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Obviousness Under 35 U.S.C. §103
in the United States
Bruce C. Haas, Esq.
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I.
35 USC §103(a)
 A patent may not be obtained though the invention is not identically
disclosed or described:
– If 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 person having ordinary skill in the art to which the subject
matter pertains
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II. Application of §103

The claimed invention must be considered as a whole

The references must be viewed without the benefit of impermissible hindsight
bias afforded by the claimed invention

Reasonable expectation of success is standard with which obviousness is
determined

The references must be considered as a whole and must suggest the
desirability and thus, the obviousness of making the combination

The Graham v. John Deere factors must always be considered
– Evidence of secondary considerations

Commercial success

Unsolved needs

Failure of others, etc.
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III. Application of §103 Prior to KSR
 Some motivation or suggestion to combine the prior art teaching
required
 Teaching – Suggestion – Motivation (TSM) Test
 US case law applied TSM test prior to KSR; yet, application of test
varied from case to case
– e.g. – Pfizer, Inc. v. Apotex, Inc., 480 F3d 1348 (Fed Cir 2007)
(amlodipine) (antihypertensive/anti-ischemic activity)
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III. Application of §103 Prior to KSR (cont’d)
 Pfizer case decided only about one month prior to Supreme
Court decision in KSR
 Rehearing en blanc denied after KSR – indicating the Federal
Circuit Court thought the obviousness doctrine it followed was
based on prior precedent and not inconsistent with KSR
 “We reject Pfizer’s first argument, since a suggestion, teaching
or motivation to combine the relevant prior art teachings to
achieve the claimed invention does not have to be found
explicitly in the prior art references sought to be combined, but
rather may be found in any number of sources, including
common knowledge, the prior art as a whole, or the nature of
the problem itself” citing DyStar 464 F3d at 1361.
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IV. KSR Int’l Co. v. Teleflex, Inc., 127 S.Ct. 1727 (2007)
(adjustable automobile gas pedal with fixed pivot point
that contains a computer sensor)
 Prior art relied on was to an adjustable gas pedal with a fixed pivot
point, but no computer sensor
 Supreme Court faulted the TSM test as being applied too rigidly
 Court did not reject TSM test, just its rigid application
 Court asked whether a claimed improvement is more than a
predictable use of the prior art elements according to their established
functions
 Obviousness may be based on the “obvious to try” standard if the art is
sufficiently predictable
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IV. KSR Int’l Co. v. Teleflex, Inc. (cont’d)
 The Supreme Court explained “The obviousness analysis cannot be
confined by a formalistic conception of the words teaching, suggestion,
and motivation, or by overemphasis on the importance of published
articles and the explicit content of issued patents.” KSR at 1741
 A flexible approach to the TSM test prevents hindsight and focuses on
evidence before the time of the invention
 Teachings, suggestions, or motivations need not always be written
references but may be found within the knowledge and creativity of
ordinarily skilled artisans
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
 Pharmaceuticals
– The TSM test directs a court to ask whether the art is generally
predictable?
– Also, do small molecular changes lead to unpredictable properties?
 Cases after KSR demonstrate flexibility of applying the test for
obviousness
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
 Cases where only routine experimentation was required where results are
predictable from limited experiments, e.g.
 Pfizer v. Apotex, 480 F3d 1348 (March 22, 2007)
CLAIMS OBVIOUS
VS.
– Cases where there was potentially an infinite number of possible
solutions/compounds
 Takeda Chem Indus. V. Alphapharm Ltd., 492 F3d 1350 (June 28,
2007)
CLAIMS NOT OBVIOUS
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)

