New Uses For Old Compounds
September 12, 2013
Chris Curfman, JD, PhD
ccurfman@mcciplaw.com
Phone (404) 645-7700
www.mcciplaw.com
Agenda
• A word about patents and the role of the claims
• Is it truly an “old” compound?
• References that are not enabled
• References that disclose a broad genus
• References that do not disclose
uses or properties
• Intermediates / Metabolites
• The compound’s “old”, now what?
Is the method truly “new”?
• Inherency cases
• Exemplary claims
• Foreign considerations
Patents and the role of the claims
• A property right it is a right to
exclude others.
– Tangible: real property,
personal property
– Intangible: right of publicity,
right of privacy
• A patent is a property right
and the right is defined by the
claims.
“The name of the game is the claim.” -- Hon. Rich
Patents and the role of the claims
1. A compound having
Formula I.
1. A method of
treating cancer
comprising
administering a
compound having
Formula I.
Is it truly an “old” compound?
35 USC 102
(1)The claimed invention was
patented, described in a printed
publication, or in public use, on
sale or otherwise available to the
public before the effective filing
date of the claimed invention; or
(2)The claimed invention was
described in a patent or
published application that as
effectively filed before the
effective date of the claimed
invention.
35 USC 103
• the differences between the
subject matter sought to be
patented and the prior art are
such that the subject matter
as a whole would have been
obvious at the time the
invention was made to a
35 USC
102 having ordinary skill in
person
the art to which said subject
matter pertains.
Is it truly an “old” compound?
• The question is whether the claimed compound is
described in the reference or not.
• The description of the compound must be “enabled.”
“If the prior art offers no more than a starting point
for further experiments, if its teachings will
sometimes succeed and sometimes fail, if it does not
inform the art without more how to practice the new
invention, it has not correspondingly enriched the
store of common knowledge, and it is not an
anticipation.”
Hon. Learned Hand, 1942.
References that are not enabled
In re Brown, 329 F.2d 1006 (CCPA 1964)
• Reference disclosed compositions comprising
copolymers of a perfluoroalkylsiloxane.
• Reference stated “attempt to prepare fluorine
containing silicone homopolymers have been
unsuccessful.”
• Claims recited compositions comprising homopolymers
of perfluoroalkylsiloxane.
• Ct. “the true test of any prior art relied on to show or
suggest that a chemical compound is old, is whether
the prior art is such as to place the disclosed
"compound" in the possession of the public.”
References that are not enabled
In re Wiggins 488 F.2d 538 (CCPA 1973)
• A reference listed two compounds within the claims, but
evidence suggested a method of synthesis was not developed
until later.
• Ct. “Mere naming of a compound in a reference, without
more, cannot constitute a description of the compound.”
• The “more” is--a person having ordinary skill in the art's ability
to make the claimed compound.
• It is not necessary that the compound have actually been
made.
• Prior Art’s description + PHOSITA’s skill = public’s possession.
It is applicant’s burden to prove this is not so.
No “use” described in the reference
In re Hafner, 410 F.2d 1403 (CCPA 1969)
• Hafner invented new chemical compounds and filed
Application 1. Problem: He didn’t disclose a use for the
compounds in the application. Rejected under §112.
• Hafner found a use for the compounds and filed Application 2
four years later. This application was enabled under 112.
Problem: now anticipated under §102 in view of Application
1.
• Double Standard! How can PTO say App 1 was not enabled
enough for it to be granted but then say it was enabled
enough to be used as prior art against App 2?
• Look to the statutes: §112 requires description of how to
make and use the compound, §102 does not.
Reference is silent as to a property
Titanium Metals Corp. v. Banner, 778 F.2d 778 (Fed. Cir. 1985)
• 1. A titanium based alloy consisting essentially of 0.6-0.9 wt.%
Ni, 0.2-0.4 wt.% Mo, up to 0.2 wt.% Fe, said alloy being
characterized by good corrosion resistance in hot brine
environments.
• Russian article had graph with data
point corresponding to alloy. No
mention of properties.
