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Exploring the latest in intellectual property law
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Exploring the latest in intellectual property law
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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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Induced Infringement Finding May Support Willfulness Finding

by | Oct 7, 2021 |

In a redux visit, the US Court of Appeals for the Federal Circuit found that the record compelled reversal of a district court’s refusal to reinstate a jury’s willful infringement verdict and enhanced damages award but affirmed an attorneys’ fees award, taking into account the finding of willful infringement. SRI International, Inc. v Cisco Systems, Inc., Case Nos. 20-1685; -1704 (Fed. Cir. Sept. 28, 2021) (Stoll, J.)

This is the second appeal in the case. In the first appeal, the Federal Circuit found that the record was insufficient to establish that Cisco’s conduct before May 2012 (when Cisco became aware of the asserted patents) rose to the level of wanton, malicious and bad faith behavior required for willful infringement. In view of the finding, the Court concluded that Cisco could not have willfully infringed and therefore vacated the district court’s enhancement of damages for pre-May 2012 conduct. As for post-2012 conduct, the Court remanded the case to the district court to decide in the first instance whether the jury’s finding of willful infringement after May 8, 2012, (the date Cisco received notice) was supported by substantial evidence. The Court also vacated the district court’s decision to award SRI its attorneys’ fees and remanded for recalculation. On remand, the district court interpreted the original Federal Circuit opinion as requiring a more stringent standard willful infringement and concluded that substantial evidence did not support the jury verdict of willful infringement after May 8, 2012. SRI appealed.

In the second appeal, the Federal Circuit determined whether the record demonstrated that substantial evidence supported the jury’s verdict of willful infringement after May 2021. In analyzing willful infringement, the Court reviewed the instructions provided to the jury on induced infringement:

“Defendant is liable for active inducement only if plaintiff proves by a preponderance of the evidence” that, among other things, (1) “Defendant took some action intending to encourage or instruct its customers to perform acts that you, the jury, find would directly infringe”; and (2) “Defendant was aware of the asserted patents at the time of the alleged conduct and knew that its customer’s acts (if taken) would constitute infringement of an asserted patent.”

The Federal Circuit found that the jury considered the evidence provided by SRI in view of the instructions on induced infringement and that Cisco induced infringement of the asserted claims. Acknowledging that the standard for induced infringement is different than that for willful infringement, the Court nevertheless found that the jury’s unchallenged finding related to induced infringement (i.e., Cisco did not challenge the jury’s findings on appeal) and, combined with Cisco’s lack of reasonable defenses to infringement, was sufficient to support the jury’s verdict of post-2012 willful infringement. Since Cisco was found to have willfully infringed on the asserted patents, the Court determined that SRI was entitled to enhanced damages.



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Federal Circuit to WD Tex.: Denial of Transfer Motion was Clear Error, Abuse of Discretion

by | Oct 7, 2021 |

For the third time in as many months, the US Court of Appeals for the Federal Circuit found clear error in the US District Court for the Western District of Texas’s denial of a defendant’s motion to transfer venue. In re Juniper Networks, Inc., Case No. 21-160 (Fed. Cir. Sept. 24, 2021) (per curiam).

WSOU Investments d/b/a Brazos Licensing filed seven complaints against Juniper Networks in the Western District of Texas for infringement of seven different patents. Juniper, a Delaware corporation headquartered in Sunnyvale, California, moved the district court to transfer the case to the Northern District of California pursuant to 28 U.S.C. § 1404(a). Juniper pointed out that Brazos is a self-described patent assertion entity that does not conduct any business other than asserting patents and argued that “whatever ties Brazos has to this District appear to have been created for the purpose of its patent litigation activities in this District.” Additionally, two of Brazos’s officers, its CEO and its president, reside in California. Juniper argued that the Northern District of California was a clearly more convenient forum, noting that potential key witnesses were located in the Northern District of California. Juniper also asserted that the accused products were designed, developed, marketed and sold primarily from its Sunnyvale headquarters. While acknowledging that six of the actions could have been brought in the Northern District of California, the district court denied Juniper’s motion to transfer based on its analysis of the four private interest and four public interest factors. Juniper petitioned the Federal Circuit for writ of mandamus directing the district court to transfer the six cases.

