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Case 1:04-cv-OO940—JJF Document 106 Filed O4/16/2007 Page 1 of 4
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April T6, 2007
BY ELECTRONIC FILING AND HAND DELIVERY
The Honorable Joseph J .. Farnan, Jr,
United States District Court for
the District of Delaware
Federal Building
844 King Street
Wilmington, Delaware 1980l
RE: The Procter & Gamble Campmor v. Teva Plranuuacerrticnls USA, Inc.,
C.A. No.: 04—9¢l0»J.lF
Dear Judge Farnan:
We represent The Procter & Garnhle Company (“P&G”) in the abovecaptioned case and
write to respond to the April 9, 2007 letter to Your Honor (DI. 105} from counsel for Teva
Pharrnaceuticals USA, inc. ("Teva’”) discussing the Federal Circuit’s recent decision in Pfizer,
Inc. v. Apotex, Inc , 2007 US. App. LEXIS 6623 (Fed Cir, Mar. 22, 2007).
Teva would have the Court believe that the Pjizer case signals a change in the burdens of
proof applicable to this suit. lt does not.
Specitically, Teva contends that the Federal Circuit’s decision in Pfizer supports the
assertion made in its post—trial briefs, that, once the alleged infringer presents apr·‘imc1,]?rcie case
of obviousness, the burden of proving rroruobviousness shifts to the patentee. As in its prior
lilings, in its letter, Teva selectively quotes language from the case law, and ignores the overall
holding of the decision. indeed, the Federal Circuit in Pfizer expressly rejected the proposition
that Teva now advances to this Court, stating:
Since we must presume a patent valid, the patent challenger bears
the burden of proving the factual elements of invalidity by clear
and convincing evidence That burden of proofucver shirts to the
patentee to prove validity, The presurnption of validity remains
intact and the burden of proof remains on the challenger
throughout the litigation, and the clear and convincing standard
does not change.
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Case 1 :04-cv-00940-JJF Document 106 Filed O4/16/2007 Page 2 of 4
The Honorable Joseph .l. Farnan
April 16, 2007
Page 2
ld. at *24 (citations omitted and emphasis added). The Federal Circuit went on to say that:
it is true that once a challenger has presented a prima facie case of
invalidity, the patentee has the burden of going forward with
rebuttal evidence But, all that means is that even though a
patentee never must submit evidence to support a conclusion . . .
that a patent remains valid, once a challenger introduces evidence
that might lead to a conclusion of invalidity ~·- what we cali a prima
facie case -~ the patentee would be well advised to introduce
evidence suflicient to rebut that ofthe challenger,
Id. at **25 (citations omitted). The Federal Circuit, however, reiterated that "this requirement
does not in substance shift the burden of persuasion, because the presumption of validity remains
intact and the ultimate burden of proving invalidity remains with the challenger thrauglwur
the litigation? ld at "‘25—26 (citations omitted and emphasis added). Thus, "[t]l1e trial court has
the responsibility to determine whether the challenger has met its burden by clear and convincing
evidence by considering the totality of the evidence, including any rebuttal evidence presented
by the patentee." id at *26 (citation omitted),
Teva would also have the Court believe that, in light of the Federal Circuit’s holding in
Pfzer, the inherent unpredictability of bisphosphonates is irrelevant to the Court’s analysis of
whether or not one of ordinary skill in the art in the 11`liCl—l98US would have had a “reasonable
expectation of success? Again, Teva rnisreads the Federal Circuit’s opinion, which stated
merely that "obviousness cannot be avoided simply by a showing of some degree af
nnpredictabiliijr so long as there was a reasonable expectation of success" and that the
expectation of success “need only be reasonable, not absolute? Irl at *38-39. ln Pjizer, there
was an admitted expectation of success but not a "gua1antee." lei. at "‘“39—40 (tinding that the
Ptizer scientist readily selected the besylate anion with the expectation, but no a guarantee, that it
would, in fact, be successful). In contrast, as was amply demonstrated during the trial in this
matter, in the bisphosphonate context, there was not merely “some degree of unpredictability";
rather, scientists in the mid-1980s (and even in the 1990s) were completely unable to predict
whether one bisphosphonate compound would be effective or safe based upon its structural
similarity to another bisphosphonate compound. See, e g., P&G’s Proposed Findings of Fact
("PFF") (D.l. 99) ill] l90, 198, l99, 203, 207-2l0. Thus, one of ordinary skill inthe art in the
1nid—l980s with knowledge of 2—pyr EHDP and its properties would not have had any
expectation of success, let alone a reasonable one, with respect to risedronate. See, e. g., PFF {lll
4.37-4.39.
