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  • Obvious to try and rigid too.

    Posted on August 6th, 2009 Sean 3 comments

    BAYER SCHERING PHARMA AG v. BARR LAB., INC., Civ. No. 2008-1282 (Fed. Cir. Aug. 5, 2009) shows the post- KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) reality of what could happen when a court ignores secondary considerations while trying to make a point about KSR.

    U.S. Patent No. 6,787,531 covers the contractive known as Yasmin®, which is said to be 99+% effective in women.  The differences between the claims and the prior art include the form of the active ingredient (AI).  While the prior art used the normal form of AI, the claims recited the micronized form of AI (i.e., smaller).  Bayer urged that it proceeded against conventional wisdom, because AI isomerizes in acid to an inactive ingredient, and micronized AI would most likely more efficiently isomerize.  Bayer also noted using enteric coatings to combat acid-isomerization would decrease bioavailability of the AI.  Bayer’s formulation unexpectedly does not require an enteric coating, and it is said to be 99+% effective in women.

    The panel majority thought this invention was obvious to try, i.e., obvious.  Without boring you with the details, the majority noted the consistency between In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) and KSR.  Then it concluded that one of ordinary skill in the art would have either micronized AI or used a straw man option.  Having only identified two options, the majority concluded that the invention fits cleanly into the finite-options obviousness of KSR and O’Farrell.  “This is a finite number of identified, predictable solutions.” Slip op. p. 14. 

    Whoa!  What “predictable solution” is the majority referring to?  Just making the forms for the sake of doing it? 

    The “predictable solution” is certainly not achieving the 99+% effectiveness that Bayer targeted and acheived.  That secondary consideration appears in Judge Newman’s strong dissent. 

    So, I ask you, did the majority apply a rigid obviousness test, notwithstanding KSR’s warnings about rigid tests?


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