Obviousness in Chemical and Biotechnology Patents: A Post-

KSR analysis

Akansha Dubey and Aritra Roy

I. INTRODUCTION

"To invent, you need a good imagination and a pile of junk"

-Thomas A. Edison, American Inventor who, singly or jointly, held a world record 1,093
patents (1847 - 1931)

It would seem that Thomas Edison would have been surprised when his patent
application for the light bulb would have been rejected as merely a collection of junk
from his pile, combined in a fashion that would be obvious to someone else. However, let
us not misinterpret Mr. Edison's words. He also said, "I never did anything worth doing
by accident; nor did any of my inventions come by accident; they came by work". While
it might have been clear to Mr. Edison when he had actually innovated something new,
the courts and legislature have long struggled with the concept of "obviousness" with
respect to the granting of patents.

In what has been called ―the most important patent case of the last 20 years,‖ 1 the
Supreme Court in 2007 clarified the contours of non-obviousness in KSR International
Co. v. Teleflex Inc.2 In establishing the framework to answer ―whether a patent claiming


Both are students of National Law University, Jodhpur pursuing B.A.LLB (Hons.) in
their second year. They can be contacted at akanshadb06@gmail.com and
aritraroy@gmail.com respectively.
1
Posting of Peter Lattman to WSJ.com Law Blog, KSR v. Teleflex: The Supreme
Court‘s Big Patent Ruling, http://blogs.wsj.com/law/2007/05/01/ksr-v-teleflex-the-
supremecourts-big-patent-ruling/ (May 1, 2007, 08:07 EDT) (quoting Michael Barclay).
2
550 U.S. 398 (2007).
the combination of elements of prior art is obvious,‖3 the Court emphasized that a proper
analysis of non-obviousness must be ―expansive and flexible.‖4 KSR thus emphasized the
need to articulate the non-obviousness criterion with enough flexibility to guarantee that
patents issue only to inventions constituting a sufficient advance in the state of the art,
thereby encouraging — rather than stifling — innovation.5 Substantial interest in the case
was evident from the outset of the litigation.

This paper analyzes KSR and the effects the Court's holding has had and is likely to have
on the biotechnology, pharmaceutical and chemical industry. Part II examines the
contours and motivating factors of the non-obviousness doctrine and traces the evolution
of modern obviousness standards. Part III highlights the Federal court‘s trend in the
―obviousness‖ jurisprudence in the post-KSR era on biotechnology, pharmaceutical and
chemical patents. Part IV analyses the findings in the last part and describes the courts‘
unsettled approach to the obviousness inquiry. Part V concludes the paper.

II.EVOLUTION OF THE OBVIOUSNESS DOCTRINE

A. The Framework for a Non-obviousness Analysis: Pre 1952

Before 1952, the statutory requirements for a patent were only that an applicant
demonstrates that his invention was novel,6 useful,7 and adequately disclosed.8 Over time,
however, the courts grafted on an additional requirement of showing that there was
sufficient inventiveness beyond mere novelty.9 In 1850, the Supreme Court prominently

3
Id. ―Prior art‖ is ―[k]nowledge that is publicly known, used by others, or available on
the date of invention to a person of ordinary skill in an art, including what would be
obvious from that knowledge.‖ BLACK‘S LAW DICTIONARY 119 (8th ed. 2004).
4
Id.
5
Id.
6
35 U.S.C. § 31 (1946), repealed by Patent Act of 1952, Pub. L. No. 82-593, § 5, 66 Stat.
792, 815–17.
7
Id.
8
See id. § 33.
9
See John F. Duffy, Inventing Invention: A Case Study of Legal Innovation, 86 Tex.
L.Rev. 1 (2007).
held in Hotchkiss v. Greenwood10 that there could be no patentable invention unless the
novel invention also possessed a sufficient ―degree of skill and ingenuity.‖ 11 This
formulation led to almost 100 years of confusion, even at the Supreme Court, as to
whether a patentable invention had to ―reveal the flash of creative genius, not merely the
skill of the calling,‖12 merely ―acquir[e] new functions and useful properties,‖13 or
something else altogether.14

Confronted by this doctrinal confusion,15 in 1952, Congress redirected all of these tests
into a requirement that inventions be ‗non-obvious‘ to be patentable. Section 103 of the
Patent Act states:
[A patent] may not be obtained . . . 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 said subject
matter pertains.16

This section effectively overruled the flash-of-creative-genius test previously enunciated

by the Supreme Court, stating that ―[p]atentability shall not be negatived by the manner
in which the invention was made.‖17 That is, obviousness does not concern how quick or
laborious it was to invent but instead how straightforward the invention was in light of
the prior art.

