Source: https://www.schwabe.com/newsroom-publications-13202
Timestamp: 2019-04-24 08:08:50+00:00

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Braintree – Another divided panel reverses a claim construction ruling and the resulting motion for summary judgment of infringement, with three different opinions being written.
St. Jude, Dominion and P&G – Denials of petitions for inter partes review were deemed not to be appealable to the Circuit.
Vaillancourt – In another dismissal of an inter partes appeal the Circuit ruled that one who assigned his patent during an inter partes reexamination had no right to appeal the inter partes decision.
The patentee Sanofi prevailed at trial, obtaining a jury verdict of over $16 million. On appeal Glenmark contended that the patent in suit was invalid, that it was entitled to a new trial based on prejudicial jury instructions and on evidence spoliation, and that no damages should be awarded due to lack of standing of the Abbott United States companies. Sanofi defends the judgment and contends the Circuit lacks jurisdiction to entertain the appeal. The panel held that jurisdiction was proper and affirmed the district court's rulings in all respects.
The Tarka® product is a combination of two hypertension medications, trandolapril and verapamil hydrochloride. The product is stated to have significant advantages including improved kidney function and improved blood vessel structure without the need for multiple daily doses. There was evidence that these benefits were not known for prior art hypertension treatments.
The jury found that the claim at issue had not been proved invalid on the ground of obviousness. Glenmark argues that the verdict cannot stand, as a matter of law, on the premise that if a combination of classes of components is already known, all selections within such classes are obvious to try. The contention is that it is irrelevant that the combination is ultimately found to have unpredicted or superior properties if those properties, though unknown in the prior art, could be attributed to one of the prior art components of the combination.
Glenmark argues that the Tarka® product simply substituted one known ACE inhibitor for another. The plaintiffs responded that there were hundreds if not thousands of potential combinations of ACE inhibitors and calcium antagonists in 1986, and that none of the available information pointed directly at the combinations claimed. Plaintiffs also pointed out that nothing in the art suggested the combination of the double-ring trandolapril with verapamil hydrochloride, or suggested that this combination would provide the previously unavailable extended and improved efficacy.
Glenmark argues that it is not controlling whether any double-ring product had previously been evaluated or suggested for combination with calcium antagonists, for all combinations were obvious as a matter of law. The argument is that because the single-ring inhibitors had been tested in combination with calcium antagonists, it was "obvious to try" every combination of effective ACE inhibitor and calcium channel blocker even if the combination is later found to possess unexpected or advantageous properties.
In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), the Court explained that "obvious to try" may apply when "there are a finite number of identified, predictable solutions" to a known problem." When the path has been identified and "leads to the anticipated success, it is likely the product [was derived] not of innovation but of ordinary skill and common sense." The Circuit has elaborated on KSR that the identified path must "present a finite (and small in the context of the art) number of options easily traversed to show obviousness."
The jury could reasonably have relied on the testimony of plaintiffs' expert, that persons skilled in the art in 1986 would not have predicted the longer-lasting hypertension control demonstrated by the double-ring structures of quinapril and trandolapril in combination with calcium antagonists, because of the widespread belief that double-ring inhibitors would not fit the pocket structure of the ACE. According to the panel, the district court's review of the evidence and confirmation of the jury verdict manifests no error of law.
Glenmark contends that the Abbott U.S. companies do not have exclusive licenses and contends that is necessary for entitlement to lost profits and price erosion damages. The district court held that in determining patent and ‎license rights in complex transfers, the standard is whether ‎the evidence as a whole convinces the trier of fact of mutual ‎intent to transfer and vest exclusive rights. Here all entities in the license chain joined in the ‎suit, such that there is no danger of multiple suits for ‎infringement. The panel thus determined there was no error in the district court's rulings on standing.
This opinion was written by Judge Newman, who wrote a spirited dissent in the recent case of Hoffman-La Roche Inc. v. Orchid Chemicals & Pharmaceuticals Ltd., (4/11/2014) on the issue of "obvious to try." In both cases she noted that the standard of "obvious-to-try" requires a limited number of specific alternatives offering a likelihood of success in light of the prior art and common sense. She determined there to be no such showing by the defendant in either case.
The following diagram illustrates the relevant dates for each patent, and shows how the ‘375 patent was filed prior to but issued later than the ‘483 patent. The ‘483 was not filed as a continuation or CIP of the ‘375.
The obviousness-type double patenting doctrine ‎prohibits an inventor from extending his right to ‎exclude ‎through claims in a later-expiring patent that are not patentably distinct from the claims of the ‎inventor's ‎earlier-expiring patent.‎ The prohibition against double patenting is a long- standing doctrine of patent law. It is based on the core principle that, in exchange for a patent, an inventor must fully disclose his invention and promise to permit free use of it at the end of his patent term. Thus, the doctrine of double patenting was primarily designed to prevent such harm by limiting a patentee to one patent term per invention or improvement.
With those principles of double patenting in mind, the panel turned to the question of whether a later-issued patent can serve as a double patenting reference for an earlier-issued patent if the later one expires first. The '375 patent expires on February 27, 2015. Thus, come February 28, 2015, the public should have the right to use the invention claimed in the patent and all obvious variants of that invention. That was the condition upon which the '375 patent was issued to the inventors. But the public will not be free to do so. The '483 patent does not expire until December 27, 2016, and it covers obvious modifications of the invention claimed in the '375 patent. The '483 patent, therefore, extends the inventors' term of exclusivity on obvious variants of the invention claimed in '375 for an additional twenty-two months past the expiration of '375. That plainly violates the public's right to use the invention claimed in the '375 patent and all obvious variants of it after '375 expires.
