Comments on inherency in the Millennium decision [ 2017 U.S. App. LEXIS 12702 ]

Dennis Crouch took issue with the inherency portion of the Millennium decision [ 2017 U.S. App. LEXIS 12702 ]:


The easy part of the decision for the district court focused-in on the motivation to combine boronate and mannitol. The district court found that an Adams Patent “pointed directly to mannitol” for the combination. However, according to the Federal Circuit, “the Adams Patent’s fail[s] to mention mannitol.”

In my view, this easy-part is sufficient for the patentee to win, and my preference would be for the court to delete the rest of its muddled opinion – and instead rest its case on the lack of the motivation to combine. The remainder of the decision is somewhat difficult to follow because it jumps back and forth dancing around but never answering the basic question: If the combination would have been obvious to try, would its natural result also be considered obvious? At times, the court appears to agree that obviousness would follow, while other sections of the opinion suggest the compound would not have been obvious since its actual structure was so unexpected.
(...)
On the topic of inherency in particular, the court seems to have simply strung together several loosely related sentences. Take the following pair as an example:

Sandoz argues that although lyophilization in the presence of mannitol produced an unexpected result, the result was “inevitable” and thus “inherent,” and thus not “inventive.” However, invention is not a matter of what the inventor intended when the experiment was performed; obviousness is measured objectively in light of the prior art, as viewed by a person of ordinary skill in the field of the invention . . .

In the end, the reversal makes sense, but the law created is somewhat of a mess.




link: https://patentlyo.com/patent/2017/07/inherent-unexpected-obvious.html

To be clear, from Judge Newman's opinion:


The district court held that the claims were obvious because they were the inherent result of an allegedly obvious process, viz., lyophilizing bortezomib in the presence of the bulking agent mannitol. Millennium argued that a person of ordinary skill would avoid lyophilization in developing a formulation involving bortezomib because "bortezomib was known to be unstable even in the dry state as a freestanding solid compound." Dist. Ct. Op. *6. The court was not persuaded by this argument and instead relied on the testimony of Sandoz's witness, Dr. Repta, to find that, as of the '446 Patent's priority date, lyophilization "was well-known in the field of formulation" and that it was considered an obvious alternative "when a liquid formulation provided limited success." Id.
(...)
the district court held the claims invalid on the ground of obviousness, agreeing with Sandoz that "Millennium conceded as a matter of law that the ester is the 'natural result' of freeze-drying bortezomib with mannitol." Id. at *8. The court reasoned that the "natural result" of a chemical procedure is inherent in the procedure, and thus the product thereof "would have been obvious to a person of ordinary skill," in the words of § 103.

(...)

The district court also clearly erred in its consideration of inherency in the case."A party must . . . meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis." Par Pharm., 773 F.3d at 1195-96. "The mere fact that a certain thing may result from a given set of circumstances is not sufficient" to render the result inherent. In re Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 26 C.C.P.A. 937, 1939 Dec. Comm'r Pat. 327 (CCPA 1939)).

(...)

Sandoz argues that although lyophilization in the presence of mannitol produced an unexpected result, the result was "inevitable" and thus "inherent," and thus not "inventive." Sandoz Br. at 1, 12-17. However, in the case.invention is not a matter of what the inventor intended when the experiment was performed; obviousness is measured objectively in light of the prior art, as viewed by a person of ordinary skill in the field of the invention. "Those charged with determining compliance with 35 U.S.C. § 103 are required to place themselves in the minds of those of ordinary skill in the relevant art at the time the invention was made, to determine whether that which is now plainly at hand would have been obvious at such earlier time." Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985). 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.



Separately, Kevin Noonan wrote:


The opinion suggests that obviousness requires the art to provide a reason for taking the particular experimental route leading to the claimed success, as well as a reasonable expectation of achieving that success. Instances, as here, where the result is unforeseen and serendipitous cannot satisfy these criteria.

As for the purported "inherency" of the outcome relied upon by the District Court in its reasoning, the panel found that the District Court had erred in agreeing with Sandoz that, because the result (the claimed bortezomib-mannitol ester) was "inevitable" it was also inherent, and therefore could not be inventive (in the archaic meaning of that term, i.e. non-obvious). The error stems from the principle that the inventor's intention is not the relevant consideration; it is whether the invention would have been objectively obvious to one of ordinary skill in the art. Here, there was no evidence that anyone "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" and hence the invention was non-obvious.




link: http://www.patentdocs.org/2017/07/millennium-pharmaceuticals-inc-v-sandoz-inc-fed-cir-2017.html


IPBiz notes that obviousness relates to that which is known or reasonably foreseeable. Inherency (in an anticipation context) does NOT require this. In Millennium, the formation of, and the inherent properties of, the bortezomib-mannitol ester were not known or reasonably foreseeable. On these facts, the mere invocation of inherency was legal error.

As pointed out in a 2012 post in IPBiz on In re Daniels:


Appellants are correct insofar as that a retrospective (retroactive or backwards) employment of inherency by the Solicitor is incorrect in a § 103 analysis. Appellants are also correct that employment of inherency is incorrect in a § 103 analysis when it is not known in the art that the inherent part is in fact inherent. Newell, 891 F.2d at 899 quoting In re Spormann, 363 F.2d 444 (C.C.P.A. 1966), (“That which may be inherent is not necessarily known. Obviousness cannot be predicated on what is unknown.”).



See Inherency in an obviousness rejection
See also RIJCKAERT, 9 F.3d 1531

Although one can discuss "objectively obvious," the key analytical point is whether the compound and its properties were known (or reasonably foreseeable).

Also:

http://ipbiz.blogspot.com/2014/12/anticipation-is-not-epitome-of.html