Friday, December 02, 2011

Teva loses rosuvastatin (Crestor) case on 1 Dec 2011

In the case, Teva was in the position of plaintiff-patentee-appellant, suing Astrazeneca for patent infringement and appealing an invalidity determination under 102(g). Ironically, this case about a statin (known by the trademarked name Crestor) was decided the day Lipitor went off-patent.

The factual matter in the case is seen in the following:

It is uncontested that AstraZeneca included crospovidone in the AstraZeneca formulation as a disintegrant, but did not understand crospovidone to have a stabilizing effect. AstraZeneca had been using crosprovidone PRIOR to Teva in the way Teva claimed a formulaton, but AstraZeneca did NOT understand crosprovidone was a stabilizer. The CAFC affirmed the district court that AstraZeneca's prior use was invalidating under 102(g).

**The CAFC did NOT cite to the Supreme Court decision in Peters, 129 U.S. 530, 9 S. Ct. 389 (1889) : That which infringes, if later, would anticipate, if earlier , although they could have, because that is what happened here. AND, Astrazeneca's limited concession of infringement was pivotal to the case, as discussed below. And, as a moral, entities who make "improvements" have to be very careful in suing originators about such improvements, less they get unpleasant surprises, as Teva did.

And, to patent reformers, contemplate how this case would have come out if the relevant dates had been shifted to be squarely under the America Invents Act [AIA].

As to 102(g), the CAFC wrote:

In Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001), a case involving the use of isobutane as a blowing agent to manufacture polyethylene foam, the district court found that the alleged prior artist had “made a product, meeting the limitations of the . . . patents” before the priority dates of the patents and that this earlier “production of foam . . . would invalidate the relevant claims . . . if the other requirements of § 102(g) were met.” Id. at 1339-40. In Dow, there was “undisputed, clear and convincing evidence in the record that [the alleged prior inventor’s] employees immediately appreciated what they had made, and indeed its signifi- cance, when they made isobutane-blown foam . . . . [and] were ‘surprised’ and ‘elated’ at the ease of making the ‘beautiful,’ ‘good’ foam that they made.” Id. at 1341.

In deciding that a prior inventor need not be “the first to appreciate the patentability of the invention,” this court explained that “the date of conception of a prior inventor’s invention is the date the inventor first appreciated the fact of what he made.” Id. In Dow, this court reaffirmed its predecessor court’s holding that “a party who first reduced to practice, but who ‘fail[ed] to recognize that he had produced a new form [of matter] . . . is indica- tive that he never conceived the invention.’” Id. (quoting Heard v. Burton, 333 F.2d 239, 243 (CCPA 1964)). The court likewise reaffirmed that § 102(g) “does not require that [a prior inventor] establish that he recognized the invention in the same terms as those recited in the count [because t]he invention is not the language of the count but the subject matter thereby defined.” Id. (quoting Silvestri v. Grant, 496 F.2d 593, 597, 599 (CCPA 1974)). As Silvestri had explained, “the language of the count is but one way to define the new form and certainly not a unique definition [. . . and a]ny claim they might have written, based on this or other information specific to [the new form] would still define the same subject matter as the count even though in different terms.” 496 F.2d at 601. See also In re Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (“The claimed subject matter is not presumed to change as a function of how one elects to measure it.”); William Shakespeare, Romeo and Juliette act 2, sc. 2 (“[T]hat which we call a rose [b]y any other name would smell as sweet.”).

The CAFC delved into the meaning of conception:

More recently, in Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005), this court again explained that:
Conception . . . requires both (1) the idea of the invention’s structure and (2) possession of an operative method of making it. Thus, with regard to a claimed chemical compound, conception requires that the inventor be able to define the compound so as to distinguish it from other materials, and to describe how to obtain it . . . . [This] require[s] more than unrecognized accidental creation. . . . In other words, conception requires that the inventor appreciate that which he has invented. Id. at 1063 (quotations and citations omitted).