• Ct. Discovery of a new property
of a known compound cannot impart
patentability to claims to the known compound.
• A compound and its properties are inseparable.
Reference forms compounds as an
intermediate or metabolite
Shering Corp. v. Geneva Pharm et al., 348 F.3d 992 (Fed. Cir. 2003)
Isolated
1. A compound of the formula
^
Prior Art
ClaritinTM
Enabled!
Reference generically describes
compound In re Baird, 16 F.3d 380 (Fed. Cir. 1994)
Prior Art
Baird Invention
X1
X
H(OR')n1O
R
O(R''O) n2H
wherein R is selected from substitute and
unsubstituted alkylene radicals having from about
2 to about 12 carbon atoms, alkylidene radicals
having from 1 to 12 carbon atoms and
cycloalkylidene radicals having from 3 to 12
carbon atoms; R’ and R” are selected from
substituted and unsubstituted alkylene radicals
having from 2 to 12 carbon atoms, alkylene
arylene radicals having from 8 to 12 carbon atoms
and arylene radicals; X and X’ are selected from
hydrogen or an alkyl radical having from 1 to 4
carbon atoms; and each n is a number from 0
(zero) to 4.
OH
C
The same as Prior Art when n1
and n2 = 0, X and X’ = H, and R =
C3 .
OH
Genus / Species Issues
Claim
Art
Art
Claim
Genus / Species Issues
• Whether an earlier disclosed genus
anticipates or renders obvious a later species
depends on the facts.
• A broad genus does not necessarily describe
every species within the genus—your
compound may still be “new.”
• Can you“at once envisage each member of the
genus”?
Guidelines for determining whether
a compound is “old”
• Does the reference describe the compound clearly?
• If so, can PHOSITA make it? Must one develop a unique
synthesis or purification to arrive at the compound?
• If not, is there a close analog described and the differences are
minimal or suggested?
• Does the reference necessarily make the compound
(intermediate or metabolite)?
• Must one make vast numbers of selections from numerous
variables to arrive at the compound?
• Are there valuable subgenus?
Don’t give up too easily on compound claims.
A truly “old” compound: Now
What?
• Cannot claim the compound.
• Must claim its method of use. But is the
method truly “new” (and non-obvious)?
• Again, the name of the game is the claim.
• The steps recited in claim must define a
different act that in the prior art.
Inherency: a classic hypo
Catalina Marketing Int’l, v. Coolsavings.com, 289 F.3d 801 (Fed. Cir. 2002)
• Inventor A patents a shoe polish for shinning
shoes (“A composition for polishing shoes
comprising X.”)
• Inventor B claims
– A method of polishing shoes comprising
applying X to shoes?
– A method of repelling water on shoes
comprising applying X to shoes?
– A method of growing hair comprising
applying X to skin?
Inherency Rules
• Under the principles of inherency, if the prior art
necessarily functions in accordance with, or
includes, the claim limitations, it anticipates.
• A limitation or the entire invention is inherent in
the prior art if it’s the “natural result flowing
from” the explicit disclosure of the prior art.
• Inherency is not necessarily coterminous with
knowledge of ordinary skill in the art. Artisans of
ordinary skill may not recognize the inherent
characteristics or functioning of the prior art.
Inherency - Perricone Case
Perricone v. Medicis Pharmaceutical, 432 F.3d 1368 (Fed. Cir. 2005)
1.
A method for treating skin sunburn comprising
topically applying to the skin sunburn [a ascorbic
acid fatty acid ester].
8.
A method for preventing sunburn damage to
exposed skin surfaces, comprising applying to
exposed skin surface. . . .
1.
A method for the treatment of skin disorders which
arises because of depleted or inhibited collagen
synthesis [which happens to all skin] comprising
topically applying to affected skin areas . . . .
9.
A method for the treatment of damaged or aging
skin and epithelial tissue disorders comprising
topically applying to affected tissue areas [skin that
ages] . . . .
Prior Art:
A composition for
topical application to
skin containing . . .
ascorbyl palmitate.
19
Inherency – Rapoport
Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001)
1. A method for treatment of
sleep apneas comprising
administering a
therapeutically effective
regimen of a compound of
Formula I (buspirone).
