ANTICIPATION

• Standard for lack of novelty; a defense in an

infringement action to invalidate the patent(s)
 INFRINGEMENT TESTS IN ANTICIPATION

1. Substantial Identity

2. Strict Identity

3. Ipsissimis Verbis Anticipation

 1. Substantial Identity

• Smith v. ACME General Corp. 614 F.2d 1086.

• Anticipation: term of art within patent law

meaning disclosure in the prior art of a thing
substantially identical with the claimed invention.
 2. Strict Identity

• All the elements of an invention, as stated in a

patent claim are identically set forth in a single
prior art reference

• General Electric Co. V. Nintendo Co. Ltd 179 F.

1350: judgment of invalidity for anticipation
requires that a single prior art reference discloses
every limitation in a patent claim
 3. Ipsissimis Verbis Anticipation

• Prior art reference need not use the same

language as a patent claim that is that
anticipation need not be Ipsissimis verbis

• American Standard Inc. V. Pfizer Inc. 772. F.

Supp.86
• The prior art need not …state the elements of the
claim in identical language.
 Genus-Species Situations

• A species will anticipate a claim to a genus

• A reference that clearly names the claimed

species anticipates the claim no matter how many
other species are named

• a generic chemical formula will anticipate a

claimed species covered by the formula when the
species can be "at once envisaged" from the
formula
• Use of Additional Reference to interpret the
teachings of an anticipatory reference

• Incorporation by reference forms a part of the

anticipatory reference

• That which infringes if later anticipates if earlier

 Inherent Anticipation

• A claim is anticipated and invalid only when a

single prior art reference discloses each and
every limitation of the claim.
• The disclosure need not be express, but may
anticipate by inherency
Anticipation in the United States

• 35 US.C 102:
(a) The invention was known or used by others in
this country, or patented or described in a printed
publication in this or a foreign country, before the
invention thereof by the applicant for patent
• (b) The invention was patented or described in a
printed publication in this or a foreign country or
in public use or on sale in this country, more than
one year prior to the date of the application for
patent in the United States

• c) he has abandoned the invention, or

• (d) the invention was first patented or caused to
be patented, or was the subject of an inventor's
certificate, by the applicant or his legal
representatives or assigns in a foreign country
prior to the date of the application for patent in
this country on an application for patent or
inventor's certificate filed more than twelve
months before the filing of the application in the
United States, or
• e) the invention was described in –
(1) an application for patent, published under section
122(b), by another filed in the United States before the
invention by the applicant for patent, or
(2) a patent granted on an application for patent by another
filed in the United States before the invention by the
applicant for patent, except that an international
application filed under the treaty defined in section 351(a)
shall have the effects for the purposes of this subsection of
an application filed in the United States only if the
international application designated the United States and
was published under Article 21(2) of such treaty in the
English language; or
• application filed in the United States only if the
international application designated in the United States
and was published under article 21(2) of such treaty in the
English language; or

•(f) he did not himself invent the subject matter sought to

be patented, or

•(g)(1) during the course of an interference conducted

under section 135 or section 291 another inventor
involved therein establishes, to
• the extent permitted in section 104, that before such
person's invention thereof the invention was made by
such other inventor and not abandoned, suppressed, or
concealed, or (2) before such person's invention
thereof, the invention was made in this country by
another inventor who had not abandoned, suppressed,
or concealed it. In determining priority of invention
under this subsection, there shall be considered not only
the respective dates of conception and reduction to
practice of the invention, but also the reasonable
diligence of one who was first to conceive and last to
reduce to practice, from a time prior to conception by
the other.
 35 U.S.C. 102 (a)

• "The statutory language 'known or used by others

in this country‘ = knowledge or use that’s
accessible to the public

• Only Knowledge or Use in the U.S. Can Be Used in

a Rejection

• Printed Publication

• Time Period –1 year

 35 U.S.C. 102 (b)

• Grace Period

• The 1-year grace period is extended to next

working day if it would otherwise end on a
holiday or weekend

• The 1-year time bar is measured from the US

filing date
SmithKline Beecham Corporation
and Beecham Group, P.L.C., v.
Apotex Corp.
• CASE
SmithKline Beecham Corporation and Beecham
Group, P.L.C., v. Apotex Corp.

