2. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 1 Obviousness Under 35 U.S.C. §103 in the United States Bruce C. Haas, Esq.

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

4. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 3 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.

5. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 4 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)

6. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 5 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.

7. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 6 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

8. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 7 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

9. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 8 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

10. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 9 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

11. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 10 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

12. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 11 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

13. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 12 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

14. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 13 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

15. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 14 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

16. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 15 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

17. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 16 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

18. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 17 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

19. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 18 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)

20. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 19 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

21. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 20 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

22. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 21 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

23. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 22 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

24. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 23 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

25. FITZPATRICK, CELLA, HARPER & SCINTO © 2008 | www.fitzpatrickcella.com 24 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