This document discusses obviousness standards for drug compounds and formulations based on a presentation given by Kevin B. Laurence and Samuel E. Webb from the Danish Patent Office. It discusses several court cases that set precedents for determining obviousness, even in cases where compounds have similar structures as prior art, if those compounds exhibit unexpected properties. It also discusses how secondary considerations can be used to overcome a prima facie case of obviousness based on structural similarity.

1. 1
Obviousness for Drug Compounds
and Formulations
Kevin B. Laurence
Samuel E. Webb
Danish Patent Office
November 11, 2009

2. 2
Disclaimer
• This presentation is for information purposes only and does not
constitute legal advice. Patent issues are fact-dependent and
require the assistance of counsel experienced with such issues.
This presentation does not establish any form of attorney-client
relationship.
• The views expressed in this presentation are solely those of the
presenter and do not represent the views of Stoel Rives LLP or
clients of Stoel Rives LLP.
• Note that while every attempt was made to insure that these
materials are accurate, errors or omissions may be contained
therein, for which any liability is disclaimed.

3. Overcoming the Presumption based on3
Structural Similarity
• In re Papesch, 315 F.2d 381 (C.C.P.A. 1963).
• The claimed compound had three ethyl
groups where the prior art had three methyl
groups.”
• Specification disclosed that the claimed
trialkyl compounds had unexpectedly potent
anti-inflammatory activity compared with the
trimethyl compound.

4. 4
In re Papesch
• The Board of Appeals held that a newly discovered
advantageous property may be useful for establishing
nonobviousness “where some doubt of unobviouness
exists,” but is “insufficient alone to override the
holding of unpatentability in a clear case of
obviousness.”
• The CCPA held that the Board of Appeals erred in
failing to consider the pharmacologically
advantageous property of the compounds on the
basis that to chemists the structure of the claimed
compounds would be so apparent that a finding of
obviousness was not questionable.

5. 5
In re Papesch
• “If that which appears, at first blush, to be
obvious though new is shown by evidence not
to be obvious, then the evidence prevails over
surmise or unsupported contention and a
rejection based on obviousness must fall.”
• “Patentability has not been determined on the
basis of the obviousness of structure alone.”

6. 6
In re Papesch
• “From the standpoint of patent law, a compound and
all of its properties are inseparable; they are one and
the same thing. The graphic formulae, and the
chemical nomenclature, systems of classification and
study such as the concepts of homology, isomerism,
etc., are mere symbols by which compounds can be
identified, classified, and compared. But a formula is
not a compound and while it may serve in a claim to
identify what is being patented…the thing that is
patented is not the formula but the compound
identified by it.”

7. 7
Patentability of structurally obvious
compounds based on new property
• Under Papesch there is a two step inquiry:
– First, is there a structurally similar
compound, which would suggest that the
claimed compound and the prior art
compound have similar properties? If there
is no such compound then the analysis is
complete.
– Second, does the claimed compound have
new, nonobvious properties?

8. 8
Patentability of structurally obvious
compounds based on new property
• Examples, under Papesch, of the patentability of a
structurally obvious variant of a prior art compound
with a new, nonobvious property:
– In re de Montmollin, 344 F.2d 976 (C.C.P.A. 1965)
(The compound able to dye cotton was obvious in
light of a structurally similar compound able to dye
wool.
– In re Hoch, 4289 F. 2d 1341 (C.C. P.A. 1970).
(Herbicide was obvious in light of a structurally
similar compound used for “treatment of plant
disease.”

9. In re Dillon, 919 F.2d 688 9
(Fed. Cir. 1990)(en banc)
• Dillon originally claimed a hydrocarbon fuel in
combination with tri- or tetra-orthoesters. Dillon’s patent
application indicated that tri- and tetra-orthoesters had
equivalent activity in reducing particulate emissions.
• Prior art taught that tri-orthoesters were known to be
useful as additives for dewatering hydrocarbon fuels.
• Dillon amended the claims to recite the fuel with only
tetra-orthoesters.
• Based on the structural similarity of the tri-orthoesters
and tetra-orthoesters, it was expected that tetra-
orthoesters would also be useful as a fuel additive
for a purpose such as dewatering fuels.

