FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | 1 Obviousness Under 35 U.S.C. §103 in the United...

FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 2

Obviousness Under 35 U.S.C. §103

in the United States

Bruce C. Haas, Esq.


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


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.


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)


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.


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


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


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


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


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


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



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



4. Forest Labs. v. Ivax Pharm, 501 F3d 1263 (Sept. 5, 2007) (Escitalopram Lexapro®) S- or (+) enantiomer


NOT OBVIOUS

– Enantiomers were difficult to separate and unexpected properties were evident



5. Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F3d 1358 (March 31, 2008) (Topiramate anticonvulsive drug)


NOT OBVIOUS

– Record shows powerful unexpected results



6. Sanofi-Synthelabo et al v. Apotex, Inc., 550 F3d 1075 (December 12, 2008 (Plavix®)


NOT OBVIOUS

– Enantiomer separation was complex and enantiomer provided all the favorable activity with no significant toxicity



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)


OBVIOUS

– Prior art disclosed idea of using cryopreserved viable human neonatal or fetal hematopoietic stem cells



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)


NOT OBVIOUS

– Affirmed District Court flexible TSM test as stated in KSR



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)


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


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



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



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


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


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

FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | 1 Obviousness Under 35 U.S.C. §103 in the United...

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