Thursday, May 14, 2009

Meet the new obviousness, same as the old obviousness?

Teva, represented by Kenyon & Kenyon, lost its appeal from a decision of Judge Farnan (D. Del.) in Procter & Gamble v. Teva over patents relating to the compound risedronate, the active ingredient of P&G’s osteoporosis drug Actonel®.

The case involved allegations of obviousness. The CAFC wrote:

A party seeking to invalidate a patent based on obviousness
must demonstrate “by clear and convincing evidence 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.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir.
2007). Clear and convincing evidence places in the fact finder “an abiding conviction
that the truth of [the] factual contentions are highly probable.” Colorado v. New Mexico,
467 U.S. 310, 316 (1984) (quotation marks omitted).

Thus, there is invocation of reasonable expectation of success, not merely
"obvious to try."

TSM seems alive and well:

Accordingly, under KSR, “it 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
Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007).

The use of unexpected results arises:

If a patent challenger makes a prima facie showing of obviousness, the owner
may rebut based on “unexpected results” by demonstrating “that the claimed invention
exhibits some superior property or advantage that a person of ordinary skill in the
relevant art would have found surprising or unexpected.” In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995).

The concept of lead compound:

An obviousness argument based on structural similarity between claimed and
prior art compounds “clearly depends on a preliminary finding that one of ordinary skill
in the art would have selected [the prior art compound] as a lead compound.” Takeda,
492 F.3d at 1359; see also Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353,
1359 (Fed. Cir. 2008) (stating that “post-KSR, a prima facie case of obviousness for a
chemical compound still, in general, begins with the reasoned identification of a lead
compound” in the prior art). Teva argues that the ‘406 patent identifies 2-pyr EHDP as
the most promising molecule for the inhibition of bone resorption. The trial court
disagreed and concluded from the evidence that a person of ordinary skill in the art
would not have identified 2-pyr EHDP as a lead compound for the treatment of

Of structural similarities:

The question of obviousness “often turns on the structural similarities and
differences between the claimed compound and the prior art compound[].” Eisai Co.
Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 1356-57 (Fed. Cir. 2008); see also
Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1086 (Fed. Cir. 2008) (“Precedent
establishes the analytical procedure whereby a close structural similarity between a new
chemical compound and prior art compounds is generally deemed to create a prima
facie case of obviousness . . . .”); In re Mayne, 104 F.3d 1339, 1343 (Fed. Cir. 1997)
(“Structural relationships often provide the requisite motivation to modify known
compounds to obtain new compounds.”); In re Payne, 606 F.2d 303, 313-15 (CCPA
1979) (discussing the presumption of obviousness based on close structural similarity).
In this case, risedronate and 2-pyr EHDP are positional isomers; they each contain the
same atoms arranged in different ways.

Of flexible TSM:

“In keeping with the flexible nature of the obviousness inquiry, the
requisite motivation [to modify] can come from any number of sources.” Eisai, 533 F.3d
at 1357 (citation omitted). Thus, in addition to structural similarity between the
compounds, a prima facie case of obviousness may be shown by “adequate support in
the prior art” for the change in structure. In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir.
1985). As we noted in Takeda:
A known compound may suggest its homolog, analog, or isomer because
such compounds often have similar properties and therefore chemists of
ordinary skill would ordinarily contemplate making them to try to obtain
compounds with improved properties. . . . [However,] it 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.

492 F.3d at 1356-57 (citation omitted).

Teva failed TSM:

In light of the Supreme Court’s
instruction in KSR, the Federal Circuit has stated that, “[t]o the extent an art is
unpredictable, as the chemical arts often are, KSR’s focus on [] ‘identified, predictable
solutions’ may present a difficult hurdle because potential solutions are less likely to be
genuinely predictable.” Eisai, 533 F.3d 1353, 1359 (quoting KSR, 127 S. Ct. at 1742).
The district court found that Teva failed to clear that hurdle, establishing insufficient
motivation for a person of ordinary skill to synthesize and test risedronate.

Teva failed "reasonable expectation of success":

Additionally, there was an insufficient showing that a person of ordinary skill in
the art would have had a “reasonable expectation of success” in synthesizing and
testing risedronate. PharmaStem, 491 F.3d at 1360. In KSR, the Supreme Court
stated that when an obvious modification “leads to the anticipated success,” the
invention is likely the product of ordinary skill and is obvious under 35 U.S.C. § 103.
127 S. Ct. at 1742. “[O]bviousness cannot be avoided simply by a showing of some
degree of unpredictability in the art so long as there was a reasonable probability of
success.” Pfizer, 480 F.3d at 1364 (citing In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir.
1985)). Here, the district court’s findings indicate that there was no reasonable
expectation in 1985 that risedronate would be a successful compound.

[Yes, Corkill is quoted.]

Routine testing arises:

Cases following KSR have considered whether a given molecular modification
would have been carried out as part of routine testing. See, e.g., Takeda, 492 F.3d at

When a person of ordinary skill is faced
with “a finite number of identified, predictable solutions” to a problem and pursues “the
known options within his or her technical grasp,” the resulting discovery “is likely the
product not of innovation but of ordinary skill and common sense.” KSR, 127 S. Ct. at
1742. So too, “[g]ranting patent protection to advances that would occur in the ordinary
course without real innovation retards progress.” Id. at 1741. In other cases, though,
researchers can only “vary all parameters or try each of numerous possible choices until
one possibly arrive[s] at a successful result, where the prior art [gives] either no
indication of which parameters [are] critical or no direction as to which of many possible
choices is likely to be successful.” In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988).
In such cases, “courts should not succumb to hindsight claims of obviousness.” In re
Kubin, __ F.3d __, No. 2008-1184, slip op. at 14 (Fed. Cir. Apr. 3, 2009).
patents are not barred just because it was obvious “to explore a new technology or
general approach that seemed to be a promising field of experimentation, where the
prior art gave only general guidance as to the particular form of the claimed invention or
how to achieve it.” In re O’Farrell, 853 F.2d at 903.


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