Applying Fifth Circuit law, the Federal Circuit noted that a motion to transfer under § 1404(a) should be granted if “the movant demonstrates that the transferee venue is clearly more convenient.” The Court noted that district courts enjoy broad discretion in transfer determinations, but that it has routinely issued mandamus when a district court’s denial of a motion to transfer amounts to clear abuse of discretion.

The Federal Circuit explained that the “single most important factor” in transfer analysis is the relative convenience and cost of attendance for witnesses. Juniper identified 11 potential witnesses, all of whom were located in the Northern District of California, while Brazos only identified one Texas-based employee as a potential witness. The district court found that this only weighed slightly in favor of transfer, assigning “little weight” to both party and prior art witnesses and concluding that many of the witnesses were “unlikely to testify.” The Court disagreed, holding that the district court clearly erred in not giving sufficient weight to this factor in light of the “striking imbalance” in the parties’ 11-to-one listing of potential witnesses. The Court noted that it previously rejected both of the arguments used by the district court to discount the weight applied to Juniper’s witnesses. In August 2021, the Court held in In re Hulu, LLC that the district court’s discounting of party and prior art witnesses was “untethered [...]

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Only One More Ratification Needed: European UPC Might Be Ready to Launch

by | Oct 7, 2021 | ,

The German parliament recently passed the Approval Act (the Act) regarding the planned European Unified Patent Court (UPC) and the protocol on a UPC on provisional application (PPA). The Act was passed after Germany’s Federal Constitutional Court rejected applications for a preliminary injunction directed against the Act. The instrument of Germany’s ratification of the PPA (not of the UPC Agreement (UPCA)) has been deposited with the European Council. The UPC Preparatory Committee published a report calling Germany’s ratification “a decisive step on the establishment of the Unified Patent Court after the work has been on hold for several years during the examination of the Agreement by the German Federal Constitutional Court.”

The PPA will only come into effect after at least 13 EU Member States (which must include Germany, Italy and France, i.e., the three Member States in which the most European Patents were in effect in 2012) ratify the PPA and deposit their respective instrument with the European Council. The PPA must also ratify the UPCA (or at least have parliament’s approval to do so) and deposit this second instrument with the European Council. In this complex scheme, the German ratification was previously the main legal hurdle.

Now, after publication of Slovenia’s Approval Act in its National Law Gazette and the expected deposit of its PPA and UPCA instruments, only one more national ratification and instrument deposit is needed to reach the required 13 ratifications. According to a note published by the Presidency of the Council of the European Union on September 24, 2021, Austria is likely to move next, whereupon the project will reach the minimum number of ratifying Member States. The Austrian Government submitted a draft for an approval act to its parliament in July 2021 and expects approval.

Upon the complete ratification of the UPCA and PPA, the UPC will form on a provisional basis and commence its existence as a legal entity. The UPC Preparatory Committee (Committee) can then formally start its work. Although there is no timeline set for the initial provisional application stage, the Committee expects that stage to continue for approximately six to 10 months following ratification. As stated in the note by the Presidency of the Council, this stage includes the adoption of the secondary legislation of the UPC, including procedures, establishment of a budget, recruitment of judges and administrative stuff, election of a president, the final configuration and testing of the file management system and ensuring that all IT infrastructure is properly set up and secured. In addition, a working agreement with the European Patent Office (EPO) on patent application and patent validation remains to be completed. Many observers regard the timeline to complete preparations as challenging, noting that several of the above points will likely require significant discussion. With these issues in mind, the Competitive Council (Council) met on September 29, 2021, to discuss further actions regarding the preparations and to invite ministers to inform the Council of recent or upcoming developments in [...]

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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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Fifth Circuit Affirms Jury Verdict on Willing Licensee FRAND Commitment

by and | Sep 30, 2021 |

The US Court of Appeals for the Fifth Circuit affirmed a jury verdict finding that a standard essential patent (SEP) owner did not breach its commitment to license its SEPs on fair, reasonable and non-discriminatory (FRAND) terms. The ruling establishes not only that willing licensee disputes can be subject to jury adjudication, but also that in willing licensee disputes, traditional patent damages factors such as apportionment are not required, since willing licensee disputes are based in contract law rather than patent law. HTC Corp. et al. v. Telefonaktiebolaget LM Ericsson et al., Case No. 19-40566 (5th Cir. Aug. 31, 2021) (Elrod, J.) The panel concluded that the district court properly instructed the jury on the meaning of FRAND and did not err in granting a post-trial declaratory judgment in the SEP owner’s favor.

