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Exploring the Latest in Intellectual Property Law
Direct Infringement
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ANDA Filing Alone Insufficient for Induced Infringement of Method Patent

by | Jan 5, 2023 |

The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a drug used to treat idiopathic pulmonary fibrosis (IPF). The Court found that the first set of patents were obvious over the prior art and standard medical practice, while the second set were not directly infringed in light of actual physician prescription practice. Genentech, Inc. v. Sandoz Inc., Case No. 22-1595 (Fed. Cir. Dec. 22, 2022) (Newman, Lourie, Prost, JJ.) (Newman, J., dissenting).

Sandoz submitted two abbreviated new drug applications (ANDAs) for approval to market a generic version of pirfenidone, which Genentech sells under the brand name Esbriet®. Genentech sued Sandoz under the Hatch-Waxman Act, asserting that Sandoz’s generic version would induce infringement of two sets of patents: one directed to modifying dosages of pirfenidone in patients with abnormal liver biomarkers (LFT patents), and the other directed to avoiding adverse interactions in patients also taking fluvoxamine (DDI patents).

The LFT patents are directed to methods of administering pirfenidone to a patient who has exhibited Grade 2 abnormalities in liver function biomarkers alanine transaminase (ALT) and/or aspartate transaminase (AST) in response to pirfenidone. The LFT patents generally recite the following administration options:

  • Temporarily reducing the dose before returning to the full dose
  • Maintaining the full dose
  • Reducing the dose
  • Temporarily discontinuing pirfenidone before returning to the full dose
  • Temporarily discontinuing pirfenidone before returning to a reduced dose.

Sandoz’s proposed label included a “Dosage Modification due to Elevated Liver Enzymes” section, which stated that if a patient exhibits grade 2 elevations of ALT and/or AST, “[t]he full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated.” Genentech argued that these instructions constituted induced infringement of the LFT patents. The district court disagreed and held that the LFT patents were obvious over the prior art and standard medical practice and that the defendant would not induce infringement because the labels “merely described” the infringing uses but did not recommend them.

The DDI patents are directed to methods for avoiding adverse interactions between pirfenidone and fluvoxamine and generally involve the steps of discontinuing fluvoxamine or modifying the dose of pirfenidone and continuing fluvoxamine. Sandoz’s proposed label warned of the adverse interactions between pirfenidone and fluvoxamine and stated that fluvoxamine should be discontinued prior to administering pirfenidone or the dose of pirfenidone should be reduced. Genentech similarly argued that these instructions constituted induced infringement of its DDI patents, but the district court held that there was insufficient evidence for infringement because Genentech had not shown that a patient would actually be prescribed both pirfenidone and fluvoxamine in practice.

Genentech appealed the district court’s holdings with respect to both the LFT and DDI patents.

LFT Patents

The Federal Circuit first observed that “varying doses in response to the occurrence [...]

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Acts Supporting Induced Infringement Allegations Must Occur During Damages Period

by | Apr 14, 2022 |

The US Court of Appeals for the Federal Circuit vacated a damages verdict because the acts supporting the induced infringement finding took place years before the statutory damages period and thus could not support a finding of specific intent to induce infringement. Roche Diagnostics Corporation v. Meso Scale Diagnostics, LLC, Case Nos. 21-1609; -1633 (Fed. Cir. Apr. 8, 2022) (Prost, Taranto, JJ.) (Newman, J., dissenting).

Meso Scale Diagnostics (Meso) was formed in 1995 pursuant to a joint venture agreement between IGEN and Meso Scale Technologies. As part of the agreement, IGEN granted Meso exclusive rights to certain patents. In 1998, Roche acquired Boehringer Mannheim GmbH, an entity that IGEN had previously licensed to develop, use, manufacture and sell ECL assays and instruments in a particular field. As a result of the acquisition, Roche acquired Boehringer’s license rights, including the field-of-use restrictions. In 2003, IGEN and Roche terminated the 1992 agreement and executed a new agreement granting Roche a non-exclusive license to IGEN’s ECL technology in the field of “human patient diagnostics.” As part of the transaction, IGEN transferred its ECL patents to a newly formed company, BioVeris. In 2007, Roche also acquired BioVeris, including the ECL patents. Roche believed the acquisition meant the elimination of the field-of-use restrictions (and hence no patent liability) and began selling its products without regard to those restrictions.

