Client Alert

What Are the Top Hatch-Waxman and BPCIA Developments for September 2018?

17 Oct 2018

This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between “blocking patents” and objective indicia of nonobviousness.


Supreme Court

Written Description at the Supreme Court?

Amgen, Inc. v. Sanofi (cert. petition)

On September 18, the Supreme Court requested a brief responding to Amgen’s cert. petition. The question presented by Amgen is: “Whether the standard for determining the adequacy of the “written description of the invention” should be as the statute says—that the description must be “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same” — or whether court-created standards should control instead.”

Federal Circuit

District Court Did Not Change Claim Construction

Supernus Pharmaceuticals, Inc. v. TWI Pharmaceuticals, Inc., 09/06/18 (Fed. Cir. No. 2017-2513)  

The Federal Circuit affirmed the district court’s decision that the patents were not invalid and would be infringed. The district court did not improperly give its prior decision in another case involving the same patents de facto preclusive effect: “the district court made express findings based on the record presented in this litigation and relied on [its earlier decision in] Actavis only to the extent that the records were similar or the parties had agreed to be bound by a subsidiary conclusion from Actavis.” The court next agreed that “enhanced” formulations, in the context of the specification, requires both of a combination of solubility and release promoters, turning on the interpretation of “and/or” in the specification. After affirming as to other noninfringement arguments, the court held that the district court did not change its construction of a key term in its post-trial decision when it described a “matrix in which the ingredients or constituents are uniformly dispersed” as containing “no localization of constituents.” That simply “clarified what was already inherent in its construction, as permitted.”

Blocking Patents and Their Effect on Secondary Considerations Are Fact Specific

Acorda Therapeutics, Inc. v. Roxane Laboratories., Inc., 09/10/18 (Fed. Cir. Nos. 2017-2078, 2017-2134)

The Federal Circuit affirmed, over Judge Newman’s dissent, the district court’s decision that the asserted claims were invalid as obvious. The court found that the evidence supported both a reasonable expectation of success and a motivation to combine the prior art teachings. The court rejected what “appears to be [appellant’s argument] that the evidence cannot support a finding of a reasonable expectation of success (in 2004) in the absence of publications showing a statistically significant difference in walking tests between the specific dose of 10 mg 4-AP taken twice daily versus placebo.” But appellant “cited no authority from the Supreme Court or this court requiring as a matter of law, for reasonableness of an expectation of success, testing of specific doses versus placebo that shows the relevant result with statistical significance.”

The court then engaged in a lengthy discussion of the role of “blocking patents” in evaluating objective indicia of non-obviousness, noting that evidence of a blocking patent can discount the significance of objective indicia evidence. “But the magnitude of the diminution in incentive in any context—in particular, whether it was great enough to have actually deterred activity that otherwise would have occurred—is” fact specific, and “challengers always retain the burden of persuasion on obviousness.” After listing a multitude of potential factors that might be considered, it noted that this inquiry may be “difficult ... as a practical matter.” It concluded that, in any “particular case, a court may ultimately be left, for its evaluation, with the solid premise of diminished incentives, plus some evidence (possibly weak or ambiguous) about the significance of the deterrence, together with a background sense of the general realities in the area at issue that can affect the weight to be given to the evidence in the specific case.” Here, the Federal Circuit determined that the district court did not err in considering a blocking patent to be evidence discounting the weight of commercial success, failure of others, and long-felt -need evidence.

66% Improvement in Bioavailability More Than a “Trivial Degree”

Orexo AB v. Actavis Elizabeth LLC, 09/10/18 (Fed. Cir. No. 2017-1333)

The Federal Circuit reversed and remanded the district court’s finding that the asserted claims were invalid as obvious. The record lacked any teaching of using citric acid as a carrier, as in the claimed combination, and the prior art gave “no suggestion that the specified elements should be selected and combined, and that the designated sublingual formulation would be less subject to abuse than prior formulations for substitution therapy.” Recognizing a need to reduce abuse “does not render the solution obvious.” Moreover, the record showed that the claimed combination improved bioavailability by 66%, “more than a trivial ‘degree.’”

District Court

Doctrine of Equivalents and Issue Preclusion

Galderma Laboratories, L.P. v. Amneal Pharmaceuticals, LLC, 08/27/18 (D. Del. C.A. No. 16-207-LPS)

In this ANDA litigation, the court released a heavily redacted version of its opinion. The court held that Galderma was not precluded from alleging infringement under the doctrine of equivalents, and that Amneal infringed certain claims of the asserted “Chang” patents -in -suit under that doctrine. Regarding a second set—the “Ashley” patents—Galderma was collaterally estopped from asserting infringement of two of those patents. The court rejected Galderma’s argument that an earlier case did not present the identical issue because it had not asserted equivalency in that case: “Doctrine of equivalents infringement is one theory of infringement, not a distinct issue itself.” Amneal infringed two other “Ashley” patents under the doctrine. The court also found that Amneal had not met its burden of proving invalidity for lack of enablement, written description, anticipation, obviousness, and indefiniteness.

Court Grants JMOL Overturning Jury Verdict on Induced Infringement and Anticipation

In re Biogen ’755 Patent Litigation, 09/7/18 (D.N.J. Civil Action No.10-2734 (CCC)(MF)(consolidated)

Following a five-week trial, the jury found that patients and doctors had directly infringed the asserted method-of-treatment claims by administering Rebif®; that defendants had contributorily infringed, but had not induced infringement; and that while not invalid as obvious, lacking written description or enablement, the asserted claims were invalid as anticipated. In an opinion released on September 28 (but dated September 7), the court granted Biogen’s motion for JMOL on anticipation and inducement and granted a conditional new trial on those issues. The court also granted a new trial on damages.