10. 10
In re Dillon
• Dillon’s broadest composition claim:
– 2) A composition comprising:
a hydrocarbon fuel; and
a sufficient amount of at least one orthoester so as to
reduce the particulate emissions from the combustion
of the hydrocarbon fuel,
wherein the orthoester is of the formula:
wherein R5, R6, R7, and R8 are the same or
different monovalent organic radical
comprising 1 to about 20 carbon atoms

11. 11
In re Dillon
• The Issue: “[W]hether the Board erred in
rejecting as obvious under 35 U.S.C. § 103
claims to Dillon’s new composition and to the
new method of reducing particulate
emissions, when the additives in the new
composition are structurally similar to
additives in known compositions, having a
different use, but the new method of reducing
particulate emissions is neither taught nor
suggested by the prior art?”

12. 12
In re Dillon
• FC: “This court, in reconsidering this case in banc,
reaffirms that structural similarity between claimed and
prior art subject matter, proved by combining references
or otherwise, where the prior art gives reason or
motivation to make the claimed compositions, creates a
prima facie case of obviousness, and that the burden
(and opportunity) then falls on an applicant to rebut that
prima facie case. Such rebuttal or argument can consist of
a comparison of test data showing that the claimed
compositions possess unexpectedly improved
properties or properties that the prior art does
not have[.]”

13. 13
In re Dillon
• FC: Dillon’s invention was obvious despite the new
use of the claimed compound.
– “We believe that the PTO has established, through
its combination of references, that there is a
sufficiently close relationship between the tri-
orthoesters and tetra-orthoesters in the fuel oil art
to create an expectation that hydrocarbon fuel
compositions containing the tetra-orthoesters
would have similar properties, including water
scavenging, to like compositions containing the
tri-orthoesters, and to provide the motivation to
make such new compositions.

14. 14
In re Dillon
• Data not presented to rebut prima facie
obviousness:
– “The art provided the motivation to make the
claimed composition in the expectation that
they would have similar properties. Appellant
had the opportunity to rebut the prima facie
case. She did not present any showing of data
to the effect that her compositions had
properties not possessed by the prior art
compositions or that they possessed them to
an unexpectedly greater degree.”

15. Prima facie obviousness: 15
In re Dillon
• “[I]t is not necessary in order to establish a
prima facie case of obviousness that both a
structural similarity between a claimed and
prior art compound be shown and that
there be a suggestion in or expectation
from the prior art that the claimed
compound or composition will have the
same or similar utility as one newly
discovered by applicant.”

16. 16
Eli Lilly and Co. v. Zenith Goldline Pharmaceuticals, Inc.
(Fed. Cir. 2006) (RADER, Schall, Gajarsa)
• DC in Indiana: Patent valid and infringed
• FC: affirmed
• Claimed compound:

17. Eli Lilly and Co. v. Zenith Goldline 17
Pharmaceuticals, Inc. (Fed. Cir. 2006)
Prior Art Compounds

18. Eli Lilly and Co. v. Zenith Goldline 18
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• “Until discovery of olanzapine, researchers attributed the
efficacy of clozapine and typical antipsychotics to their
“neuroleptic substituent”—an electron-withdrawing
group considered important to the antipsychotic activity
of the compounds. Id. Halogen – a fluorine (F) or
chlorine (Cl) atom – is such an electron withdrawing
group.”
• “Olanzapine does not have a halogen atom, i.e. a fluorine
(F) or chlorine (Cl) atom. Instead, it has a hydrogen atom
(H), which is not an electron withdrawing (or
electronegative) group. Id. at 48.”

19. Eli Lilly and Co. v. Zenith Goldline 19
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• “For a chemical compound, a prima facie
case of obviousness requires “structural
similarity between claimed and prior art
subject matter . . . where the prior art gives
reason or motivation to make the claimed
compositions.” In re Dillon, 919 F.2d 688,
692 (Fed. Cir. 1990) (en banc). “[A]
reasonable expectation of success, not
absolute predictability” supports a
conclusion of obviousness. In re Longi, 759
F.2d 887, 896 (Fed. Cir. 1985).”

20. Eli Lilly and Co. v. Zenith Goldline 20
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• “Prior art taught that the addition of a
fluorine or chlorine enhanced
antipsychotic activity. It also taught that
the unfluorinated Compound ‘222 was
less active than the benchmark
compound, clozapine. Thus, rather than
providing the requisite motivation, the
prior art taught away from selecting
Compound ‘222 as a lead compound for
further development.”

21. Eli Lilly and Co. v. Zenith Goldline 21
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• Prior art compounds “had significant
detrimental side effects.”
• Nothing in prior art taught that the
detrimental side effects could be
avoided by making structural
changes.

