does not require
a skilled artisan to recognize the inherent characteristic in the
prior art that anticipates the claimed invention.”
SID ACUYONG | BASIL MAGUIGAD | GAITA MASANGKAY | KAT NIETO | JO SANTOS | TYN SISON | ALLEN UY

28 Schering v. Geneva Pharma

Uploaded by

Copyright:

Available Formats

28 Schering v. Geneva Pharma

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

28 Schering v. Geneva Pharma

Uploaded by

Copyright:

Available Formats

(#28) PATENT || AFH

“In the context of accidental anticipation, DCL is not formed

You might also like