Schering v Geneva Pharmaceuticals (‘233 patent v.
‘716 patent)
Aug. 1, 2003
FACTS:
- Essentially, what are involved are patents on antihistamines (which deal
with allergies), both of which came from Schering Corporation.
- The first patent is the ‘233 patent AKA Loratadine which is marketed as
CLARITIN (non-drowsy; was issued 1981 so expired na)
- The second patent is the ‘716 patent which covers a metabolite of
loratadine called descarboethoxyloratadine (DCL)
- Metabolite = compound formed when a patient ingests a pharmaceutical
(ex. Pag uminom ka ng gamot tapos matutunaw na siya sa tiyan
mo/during digestion, may metabolite na nabubuo through chemical
conversion)
- Difference between ‘233 and ‘716 patents: ‘233 patent (loratadine) has
a carboethoxy group (i.e. -COOEt) on a ring nitrogen, while ‘716 patent
(DCL) has a hydrogen atom on that ring nitrogen (technical talaga)
- Premise: When you ingest CLARITIN, the digestion process leads to the
formation of DCL metabolite, which is the same thing being claimed in
Claim 1 and 3 of the ‘716 patent
o Problem starts when you realize na nasa 2 patents yung
metabolite na DCL: ingesting CLARITIN eventually forms DCL,
but DCL is in a separate patent as well
- Patent was issued for ‘716 while ‘233 patent already expired
- Since the ‘233 patent is expired, other companies (like Geneva Pharma)
wanted to market generic versions of loratadine
o Submitted an application to the Food and Drug Admin (FDA)
o Noted that Schering has listed the ‘716 patent in the orange book
for loratadine, so they wanted to invalidate the patent grant so
they can market loratadine in its generic versions
- Upon discovering this, Schering filed a suit for infringement because
other companies were about to market generic versions of their product
- District Court: ‘716 patent covers DCL in all its forms (so bawal yung mga
generic versions kasi pag lumunok ka ng gamot na yun, DCL lalabas
during digestion)
o (important for Anticipation and Doctrine of Inherency) Note:
‘233 patent did not expressly disclose DCL
o Court found out that DCL was necessarily formed as a
metabolite carrying out the process disclosed in the ‘233 patent
(so inevitable na may DCL talagang lalabas pag umiinom ka ng
CLARITIN)
o CONCLUDED THAT ‘233 PATENT ANTICIPATED CLAIMS 1
and 3 of the ‘716 PATENT UNDER LAW (35 U.S.C. § 102(b)).
So they granted the motion of Geneva for summary
judgment of invalidity (‘716 patent invalidated)
- Schering appealed to Circuit Court
ISSUE: WoN ‘233 patent anticipated ‘716 patent (essentially, if you give reference
to an older claim’s process which necessarily produces the present claim, does
that mean you can’t patent the present claim?) – YES, a patent claim is anticipated
if a single prior art reference (in this case, ‘233 patent) reveals or enables a later
claim (in this case, ‘716 patent)
MY UNDERSTANDING: walang bagong step, the most recent patent only reveals
what was already revealed by the earlier patent
RULING: Judgment by district court affirmed.
RATIO:
- A patent is invalid for anticipation if a single prior art reference discloses
each and every limitation of the claimed invention.
o Moreover, a prior art reference may anticipate without
disclosing a feature of the claimed invention if that missing
characteristic is clearly present/inherent in the single
anticipating reference.
- According to previous cases, DOCTRINE OF INHERENCE: it doesn’t
require that a person of ordinary skill in the art at the time would have
recognized the inherent disclosure (di kailangan na maipakita ng normie
na may nageexist nang something sa previous patent to prove
anticipation by inherency which will invalidate the latest patent sought)
- The instant case does not even involve accidental anticipation because
DCL necessarily and inevitably forms when loratadine is ingested. This
may be a case of first impression since the Loratadine patent (‘233
patent) does not disclose DCL.
o The record also shows that DCL provides a useful result, because
it serves as an active non-drowsy antihistamine.
- In sum, the court’s precedent does not require a skilled artisan to
recognize the inherent characteristic in the prior art that anticipates the
claimed invention
- Patent law nonetheless establishes that a prior art reference which
expressly or inherently contains each and every limitation of the claimed
subject matter anticipates and invalidates. According to some cases:
o “A prior art reference anticipates a patent claim if the reference
discloses, either expressly or inherently, all of the limitations of
the claim.”
o “A claim is anticipated only if each and every element as set forth
in the claim is found, either expressly or inherently described, in
a single prior art reference”
o In these prior cases, however, inherency was only necessary to
supply a single missing limitation that was not expressly
disclosed in the prior art.
 o This case asks this court to find anticipation when the entire
structure of the claimed subject matter is inherent in the prior
art.
- Essentially, if a claim is inherent to a prior art, it places such claim in the
public domain as well as an express disclosure by it
o the inherent disclosure of the entire claimed subject matter
anticipates as well as inherent disclosure of a single feature
of the claimed subject matter
o In general, a limitation or the entire invention is inherent and
in the public domain if it is the “natural result flowing from”
the explicit disclosure of the prior art.
- APPLIED TO THE CASE: Here, Geneva’s use of loratadine (‘233 patent
aka the prior art) infringes upon claims 1 and 3 of the DCL patent (‘716
patent aka the new claim) because all loratadine metabolizes into DCL.
o The record shows that the metabolite of loratadine (prior art) is
the same compound as the DCL patent (claimed invention).
o Because the prior art inherently disclosed DCL, claims 1 and 3
of the ‘716 patent are anticipated and invalid
o (IMPT) In other words, the record shows that a patient
ingesting loratadine would necessarily metabolize that
compound to DCL. That later act would thus infringe claims 1
and 3. Thus, a prior art reference showing administration of
loratadine to a patient anticipates claims 1 and 3.
- The district court did not err in finding that the ‘233 patent discloses
administering loratadine to a patient, and that DCL forms as a natural
result of that administration.

Dissent: Newman, J.
1. Although DCL did not exist previously and was not known to the prior
art, the Court today holds that it was anticipated. The issue in the suit
was infringement, not validity. The Court was correct to hold no liability
for infringement, but was unnecessarily strained to find the patent
claims invalid.
2. An unknown product that existed previously is eligible for patent.
a. In this case, the panel wanted to overturn precedent that
analyzes inherency as applied to subject matter not taught in the
single prior art reference.
b. The panel held that since no one knew of the existence of DCL,
that no person of ordinary skill in the prior art could have
known that ingesting loratadine would result in DCL.
c. The Court en banc should have heard the case to rule on the
inherency issue.