22. Eli Lilly and Co. v. Zenith Goldline 22
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• “Mere identification in the prior art of each
component of a composition does not show that
the combination as a whole . . . is obvious.”
• Rather, to establish a prima facie case of
obviousness based on a combination of elements
in the prior art, the law requires a motivation to
select the references and to combine them in the
particular claimed manner to reach the claimed
invention.

23. Eli Lilly and Co. v. Zenith Goldline 23
Pharmaceuticals, Inc. (Fed. Cir. 2006)
• Furthermore, Lilly overcame any prima
facie case of obviousness by extensive
evidence regarding secondary
considerations.
• “Lilly established:
(1) a long-felt and unmet need;
(2) failure of others;
(3) industry acclaim; and
(4) unexpected results”

24. Eli Lilly and Co. v. Zenith Goldline 24
Pharmaceuticals, Inc. (Fed. Cir. 2006)
The record showed:
• a long-felt need for a safer, less toxic, and more
effective clozapine-like drug;
• a decade (or more) of failure to find a replacement
for clozapine;
• a reasonable amount of commercial success for
olanzapine;
• a number of awards for olanzapine as indicators
of industry acclaim;
• unexpected differences between olanzapine and
the closest analog, Compound ‘222, as well as
other similar drugs.

25. 25
Federal Circuit – Post KSR
• On April 30, 2007, in KSR v. Teleflex, t U.S. Supreme
the
Court held that the Federal Circuit applied the TSM
test in a narrow, rigid manner that is inconsistent with
§ 103 and Graham v. John Deere and provided a
variety of rationales for finding obviousness.
• The Federal Circuit already began adjusting its
obviousness jurisprudence before the KSR decision.
However, it was still surprising in May 2007 that the
Federal Circuit denied a petition for panel rehearing
of Pfizer v. Apotex which involved a finding of
obviousness based on an “obvious to try” rationale
which seemed to.

26. U.S. PTO – Post KSR 26
A. Combining prior art elements according to known methods to yield predictable
results.
B. Simple substitution of one known element for another to obtain predictable results.
C. Use of known technique to improve similar devices in same way to achieve a result
that would have been predictable to one of ordinary skill in the art.
D. Applying a known technique to a known device ready for improvement to yield
predictable results.
E. “Obvious to try”—choosing from a finite number of identified, predictable solutions,
with a reasonable expectation of success.
F. Known work in one field may prompt variations of it for use in same or different field
based on design incentives or market forces if the variations would have been
predictable.
G. The teaching-suggestion-motivation (TSM) test.
H. Anything else that can be used to prove obviousness.

27. Pfizer v. Apotex 27
480 F.3d 1348 (Fed. Cir. March 22, 2007) reh’g and reh’g en banc denied, (Fed.
Cir. May 21, 2007), cert denied, (U.S. Oct 01, 2007) (MICHEL, Meyer, Linn)
• “Even if the patentee showed that the claimed
compound “exhibits unexpectedly superior results, this
secondary consideration does not overcome the strong
showing of obviousness in this case. Although
secondary considerations must be taken into account,
they do not necessarily control the obviousness
conclusion.”
• This contradicts In re Papesch as pointed out by Judge
Lourie in his dissent. “Any useful and unexpected
property should be eligible to overcome a prima
facie obviousness determination.”

28. 28
Pfizer v. Apotex
• Judge Lourie’s dissent criticized the emphasis
on therapeutic properties instead of
manufacturing properties and quoted In re
Papesch, 315 F.2d 381 (CCPA 1963):
• “From the standpoint of patent law, a
compound and all of its properties are
inseparable; they are one and the same
thing.... There is no basis in law for ignoring
any property in making such a comparison.”

29. 29
Takeda Chem v. Alphapharm
492 F.3d 1350 (Fed. Cir. June 28, 2007) (LOURIE, Bryson, Dyk)
• Claim 1 recites:
• The ethyl-substituted pyridyl ring
encompasses four possible compounds as the
ethyl substituent (C2H5) is located at one of
four available positions on the pyridyl ring.