Addressing anticipation, the court concluded that, because defendants had failed to present a single prior art reference describing therapeutic use of a recombinant interferon-13 polypeptide made in a non-human host, the jury could not have reasonably found anticipation. Instead, the key prior art disclosed the use of “native” human interferon, not recombinant. Regarding inducement, and particularly in view of the inconsistent verdicts on direct and contributory infringement, “no reasonable jury could have concluded that Pfizer did not intend that Rebif® be used to treat MS through immunomodulation. The court also found that other invalidity defenses raised during litigation, but not at trial, were waived.

Turning to defendants’ motions for JMOL, the court first rejected a patent-eligibility challenge, holding that the method-of-treatment claims were not directed to patent-ineligible subject matter, and that the claims did not concern the performance of “well-understood, routine, [and] conventional activities previously known to the industry.” Substantial evidence supported the jury verdicts on obviousness, enablement, written description, and contributory infringement.

Claim Construction and Disclaimer

Galderma Laboratories L.P. v. Teva Pharmaceuticals USA, Inc., 09/07/18 (D. Del. Civil Action No. 1:17-cv-01783-RGA) – subscription required

The court construed several terms in this ANDA litigation. The term “oily solvent” excluded alcohols or glycols expect for octyl dodecanol, as disclaimed during prosecution. In addition, a first and second “fatty phase” need not be separated in the claimed emulsion. The court also rejected several indefiniteness arguments.

No DJ Jurisdiction: FDA Approval Is “Too Uncertain”

Teva Pharmaceuticals Int’l GMBH v. Eli Lilly and Co., 09/27/18 (D. Mass. Civil Action No. 1:17-cv-12087-ADB)

Lilly filed a BLA for galcanezumab. Teva, relying on “imminent” FDA approval, filed suit. Lilly moved to dismiss for lack of a justiciable controversy. The court granted the motion.

The court agreed that FDA approval was “too uncertain” to support finding sufficient immediacy and reality to warrant the exercise of jurisdiction. The court disagreed with Teva that Hatch-Waxman cases were analogous, concluding that Teva “cannot invoke any statutory relaxation of otherwise-applicable immediacy and reality requirements where no federal statute similarly contemplates litigation upon the filing of a BLA.” While the court noted that “there is no real doubt that Defendant intends to market galcanezumab if it receives FDA approval” and that Lilly had taken steps toward a commercial launch, that evidence was not sufficient to overcome the uncertainty of FDA approval. Finally, even if an actual controversy existed, “exercising jurisdiction in this case would conflict with the carefully calibrated regulatory scheme that Congress has established,” citing the importance of the 271(e) safe harbor.

On the Equivalence of Salts

Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., 09/28/18 (D. Mass. Civil Action No. 15-13099-FDS)

The court addressed defendant’s summary judgment motions. Regarding issue preclusion, questions of fact regarding whether additional limitations in the claims of the patent-in-suit versus those of related patents held invalid in prior litigation barred summary judgment. The court expressed “substantial doubt,” however, that the additional limitations are material to validity. The court also rejected defendant’s motion for summary judgment of no infringement under the doctrine of equivalents as to one patent. The patentee was not barred by prosecution history estoppel from asserting that oxycodone myristate is equivalent to oxycodone hydrochloride; and a genuine issue of disputed material fact exists whether oxycodone myristate performs substantially the same function as that of oxycodone hydrochloride. The court granted summary judgment of no infringement on two other patents, because defendant’s product did not contain an “irritant” as claimed.

The Basic and Novel Properties of the Invention

Prostrakan, Inc. v. Actavis Laboratories UT, Inc., 09/28/18 (E.D. Tex. Civil Action No. 2:16-CV-00044-RWS) – subscription required

Following a bench trial in this ANDA litigation, the court held Actavis’ product infringed and the patent-in-suit was not invalid. The court construed “consisting essentially of” as “including the listed ingredient and open to unlisted ingredients that do not materially affect the basic and novel properties of the invention. After concluding that Actavis’ product, despite containing unlisted ingredients, did not alter the basic and novel properties of the invention, the court analyzed whether any of the unlisted ingredients materially affected the properties of the invention. They did not. The court then rejected defendants’ invalidity arguments.

Regarding enablement, Actavis placed “far too rigid of a definition on the term ‘complete release’” by arguing the term required that 100% of the active ingredient be depleted from the claimed patch. One skilled in the art would have known at the relevant time that no patch underwent complete release. Finally, the court addressed defendants’ inequitable -conduct argument, based on discrepancies between permeation data presented in an example of the patent and plaintiff’s NDA, finding neither materiality nor intent.

And Another DOE Decision

Belcher Pharmaceuticals, LLC v. Hospira, Inc.¸ 09/28/18 (D. Del. C.A. No. 17-775-LPS) – subscription required

The district court denied partial summary judgment of no infringement under the doctrine of equivalents. There was no unmistakeable disavowal of concentrations other than those claimed; applicant’s comments during prosecution were simply clarifying. Amendment to remove the word “approximately” from the claims likewise did not effect a surrender. A genuine issue of material fact—whether the prior art inherently possesses the claimed adrenalone levels—precluded summary judgment that asserting equivalency would ensnare the prior art.



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