Ericsson holds patents that are essential to the 2G, 3G, 4G and WLAN wireless communication standards and made a commitment to the European Telecommunications Standards Institute (ETSI) to license those SEPs on FRAND terms. In order to minimize the risk of anticompetitive behavior, standards setting organizations such as ETSI may exclude patented technology from their standards if an SEP holder does not commit to license the patent on FRAND terms.

HTC makes smartphones that implement Ericsson’s SEPs. In 2016, Ericsson and HTC were engaged in negotiations to renew their third licensing agreement. Negotiations broke down, and HTC filed a lawsuit alleging that Ericsson breached its commitment to provide a license on FRAND terms. HTC argued that Ericsson’s royalty rate should be based on the smallest salable patent-practicing unit (SSPPU) of HTC’s smartphones—specifically, the baseband processor component—rather than the net sales price of the entire end-user device. Ericsson counterclaimed for a declaration that it had complied with its FRAND obligation. Ericsson argued that its offer to HTC was fair and reasonable because its licenses to other similarly situated device makers were also based on the value of the end-user product, not just the smallest salable unit. After an earlier Fifth Circuit decision (applying French law) determined that the ETSI intellectual property rights policy contained no express language requiring SEP holders to base royalties on the SSPPU. The Court also noted that the prevailing industry standard has been to base FRAND licenses on the end-user device. Thus, a “reasonable person” would not interpret Ericsson’s FRAND commitment to mean that it must base its SEP royalties on the SSPPU.

The case proceeded to trial, and a Texas jury found that Ericsson did not breach its FRAND commitment. The district court also granted a declaratory judgment in Ericsson’s favor following trial, concluding that Ericsson’s offers were FRAND. HTC appealed to the Fifth Circuit, challenging the district court’s exclusion of several of its proposed jury instructions and the declaratory judgment in Ericsson’s favor. At trial, the district court had instructed the jury that whether a license is FRAND “will depend on the totality of the particular facts and circumstances,” and that “there is no fixed or required methodology for setting or calculating [...]

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Discretion to Authorize Hague Alternative Service on Foreign Defendant—it’s All About Time and Cost

by | Sep 23, 2021 |

The US Court of Appeals for the Federal Circuit denied a petition for a writ of mandamus, directing the US District Court for the Western District of Texas to dismiss multiple infringement actions for insufficient service of process and lack of personal jurisdiction where the plaintiff used alternative methods to effect service of process on a foreign defendant instead of the more conventional Hague Convention. Although the Court expressed reservations about the district court’s authorization of alternative service methods solely because of the Hague Convention’s slower and more expensive procedures, it found the decision to be within the district court’s discretion. In re: OnePlus Tech. (Shenzhen) Co., Ltd., Case No. 21-165 (Fed. Cir. Sept. 10, 2021) (non-precedential) (per curiam).

OnePlus is a Chinese consumer electronics manufacturing company. WSOU Investments d/b/a Brazos Licensing and Development is a non-practicing entity headquartered in Texas. Brazos filed five patent infringement actions against OnePlus and alleged that OnePlus had no place of business or employees in the United States. Although the People’s Republic of China is a signatory to the Hague Convention, Brazos decided not to attempt service on OnePlus by invoking the Hague Convention because of the burdens involved. Instead, Brazos requested that the district court grant leave under Fed. R. of Civ. Pro. 4(f)(3) to use alternative methods to effect service. Brazos made no showing that service under the Hague Convention had been tried and failed, would have been unlikely to succeed or was otherwise impracticable. The district court regarded the Hague Convention procedure as slow and expensive and granted the motion. Brazos served the complaint and summons on lawyers who represented OnePlus in the past and on OnePlus’s authorized agent for service in California.

OnePlus made a special appearance to challenge the sufficiency of the service and the district court’s jurisdiction over OnePlus. The district court rejected the challenge on the basis that Rule 4(f)(3) gave it discretion to order service on a foreign defendant by means other than those prescribed by the Hague Convention, and that the service was effective to grant the district court personal jurisdiction over OnePlus. OnePlus sought mandamus.

OnePlus’s mandamus petition requested that the Federal Circuit compel the district court to vacate its order authorizing alternative service and require that Brazos effect service pursuant to Hague Convention procedures. OnePlus argued that:

  • Brazos’s service was ineffective because it did not satisfy Texas state law.
  • As a result of the ineffective service, the district court lacked personal jurisdiction over OnePlus.
  • It was an abuse of discretion for the district court to authorize alternative service absent showing of a need to forego Hague Convention procedures.