In 2017, Roche sued Meso seeking a declaratory judgment that it did not infringe Meso’s rights arising from the 1995 joint venture license agreement. Meso counterclaimed for infringement. At summary judgment, Roche argued that Meso’s 1995 license didn’t convey the rights Meso asserted. The district court denied Roche’s summary judgment motion, and the parties tried the case to a jury. The jury found that Meso held exclusive license rights to the asserted claims, that Roche directly infringed one patent and induced infringement of two others and that Roche’s infringement was willful. The district court denied Roche’s post-trial motions challenging the infringement verdict and damages award. The district court granted Roche’s motion for judgment as a matter of law (JMOL) on willfulness but denied Meso’s motion to enhance damages. The district court also rendered a non-infringement judgment on three additional patents on the ground that Meso waived compulsory counterclaims. Roche appealed the findings regarding the scope of Meso’s license rights, the induced infringement verdict and the damages award. Meso appealed the district court’s application of the compulsory counterclaim rule.

The Federal Circuit first addressed the scope of Meso’s rights under the 1995 license agreement, which was the only ground on which Roche challenged the direct infringement judgment. The Court found that there was clear testimony from the manager of the joint venture that the work involved in developing the patent that was found to be directly infringed was part of the joint venture. The Court dismissed Roche’s argument that Meso acted in a manner that demonstrated that it had accepted Roche’s rights to the asserted patents, finding that the argument was “made in passing only in a footnote,” [...]

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Federal Circuit Sends iPhone Patent Dispute Back for Third Damages Trial

by | Feb 17, 2022 |

Considering numerous claim construction, infringement and damages issues related to patents allegedly covering Apple’s iPhones 5 and 6 series technology, a panel of the US Court of Appeals for the Federal Circuit determined that the district court should have held a third trial on damages because the plaintiff’s expert improperly treated the asserted patents as key during his analysis of purportedly comparable license agreements. Apple Inc. v. Wi-Lan Inc., Case No. 20-2011 (Fed. Cir.) (Moore, C.J.; Bryson, Prost, JJ.)

This appeal is the latest iteration of a patent dispute between Apple and Wi-Lan that has lasted eight years and included two trials. The two patents at issue are directed to bandwidth technology that allows a “subscriber unit” rather than the “base station” to allocate bandwidth. At issue in the appeal were numerous challenges from both Apple and Wi-Lan.

The Federal Circuit rejected Apple’s challenge to the district court’s construction of “subscriber unit,” which Apple claimed was limited to “customer premises equipment [CPE]” (e.g., home routers). Although Apple pointed to parts of the specification that suggested that a CPE was a subscriber unit, the Court found that no language met the heavy burden of a clear and unmistakable redefinition of “subscriber unit.” That the sole disclosed embodiment was a CPE did not move the needle, as nothing indicated that the embodiment was limiting.

Next, the Federal Circuit affirmed the jury verdict on liability, finding that substantial evidence supported the jury’s determination that the accused iPhones contained a subscriber unit. The Court found that a jury could conclude from expert testimony that an iPhone allocates bandwidth between two separate connections—voice-over-LTE and data.

Because of the appeal, Apple may now be on the hook for additional infringement liability. The district court had granted Apple summary judgment of noninfringement based on a license agreement between Intel (the maker of Apple’s processor chips in the accused products) and Wi-Lan. According to Apple, this agreement gave Intel a license through patent expiry rather than for the license term. The Federal Circuit rejected that reading of the license between Intel and Wi-Lan, instead finding that the license extended only to pre-termination sales, not in perpetuity as Apple claimed.

Finally, the Federal Circuit found that the district court correctly ordered a new trial on damages after the first trial in the case but erred by not ordering the new trial on damages based on expert testimony admitted at the second damages trial. Regarding the first damages trial, the Court rejected Wi-Lan’s challenge to the district court’s determination that Wi-Lan’s damages expert did not appropriately tie his damages opinion to the benefits of the patented technology. With respect to the second damages trial, the Court found that Wi-Lan’s damages expert gave improper testimony because, without tying his opinion to the facts of the case, he stated that the asserted patents were the “key” drivers of the royalty rates in other license agreements he relied upon—licenses that were to a much larger patent portfolio. Without a sound basis in evidence, [...]