30. 30
Takeda Chem v. Alphapharm
• Claim 2 covers pioglitazone (the 5-ethyl
compound) which has the ethyl substituent
attached at the 5-position of the pyridyl
ring

31. 31
Takeda Chem v. Alphapharm
• Alphapharm asserted that the claimed
compounds were obvious based on a prior
art compound known as "compound
b." Compound b possesses a pyridyl ring in
which a methyl (CH3) group is attached to
the 6-position.
O O
C 2H 5
NH NH
S S
N O CH 3 N O
O O
Pioglitazone "Compound b"

32. 32
Takeda Chem v. Alphapharm
• DC concluded that “there was no motivation in
the prior art to select compound b as a lead
compound for antidiabetic research, and that
the prior art actually taught away from its use.”
• DC also concluded that even if Alphapharm had
succeeded in making a prima facie case
of obviousness, such a showing would be
rebutted by the unexpected results of
pioglitazone's nontoxicity.

33. 33
Takeda Chem v. Alphapharm
• DC and FC: nonobvious
• FC’s analysis:
– Alphapharm failed to shows that
Compound b would have been selected
as the lead compound
– Alphapharm failed to show a reason to
modify Compound b to achieve the
claimed compounds.

34. Aventis v. Lupin 34
(Fed. Circ. September 11, 2007) (LINN, Mayer, Robertson by designation)
• ramipril (Altace), for blood pressure
• contains 5 stereocenters, all “S” configuration
• prior art = enalapril (3 stereocenters, all “S”)
ramipril enalapril

35. 35
Aventis v. Lupin
• prior art (Schering) synthesized a mixture of 5S isomer
with SSSSR isomer of ramipril
• prior art (Merck, etc) disclosed previous ACE inhibitors
with all “S” stereochemistry, including enalapril, with
SSS having stronger activity than SSR isomer
• prior art (Schering) disclosed separation of ramipril
isomers by chromatography or crystallization
• since KSR, no need for an explicit teaching in the prior
art to purify the 5S isomer from a mixture: obvious
• Aventis failed to show unexpected results to rebut

36. 36
Ortho-
Ortho-McNeil v. Mylan Laboratories
(Fed. Cir. March 31, 2008) (RADER, Michel, Linn)
• topiramate (Topomax); epilepsy drug
• lower court permanently enjoined Mylan from infringing Ortho’s
product, and the FC affirmed
• Ortho was searching for new diabetes drugs, but found that a
synthetic intermediate (itself derived from DPF) for an anti-
diabetic compound was a potent anticonvulsant
O OH O OSO2NH2
O O O O
O O O O
DPF (di-isopropylidine fructose) topiramate

37. 37
Ortho v. Mylan
• CAFC: a skilled artisan “would not even be likely” to
start with DPF as a lead compound to design a diabetes
drug
• hindsight analysis is inappropriate
• the subject matter as a whole must be examined at the
time the invention was made; not obvious
• secondary considerations also support nonobviousness
– powerful unexpected results
– skepticism of experts and copying
– commercial success

38. 38
Eisai v. Dr. Reddy’s/Teva
(Fed. Circ. July 21, 2008) (RADER, Linn, Prost)
• rabeprazole (Aciphex); PPI for ulcers, GERD
• prior art = lansoprazole, omeprezole,
Brändström

39. 39
Eisai v. Dr. Reddy’s/Teva
• Teva claimed rabeprazole was obvious because of
lansoprazole, omeprazole and Brändström’s core
• prior art (lansoprazole) contained a CF3 group in order to
increase lipophilicity, but rabeprazole has no F’s
• omeprazole not structurally similar enough
• no “reasoned identification of a lead compound” since
the F’s were removed, so lansoprazole not a valid lead
because no motivation to select it
• no other support to select leads other than lansoprazole
• thus, not obvious to make rabeprazole

40. 40
Sanofi v. Apotex
(Fed. Circ. December 12, 2008) (NEWMAN, Lourie, Bryson)
• clopidogrel bisulfate (Plavix); blood thinner
• single enantiomer
• prior art = racemic mixture

41. 41
Sanofi v. Apotex
• CAFC: the separation of the mixture was not
routine or simple (salt with (+)-camphorsulfonic
acid/acetone)
• Apotex cited no reference that showed or
suggested a reliable method of separation for
analogous compounds
• success in the separation was unpredictable
• unknown before the separation which isomer
desirable
• KSR recognized hindsight bias as inappropriate
• not obvious to separate the enantiomers

42. 42
P&G v. Teva
(Fed. Circ. May 13, 2009) (Mayer, Dyk, Huff by designation)
• risedronate (Actonel); osteoporosis
• 3-pyridyl EHDP
risedronate prior art