Districts Court Ruling

• United States District Court for the Northern

District of Illinois determined that the paroxetine
hydrochloride anhydrate product produced by
Apotex Corp., Apotex, Inc., and TorPharm, Inc.
(collectively Apotex) will not infringe claim 1 of
 U.S. Patent No 4,721,723 owned by SmithKline
Beecham Corp. and Beecham Group, P.L.C.
(collectively SmithKline).

• Claim 1 of the ’723 patent recites, in its entirety,

“Crystalline paroxetine hydrochloride
hemihydrate.”

• Upon this court’s revision of the trial court’s

erroneous claim construction, Apotex’s product
will infringe this claim.
• Federal Circuits Decision

The Federal Circuit reversed the district court’s

finding that Apotex’s generic product did not
infringe Smithkline’s patent, but affirmed
judgment in favor of Apotex because the
Federal Circuit found the patent invalid due to
the public use bar of 35 U.S.C. §102(b).
• Smithkline’s patent claimed “crystalline paroxetine
hydrochloride hemihydrate,” which it marketed
under the name Paxil®, and Apotex sought approval
to market a generic version of it.

• Apotex argued that its generic version did not

include a hemihydrate, but rather the anhydrate

Smithkline urged that Apotex’s anhydrate tablets

necessarily contain at least trace amounts of the
hemihydrate due to a conversion process.
• Smithkline’s patent claimed “crystalline
paroxetine hydrochloride hemihydrate,” (Paxil®)
– Apotex sought approval to market generic
• Apotex’s argument: does not include
hemihydrate, but rather the anhydrate

• Smithkline’ argument”: Apotex’s anhydrate

tablets necessarily contain at least trace
amounts of the hemihydrate due to a
conversion process
• Anticipation Issue
• District court determined:
– Apotex did not present clear and convincing evidence
of inherent anticipation
– “no one knows when the hemihydrate form of
paroxetine came into existence, although it is a
reasonable inference that it did not exist in a
detectable amount until” SmithKline’s “serendipitous”
discovery

• Apotex did not appeal that ruling

• Federal Court held:
– Apotex seeks to practice the prior art
– That practice infringes; next logical inquiry involves
anticipation.
• if the prior art infringes now, logically the prior art should
have anticipated the claim before the filing of the 723 patent
• Public Use - § 102(b):
– A patent claim is not valid if “the invention was . . in
public use . . . in this country, more than one year prior
to the date of the application for patent in the United
States”

• Federal court agrees with the district court and

parties
– no material facts relating to the public use bar are in
dispute
– record shows that PHC hemihydrate was in public use
before the critical date of the ’723 patent
 Anticipatory Reference Must Be Enabling

• To anticipate, reference must…enable one skilled

in the art to make and use the claimed invention

• Bristol-Myers Squibb Co. V. Ben Venue

Laboratories Inc. 246 F.3d 1368

• No utility needs to be disclosed in anticipatory

reference
 No utility needs to be disclosed in an anticipatory
reference

• In re Schoenwald 964 F.2d 1122

• Federal Circuit confirmed that no utility need to
be disclosed for a reference to be anticipatory of
an old compound

• Applicants disclosed and claimed a compound (N-

cyclohexyl –N- methyl-2- phenylethylamine)
• Which they used to treat dry eye syndrome. The
compound acted as “tear stimulant” when applied
topically to the eye.

They obtained a patent to the method of treatment by

use of the compound and sought additionally to patent
the compound itself.

The PTO rejected the compound claim as anticipated by

the Bumgarderner publication, which adequately
described and enabled the compound.
• But did not disclose a utility for it.

• Affirming the court rejected applicants

argument that an anticipatory reference
must disclose a use
A Switch: From a look at
Public Use to a Look at
Inherent Anticipation
 Why was it reversed?
• Fed. Cir. Determined that the dist. Court:
– Erred in construing the meaning of claim 1
– Limited to commercial use
– Definiteness
– Correctly determined infringement
• Apotex would still infringe under Fed. Cir. Claim
construction
• Apotex’s production of prior art (‘196 patent)
infringes
• Why was it reversed?
Previously, Incorrectly Analyzed Anticipation
– -If the prior art anticipates now, then it anticipated
before ‘723 was filed
• ‘196 patent inherently anticipates claim 1 of
‘723 patent because it inherently discloses
PHC hemihydrate
– -Prior art can anticipate without disclosing feature
of claimed invention if that missing characteristic is
necessarily present, or inherent, in single
anticipating reference
• Dist. Court did not find anticipation because
Apotex “did not prove by clear and convincing
evidence that it was impossible to make pure
PHC anhydrate (that contained no PHC
hemihydrate) in US before critical date of ’723 patent”
 too exacting
 Previously, Incorrectly Analyzed Anticipation
continued