10
52 U.S. 248 (1850).
11
Id. at 267.
12
Cuno Eng‟g Corp. v. Automatic Devices Corp., 314 U.S. 84, 91 (1941).
13
Smith v. Goodyear Dental Vulcanite Co., 93 U.S. 486, 496 (1876).
14
See, e.g., Atl. Works v. Brady, 107 U.S. 192, 200 (1883).
15
See Giles S. Rich, Why and How Section 103 Came To Be, in NONOBVIOUSNESS —
THE ULTIMATE CONDITION OF PATENTABILITY (John F. Witherspoon ed., 1980)
at 1:201, 1:203–08.
16
35 U.S.C. § 103(a) (2006).
17
Id; see also ROBERT L. HARMON, PATENTS AND THE FEDERAL CIRCUIT §
4.2(a), at 169 (8th ed. 2007).
B. The Graham Factors

Little more than a decade after Congress adopted the statutory requirement of non-
obviousness, the Supreme Court in Graham v. John Deere Co. of Kansas City laid out a
multifactor test to assist in drawing a line between what is or is not obvious.18 At least
one reason why the Court examined the non-obviousness issue was ―a notorious
difference between the standards applied by the Patent Office [and those applied] by the
courts.‖19 The Court analyzed the legislative history of §103 and found that Congress, in
enacting § 103, had not intended to lower the bar on patentability but merely intended to
bring ―uniformity and definiteness to the issue of what is ―new‖. 20 The Court concluded
that this congressional goal could be achieved by conducting a case-by-case inquiry into
non-obviousness pursuant to a practical test of patentability, later referred to as the
Graham factors.21

The Graham factors provide a step-by-step analysis of non-obviousness according to the

statutory language in § 103. The first step of the inquiry is to determine ―the scope and
content of the prior art [and to ascertain the] differences between the prior art and the
claims at issue.‖22 The second step is to resolve ―the level of ordinary skill in the
pertinent art‖23 to determine whether ―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.‖24
Additionally, the Court noted that factors termed ―secondary considerations‖ might be
used ―to give light to the circumstances surrounding the origin of the subject matter
sought to be patented[,]‖ including ―commercial success, long felt but unsolved needs,

18
Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966). [hereinafter
‗Graham‟]
19
Patent Act § 102
20
For the requirement that an invention needs to be new to be patentable, see Patent Act
§ 101.
21
Graham, 7–18.
22
Graham, 17.
23
Id.
24
Patent Act § 103(a).
failure of others, etc.‖25 The Court further explained that secondary considerations were
included to ―guard against slipping into use of hindsight‘26 . . . and to resist the
temptation to read into the prior art the teachings of the invention in issue.‖27- which had
arisen in other post-Hotchkiss cases.28 In fact, the Federal Circuit has since mandated the
consideration of secondary factors in non-obviousness inquiries.29

The Court recognized that irrespective of its formal pronouncements in Graham, uniform
application of the non-obviousness test would require further development of the doctrine
in the lower courts.30 In fact, the Court of Customs and Patent Appeals (C.C.P.A.) had
already devised a method to implement the holding of Hotchkiss. The teaching-
suggestion-motivation (TSM) standard, first articulated five years before Graham,31
became the cornerstone of obviousness determination in the lower courts. Under the TSM
test, an invention is obvious where there is a teaching, suggestion, or motivation in the
analogous prior art to make the product in question.32 References are selected for their
relevance to the subject matter based on the judgment of a person of ordinary skill in the
art, but are not limited to explicit statements.33 Motivation may be implicit in the prior art
as a whole, or suggested by the nature of the problem addressed by the invention. 34 In the
Federal Circuit‘s view, this test ―picks up where the analogous art test leaves off and
informs the Graham analysis,‖35 lending both direction and scope to the inquiry.36