43. 43
P&G v. Teva
• prior art = 2-pyridyl EHDP
• bisphosphonate art at the time was very unpredictable
• 3-pyr EHDP much less toxic, 4-pyr EHDP not active
• CAFC: no evidence that the structural modification was
routine in the art, so no prima facie case of
obviousness
• even if a prima facie case had been shown, the
unexpected results would successfully rebut
• secondary considerations (commercial success and
meeting a long-felt need) supported nonobviousness

44. Altana v. Teva 44
(Fed. Circ. May 14, 2009)
Newman (concur), Gajarsa, WARD by designation)
• pantoprazole (Protonix); PPI for ulcers, GERD
• 3-methoxy pyridine group; prior art = 3-methyl
pantoprazole prior art

45. 45
Altana v. Teva
• review of a denied preliminary injunction
requested by Altana in the lower court decision
• CAFC can only reverse if lower court abused
discretion and their decision was clearly
erroneous
• lower standard for determining obviousness
– must only establish a likelihood of success on the
merits
– burden then shifts to patentee to show lack of merit
– not the “clear and convincing” evidence standard for
trials

46. 46
Altana v. Teva
• prior art compound was identified as one of the “more potent” of
18 compounds for which data was given
• additional prior art (Sachs) taught that the optimum pKa for PPI = 4
• additional prior art (Bryson) taught that the pKa of 3-methoxy
pyridine is closer to 4 than the pKa of 3-methyl pyridine
• CAFC: prior art compound was a reasonable lead compound from
which to pursue further development
• lower court’s decision for sufficient case of obviousness on merits
was affirmed (i.e., likelihood of success)
• Newman concurrence: evidence doesn’t establish obviousness,
but deference to lower court given in a preliminary injunction
phase

47. 47
Summary of Recent Drug
Structural Obviousness Cases
case date holding comments
Aventis v. Lupin Sept 2007 obvious
Ortho v. Mylan March 2008 not obvious
Eisai v. Dr. Reddy July 2008 not obvious strategic error by
Defense?
Sanofi v. Apotex Dec 2008 not obvious
P&G v. Teva May 2009 not obvious weak experts by
Defense?
Altana v. Teva May 2009 obvious preliminary
injunction

48. 48
Recent CAFC Decisions on Obvious Drug
Formulation Claims
• 6 cases post-KSR discuss obviousness as
applied to drug formulations
• much “closer” cases; half (3/6) were 2:1
– dissent by Gajarsa in Abbott v. Sandoz
– dissent by Newman in Bayer v. Barr
– dissent by Mayer in Ortho v. Teva

49. McNeil v. Perrigo 49
(Fed. Circ. April 14, 2008)
Lourie, Rader, Bryson (per curiam)
• CAFC affirmed lower court decision without opinion
• famotidine (Pepsid Complete)
• oral histamine H2 receptor NH 2
antagonist drug + antacid N NH 2
• bitter-tasting
• McNeil added a coating to
S N
S N
the drug granules to SO NH
2 2
mask the bitterness NH 2

50. McNeil v. Perrigo 50
• prior art A = uncoated famotidine + antacid for solid oral
dosing, with or without a flavoring agent
• prior art B = coating oral drugs to mask taste
• prior art C = cimetidine + antacid + coating to mask
bitter drug taste (cimetidine = Tagamet, also H2 blocker)
• CAFC = predictable results from A + predictable results
from B or C, together with motivation to coat the drug
to mask a bitter taste, make McNeil’s patent obvious
• secondary considerations not enough to overcome
the strong showing of obviousness

51. Novartis v. Teva 51
(Fed. Circ. June 9, 2008)
Mayer, Schall, Linn (per curiam)
• affirmed denial of preliminary injunction, no
opinion
• famciclovir (Famvir); antiviral
• a prodrug of penciclovir, an acyclic nucleoside
N N
N N
H2N N N H2N N N penciclovir
O
famciclovir O OH
O OH
O

52. 52
Novartis v. Teva
• prior art = taught how to make acetyl ester prodrugs of
other acyclic nucleosides to increase oral bioavailability
• prior art = penciclovir had high antiviral activity and low
toxicity, but poor oral bioavailability
• prior art = penciclovir was one of only 5 known acyclic
nucleosides with high activity/low toxicity (finite
number)
• CAFC; penciclovir was an obvious lead compound, there
was motivation to make an orally active drug, and it
was obvious to make the acetyl ester prodrugs
• no unexpected results