In that case, Invitrogen had invented a mutant reverse transcriptase enzyme with DNA polymerase but no RNase H activity (“RNase H minus reverse transcriptase”). Id. at 1058. Clontech established that scientists using a technique called “random mutagenesis” had previously pre- pared a panel of some 100 mutant genes for reverse transcriptase without knowing at the time where each of the mutant genes had been altered. Id. Later, two of these roughly 100 mutant genes turned out to code for an RNase H minus reverse transcriptase enzyme. Id. As the court explained, “[w]ith unrecognized accidental duplica- tion, the invention exists but remains unrecognized. . . . In the appreciation analysis, the relevant uncertainty relates to the emerging recognition of something new.” Id. at 1064. In vacating the district court’s § 102(g) determination, the court explained that the record did not support the view that the supposed prior inventors actually knew what they had made at the relevant time and that the case therefore fit “squarely within the unrecog- nized, accidental duplication cases.” Id. at 1066.

As to the case itself, the CAFC noted:

Dow, Mycogen Plant Sciences, and Invitrogen are consistent applications of the same rule. To establish prior invention, the party asserting it must prove that it appre- ciated what it had made. The prior inventor does not need to know everything about how or why its invention worked. Nor must it conceive of its invention using the same words as the patentee would later use to claim it. In this light, it is apparent that the district court correctly entered summary judgment.

Teva’s entire argument turns on the the phrase “stabilizing effective amount.” As stated in Invitrogen, this court must resolve questions of priority “using a properly defined invention.” 429 F.3d at 1062. There is no ques- tion that AstraZeneca appreciated that AstraZeneca’s drug contained an “amount” of crospovidone. And because of AstraZeneca’s limited concession of infringement, there is no question that the amount of crospovidone Astra- Zeneca’s drug contained falls within the scope of the asserted claims as defined by the limitation “stabilizing effective amount.”

The crux of the matter:

AstraZeneca had to appreciate that the compound it asserted as its invention was stable and what the compo- nents of this formulation were. There is no question that AstraZeneca had this appreciation. However, Astra- Zeneca did not need to appreciate which component was responsible for the stabilization. Teva effectively asks this court to fault AstraZeneca for not first conceiving of its drug in the same words in which Teva later chose to claim it. This case therefore falls squarely within the holdings of Dow and Silvestri. Because “[t]he invention is not the language of the [claim] but the subject matter thereby defined,” Teva’s argument must fail. Dow, 267 F.3d at 1341 (quoting Silvestri, 496 F.2d at 599).

That is, AstraZeneca had to have the thing in the claim. AstraZeneca did not have to understand how the thing worked.

And Teva's lawyers were out-lawyered here:

Teva’s allegations and AstraZeneca’s limited concession of infringement did that. Thus, while Teva appears to make a “claim construction” argument, it is actually asking this court to hold that AstraZeneca needed to understand its invention in the same terms used in the asserted claims. As explained above, such a holding would directly conflict with the holdings of Dow and Silvestri. Teva’s “claim construction” argument is therefore without merit.


Teva also argues that this case requires us to resolve exactly how, if at all, the doctrine of inherency applies to priority under § 102(g). But this case does not involve a factual dispute about whether or not the prior art includes a certain claim limitation (expressly or inherently). Again, Teva’s allegations and AstraZeneca’s limited concession of infringement took any such dispute off the table. Accordingly, there is no role for this court’s inherency doctrine to play. Teva’s argument is thus unavailing.


Teva argues that if AstraZeneca understood this and did not disclose it, then it necessarily suppressed or concealed its understanding. But Teva’s argument depends on the same premise already rejected above— that AstraZeneca needed to appreciate the stabilizing effect of crospovidone. This argument is therefore without merit for the same reasons.


Note also Jackson Fence v. Peerless Wire Fence, CA6, 1915.


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