25
Graham, 17–18.
26
Quoting Monroe Auto Equip. Co. v. Heckethorn Mfg. & Supply Co., 332 F.2d 406, 412
(1964).
27
Id.
28
See, e.g., Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435 (1911).
29
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007).
30
Graham, 18.
31
Application of Bergel, 292 F.2d 955, 956–57 (C.C.P.A. 1961).
32
See, In re Kahn, 441 F.3d 977, 986–87 (Fed. Cir. 2006) (―Although our predecessor
court was the first to articulate the motivation-suggestion-teaching test, a related test—the
analogous art test—has long been part of the primary Graham analysis articulated by the
Supreme Court.‖) (citing Dann v. Johnston, 425 U.S.219, 227–29 (1976)).
33
Id. at 987.
34
Id. at 987–88.
35
Alza Corp. v. Mylan Labs., 464 F.3d 1286, 1290 (Fed. Cir. 2006) (quoting Kahn, 441
F. 3d at 987).
36
See id. at 1290–91.
The courts applied the TSM test because, without evidence of this teaching, suggestion,
or motivation, a non-obviousness analysis ―simply takes the inventor‗s disclosure as a
blueprint for piecing together the prior art to defeat patentability‖. 37 Use of the Federal
Circuit‘s TSM test in the lower courts went largely unchallenged for over four decades.

The high tech industry, among others, sharply criticized the TSM test. First, these critics
argued that the Federal Circuit—not Supreme Court—created the TSM test and, in doing
so, improperly added an additional step to the Graham analysis. Second, the critics
claimed that even if the TSM test was a justified application of Graham, the Federal
Circuit applied the test too rigidly, making it difficult to invalidate bad patents and
thereby stifling innovation. The pharmaceutical industry, on the other hand, supported the
TSM test as a way to protect chemical patents against impermissible hindsight analysis,
since chemical inventions may involve only minor structural differences over the prior art
and yet still produce unexpected results.38

C. The KSR Decision: The Return of the Graham Factors

In KSR International Co. v. Teleflex Inc., the Court made its first substantive changes to
Graham, broadening the scope of the relevant prior art and rejecting the Federal Circuit‘s
TSM application as impermissibly narrow.39

The dispute in KSR involved rights to an adjustable automobile pedal featuring electronic
sensing devices.40 The individual elements of the invention were present in the prior art,
but the combination of elements had not been previously disclosed.41 The Federal Circuit
reversed the finding of patent invalidity for failure of the lower court to properly apply

37
Teleflex, Inc. v. KSR Int„l Co., 119 Fed. App‗x 282, 285 (Fed. Cir. 2005).
38
Stephen G. Kunin & Andrew K. Beverina, Commentary, KSR‟s Effect on Patent Law,
106 Mich. L. Rev. First Impressions 50 (2007).
39
KSR Int‟l Co. v. Teleflex, Inc., 550 U.S. 398, 418–19 (2007).
40
Id. at 407–08.
41
See id. at 408–09.
the TSM test.42 The court recognized that the elements of the invention were known in
the industry, but held that the district court failed to identify a motivation in the prior art
that would lead a person of ordinary skill in the art to combine the elements.43

In reversing the Federal Circuit‘s holding, the Supreme Court criticized its application of
the TSM test as a ―rigid rule that limits the obviousness inquiry.‖44 The Court did not
consider the test fundamentally at odds with Graham, only the manner in which the
Federal Circuit had applied it in this and other cases.45 Specifically, the Court held it is
error to limit the Graham inquiry to the particular problem the inventor is trying to solve
or prior art addressing the same issue, stating that, ―[u]nder the correct analysis, any need
or problem known in the field . . . can provide a reason for combining the elements in the
manner claimed.‖46 Moreover, courts should not assume that inventors will be guided
only by prior art elements directed to the particular problem they are working on, but
should regard the person of ordinary skill in the art as having the ―ordinary creativity‖ to
assemble even unrelated prior art ―like pieces of a puzzle.‖47 The Court minimized the
Federal Circuit‘s concern that poorly-defined obviousness criteria may give way to
hindsight bias,48 and called for a ―common sense” approach to obviousness
determination, including consideration of what may be obvious to try in a given field of
endeavor.49

With this language, the Supreme Court conceivably advocated some version of an
obvious-to-try standard of patentability.50 Importantly, however, the Court limited this

