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Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

by | Apr 24, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as the term “sterilized” in the United States. Sage Products LLC v. Stewart, Case No. 23-1603 (Fed. Cir. Apr. 15, 2025) (Reyna, Cunningham, Stark, JJ.)

Sage owns two patents related to a sterilized chlorhexidine product in a package, such as an applicator filled with an antiseptic composition for disinfecting skin. Becton, Dickinson and Company petitioned for inter partes review (IPR) of both patents. The Board relied on four key pieces of prior art, including one that was a UK publication, to find the challenged claims unpatentable. In instituting the IPR and evaluating the petition, the Board construed the term “sterilized” to mean that “the component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” In the final written decision, the Board found that a skilled artisan at the time of the invention would have known, through education and experience, that the term “sterile,” as used in the UK prior art publication, is equivalent to the term “sterilized,” as used in the US and particularly in the Sage patents. Reviewing the totality of the evidence before it, including both parties’ experts’ reports and testimony, the Board determined the challenged claims were unpatentable. Sage appealed.

The Federal Circuit declined to overturn the Board’s findings, affirming the Board’s definition of a person of ordinary skill in the art and their understanding of the term “sterilized” at the time of the invention. The Court found that the Board did not ignore or disregard evidence but properly weighed the evidence before it, concluding that a skilled artisan having the education and experience required by the Board’s definition would know the differences between the US and UK regulatory standards for “sterile” and therefore would know that UK references to “sterile” items would satisfy the challenged claims’ requirement for “sterilized” items.



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New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

by | Apr 17, 2025 | ,

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

Based on [...]

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Opposers Beware: Your Own Mark May Not Be Protectable

by | Apr 17, 2025 |

The US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s dismissal of an opposition to the registration of the marks IVOTERS and IVOTERS.COM while also noting that the US Patent & Trademark Office (PTO) might want to reconsider whether it permits registration of those marks. Heritage Alliance v. Am. Policy Roundtable, Case No. 24-1155 (Fed. Cir. Apr. 9, 2025) (Prost, Taranto, Stark, JJ.)

American Policy Roundtable (APR), a publisher of campaign and political information since June 2010, filed applications to register the marks IVOTERS and IVOTERS.COM for “providing a web site of information on current public policy issues, political campaigns and citizen concerns related to political information” after the PTO approved the marks for publication. Heritage filed an opposition.

Since the 2008 US presidential election season, Heritage has published online voter guides under the names “iVoterGuide” and “iVoterGuide.com” (the iVoters marks). Without a valid registration but having priority of use, Heritage filed an opposition asserting its common law rights in the iVoters marks.

The Board considered Heritage’s opposition but ultimately found that Heritage’s mark was not distinctive. The Board first considered whether the iVoters marks were inherently distinctive and determined they were not just descriptive but “highly descriptive.” The Board next considered whether the iVoters marks had acquired distinctiveness through secondary meaning but found that the record evidence Heritage submitted was inadequate to support a finding that the iVoters marks had any source-identifying significance. Heritage appealed.

On appeal, Heritage argued that the Board had erred by finding the iVoters marks to have neither inherent nor acquired distinctiveness and that the Board violated the anti-dissection principle by evaluating the individual components of the marks instead of the marks as a whole. The Federal Circuit disagreed. The Court found the Board’s determination that the iVoters marks were highly descriptive to be supported by substantial evidence because the prefix “i” generally refers to something internet based. Heritage chose not to challenge the Board’s finding that “VoterGuide” and “.com” were not distinctive, a ruling the Court characterized as “facially reasonable.”

The Federal Circuit also disagreed with Heritage’s argument that the Board improperly evaluated the marks’ individual components. The Court found the Board properly considered the marks as a whole through its determination that the iVoters marks “on their face refer to online voter guides” and because no evidence demonstrated that the combination of the individual components conveyed “any distinctive source identifying impression contrary to the descriptiveness of the individual parts.”