– -Only needed to show that “disclosure of prior art is sufficient

to show that natural result flowing from operation as taught
in prior art would result in” claimed product
• Dist. Court didn’t consider teachings of ‘196 separately
from actual PHC hemihydrate production
• ‘196 discloses method of manufacturing PHC anhydrate
that naturally results in production of (at least trace
amounts of) PHC hemihydrate
– -Irrelevant to show if it was actually possible to make PHC
anhydrate in US before critical date
• Dist. Court’s decision supposition that Apotex could
possibly prevent PHC anhydrate from converting to PHC
hemihydrate by building new plant that wasn’t seeded by
PHC hemihydrate, or by preventing PHC anhydrate from
being exposed to moisture, doesn’t change result
• Court’s law doesn’t require Apotex to take such
extraordinary measures to avoid claim 1 infringement
 SCHERING CORPORATION
v.
GENEVA PHARMACEUTICALS, INC. and
NOVARTIS CORPORATION

• 339 F.3d 1373 (Fed. Cir. 2003)

 Brief History

• Schering owns two patents related to

antihistamines U.S. Patent No. 4,282,233 ("the
’233 patent"), which covers loratadine,
• More recent patent, U.S. Patent No. 4,659,716
("the ’716 patent"), which covers
descarboethoxyloratadine ("DCL"), a metabolite
of loratadine that is formed in the human body
after ingestion of loratadine
 District Court Ruling
• The district court found that the prior art 233
patent inherently anticipated the compound claims
of the 716 patent because people who took
loratadine produced DCL, and therefore DCL was
not new .
The district court found that DCL was necessarily
formed as a metabolite by carrying out the process
disclosed in the 233 patent., even though 233 did
not disclose DCL
 Federal Circuit Ruling
• general rule that prior art reference may anticipate without
disclosing feature of claimed invention if that missing
characteristic is necessarily present, or inherent, in that
reference

• inherent anticipation does not require that person of

ordinary skill in the art recognize inherent disclosure

• The Federal Circuit remarked that DCL is not formed

accidentally or under unusual conditions when loratadine is
ingested, and that DCL necessarily and inevitably forms
from the ingestion of loratadine under normal conditions.
• Accordingly, the record showed that a patient
ingesting loratadine as taught in the prior '233
patent would necessarily metabolize that
compound to DCL
• The Federal Circuit stated that since inherency
may anticipate as effectively as does an express
disclosure, the inherent disclosure can be of the
entire claimed subject matter, not just of a single
feature of the claimed subject matter. The extent of
the inherent disclosure does not limit its
anticipatory effect
• Federal Circuit held that this conclusion regarding
inherent anticipation does not preclude all patent
protection for metabolites of known drugs.
However, such metabolites must be claimed in a
way that is both new and non-obvious. Bare
compound claims that include within their scope
the recited compounds as chemical species in any
surroundings, including within the human body,
may not be "new," even if they have not been
recognized
 Metabolite Cases
In re Buspirone
• patent at issue claimed metabolite of drug buspirone; would be
invalid under Section 102(b) of Patent Act if it were construed to
cover uses of buspirone
• court also upheld Mylan’s on-sale argument by noting that
buspirone was on commercial market as drug for treating anxiety
since 1986 and approved methods of using buspirone inherently
produce claimed amount of 6-hydroxy-metabolite in bloodstream
• claim to use of compound by its production in vivo is anticipated by
a prior commercial use of pro-drug
• no appreciation or awareness of fact that compound responsible
for activity within body was not pro-drug covered by prior art
patents claims, but metabolite formed on ingestion
• Despite this fact, court found that patent for metabolite was
anticipated by prior art disclosing pro-drug
Application of Petering
49 C.C.P.A. 993, 301 F.2d 676