The majority noted that using the expiration date as a bench-mark in post-Uraguay Round cases of obviousness-type double patenting (that is, those patents whose term is measured from the filing date and not the issue date) preserves the ability of inventors to use a terminal disclaimer of later-expiring patents to create one expiration date for their term of exclusivity over their inventions and obvious variants, "which is tantamount for all practical purposes to having all the claims in one patent." In such a situation, the MPEP instructs that a terminal disclaimer is required for the later of the two applications (which the hypothetical anticipates to have the later expiration date) before that application can issue. Applied to the facts here, a terminal disclaimer would have been required for the ‘483 patent.
Chief Judge Rader dissented, essentially because he thought the change in the term of patents pursuant to the Uruguay Round renders unnecessary the majority's expansion of double patenting doctrine. When the term was measured from the issue date, a patentee could file successive continuations and obtain additional patent term for obvious modifications of its earlier claims where its earlier patents and applications did not qualify as prior art, and perhaps do so ad infinitum. However, when term is measured from the filing date, successive continuations generally do not result in any additional patent term. Thus a primary motivation behind the doctrine — preventing the effective extension of patent term —is largely no longer applicable.
That being said, according to Judge Rader, the doctrine of obviousness-type double patenting is also predicated on a second underlying policy concern—preventing multiple infringement suits by different assignees asserting essentially the same patented invention. However, in cases like the present the '375 patent is subject to a terminal disclaimer with respect to the '483 patent and thus is only enforceable ‎so long as it and the '483 patent are commonly owned. The risk of separate parties suing on the two patents is therefore adequately mitigated.
As a final point, Judge Rader expressed the concern about the interplay between today's decision and the new "first- inventor-to-file" provision of the AIA." Under the AIA's new "first-inventor- to-file" framework, prospective patentees are under tremendous pressure to file their applications early. He expressed concern that today's opinion will have unforeseen consequences in this new race to the Patent Office.
In a divided decision with three different opinions, Judge Probst, writing for the majority, holds that the district court erred in its construction of the claim term "clinically significant electrolyte shifts." The panel therefore reverses the court's construction and vacates summary judgment of infringement. However, the panel affirms the district court's findings that the claims were not anticipated, obvious or indefinite.
After construing several of the terms of the claim, including "purgation" and "clinically significant electrolyte shifts," the district court granted summary judgment of infringement. The case proceeded to bench trial and after a six-day trial the court ruled that Novel had not met its burden of proving invalidity. On appeal, Novel contests the court's construction of the two terms, argues that the court erred when it failed to find the claims anticipated and obvious, and contends that the claim is indefinite under ‎35 USC‎ § 112, ¶ 2‎.
In its discussion of the construction of "purgation" the majority noted that the analytical focus must begin and remain centered on the language of the claims themselves. The asserted claims only require that the compositions induce diarrhea and do not contain language that requires achieving a fully cleansed colon as contended by Novel. Novel also relies upon the term "effective amount" in combination with the fact that the specification contemplates a full cleansing, but the panel notes that the specification does so only in terms of the preferred embodiment. Finally the panel finds that Braintree's statement in the prosecution history that this is a product for "cleansing (i.e., purging)" does not redefine "purgation" as "cleansing." This does not amount to a "clear and unmistakable disavowal" of a broader definition of "purgation" which is what is required for the prosecution history to narrow a claim construction in this fashion. Therefore, the panel affirmed the district court's construction of the term "purgation."
The majority then turned to the district court's motion for summary judgment of infringement. Based upon its construction of "purgation," which the panel affirmed, the district court determined that the generic product infringed. In examining whether summary judgment was appropriate, the panel noted not only that the term "clinically significant electrolyte shifts" was improperly construed but also that the court had improperly construed "patient" to mean "one or more patients." This was significant because it meant that if there was at least one patient to whom the accused product was administered would experience, or has experienced, no ‎clinically significant electrolyte shifts," then infringement was established.‎ The panel found this to be an "absurd" result since such an interpretation would allow a composition to meet the claims even if 99 patients ‎out of ‎100 experienced clinically significant electrolyte shifts, as long as one patient did not.‎ Therefore, the majority instead interpreted "a patient" to mean the general class of persons to whom ‎the patented compositions are directed, i.e., a patient population. According to the majority, this definition of a ‎patient is consistent with the invention that the patentee intended to define and protect. Therefore, the panel concluded that there ‎remains a genuine dispute as to whether the generic product avoids producing any ‎clinically significant electrolyte shifts in a patient population.
In St. Jude, the denial of petition for inter partes review was appealed to the Circuit but was dismissed as lacking jurisdiction. According to the panel, a final decision in an inter partes reexamination may be appealed to the Federal Circuit under 35 USC §141(c) but ‎since 35 USC §314(d) provides that the determination by the Director of the PTO of whether to institute an inter partes review shall be final and unappealable, a motion to dismiss the appeal for lack of jurisdiction was granted. In Dominion and P & G, denials of petitions for inter partes review were the subject of petitions for mandamus, both of which were denied for the same reason.
Appellant Vaillancourt owned the patent in suit but while reexamination proceedings were pending, he assigned the patent to another. The pertinent statute, 35 USC §141, provides that a patent owner in an inter partes reexamination dissatisfied with the final decision may appeal the decision to the Federal Circuit.‎ The statute is unambiguous that this right of appeal is not granted to others so Vaillancourt's appeal was dismissed.

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