Heritage argued that the Board had erred in its determination that notwithstanding over five years of use, the iVoters marks did not have statutory acquired distinctiveness. Under Section 2(f) of the Lanham Act, registration applicants may submit evidence that a mark has acquired distinctiveness because as a consequence of extensive use and promotion of the mark, consumers now directly associate the mark with the applicant as the source of those goods. Heritage argued that the Board should have accepted its five-plus years of continuous use as prima facie [...]

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High Burden Dooms Intra-District Transfer Request

by | Apr 17, 2025 |

The US Court of Appeals for the Federal Circuit denied a mandamus petition requesting transfer from the Marshall division to the Sherman division within the US District Court for the Eastern District of Texas, finding that there was lack of clear error and no abuse of discretion in the district court’s decision to deny transfer. In re SAP America, Inc., Case No. 25-118 (Fed. Cir. Apr. 10, 2025) (Dyk, Prost, Chen, JJ.) (per curiam).

Valtrus Innovations and Key Patent Innovations (collectively, Valtrus) filed a patent infringement lawsuit against SAP. SAP moved for an intra-district transfer from the Marshall division, where the case was originally filed, to the Sherman division. In support of the motion, SAP cited the presence of SAP offices, relevant witness residences, and two SAP employees, all located in Sherman. Valtrus opposed the transfer, pointing out that co-pending litigation in Marshall involved the same asserted patents.

The district court denied SAP’s motion, even though the co-pending case had been closed. The district court also pointed out that most of SAP’s witnesses were out of state or international, making either Texas division equally inconvenient for those witnesses. SAP appealed.

The Federal Circuit reviewed the district court’s ruling under the stringent standards for mandamus relief, which are as follows:

  • There is no other adequate means to attain the desired relief.
  • There is a clear and indisputable right to relief.
  • The writ is appropriate under the circumstances.

Under the Federal Circuit’s 2022 decision in In re Volkswagen, there must be “clear abuses of discretion that produce patently erroneous results.”

Under Volkswagen, a court must consider both private and public factors when deciding whether to transfer venue. The private factors are:

  • The relative ease of access to sources of proof.
  • The availability of a compulsory process to secure the attendance of witnesses.
  • The cost of attendance for willing witnesses.
  • All other practical issues that make trial of a case easy, expeditious, and inexpensive.

The public interest factors are:

  • The administrative difficulties flowing from court congestion.
  • The local interest in having localized issues decided at home.
  • The forum’s familiarity with the law that will govern the case.
  • The avoidance of unnecessary conflict of laws issues or in the application of foreign law.

The Federal Circuit found that the district court erred in assigning weight to the co-pending litigation in Marshall, which had been closed and had all defendants dismissed by the time the motion to transfer was resolved. The Court added that the district court improperly weighed the court congestion factor against transfer based solely on the case’s smooth progression to trial.

Despite these errors, the Federal Circuit concluded that SAP failed to demonstrate that the denial of transfer was erroneous. The district court had plausibly found the convenience of the two divisions comparable for most potential witnesses who resided outside of Texas, and that SAP had not sufficiently shown that its Sherman-based employees had relevant knowledge or would be trial witnesses. The Court therefore denied [...]

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Munich Court Addresses Implementer’s Obligation To Provide Security in FRAND Negotiations

by and | Apr 17, 2025 | ,

The Munich Higher Regional Court issued a decision concerning the fair, reasonable, and nondiscriminatory (FRAND) negotiation process and an implementer’s obligation to provide security if a license offer for standard essential patents (SEPs) is rejected. HMD Global v. VoiceAge, Case No. 6 U 3824/22 Kart, (Judgment of 20 March 2025).

In this case, the Munich Higher Regional Court attempted to fill a gap left by the Court of Justice of the European Union (CJEU) in Huawei v. ZTE regarding an implementer’s obligation to provide adequate security for royalties. This obligation arises when an implementer rejects a SEP holder’s license offer and the SEP holder rejects the implementer’s counteroffer, so there is no agreement on a license.

The Munich Court found that the implementer, HMD Global, provided an inadequate security that was based on HMD Global’s lower counteroffer. The Court explained that it is the SEP holder’s, here VoiceAges, final offer (i.e., the requested royalty) that is determinative for calculating the security amount that an implementer should provide. This is because a willing licensee must accept the SEP holder’s offer if a court declares it to be FRAND and the royalties subject to this offer must be covered by the security. The Court emphasized that an implementer can only establish that it is a willing licensee by making a counteroffer and providing adequate security after rejecting the offer.