53. In re Omeprezole 53
[AstraZeneca v. Apotex]
(Fed. Circ. August 20, 2008) (Lourie, BRYSON, Gajarsa)
• omeprezole (Prilosec); PPI for ulcers, GERD
N O H3C OCH3
S
H3CO N CH3
H
N
omeprazole

54. 54
In re Omeprazole
• AstraZeneca found that alkaline reacting compound (ARC)
addition to drug core helped stabilize drug in storage, and
that an enteric coating was needed to keep drug from
decomposing in the stomach, but normal enteric coatings
were known to dissolve the ARC
• AZ determined that a water-soluble subcoating would
keep ARC intact but allow drug release in small intestine
• no prior art showed a negative interaction between ARC
and enteric coatings or discussed subcoatings, thus no
motivation to introduce a subcoating; not obvious
• even if there were motivation, a water-soluble
subcoating would not be obvious to try

55. Abbott v. Sandoz 55
(Fed. Circ. October 21, 2008)
NEWMAN, Archer, Gajarsa (dissent by Gajarsa)
• affirmed preliminary injunction
• clarithromycin (Biaxin XL)
• extended release
formulation of a
macrolide
antibiotic

56. 56
Abbott v. Sandoz
• prior art taught dissolution control with polymer
addition or alginate salt + azithromycin
• prior art also taught extended release formulations
of erythromycin derivatives in general
• CAFC; physical properties (PK) of azithromycin very
different than clarithromycin, so skilled artisan could
not predict how clarithromycin would act using the
extended release formulation for azithromycin
• dissent; only routine experimentation needed
here

57. Bayer v. Barr 57
(Fed. Circ. August 5, 2009) (MAYER, Newman, Friedman) (dissent
by Newman)
• drospirenone (Yasmin); oral contraceptive
• poorly soluble in water
• isomerizes in acid to a
compound with
undesired properties

58. 58
Bayer v. Barr
• prior art taught micronization to improve solubility in
water, but it also increased acid sensitivity
• enteric coatings known to protect oral drugs from
stomach acid, but also decreased bioavailability
• Bayer found that the micronized drug with an enteric
coating had same bioavailability as without the coating
• CAFC; prior art narrowed options to a finite number
of identifiable predictable solutions, so obvious
• Newman dissent; no reasonable expectation of
success here

59. Ortho v. Teva 59
(Fed. Circ. August 26, 2009) (PROST, Moore, dissent by
Mayer)
• combination of acetaminophen + tramadol (Ultracet)
O
H
N
tramadol
OH
O
HO N
acetaminophen

60. 60
Ortho v. Teva
• prior art = tramadol + para-acetaminophenol in a
combination drug, at 1:10 ratio
• 2 kinds of Ortho formulation claims
– one set with ratio “consisting of about 1:5 – 1:19”
– one claim with ratio “comprising about 1:5”
• Ortho got narrowing reissue to avoid prior art
(discovered that para-acetaminophenol = acetaminophen)
• CAFC construed “about 1:5” to mean 1:1.36 – 1:1.71
(Ortho v. Caraco)

61. 61
Ortho v. Teva
• CAFC: the difference between 1:7.1 and 1:10 is
slight, so a prima facie case of obviousness regarding
the “comprising about 1:5” claim
• Ortho’s unexpected result rebuttal (synergy) failed,
as there was no difference in the synergistic effect
between these ratios
• claims with ratio “consisting of about 1:5 – about
1:19” raise an issue of material fact (remand)
• “dissent” (Mayer); all claims are obvious

62. Summary of Recent Drug 62
Formulation Obviousness Cases
case date holding comments
McNeil v. Perrigo April 2008 obvious per curiam
Novartis v. Teva June 2008 obvious prelim. injunction;
per curiam
In re Omeprezole August 2008 not obvious
Abbott v. Sandoz October 2009 not obvious Gajarsa dissent
Bayer v. Barr August 2009 obvious Newman dissent
Ortho v. Teva August 2009 some obvious Mayer dissent
some not

63. 63
For More Information
Kevin B. Laurence
Partner
Salt Lake City, UT
(801) 578-6932 Direct
(801) 578-6999 Fax
200 S Main Street, Suite 1100
Salt Lake City, UT 84111
kblaurence@stoel.com
Samuel E. Webb
Partner
Seattle, WA
(206) 386-7683 Direct
(206) 386-7500 Fax
600 University Street, Suite 3600
Seattle, WA 98101
sewebb@stoel.com