Genus-Species Anticipation
 Background
•Harold G. Petering and Harry H. Fall
appealed decision of Board of Appeals for
the US that affirmed Examiner’s rejection of
claims 1, 2, 4, 5, 7, and 10-12 of appellants‘
application for a patent on "Isoalloxazines”
(and method of preparation)
•18 claims stood allowed by Examiner
•Filed September 7, 1954
 Prior Art
•Karrer, Patent # 2,155,555
•April 25, 1939
•Is subject matter of the appealed
claims patentable in view of Karrer
patent?
•the prior art disclosed a generic chemical formula
"wherein X, Y, Z, P, and R"- represent either
hydrogen or alkyl radicals, R a side chain containing
an OH group.“

•court held that this formula, without more, could not

anticipate a claim to 7-methyl-9-[d, l"-ribityl]-
isoalloxazine because the generic formula
encompassed a vast number and perhaps even an
infinite number of compounds.

•However, the reference also disclosed preferred

substituents for X, Y, Z, >P,< R, and R" as follows:
where X, P, and R" are hydrogen, where Y and Z may
be hydrogen or methyl, and where R is one of eight
specific isoalloxazines.
 The Ruling
•court determined that this more limited generic class consisted of
about 20 compounds.

•The limited number of compounds covered by the preferred formula

in combination with the fact that the number of substituents was low
at each site, the ring positions were limited, and there was a large
unchanging structural nucleus, resulted in a finding that the reference
sufficiently described "each of the various permutations here involved
as fully as if he had drawn each structural formula or had written
each name.“

•The claimed compound was 1 of these 20 compounds.

•Therefore, the reference "described" the claimed compound and the

reference anticipated the claims.
Anticipation Standards in US and
UK
• differences between the 2 countries in applying
anticipation is derived from judgments dealing with same
product, atorvastatin calcium

– UK and US patents covering it were challenged by Ranbaxy in US

district court and UK High court (patents division)
– UK court held that patent was invalid while US court upheld it on
question of anticipation
– same prior art was cited against patent in both jurisdictions
– Ranbaxy alleged that claims to Lipitor were anticipated by a prior
patent which described process for producing atorvastatin in its
lactone ring form
– Claim, however, was to atrovastatin hemicalcium salt
– According to US district court, claim was not anticipated
because calcium salt of atorvastatin wasn’t specifically
disclosed in cited reference though reference generally
taught that pharmaceutically acceptable salts of disclosed
compounds included the calcium salts
– ‘Claim 14 of the ’080 patent: claims process for producing
single compound atorvastatin lactone
– Neither this process nor this compound are contemplated
by claim 6 of ’995 patent
– When ’995 was filed, only statin marketed was Lovastatin,
in lactone form, not acid or salt.
– if any salt was preferred at time, it was sodium salt form,
not calcium salt form
– UK court achieved different result.
– In Ranbaxy UK Ltd v. Warner-Lambert Co , same claim was held anticipated
over same prior art reference.
– Relying on disclosure in reference that, "In the ring-opened dihydroxy acid
form, compounds of the present invention react to form salts with
pharmaceutically acceptable metal and amine cations formed from organic
and inorganic bases. The term ' pharmaceutically acceptable metal salt'
contemplates salts formed with the sodium, potassium, calcium, magnesium,
aluminum, iron and zinc ions”, the UK court held that,
– ‘It follows that the material claimed in claim 1 is an expressly specified salt
(calcium) of the preferred isomer of one of the three materials explicitly
specified. If one is in any doubt, it is easy to compare the final structural
formula on p.12 of '281 against formula XII on p.40 of '598. They are identical,
save that in '281 the calcium salt, and in '598 the acid, are shown. In fact, the
synthetic route described in '598 actually produces a racemate. But this time,
the precise enantiomer (4R,6R) is specified. This notation means the same
thing as the [R-(R*,R*] ... used in respect of the acid in claim 1 of '281. The
evidence (which I have already discussed) was that resolution to obtain the
enantiomers was common general knowledge. It is no answer to an allegation
of anticipation that the specification gives clear and unmistakable directions to
use the common general knowledge to produce a specific material.’
– difference between conclusions of validity is instructive of
how anticipation is perceived in 2 countries
– In US, anticipation doesn’t exist unless every element of
claim is disclosed in single prior art reference, no matter
how insignificant the limitation.
– In UK, never required that claimed invention, with all its
limitations, be specifically disclosed in prior art reference if
one skilled in art could immediately recognize limitation
from common general knowledge