Wannabe Experts

February 13, 2018

In an “Expert Analysis” of the decision of the Federal Circuit in Millennium Pharmaceuticals Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir 2017), entitled “Fed. Circ. Resurrects Hindsight Bias In Post-KSR Word” dated August 23, 20171, the authors severely criticized the Court’s reversal of a district court’s invalidation of U.S. Patent 6,713,446.  The alleged “experts” pronounced (p. 4, last ¶):

In Millennium, the Federal Circuit fell prey to hindsight bias, resuscitating arguments repudiated by the Supreme Court in KSR and by its own subsequent decisions.  The Federal Circuit panel’s opinion [by Judges Newman, Mayer, and O’Malley] in Millennium should be reconsidered by the panel or reheard en banc to conform the decision to the requirements of KSR.

NONSENSE!  The decision in Millennium was well-considered by a panel of experienced Federal Circuit judges that meticulously reviewed all the evidence of record and concluded that the district court’s conclusion of obviousness was erroneous.  Judges Newman and Mayer do not readily fall victim to hindsight and recognize unpatentability when indicated by a preponderance of the evidence.  See In re Gorman, 933 F.2d 982 (Fed. Cir. 1991) (Newman writing); see also In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991) (Mayer dissenting).

Why then are the so-called “experts” confused and mistaken?  They are confused and mistaken because they did not carefully read the Millennium Decision in its entirety and did not consider all the evidence.

The Federal Circuit conceded (Millennium Decision, pp. 11-13):

      Sandoz argues that lyophilization was generally known in formulating pharmaceutical products.  It states that bulking agents were known for use in lyophilization, and that mannitol was a known bulking agent.  All true.  However, the prior art does not teach or suggest that lyophilization of bortezomib in the presence of mannitol would produce a chemical reaction and form a new chemical compound, or that this new compound would solve the previously intractable problems of bortezomib formulation.  Although mannitol was a known bulking agent, and lyophilization was a known method of drug formulation, nothing of record teaches or suggests that a person of ordinary skill should have used mannitol as part of a synthetic reaction to make an ester through lyophilization. . . . Sandoz failed to show that it was obvious to use mannitol to make an ester during lyophilization, or that the ester would solve the problems experienced with bortezomib.

. . . . .

      The sole reason Sandoz provides for choosing mannitol to make a new ester of bortezomib is because mannitol is one of a relatively small number of bulking agents used in lyophilization.  Sandoz provides no reason why a person of ordinary skill in the art who is seeking to make esters of bortezomib would look to lyophilization bulking agents. . . . .

. . . . .

. . . Millennium offered persuasive evidence that chemical modification of bortezomib would have been unattractive to a person of ordinary skill for fear of disturbing the chemical properties whereby bortezomib functions effectively as an anti-cancer agent; in particular, . . . the ester blocks a portion of the bortezomib molecule. . . . .

At page 17 of the Millennium Decision, the Court stated, “No expert testified that they foresaw, or expected, or would have intended, the reaction between bortezomib and mannitol, or that the resulting ester would have the long-sought properties and advantages.”

                  The Millennium Court found no prior art teaching of a reaction between bortezomib and a bulking agent during lyophilization.  The Millennium Court found that inherent properties and benefits in the new ester compound could not have been predicted since the esterification reaction and the resultant new ester compound was not anticipated and reasonably would not have been expected by the prior art.  The new compound and the benefits thereof were not predicted or expected.  The properties and benefits of the new compounds would not have been inherent in, or necessarily attributable to, a mere mixture of bortezomib and mannitol.

Quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007), the Millennium Court stated (Millennium, p. 13):

[I]n determining obviousness, the challenger bears the burden of establishing that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.”

Finally, the Millennium Court added (Millennium, p. 19):

Unexpected results are shown in comparison to what was known, not what was unknown.  See Pfizer, 480 F.3d at 1370-71; see also Kao [Corp. v. Unilever U.S., Inc.], 441 F.3d [963 (Fed. Cir. 2006)] at 970.  Millennium was not required to create the glycerol ester, when the product had not been created in the prior art.

While Judges Newman, Mayer, and O’Malley need no additional help, I’ll throw in the following precedent:

“[I]t remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.”  Takeda Che. Indus., Ltd v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007).

In Takeda Che. Indus., Ltd v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1355-60 (Fed. Cir. 2007), the Federal Circuit acknowledged that the prior art “disclosed a broad selection” of compounds any one of which could have been selected as a lead compound for further investigation.  However, the Court held that the claimed compound was not obvious due to a lack of “adequate support in the prior art” for the change in structure.  Id.  The Court explained, “[I]n order to establish a prima facie case of unpatentability in such instances, a showing that the ‘prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention’ was also required.”  Id., citing In re Jones, 958 F.3d 347, 351 (Fed. Cir. 1992).   

              If one of ordinary skill in the art would have had to select from “numerous possible choices” with the prior art providing “either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” the claimed invention would not have been obvious.  Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 996-97 (Fed. Cir. 2009) (quoting In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988).

We can be grateful that obviousness in Millennium was determined by real experts, not a band of Wannabe experts from Chicago who appear to have been so blinded by their need for speed, criticism, and celebrity that they failed to consider all the evidence and ultimately to reach the correct result.  Do not applaud their folly.  Do not heed their words.  If you do, you will fall into the same trap and denigrate our purpose to “promote the useful arts.”

  1. (https://www.law360.com/ip/articles/956635/fed-circ-resurrects-hindsight-bias-in-post-ksr-world).