Fresh From the Bench: Recent Patent Cases From the Federal Circuit
Sanofi –In her second discussion of the "obvious-to-try" issue in the past two weeks, Judge Newman, this time writing for a unanimous panel, reminded us 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.
Gilead Sciences - A divided panel expands the double patenting doctrine by concluding that a patent that issues after but expires before another patent can qualify as a double patenting reference for the other patent.
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.
Sanofi-Aventis Deutschland GmbH et al. v. Glenmark Pharmaceuticals Inc., USA et al., Fed. Cir. Case 2012-1489 (4/21/2014)
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.
Sanofi contends that because Glenmark filed its notice of appeal before the district court entered a document called "Final Judgment," its appeal was premature and there is no appellate jurisdiction. However, 28 U.S.C. §1292(c)(2) recognizes finality for purposes of appeal although the accounting of damages may not be complete. The court's issuance of an Order closing the case, with provision for an accounting of any additional damages that may accrue if the decision is affirmed on appeal, does not negate finality of a judgment that meets the terms of §1292(c)(2). No magic words are needed to confer final judgment status. Therefore, the judgment was final and ripe for appeal, and the Circuit is properly exercising jurisdiction.
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.
The district court concluded that Glenmark had violated its duty to preserve relevant evidence when litigation is planned or reasonably foreseen. The court denied plaintiffs' motion for default, but instructed the jury that it was permitted to draw an adverse inference that the electronic documents that Glenmark deleted would have been unfavorable.
It was reasonable for the district court to infer that some destroyed emails related to issues for which litigation was expected by Glenmark, and informing the jury of the destruction was not an abuse of discretion. Although the district court declined to impose the sanction of forfeiture, the court was well within its discretion in informing the jury that it may draw an inference that the destroyed documents may have been unfavorable to Glenmark. A new trial on this ground is, according to the panel, not warranted.
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.
Gilead Sciences, Inc et al. v. Natco Pharma Limited et al., Fed. Cir. Case 2013-1418 (4/22/2014)
A divided panel described the issue in this case as follows: Can a patent that issues after but expires before another patent qualify as a double patenting reference for the other patent? The majority concluded that it can and therefore the district court improperly excluded the earlier-filed but later-issued patent as a potential double patenting reference for the later-filed but first-issued patent.
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 '375 and '483 patents were issued to the same inventors and are commonly owned by Gilead. The inventions disclosed in both patents are related to the inhibition of viruses through selective interference with certain enzymes. The written descriptions of the patents are very similar. Despite their similarities, however, the patents are not part of the same family and were not before the same patent examiner. After the '483 patent issued, Gilead filed a terminal disclaimer in the application that led to the '375 patent. Through it, Gilead disclaimed any portion of the '375 patent term that extended beyond the expiration date of the '483 patent—which, absent abandonment, would not occur since, as explained above, the '375 patent's expiration date is before the '483 patent's expiration date. No terminal disclaimer was filed for the '483 patent.
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.
Braintree Laboratories, Inc. v. Novel Laboratories, Inc., Fed. Cir. Case 2913-1438 (4/22/2014)
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.
This action was initiated by Braintree after Novel filed an ANDA application to introduce a generic version of Braintree's colon cleansing kit used for colonoscopy preparation. The representative claim provides:
A composition for inducing purgation of the colon of a patient, the composition comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.
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 district court construed "clinically significant electrolyte shifts" to be "alterations in blood chemistry that are both outside the normal upper or lower limits of their range and accompanied by or manifested as other untoward effects." On appeal, Novel argues that in requiring both alterations in blood chemistry and other untoward effects, the district court ignored the inventor's clear definition of the term "clinically significant electrolyte shifts" in the specification. ("The terms ‘clinically significant' as used herein are meant to convey alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other untoward effects."). In defending the district court's final construction, Braintree argues that the preferred embodiment— referred to as Solution D in the '149 patent—caused alterations in some patients' blood chemistry, but those alterations were found to be "clinically insignificant." Thus, according to Braintree, the definition found in the specification would exclude Solution D, which is the preferred embodiment in the '149 patent. And "[a] claim construction that excludes the preferred embodiment ‘is rarely, if ever, correct." The majority disagreed, noting that the patentee's lexicography must govern the claim construction analysis. Therefore the panel reversed the district court's claim construction and construed "clinically significant electrolyte shifts" to be "alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other untoward effects."
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.
As to Novel's contention that the claims are anticipated, the panel noted that anticipation is a question of fact, and the district court's findings on this issue are reviewed for clear error. The panel agreed with the court that Novel had not met its burden of proving anticipation by clear and convincing evidence. With respect to obviousness, the review is de novo based on the Graham v. Deere underlying factual findings. The panel agreed with the district court that Novel had not proven that one of ordinary skill in the art would have been motivated to combine the many references relied upon by Novel to demonstrate obviousness. As to indefiniteness, the panel stated the standard of review to be de novo. The district court construed "purgation" to mean "an evacuation of a copious amount of stool from the bowels after oral administration of the solution," and this definition was affirmed by the panel. The issue raised by Novel is whether one with skill in the art would have understood what is meant by "copious." The panel was not persuaded that the term is indefinite in this context. According to the panel, descriptive words like "copious" are commonly used in patent claims, to "avoid a strict numerical boundary to the specified parameter." Further, when asked what copious would mean to one of skill in the art, Braintree's expert witness stated "[w]ell, copious is a lot. . . . I think anyone who has taken a bowel prep prior to [a] colonoscopy, knows that it's quite a bit of diarrhea that comes out." The panel therefore concluded that one of skill would understand what a "copious" amount of diarrhea is in this context.
In a partially concurring and partially dissenting opinion, Judge Dyk disagreed as to the interpretation of the ANDA disclosure and felt that Novel had demonstrated noninfringement as a matter of law. He nonetheless joined the remand for further proceedings on that issue. Judge Moore joined the majority except as to majority's determination that "a patient" requires multiple patients, a patient population, or a patient claims. The plain language dictates otherwise. She therefore would affirm the district court's summary judgment of infringement because undisputed evidence shows that at least one patient who was treated with the accused composition has experienced "clinically significant electrolyte shifts" within the meaning of the claims.
St. Jude Medical Cardiology Division, Inc., v Volcano Corporation, Fed. Cir. Case 2014-1183 (4/24/2014); In re Dominion Dealer Solutions, LLC, Fed. Cir. Misc. Docket 109 (4/24/2014); In re the Proctor & Gamble Company, Fed. Cir. Docket 121 (4/24/2014)
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.
Vaillancourt v. Becton Dickinson & Co., Fed. Cir Case 2013-1408 (4/24/2014)
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.