OnePlus argued that the district court had jurisdiction over it only if OnePlus was subject to jurisdiction in Texas under the Texas long-arm statute. Because valid service under Texas law required the transmittal of documents abroad and triggered the Hague Convention (which Brazos did not use), OnePlus contended that there was no valid service and the district court therefore lacked personal jurisdiction over [...]

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Federal Circuit: Contractual Arbitration Agreements Don’t Bind PTAB Institution Decisions

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit issued an order declining to intervene in inter partes review (IPR) institution decisions by the Patent Trial & Appeal Board (PTAB) and further denied a writ of mandamus to stay the PTAB’s IPR institution pending contractually required arbitration of the dispute between MaxPower and ROHM Japan. In re: MAXPOWER SEMICONDUCTOR, INC., Case No. 21-146 (Fed. Cir. Sept. 8, 2021) (Reyna, J.) (O’Malley, J., concurring in part and dissenting in part).

MaxPower owned patents directed to silicon transistor technology and licensed the patents to ROHM Japan. The license agreement contained an arbitration clause that applied to any disputes arising from or related to it—including patent validity. A dispute arose between the parties as to whether the patents covered certain silicon carbide transistor ROHM products. After MaxPower notified ROHM that it was initiating arbitration under the terms of their license agreement, ROHM challenged the validity of four MaxPower patents at the PTAB, which granted ROHM’s petitions to institute IPRs for the four challenged patents.

MaxPower appealed the PTAB’s institution decision to the Federal Circuit and sought a writ of mandamus to stay or terminate the IPR proceedings without prejudice to later institution if an arbitrator decided that IPR proceedings were appropriate.

The Federal Circuit held that the PTAB’s decision to institute IPR is non-appealable under 35 U.S.C. §314(d), which plainly “confirms the unavailability of jurisdiction” for the Court to hear direct appeals. The Court also found that MaxPower failed to meet the criteria necessary to invoke the collateral order doctrine, which allows appeals from interlocutory rulings if they decide an issue “separate from the merits of the case” that would not be reviewable after final judgment. The Court noted that MaxPower could still raise its arbitration-related challenges after the PTAB issued its final written decisions in these cases.

The Federal Circuit also rejected arguments that the appeals were authorized under 9 U.S.C. § 16(a)(1) and that MaxPower failed to show that its mandamus petition was not “merely a ‘means of avoiding the statutory prohibition on appellate review of agency institution decisions,’” citing the Court’s 2018 decision in In re Power Integrations.

Since the PTAB is not bound by private contracts enforcing arbitration agreements between parties, the Federal Circuit ruled that MaxPower had failed to show that the PTAB’s institution decisions in this case “clearly and indisputably exceeded its authority,” also stating that 35 U.S.C. § 294 does not authorize the PTAB to enforce private arbitration agreements.

In a partial dissent, Judge Kathleen O’Malley argued that the majority decision casts “a shadow over all agreements to arbitrate patent validity” and goes against strong federal policy in favor of enforcing arbitration agreements. While concurring with the majority that the PTAB’s IPR institution decisions are not appealable, Judge O’Malley stated that the case “provides exactly the sort of extraordinary circumstances under which mandamus review is appropriate” in what she called an important issue of first impression. The Supreme Court of the United States has held that [...]

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Notice Under § 287 Means Knowledge of Infringement, Not Knowledge of Patent

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit reversed a district court’s finding of liability for infringement that occurred prior to the filing of the action, explaining that notwithstanding the defendant’ admission that it was aware of the asserted patent, the actual notice requirement of § 287(a) is only satisfied when the recipient is informed of the identity of the patent and the activity that is believed to be an infringement. Lubby Holdings LLC v. Chung, Case No. 19-2286 (Fed. Cir. Sept. 1, 2021) (Dyk, J.) (Newman, J., dissenting in part).