Further factual distinctions between this case and the Pfizer case render the outcome in
Pfizer inapplicable here:
• In Pfizer, scientists had to vary only one parameter and tried only seven different
formulations before arriving at the patented formulation. Pjizer, 2007 U.S. App. LEXIS
6623 at *44. As proven at trial in this case, by contrast, when researchers attempted to
identify a bisphosphonate that would achieve a suitable balance of antiresorption and
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Case 1 :04-cv-00940-JJF Document 106 Filed O4/16/2007 Page 3 of 4
The i—Ionorable Joseph J. Farnan
April 16, 2007
Page 3
antimineralization, they examined numerous parameters that could be altered, including
the length ofthe linking chain, substitutions on the pyridyl ring, and substitutions in the
linking chain. See, eg., PFF 246-260, As a result, the P&G inventors and others
working with them made hundreds of different bisphosphonates before stumbling upon
risedronate, See, e g, PFF {lil 172, 229, 231, 375, The Federal Circuit in Pfizer reiterated
that, under such circumstances, there is unlikely to be a reasonable expectation of
success, stating °"to have a reasonable expectation of success, one must be motivated to
do more than merely vary all parameters or try each of numerous possible choices until
one possibly arrived at a successful result, where the prior art gave either no indication of
which parameters were critical or no direction as to which of many possible choices is
likely to be successfui."’ Pfizer, 2007 U.S. App, LEXIS 6623 at *42 (quoting Medicham,
SA. v. Roiabo, SL., 437 F.3d 1157, 1165 (Fed Cir. 2006)).
• The claimed product in Pfizer was merely a different salt of a previously—l·tnown
compound. Pfizer, 2007 U.S. App. LEXIS 6623 at *9~10. In contrast, the invention at
issue in this case is an altogether new chemical entity (“1`~iCE”), risedronate. Indeed, the
Federal Circuit expressly recognized the importance of this distinction to the "reasonable
expectation of success" analysis when it stated, "These type of experiments used by
Ptizerls scientists to verify the physicochemicai characteristics of each salt are not
equivalent to the trial and error procedures often employed to discover rr new compound
where the prior art gave no motivation or suggestion to make the new compound nor a
reasonable expectation of success." Pjfzer, 2007 U.S. App. LEXIS 6623 at *49
(emphasis added).
• The claimed product in Pjizer contained the same active ingredient as the prior art, and,
as a result, there was no difference in the therapeutic effectiveness of the new formulation
as compared to the prior art. Id. at *41, 5i. In contrast, risedronate and the "prior art" 2~
pyr EHDP are not the same active ingredient} And, as the extensive evidence at trial
demonstrated, 2—pyr EHDP and risedronate have vastly different therapeutic properties,
See, e g, PFF 'llil 337, 342, 364, 37l~383. For example, 2-pyr EHDP killed all of the test
animals at the relatively low dose of LO mg P/kg/day, while risedronate showed more
than a 200% increase in bone volume at that dose. See, PFF {lil 335, 336. The
differences in structure thus signiticantly and unexpectedly affect the biological
properties of the compounds.2
' Contrary to Teva’s assertion, P&G most assuredly does dispute that the molecular
structure of risedronate is "almost identical to that of 2-pyr EI-lDi°." While the structures may
appear similar when depicted twowlimensionally on paper, the actual three-dimensional
molecular structures have important differences, which result in significant chemical and
biological differences. See, e g , FFF {lil 434, 435, 437-456.
2 Indeed, the facts of the instant case are more similar to those in Eli Lilly and Company v.
Zenin'1 Goldline Pho1·mczcezrricc1!s, 471 F.3d i369 (Fed. Cir; 2006). Lilly involved a new
(Continued)
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Case 1 :04-cv-00940-JJF Document 106 Filed O4/16/2007 Page 4 of 4
The Honorable Joseph J. Farnan
April 16, .2007
Page 4
In short, "i`eva”s reliance on the Federal Circuit’s decision in Pfizer is misplaced. That
decision only coniirins that the asserted claims of the ‘l22 patent are non—ol:>vious, and that
judgment should he entered for P&G.
Respectfully,
in ( ©l=*=·@p ""'
Frederick L. Cottrell, lil (#2555)
l?LC,l1l/afg
Enclosures
cc: Karen Pascale, Esquire (By Electronic Filing) (By I-land Delivery)
James Galbraith, Esquire (By Telecopy)
Vinita Ferreira, Esquire (By Telecopy)
chemical entity that was a homolog of similar structure to a prior art compound. In that case, the
Federal Circuit stated: "i"his court will not ignore a relevant property of a compound in the
obviousness calculus. When claimed properties differ from the prior art, those differences, if
unexpected and significant, may lead to nonobviousness? Lilly, 471 F.3d at i378 (citations
omitted).
As in Lilly, in the present case, there was nothing in the ‘406 patent to suggest selecting
2—pyr EHDP as the lead compound to modify. In fact, the lethal toxicity ofthe compound
described therein would teach away from selecting 2·—pyr EHDP for modiiication. Sec PFI: iii]
408, 409.
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