Other Post KSR Pharmaceutical Cases
1. Aventis Pharma Deutschland v. Lupin, 499 F3d 1293 (Sept. 11,
2007) (5(S)-enantiomer)
– Prior art disclosed racemic mixture
– Federal Circuit found claim to specific stereoisomer was
OBVIOUS
– No specific teaching in prior art to separate/purify the 5(S)
stereoisomer was required
– Unexpected results did not change the Court’s finding
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
2. Daiichi Sankyo Co. v. Apotex, Inc., 501 F3d 1254 (Sept. 12, 2007)
(method of treating bacterial infection by topical administration of
antibiotic ofloxacin in ear without damaging a patient’s hearing)
– Federal Circuit found claim to method was
OBVIOUS
– A flexible approach in analyzing obviousness was conducted
as prescribed by KSR
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
3. Takeda Chem. Indus. Ltd v. Alphapharm Pty Ltd, 492 F3d 1350
(June 28, 2007) (pioglitazone-Actos®)
– Federal Circuit found claim was
NOT OBVIOUS
– Prior art taught away and unexpected properties were evident
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
4. Forest Labs. v. Ivax Pharm, 501 F3d 1263 (Sept. 5, 2007)
(Escitalopram Lexapro®) S- or (+) enantiomer
– Federal Circuit found claim was
NOT OBVIOUS
– Enantiomers were difficult to separate and unexpected
properties were evident
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
5. Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520
F3d 1358 (March 31, 2008) (Topiramate anticonvulsive drug)
– Federal Circuit found claim was
NOT OBVIOUS
– Record shows powerful unexpected results
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)
6. Sanofi-Synthelabo et al v. Apotex, Inc., 550 F3d 1075 (December
12, 2008 (Plavix®)
– Federal Circuit found claim was
NOT OBVIOUS
– Enantiomer separation was complex and enantiomer provided
all the favorable activity with no significant toxicity
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)

Biotechnology Cases Post KSR
1. PharmaStem Therapeutics v. Viacell, Inc., 491 F3d 1342 (July 9,
2007) (compositions and method of treating/using cryopreserved stem
cells)
– Federal Circuit found claim was
OBVIOUS
– Prior art disclosed idea of using cryopreserved viable human
neonatal or fetal hematopoietic stem cells
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)

Biotechnology Cases Post KSR (cont’d)
2. Innogentics N.V. v. Abbott Labs, 512 F3d 1363 (January 17, 2008)
(method of genotyping HCV based on distinct genetic sequences)
– Federal Circuit found claim was
NOT OBVIOUS
– Affirmed District Court flexible TSM test as stated in KSR
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V.
Impact of KSR in Pharmaceuticals and Biotechnology
(cont’d)

Biotechnology Cases Post KSR (cont’d)
3. In re Sullivan, 498 F3d 1345 (August 29, 2007) (antivenom
composition to treat snake bites)
– Federal Circuit found prima facie OBVIOUS, but
– Remanded to Patent Office to consider declarations on secondary
considerations (unexpected results)
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VI. Supreme Court Rationale in KSR – Why Encourage More
Flexible Approach to TSM Test?
 Combining prior art elements according to known methods to yield
predictable results may likely lead to an obviousness finding
 Choosing from a finite number of identified, predictable solutions with a
reasonable expectation of success may likely lead to an obviousness
finding
 Teaching, suggestion, or motivation in the prior art to make the
combination may likely lead to an obviousness finding
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VI. Supreme Court Rationale in KSR – Why Encourage More
Flexible Approach to TSM Test? (cont’d)
 What Counts Now After KSR?
– Any legitimate reason to combine references
 e.g., common sense, common knowledge, market demands
 What Doesn’t Count Now After KSR?
– Inventor’s motivations/purpose
– Problem faced by inventor
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VI. Supreme Court Rationale in KSR – Why Encourage More
Flexible Approach to TSM Test? (cont’d)
 Coping With KSR
– Unexpected results are powerful evidence of non-obviousness
– Teaching Away is still viable evidence of non-obviousness
– Secondary Considerations are still powerful
 Long felt but unresolved needs
 Failure of others
 Copying
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VI. Supreme Court Rationale in KSR – Why Encourage More
Flexible Approach to TSM Test? (cont’d)
 KSR reminded Federal Circuit to apply TSM test flexibly
 The law has arguably not been substantively changed
– What has changed is the heightened awareness of obviousness
considerations
– What is most powerful to counter an obviousness challenge are
secondary considerations, particularly unexpected results
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VII. Enantiomer Cases
 Ortho-McNeil Pharma. Inc. v. Mylan, 348 F.Supp 713 (December 23,
2004) – claims were not obvious
 Aventis Pharma Deutschland v. Lupin, 499 F3d 1293 (September 11,
2007) – claims were obvious
 Forest Labs v. Ivax Pharm, 501 F3d 1263 (September 5, 2007) –
claims were not obvious
 Sanofi-Synthelabo, Inc. v. Apotex, 550 F3d 1075 (December 12, 2008)
– claims were not obvious
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PLAVIX® Canadian Case
 Selection patent for a key ingredient of Plavix® is VALID
 Brings Canadian obviousness standard closer to US under KSR
 Could signal more difficulty in defending against obviousness
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