42
Teleflex, Inc. v. KSR Int‟l. Co., 119 F. App‘x 282, 286 (Fed. Cir.2005), rev‟d, 550 U.S.
398 (2007).
43
Id. at 288.
44
KSR Int‟l, 550 U.S. at 419.
45
Id.
46
Id. at 420 (emphasis added).
47
Id. at 420–21.
48
Id. at 421.
49
The Court called for the use of a common sense approach to obviousness determination
no fewer than four times throughout the opinion.
50
See, e.g., Harold C. Wegner, Commentary, Making Sense of KSR and Other Recent
standard to scenarios accompanied by ―predictable solutions‖ and ―anticipated success.‖
Ultimately, the Court called for the Federal Circuit to apply a ―flexible‖ TSM test that
considers common knowledge and common sense to assess obviousness in light of prior
art.51

III. THE LOWER COURTS AND OBVIOUSNESS

The patentability scenario received a path-breaking jolt with the KSR ruling of the U.S.
Supreme Court. The Court‘s approach initially paved way for a metamorphosis in post-
KSR decisions, furthering the novel outlook. Though the decision of dismantling the
application of the TSM test in KSR was met with surprise yet various concurrences were
seen. In response to KSR the USPTO Board of Patent Appeals and Interferences (BPAI)
implemented the conclusions in three precedential opinions affirming examiners'
obviousness rejections in the biotechnological, electrical and mechanical arts.52 Out of
these, Ex Parte Kubin53 pertains to a biotechnology patent.

A. Impact of KSR on biotechnology patents: Ex Parte Kubin and In Re Kubin

One of the first attempts to implement KSR standards by BPAI was seen in Ex parte
Kubin, in context of a biotechnology patent. In this case the Board upheld the rejection of
claims to nucleic acid sequences encoding the human NAIL protein.54 The claims were
held obvious as the methods employed for the isolation of the sequences were known in

Patent Cases, 106 Mich. L. Rev. First Impressions 39, 41 (2007), (arguing that the post-
KSR ―tightening of the patentability standard is . . . manifested by KSR‘s endorsement of
the ‗obvious to try‘ standard that had been in disfavor throughout the history of the
Federal Circuit‖).
51
KSR Int‟l, 550 U.S. at 421–22.
52
Michael R. Dzwonczyk Implementing a “Predictable” Obviousness Standard Post-
KSR Intellectual Property Institute of Canada‘s 83rd Annual Meeting, St. John‘s,
Newfoundland, Canada, September 23-25, 2009.
53
83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007).
54
Natural killer cell activation-inducing ligand. See Marek Z. Kubin et al., Molecular
Cloning and Biological Characterization of NK Cell Activation-Inducing Ligand, a
Counterstructure for CD48, 29 EUR. J. IMMUNOLOGY 3466 (1999).
the prior art, as the existence of the protein in some form was known. Though the actual
sequences claimed were not disclosed in the concerned prior art. This approach
contradicted the Federal Circuit precedent In re Deuel55 which dominated the sphere of
biotechnology obviousness for over a decade. The Board justified the action by citing that
the language used in KSR was critical and thus conveniently over-ruled the precedent.
The reasoning of the Board emphasised that there were a limited number of
methodologies available to isolate the NAIL cDNA and [t]he skilled artisan would have
had reason to try these methodologies with the reasonable expectation that at least one
would be successful. Thus, isolating NAIL cDNA was “the product not of innovation but
of ordinary skill and common sense, leading us to conclude NAIL cDNA is not patentable
as it would have been obvious to isolate it.”

56
The Federal Circuit panel affirmed the above approach in In re Kubin , in context of
genetic innovation obviousness, stating that the methods used were well-known raising
the expectation of success reasonably thus hindering the patentable potentiality of the end
product. Moreover, it was admitted that certain aspects of In re Deuel were challenged by
the outlook adopted in KSR.

The Federal Circuit readily interpreted the KSR approach in Black & Decker, Inc. v.
Robert Bosch Tool Corp., by defending the TSM test, holding that ‗the teaching,
suggestion, motivation test remains good law for obviousness, only a rigid application of
that test is problematic.‘57 The TSM test was further discussed in the Ortho-McNeil
Pharmaceuticals v. Mylan Laboratories58 case wherein the acceptance of knowledge and
creativity of the ordinary skilled artisans as a part of the teachings, suggestions and
motivations was upheld.