However, the Munich Court left open the issue of whether security must be provided if the SEP holder’s final offer is obviously not FRAND, noting that there may be “special cases” where the SEP holder’s final offer may not be determinative of the security without further defining those cases.

The CJEU’s Guidelines to FRAND Negotiations Are Not a Rigid Set of Rules

The Munich Court also took a critical stance in response to the European Commission’s amicus curiae brief and found that the FRAND guidelines set by the CJEU in Huawei v. ZTE are not to be viewed as a rigid set of rules but rather as a “dynamic concept for negotiation.” A court is not limited to assessing the FRAND defense by strictly examining in sequence each step of the CJEU’s guidelines, which includes the following:

  • The SEP holder must send a notice of infringement to the implementer.
  • The implementer must declare to be a willing licensee.
  • The SEP holder must make a FRAND offer.
  • If the offer is not FRAND, the implementer is allowed to reject it but must make a counteroffer.
  • The implementer must provide adequate security for royalties if the SEP holder rejects the implementer’s counteroffer.

The European Commission argued that a court must examine each step before moving on to the next one. This means that, for example, once a court has found that the implementer is a willing licensee, the court must leave the implementer’s subsequent (possibly non-FRAND) conduct out of consideration and cannot undermine the implementer’s established willingness to take a license. A court must then assess whether [...]

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Prosecution Disclaimer Alive and Well, Especially in Closed Claim

by | Apr 17, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc. v. Alkem Lab’ys Ltd., Case No. 23-1977 (Fed. Cir. Apr. 8, 2025) (Moore, Chen, Murphy, JJ.)

Azurity owns a patent directed to a nonsterile, stable liquid formulation of vancomycin hydrochloride, specifically designed for oral administration to treat Clostridium difficile infections. Following Alkem’s submission of an Abbreviated New Drug Application (ANDA), Azurity brought a Hatch-Waxman Act claim against Alkem for infringement of certain claims of the patent. The district court found that Azurity had disclaimed the presence of propylene glycol in the claimed formulation during the prosecution. Since Alkem’s ANDA product contained propylene glycol, the district court held that it did not infringe. Azurity appealed.

The Federal Circuit affirmed, focusing on the patent’s prosecution history and noting that Azurity used the lack of propylene glycol to distinguish its claimed invention from the prior art. The Court noted that this distinction was made during prosecution multiple times in response to the examiner’s rejections, and that Azurity had added negative claim limitations that specifically omitted propylene glycol from the scope of the claims.

The Federal Circuit also noted that Azurity used a “consisting of” transitional phrase to narrow the claims and relied on the closed transition to overcome the prior art. The Court explained that “consisting of” is a closed transition that limits the claim scope to only the recited components. By using this transition and not including propylene glycol as one of the claim components, Azurity effectively disclaimed propylene glycol from the invention. Therefore, the Court found that omission of propylene glycol during patent prosecution was “clean, unambiguous, and complete.”

Azurity argued that a pretrial stipulation between the parties, which stated that “[s]uitable flavoring agents for use in the asserted claims include flavoring agents with or without propylene glycol,” should preclude the application of the disclaimer. The Federal Circuit did not find this argument persuasive, concluding that the stipulation did not alter the clear and unambiguous disclaimer made during prosecution, nor did it affect the noninfringement finding. Since Alkem’s ANDA product contained propylene glycol and Azurity disclaimed inclusion of propylene glycol, there was no infringement.



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When Is a Trade Secret Accessible? As Soon as It Can Be Reverse Engineered

by | Apr 10, 2025 |

Although the US Court of Appeals for the Federal Circuit upheld a damages award for trade secret misappropriation and breach of a confidentiality agreement, it found that the district court erred in its determination of when the trade secret became publicly accessible for the purpose of applying a reverse engineering defense. The Federal Circuit also vacated and remanded the prejudgment interest award, finding that interest should not accrue on future sales. ams-OSRAM USA Inc. v. Renesas Elect. America, Inc., Case No. 22-2185 (Fed. Cir. Apr. 4, 2025) (Taranto, Schall, Chen, JJ.)