• Application referred to
administration at bedtime
and at higher doses.
• Prior art disclosed
treatment of anxiety in
patients suffering from
sleep apnea with buspirone.
• Did not address treatment
of underlying disorder.
• Did not actually administer
to those suffering with
sleep apnea.
• Disclosed lower doses.
20
Inherency – Cruciferous
In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir. 2002)
1. A method of preparing
a food product rich in
glucosinolates,
comprising germinated
cruciferous seeds. . .
harvesting sprouts
before the 2-leaf stage
to form a food product
comprising a plurality of
sprouts.
• Prior art was nature.
• Ct. A new sprout was
not claimed nor a new
way of growing it.
• Patentee simply
describes unexpected
benefit of a known
process.
Scenarios to look out for
• Treatment and the mechanism underlying the
treatment.
• Related methods of treatment or prevention.
• Discovered benefits or advantages of a
method.
22
Now that you know what you know,
what can you do differently?
• Give compound to a different group of
people?
• Give compound in a different way (route or
timing)?
• Give compound in a different dose?
• Combine compound with a different
composition, therapy, or test?
Example claims
• Claims reference a different patient
population.
– Method of treating a patient with disease X,
comprising administering to said patient
compound Y.
– Method of treating disease X, comprising
screening/identifying a patient with disease X and
administering to said patient compound Y.
• Caution: recite intended purpose for which
the method is performed not merely a desired
effect the method may achieve
Example claims
• Claims reference a different regimen.
– A method of treating disease X, comprising
administering an amount of compound Y effective
to treat disease X.
– A method of treating disease X, comprising
administering twice daily compound Y.
– A method of treating disease X, comprising coadministering compounds Y and Z.
– A method of treating disease X, comprising
topically administering a composition comprising Y.
Example claims
• Compositions
– A composition comprising compound Y and a
pharmaceutically acceptable carrier.
– An emulsion for optical administration comprising
compound Y, an emulsifier, and a preservative.
– A composition (or kit) comprising compound Y
and compound Z.
– A pill comprising 10 mg of compound Y.
– A kit comprising an assay for detecting disease X
and a composition comprising compound Y.
Example claims
• Claims for screening
– A method of identifying a compound that treats
disease X, comprising contacting a cell with
compound Y and a test compound; and
determining whether the test compound is more
efficacious than compound Y
Domination
• Domination of second party by first party
– First party’s compound claim dominates all subsequent
uses of that compound
– Second party is infringing first party’s compound claim
even for new use of claimed compound
– Second party, to avoid liability on compound patent, has to
• 1. Take a license
• 2. Invalidate patent
• 3. Await expiration of patent
– Second party has a blocking patent on the new use. First
party cannot practice new use without infringing Second
party.
Problems with method of use claims
• Dominated by a patent on composition.
• Difficult to detect infringement of the method
• If detected, it is usually the end user. Sue
manufacturer under contributory
infringement
– Sale of compound isn’t infringement if sale is
connected to non-infringing use / not directed to
infringing use
Foreign considerations
• Methods of use in non-medical fields are ok.
• Compositions are patentable –even if only used
in medical treatment.
• Methods of medial treatment are NOT eligible
subject matter in foreign countries.
– “First medical use” claims.
• Compound Y (novel) for use in therapy.
• Compound Y (known) for use in therapy.
• A purpose limited product claim.
– “Second medical use” or “Swiss-style” claims
• Use of compound Y (known) for the manufacture of a
medicament for treating disease X (a secondary indication).
Foreign considerations
• Is it really a medical method?
– Contraception is not a medical method.
– Solely cosmetic effects are not medical methods
(e.g., weight loss in non-obese people).
– Cosmetic and therapeutic are medical methods
(e.g., removing plaque in teeth).
– Diagnosis is a medical method if it leads to
concrete diagnosis.
It’s all in how you claim it
Thank You
Chris Curfman, JD, PhD
ccurfman@mcciplaw.com
Phone (404) 645-7700
www.mcciplaw.com