55
51 F.3d 1552 (Fed. Cir. 1995).
56
561 F.3d 1351, 1352 (Fed. Cir. 2009).
57
260 F. App‘x 284, 290 (Fed. Cir. 2008).
58
520 F.3d 1358, 1365 (Fed. Cir. 2008).
B. Impact of KSR on pharmaceutical and chemical patents

KSR‘s influence in the area of pharmaceutical patentability has been viewed dubiously,
creating pointless uncertainties. The case of Pfizer v. Apotex59 puts forth a patent dispute
over a hypertension drug. It questioned the marketed salt form of amlodipine, active
ingredient in Norvasc.60 Pfizer originally developed amlodipine as a maleate salt, but due
to chemical instability and a tendency of the tablet blend to stick to the manufacturing
equipment switched to besylate salt. The controversy revolved around the validity of
claims directed to amlodipine besylate regarding prior art, the patent that originally
disclosed amlodipine maleate salt accompanied by a publication describing 53 different
ppreviously approved salt-forming acids. The panel rejected the claims terming them as
obvious, neglecting the association between unpredictability and non-obviousness as the
action was ‗obvious to try‘. The decision being given before KSR, Pfizer furthered a
petition for the re-hearing of the matter which was denied by the Federal Circuit
indicating the decision to be in consonance with the KSR approach.

The case of Takeda Chemical Industries, Ltd. v. Alphapharm Pty.61 deals with the
concept of „obvious to try‟ post-KSR decision. The court considered the validity of claims
relating to the chemical structure of pioglitazone, active ingredient in a diabetes drug. It
was contended that Takeda‘s claims were obvious in light of a prior art compound
referred to as ‗compound b.‘ The Court focused on the Supreme Court‘s requirement in
KSR that the claimed solution needs to be predictable before it can be invalidated on
obvious-to-try grounds and thus upheld the District Court decision of affirming the claim.
The court thus emphasized the lack of predictability in the field of pharmaceutical
chemistry.

59
480 F.3d 1348 (Fed. Cir.2007).
60
Petition for a Writ of Certiorari at 2, Pfizer, 480 F.3d 1348 (No. 2006-1582), 2007 WL
1573945
61
492 F.3d 1350 (Fed. Cir. 2007).
The influence in the area of chemical patents62 can be analyzed through the following
decisions wherein the interpretation of the Courts provides an appropriate base. The
District Court case of Sanofi-Synthelabo v. Apotex63 concerns patentability of
enantiomers. The patent is claimed for drug Plavix, the key pharmaceutical ingredient
being clopidogrel bisulfate, a d-enantiomer. The Court took into account that racemic
compounds may be separated into their enantiomers which may exhibit different or
different degrees of biological activity, proving that no motivation in the prior art was
present. The Court affirmed the claims distinguishing it from Pfizer, wherein the structure
of the product was identified prior to the innovation terming it as a non-finite obvious-to-
try situation.

In Forest v. Ivax,64 the Federal Circuit found that the claimed enantiomers would have
been non-obvious. It was seen that the method used to separate enantiomers was novel,
unpredictable providing no reasonable expectation of success. In the case of Aventis v.
Lupin65 there was a separation of two stereoisomers of ramipril. The Federal Circuit
reversed the District Court judgment as there was ample evidence to prove that there was
motivation in the prior art to resolve the mixture, making the enantiomer prima facie
obvious over the prior art.66

IV. KSR: LOST IN TRANSLATION

The above mentioned decisions were glimpses of the vast impact of the KSR decision
upon the different legal forums. The analysis puts forth that the obvious ruling rate
increased from 0.42 to 0.60 of the CAFC (Court of Appeals for the federal Circuit) cases
decided from 2001 to April 30, 2009, indicating that after KSR, the obvious and non-