In 2008 ams sued Renesas for patent infringement, trade secret misappropriation, and breach of contract for using information that ams revealed in confidence. In 2015 a jury found for ams, and the district court entered judgment for trade secret misappropriation damages, but not for breach of contract. The district court determined that the breach award was duplicative of the misappropriation award. On appeal, in 2018 the Federal Circuit affirmed Renesas’ liability for misappropriation on a more limited basis than had been presented to the jury. The Court vacated the misappropriation award and remanded, instructing that disgorgement of profits damages should be decided by the judge, not the jury.

On remand, ams argued that it was entitled to “re-elect its remedy” and narrowed to the misappropriation and contract claims, which required the case to be retried. The new jury also found in favor of ams. The district judge then determined the monetary award for trade secret misappropriation, consisting of disgorgement of profits for one product and exemplary damages of double that sum. On ams’s breach of contract claim, the jury awarded a reasonable royalty on sales of products, other than the one subject to disgorgement damages. ams was also awarded prejudgment interest on both its misappropriation and contract claims, and attorneys’ fees on its breach of contract claim. Both parties appealed.

Trade Secret Accessibility and Reverse Engineering

The district court ruled that ams’s trade secrets became accessible in January 2006 when Renesas successfully reverse engineered the trade secret embodied in ams’s product. The district court determined that the relevant inquiry for accessibility is what the misappropriator actually did rather than what the misappropriator or other parties could have done. Renesas argued that the trade secret first became accessible when it could have reverse engineered the trade secret in February 2005.

The Federal Circuit agreed with Renesas, explaining that the district court’s ruling was inconsistent with Texas law. Under Texas law, information that is generally known or readily available by independent investigation does not qualify as a trade secret. Citing Fifth Circuit precedent, the Federal Circuit emphasized that the public is free to discover and exploit trade secrets through reverse engineering of products in the public domain. The Court found that Renesas could have accessed ams’s trade secrets through proper and straightforward means by February 2005. While acknowledging that the trade secret may not have been immediately apparent through casual inspection, the Court pointed out that reverse engineering is a common [...]

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Impermissible Convoyed Sales Wash Away Damages Award

by | Apr 3, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of infringement but vacated its damages award because the award improperly included auxiliary products lacking any functional relationship to the infringed patent claim. Wash World Inc. v. Belanger Inc., Case No. 2023-1841 (Fed. Cir. Mar. 24, 2025) (Stark, Lourie, Prost, JJ.)

Belanger owns a patent related to a spray-type car wash system. A competitor, Wash World, filed for a declaratory judgment that its car wash system did not infringe the patent.

A jury returned a general verdict of infringement and awarded Belanger $9.8 million in lost profit damages. Wash World moved for judgment as a matter of law of noni  nfringement based on the positions it previously raised and challenged the damages award. Wash World argued that Belanger failed to prove entitlement to lost profits for convoyed sales. The district court rejected Wash World’s arguments. Wash World appealed, challenging the district court’s constructions of three claim terms that Wash World argued were dispositive to noninfringement and the damages award for improperly including nearly $2.6 million in ineligible convoyed sales.

The Federal Circuit concluded that for two of the three claim terms, the constructions Wash World argued for on appeal were materially different from the constructions it urged the district court to adopt. The Federal Circuit emphasized that while a party is not confined to the precise wording of the constructions it advances at the district court, it must still present essentially the same dispute on appeal. Finding no exceptional circumstances, the Court deemed Wash World’s appellate positions on the two claims to be forfeited. As to the remaining term, the Court found that while Wash World had preserved the issue for appeal, the district court’s interpretation was correct.

On the issue of remittitur, the Federal Circuit first found that Wash World had properly preserved the issue for appeal and that even if it had not, exceptional circumstances would justify reaching the merits. The Court stated that it could discern the precise damages the jury awarded based on convoyed sales, and that the requirements for lost profits on such sales were plainly not satisfied.