Lubby Holdings sued Henry Chung for infringement of its patent relating to leak-resistant vaping products. Lubby sought damages for alleged pre-filing sales based on alleged compliance with the marking requirement of § 287. Chung raised the issue of whether Lubby’s products were properly marked as required by § 287(a), pointing to one of Lubby’s products as an example. At trial, Chung moved for judgment as a matter of law (JMOL) under Fed. R. Civ. Pro. 50(a), arguing that Lubby did not meet its burden to show that it complied with the § 287 marking requirement. The jury ultimately found Chung liable for direct infringement and awarded Lubby almost $900,000. Chung renewed his motion for JMOL under Rule 50(b) and moved for a new trial under Rule 59(a). After both motions were denied, Chung appealed.

Chung argued that there was no evidence that Lubby complied with the marking or notice requirements of § 287. Lubby argued that Chung did not meet his initial burden to point to products that were sold unmarked.

The Federal Circuit explained that under § 287(a), a patentee must properly mark its articles that practice its own invention, or the patentee is not entitled to damages for patent infringement that occurred before “actual notice” was given to an alleged infringer. The Court noted that once Chung met the “low bar” burden bar under Artic Cat to “articulate the products he believed were unmarked patented articles, the burden of proving compliance with the marking requirement is on the patentee.” The Court explained that Chung met this burden by specifically pointing to Lubby’s J-Pen Starter Kit. The Court continued that the burden shifted to Lubby, and Lubby failed to present any evidence that its products were properly marked or that its products did not practice its invention. As a result, Lubby could only recover damages for the period after Chung was provided with “actual notice.”

The Federal Circuit explained that actual notice under § 287(a) requires that the recipient be informed “of the identity of the patent and the activity that is believe to be an infringement, accompanied by a proposal to abate the infringement.” The Court further explained that it is irrelevant whether the defendant knew of the patent or knew of its own infringement. As applied to this case, the Court found that it was not relevant that Lubby told Chung that he could not use the patented technology, or that Chung [...]

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Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent, sufficient evidence for a finding of inequitable conduct. Belcher Pharmaceuticals, LLC v. Hospira, Inc., Case No. 20-1799 (Fed. Cir. Sept. 1, 2021) (Reyna, J.)

The patent in issue relates to injectable formulations of l-epinephrine. Epinephrine is a hormone that has been on the market since approximately 1938 and is used for a variety of medical purposes. It is also known that l-epinephrine degrades into a more potent isomer known as d-epinephrine. L-epinephrine also degrades into an impurity known as adrenalone through a process called oxidation.

In 2012, Belcher first submitted a New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based, meaning that Belcher did not perform any clinical or non-clinical studies on its epinephrine formulation to support its application. Among the materials submitted to the FDA was an article by Stepensky et al to support its statement that “racemization of the enantiomerically pure L-Epinephrine isomer in injectable formulations of epinephrine is a well-known process.” It also submitted data from Swiss pharmaceutical company Sintetica SA’s formulation that had a pH range of 3.1 – 3.3 and undetectable levels of adrenalone. Ultimately, Belcher pursued a formulation with a similar pH range of 2.8 – 3.3.

In 2014, Belcher filed a patent application that was ultimately issued as the asserted patent. The patent taught that increasing the in-process pH to 2.8 – 3.3 unexpectedly reduced the racemization of l-epinephrine to d-epinephrine at release by approximately two thirds. The asserted claims covered pharmaceutical epinephrine formulations having a pH between 2.8 – 3.3 and certain concentrations of l-epinephrine, d-epinephrine and adrenalone at the time of release and 12 months later.

The prosecution of the application involved a single office action in which the pending claims were rejected in view of Helenek. The examiner explained that Helenek taught 1 mg/ml of epinephrine injection that, among other things, had a pH range of 2.2 – 5.0. Belcher overcame this rejection by arguing that Helenek did not render obvious the claimed range of 2.8 – 3.3 because the claimed range was unexpectedly found to be critical to reduce racemization of l-epinephrine.

Hospiria also submitted an NDA seeking approval of an injectable l-epinephrine formulation, which included a certification under 21 U.S.C. § 355(b)(2)(A)(iv)(Paragraph IV) that the asserted patent’s claims were invalid, unenforceable and/or not infringed by Hospira’s NDA product. Belcher subsequently sued Hospira for patent infringement.

During trial, Darren Rubin, Belcher’s Chief Science Officer, testified that in his role at Belcher, he was involved in the drafting and development of the NDA and in the prosecution of the asserted patent—including drafting the claims and specification and responding to the examiner’s office action. Darren admitted he knew of Stepensky before the application was filed and that he possessed a label for a 1 mg/mL epinephrine product marked [...]

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