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Magazine Reload: Claim Construction Error Requires Reversal and Remand

by | Jan 20, 2022 |

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment ruling based on a claim construction error because nothing in the claims or specification of the asserted patent supported the district court’s overly narrow interpretation of the disputed claim term. Evolusion Concepts, Inc. v. HOC Events, Inc. d/b/a Supertool USA, Case No. 21-1963 (Fed. Cir. Jan. 14, 2021) (Prost, Taranto, Chen, JJ.); Evolusion Concepts, Inc. v. Juggernaut Tactical, Inc., Case No. 21-1987 (Fed. Cir. Jan. 14, 2021) (Fed. Cir. Jan. 14, 2021) (Prost, Taranto, Chen, JJ.).

Evolusion owns a patent directed to a device and method for converting a semi-automatic rifle with a detachable magazine to one with a fixed magazine. A detachable magazine allows a user to fire the weapon until the magazine is depleted, then release the magazine, insert a new magazine and resume firing. In contrast, a fixed magazine can be removed and replaced only by disassembling certain nonmagazine parts of the firearm, which slows the rate of fire. The specification states that firearms with detachable magazines are likely to face increased legal restrictions, noting that bills recently introduced in US Congress would have banned semi-automatic weapons with detachable magazines. The claims of the patents recite, among other limitations, a “magazine catch bar.”

Evolusion sued Juggernaut for infringement. Juggernaut asserted invalidity and noninfringement. The parties cross-moved for summary judgment relating to infringement of the device claims, agreeing that the question of infringement depended entirely on whether the claimed “magazine catch bar” included a factory-installed (OEM) magazine catch bar. The district court concluded that the term “magazine catch bar,” as used in the claims and specification, excluded an OEM magazine catch bar. The court’s conclusion was based primarily on the sentence in the specification that states: “The invention is a permanent fixture added to a semi-automatic firearm by removing the standard OEM magazine catch assembly and installing the invention.” The court reasoned that the “magazine catch bar” of the invention could not be an OEM magazine catch bar since the OEM magazine was one of the components removed to install the invention. Based on the construction, the court concluded that Juggernaut did not literally infringe the patent. The court also found that Juggernaut could not infringe under the doctrine of equivalence because Evolusion had dedicated a factory-installed magazine catch bar to the public by disclosing, but not claiming, this embodiment.

Evolusion also sued Supertool for infringement. When Supertool failed to respond to the complaint, the district court clerk entered a default under Rule 55(a) of the Federal Rules of Civil Procedure. With the requests for relief not yet adjudicated, Evolusion moved for a “default judgment” under Rule 55(b), but the court denied the motion. In its denial, the court, citing its ruling in the Juggernaut case, stated that Evolusion failed to state a viable claim for infringement against Supertool because its products also required reusing the factory-installed magazine catch bar. Evolusion appealed the Juggernaut and Supertool rulings.

The Federal Circuit reversed the noninfringement [...]

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Failing to Address All Reasons for Noninfringement Renders Appeal Moot

by | Oct 14, 2021 |

In deciding whether the district court correctly interpreted various claim terms in four patents related to communication techniques used in computer gaming technology, the US Court of Appeals for the Federal Circuit found that rendering a decision as to the terms for at least two of the patents would be moot. Accordingly, the Federal Circuit affirmed the district court’s grant of summary judgment on noninfringement. Acceleration Bay LLC v. Take-Two Interactive Software (Oct. 4, 2021) (Reyna, J.)

Acceleration Bay is the owner of four unrelated patents that are generally directed to communication techniques associated with computer gaming. In particular, certain of the patents teach that an originating computer sends a message to its neighbors on a broadcast channel using point-to-point connections, and that the neighboring computers then sends the message to only their neighboring connections. This reduces the number of connections that each computer must maintain and improves efficiency in the system.