62
Monica Bhattacharyya, David Galluzzo, Kasowitz Benson Torres and Friedman LLP
Obviousness of Enantiomers After KSR Law360, New York (March 26, 2009).
63
492 F. Supp. 2d 353, 369 (S.D.N.Y. 2007).
64
501 F.3d 1263 (Fed. Cir. 2007).
65
499 F.3d 1293, 1297-98 (Fed. Cir. 2007).
66
Jonathan M. Spenner Obvious-to-try obviousness of Chemical Enantiomaers in view of
Pre and Post KSR Analysis Journal of the Patent and Trademark Office (Vol. 90, July
2008 pgs 469-540).
obvious ruling rates in CAFC decisions significantly increased and decreased,
respectively while the obvious ruling rate for biotechnology cases was lower.67

Emphasis is to be laid that KSR brought forth the concept of predictability of a claimed
combination or method as a criterion for obviousness. This concept had neither been
mentioned in the previous landmark decisions nor in the rulings relied upon in KSR. One
may argue that this involves a question of semantics wherein the terms ‗expectedness‘
and ‗predictability‘ have been used inter-changeably. However, these terms denote
alternative formulations of the same concept. If it is expected because it is predictable the
threshold for proving unexpected results becomes insurmountable while if it is
unexpected even though it is predictable, it gives rise to an irreconcilable conflict
between the extent of showing of obviousness and an effective rebuttal to it.

The Federal Circuit struck down two patents regarding stem cell technology as obvious,
relying on the Supreme Court‘s non-obviousness requirement in KSR in 2007.68 These
decisions highlight the usage of „invention‟ and „inventor‟ as qualitative standards for
patentability. This approach puts forth the circularity of argument by the Courts that an
‗invention had to involve invention‟. Post-KSR establishing a prima facie case of
obviousness in chemical arts has become easier, hence questions69 regarding the level of
ordinary skill in the art, role of reasonable expectation of success in prior art teachings
and establishment of a prima facie case have arisen which require deliberation to ensure
accurate applicability of the obviousness test.

Moreover, the Federal Circuit decisions show immediate and significant influence of KSR
in pharmaceutical and biotechnology arts. The Federal Circuit‘s opinions in Pfizer and

67
Shyh-Jen Wang The Obviousness Rejection As A Barrier To Biotech Patent
Prosecution Nature Biotechnology 27, 1125 - 1126 (2009).
68
PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007)
(citing KSR, 127 S. Ct. at 1740).
69
Mueller, Janice M., Chemicals, Combinations, and 'Common Sense': How the Supreme
Court's KSR Decision is Changing Federal Circuit Obviousness Determinations in
Pharmaceutical and Biotechnology Cases. Northern Kentucky Law Review, Vol. 35, No.
4, 2008; U. of Pittsburgh Legal Studies Research Paper No. 2008-07.
Takeda illustrate two contrasting applications.70 They indicate that the reasonable
expectation of success for combining or modifying prior art teachings is essential in non-
obviousness analyses. The explicit contradiction is symbolic of the vague interpretation
and uncertainty put forth by the KSR ruling which results in the blindfold application in
different controversies, irrespective of the contrasting circumstances.

The KSR ruling validates the obvious-to-try patentability test in situations involving ‗a
finite number of identified, predictable solutions.‘ Following so, the KSR decision
contradicted the long standing view of the impropriety of the concept of obvious-to-try as
a criterion for obviousness. In the area of pharmaceutical arts an obviousness ruling
requires whether a skilled artisan would have possessed a reasonable expectation of
achieving a successful invention. The predictability is supported by the narrow-minded
view of the Federal Circuit in obvious-to-try jurisprudence, hence as pharmaceuticals
provide unaccountable evidence regarding predictability, making the concept
inappropriate in the area where experimental research leads to innovation.

An important issue is that KSR in essence was a case relating to patenting of mechanical
arts, yet as seen from the myriad post-KSR rulings the inclination of the legal forums is
towards applying the standard of predictability in the areas of biotechnology and
pharmaceuticals. This poses a threat as different arenas which require rationale and
discussion on distinct bases. The applicability of the test is seen keeping in mind the
subject matter of KSR. The role of mechanical-type predictability is minimal in complex
areas of software and biotechnology71 hence the implementation of similar standards
results in injustice to the inventor and the invention itself. A substantive discussion is
essential as unpredictability does not automatically render patentability, though it
becomes an important determinant. Reasoning contradicts the implementation to
technical arts other than mechanical where small incremental differences from prior art

70
Trask, Andrew V., 'Obvious to Try': A Proper Patentability Standard in the
Pharmaceutical Arts? Fordham Law Review, Vol. 76, No. 5.
71
Jeanne C.Fromer, The Layers of Obviousness in Patent Law, Harvard Journal of Law
and Technology, Vol. 22, 2008.
are taken into account, thus inappropriate standards are applied in different spheres of
innovation.