The Federal Circuit explained that entitlement to lost profits for convoyed sales exists only where the unpatented products (e.g., dryers sold together with a patented car wash system) and the patented product together constitute a “functional unit,” like parts of a complete machine. The Court found that no evidence in the record could support such a finding and that damages awarded for sales of the unpatented products were thus improper. The Court further rejected Belanger’s argument that the jury’s return of a general verdict insulated the award from further scrutiny. The Court noted that based on the evidence presented, it was overwhelmingly likely that the jury’s verdict included the impermissible damages for convoyed sales. Therefore, the Federal Circuit instructed the district court on remand to remit $2.6 million in damages corresponding to sales of the unpatented components.



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Fintiv Guidelines for Post-Grant Proceedings Involving Parallel District Court Litigation

by | Apr 3, 2025 |

On March 24, 2025, the US Patent & Trademark Office (PTO) released new guidance that clarifies application of the Fintiv factors when reviewing validity challenges simultaneously asserted at the Patent Trial & Appeal Board and in district court or at the US International Trade Commission.

This guidance follows the PTO’s February 28, 2025, announcement reverting to its previous guidelines for discretionary denials of petitions for post-grant proceedings where district court litigation is ongoing. That announcement rescinded the PTO’s June 21, 2022, memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which prevented the Board from rejecting validity challenges where there was “compelling evidence of unpatentability.”

Based on the new guidance, the Board is more likely to defer to the district court or the Commission if the Commission’s projected final determination date is earlier than the deadline for the Board’s final written decision. The PTO pointed out that a patent challenger’s stipulation not to raise the same invalidity arguments in other proceedings if the PTO institutes an inter partes review or post grant review is highly relevant but not dispositive.

This change in policy increases the likelihood that the Board will grant discretionary denials in situations involving parallel district court or Commission proceedings.



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Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

by | Apr 3, 2025 | ,

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America Invents Act (AIA) 35 U.S.C. § 102(e) as of the provisional filing date, explaining that all portions of the published patent application that are relied upon by the US Patent & Trademark Office (PTO) to reject the claims must be sufficiently supported in the provisional application. In re Riggs, Case No. 22-1945 (Fed. Cir. Mar. 24, 2025) (Moore, Stoll, Cunningham, JJ.)

Several inventors who work for Odyssey Logistics filed a patent application directed to logistics systems and methods for the transportation of goods from various shippers by various carriers across different modes of transport (e.g., by rail, truck, ship, or air). PTO rejected the application under § 102(e) in view of Lettich, which claimed the benefit of a provisional application (Lettich provisional), and as obvious in view of Lettich in combination with the Rojek reference.

The inventors appealed the Lettich rejections to the Patent Trial & Appeal Board, arguing that Lettich did not qualify as prior art under § 102(e). The Board initially agreed with the inventors, but the Examiner assigned to the application requested a rehearing, asserting that the Board applied the incorrect standard for § 102(e) prior art. The Board ultimately issued its decision on the Request for Rehearing, stating that it had jurisdiction over the Examiner’s request and that the Examiner’s arguments regarding Lettich’s status as prior art under § 102(e) “[we]re well taken.” The Board amended its original decision “to determine that Lettich is proper prior art against the instant claims.” The Board then reviewed and affirmed the Examiner’s anticipation and obviousness rejections. The inventors appealed.

The Federal Circuit vacated and remanded the Board’s decision. With respect to whether Lettich qualified as § 102(e) prior art, the Court found that the Board’s analysis was incomplete. The Court concluded that the Board correctly applied the test set forth in the Federal Circuit’s 2015 decision in Dynamic Drinkware v. National Graphics by determining that the Lettich provisional supported at least one of Lettich’s as-published claims. However, the Court found that this test was insufficient because all portions of the disclosure that are relied upon by the PTO to reject the claims must also be sufficiently supported in the priority document. Although the PTO asserted that the Board had conducted this additional analysis, the Federal Circuit disagreed and vacated and remanded for the Board to determine whether the Lettich provisional supported the entirety of the Lettich disclosure that the Examiner relied on in rejecting the claims.



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