Acceleration Bay filed a patent infringement suit claiming that Take-Two Interactive Software, a software designer for various video games, including Grand Theft Auto V, NBA 2K15 and NBA 2K16, directly infringed the four asserted patents. As part of the district court proceedings, multiple terms recited in the claims of the four patents were construed. In particular, the court construed the claim term “m-regular” to mean “a state that the network is configured to maintain, where each participant is connected to exactly m neighbor participants.” Additionally, the court effectively embedded this definition of “m-regular” into other construed claim terms, including “fully connected portal computer” and “each participant being connected to three or more other participants.”

After claim construction, the district court granted summary judgment of noninfringement in favor of Take-Two on all asserted patents. In granting summary judgment, the court observed that Take-Two makes software, not computer networks or broadcast channels, and therefore its customers must introduce those elements. As such, direct infringement is inappropriate because multiple entities, not just Take-Two, contribute to the allegedly infringing system. The court rejected Acceleration Bay’s argument under Centrak, Inc. v. Sonitor Techs., Inc. that Take-Two was actually the “final assembler” because it installed the software for its customers. The court additionally identified multiple reasons why the “m-regular” limitation was not met in the accused products, including the fact that Acceleration Bay identified no source code to support its theory. Acceleration Bay appealed.

With respect to two of the four patents on appeal, Take-Two argued that Acceleration Bay’s appeal is moot because it only addressed one of the two reasons the district court granted summary judgment of noninfringement. Specifically, the court granted summary judgment on these two patents because (1) the accused products do not meet the “m-regular” limitation and (2) Acceleration Bay’s “final assembler” theory fails as a matter of law. On appeal, Acceleration Bay addressed only the “final assembler” theory. As such, the Federal Circuit found that a ruling on this issue would not affect the court’s summary judgment ruling, and the appeal of these two patents is [...]

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One for All, and All for One . . . Except When It Comes to Patent License Comparability

by | Sep 30, 2021 |

Examining whether portfolio patent licenses can be sufficiently comparable to a single-patent license for the purposes of supporting a patent damages verdict, a split panel of the US Court of Appeals for the Federal Circuit concluded that, at least without accounting for distinguishing features, the answer is no. Omega Patents, LLC v. CalAmp Corp., Case No. 20-1793 (Fed. Cir., Sept. 14, 2021) (Prost, J.)

The most recent decision was the result of a second jury trial, after the Federal Circuit previously ordered a new trial. At issue in this appeal were certain direct-infringement findings, admission of technical expert testimony and the underlying damages determination. Multiple errors were raised regarding the latter, the most significant of which was the court’s apportionment analysis.

At trial, the jury awarded a royalty of $5 per unit to Omega for CalAmp’s infringement of a single patent that covered multi-vehicle tracking units. On appeal, CalAmp contended that patent damages law required apportionment, and that the evidence was insufficient to support apportionment. Judge Prost, joined by Judge Dyk, agreed, while Judge Hughes dissented in part.

First, the Federal Circuit rejected Omega’s argument that apportionment was unnecessary because all parts of the infringing units were covered by the claims. According to the Court, even where all elements of the infringing unit are claimed, a patentee still must approximate the value of the patented features as compared to the conventional, pre-existing elements. Thus, the jury could not, as a matter of law, merely value the entire unit.

Next, the Federal Circuit held that Omega could not rely on the entire-market-value rule to support its damages verdict. That rule permits a patentee to value the infringement where the patented feature drove demand for the entire product. But on the record here, it was undisputed that other conventional elements contributed to sales of the underlying product. At most, the record indicated that the patent technology was important or helpful—which was insufficient to show that it actually drove sales.

Lastly, Omega contended that its royalty was supported by licensing evidence, which included (1) Omega’s president’s testimony that its policy was to license its entire portfolio for a certain amount regardless of the number of patents included at the time of licensing, and (2) 18 license agreements consummated by Omega, some of which included the patent at issue. For both items, the Federal Circuit found evidence of apportionment lacking. To the first claim (i.e., that Omega would not have hypothetically licensed on a patent-by-patent basis), the Court concluded that crediting such testimony would serve as an end-run around the apportionment requirement because it did not approximate the value of the specific patent at issue. So too with the 18 license agreements, many of which identified a portfolio that included almost 50 additional patents. And although the damages expert identified the portfolio feature as distinguishing, the expert’s failure to explain how to separate out the value of the individually asserted patent was fatal.

In dissent, Judge Hughes would have permitted the conventional, more [...]

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