The lack of defined fundamental concepts in the KSR decision strikes at the root of the
ruling. The fact that there exists ambiguity in the extent and usage of market pressure, in
the discussion of the ‗common sense‟ approach rendering it inadequate to address this
complex question of law. Gene patents will be unable to endure an obviousness inquiry
as a common sense approach requires not only the specific claimed sequence being
disclosed in the prior art but also whether identifying the gene would be obvious
considering the present resources and techniques.72 An obviousness inquiry focussed on
the means employed by the inventor instead of the product of the inventive effort proves
to be contrary to § 103 stating that ‗[p]atentability shall not be negatived by the manner in
which the invention was made.‘ It is to be noted that a strict reading of KSR would
revoke patent protection for innovations that are standard in the biotechnology industry,
as illustrated by the Board‟s mechanical application of KSR in Ex parte Kubin.73

V. CONCLUSION

The credit given to the KSR decision in streamlining the vague issue of obviousness with
regard to patents is a myth. The consequences, as seen from the analysis, have
unnecessarily complicated the area of patentability, given rise to numerous interpretations
and have become a dangerous tool in the hands of the legal forums. Further, it has been
taken up as a measure to disregard the pre-KSR case-laws which require to be applied in
other areas of biotechnology and pharmaceuticals wherein principles of mechanical arts
are inappropriate to be implemented.

72
Anna Bartow Laakmann, Restoring the Genetic Commons: A “Common Sense”
Approach to Biotechnology Patents in the Wake of KSR v. Teleflex 14 Mich. Telecomm.
Tech. L. Rev. 43 (2007).
73
Hays R. Biotechnology Obviousness in the Post-Genomic Era: KSR v. Teleflex and In
re Kubin. MINN. J.L. SCI. & TECH. 2009;10(2): 801-835.
The patentability scenario is significantly advancing in the modern times requiring a
detailed process of determining a deserving innovative effort. KSR‟s approach is
inadequate to address the needs of varied modern industries, the highly technical
biological arts in particular. While the Court purported to set forth a generic standard,
broadly applicable to the patentable arts, it crafted a standard that is too narrow and vague
to be of use generally.

Obviousness standards that tolerate the realities of biotechnology research are necessary
to foster continued investment in the industry and dissemination of research data to the
public. Standards that parallel the Federal Circuit‘s pre-KSR biotechnology jurisprudence
would promote the public interest in advancing high-level research while maintaining
reasonable standards for patentability. Taken with PharmaStem, these decisions signal
that the reasonable expectation of success for combining or modifying prior art teachings
is now pivotal in non-obviousness analyses. This not only drives up the already-
staggering legal costs associated with intellectual property protection, it essentially makes
the likelihood of winning effective patent protection even more of a crapshoot. Investors
funding technology R&D endeavors will necessarily be assuming a much higher risk in
funding already high-risk/high-cost projects. Because biotechnology relies heavily on
private funding, conditioned on the probability of profit, KSR could have profound,
negative implications for the ability of biotech to secure adequate financing for its
ambitions. Inventions require research and research requires money ... money requires the
opportunity to earn a profit.

KSR severely diminishes this opportunity, and the trickle-down effect is immediately
evident. Not only will it be more difficult to get a patent issued, but once issued, it carries
much less strength and security--as a challenge on grounds of obviousness will have a
greater likelihood of success. In addition, existing patents may be re-opened for re-
examination, endangering issued patents. Litigation costs associated with defending these
patents could put a stranglehold on the corporations, as a larger percentage of funds will
necessarily be devoted to legal expenses rather than R&D. These initial Federal Circuit
applications of KSR show that its impact extends well beyond merely expanding the
reasons for combining multiple prior art teachings. Contrary to some predictions, KSR is
not limited in application to mechanical combinations. Its impact in the biological and
chemical arts will be equally, if not more, significant. The future intensifies the need of a
strong patent system which takes into account the features of different areas and arts,
keeping in mind that scientific and technological progress shoulders responsibility and
analytical approach.