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Exploring the Latest in Intellectual Property Law
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Inventor’s Motivation to Combine Does Not Control Obviousness

by | Mar 13, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the motivation to use the claimed dosing was not the same as the inventor’s motivation. ImmunoGen, Inc. v. Coke Morgan Stewart, Case No. 23-1763 (Fed. Cir. Mar. 6, 2025) (Lourie, Dyk, Prost, JJ)

The claims at issue involved a dosing regimen for administering IMGN853, an already-patented antibody drug conjugate used for treating certain cancers, at a claimed dose of six milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.

ImmunoGen argued that it was undisputed that, at the time of the invention, a person of ordinary skill in the art would not have known that IMGN853 caused ocular toxicity in humans and that without a motivation to address the problem of ocular toxicity, the claimed dosing limitation could not have been obvious. Therefore, according to ImmunoGen, the district court erred in its motivation-to-combine analysis. The Federal Circuit disagreed, stating, “that the specific problem the inventors . . . purported to solve via the claimed dosing regimen was unknown does not necessarily mean that the dosing regimen itself was not obvious.” The Court also noted that because ocular toxicity was a well-known adverse event in the administration of drugs containing a payload included in IMGN853, “a person of ordinary skill in the art, despite not knowing of IMGN853’s ocular toxicity, would have nonetheless been motivated to monitor for those side effects when administering the drug to a human.”

ImmunoGen also argued that the district court erred in finding that a person of ordinary skill in the art would have been motivated to use AIBW dosing to eliminate ocular toxicity. The Federal Circuit again disagreed, reasoning that although AIBW dosing has not been used for drugs such as IMGN853, it would still have been within the range of knowledge of a person of ordinary skill in the art when addressing dosing-induced ocular toxicity. The Court explained that AIBW was well known, had been used for drugs both smaller and larger than IMGN853, and had proven effective in reducing ocular toxicity.

The Federal Circuit concluded that the district court did not clearly err in determining that a person of ordinary skill in the art would have been motivated to select the claimed dose of six mg/kg AIBW with a reasonable expectation of success. The claimed dose had already been described in the literature for patients at their ideal body weight, regardless of whether a doctor was aware of AIBW dosing specifically. The Court also noted that the district court was not required to find that a person of ordinary skill in the art would have had a reasonable expectation of eliminating ocular toxicity using the claimed dose, as “the obviousness inquiry is generally agnostic to the particular motivation of the inventor” and the claims made no reference to ocular toxicity.

Practice Note: [...]

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Economic Prong of Domestic Industry Requirement Includes All Sorts of Labor and Capital

by | Mar 13, 2025 |

Addressing the economic prong of the domestic industry requirement under Section 337(a)(3)(B) of the Tariff Act of 1930, the US Court of Appeals for the Federal Circuit reversed a US International Trade Commission decision, finding that the Commission had applied an overly narrow interpretation of the requirement. The Court explained that expenses related to sales, marketing, warehousing, quality control, and distribution may qualify as “labor and capital” for establishing the existence of a domestic industry, even if there is no domestic manufacturing. Lashify, Inc. v. International Trade Comm’n, Case No. 23-1245 (Fed. Cir. Mar. 5, 2025) (Taranto, Prost, Chen, JJ.)

Lashify is a US-based company that sells eyelash extension products. Concerned about the importation of similar goods, Lashify filed a complaint with the Commission, alleging that certain importers were infringing its patents. As an importer itself, Lashify had its products manufactured abroad before selling them to customers in the United States. In doing so, Lashify incurred significant expenses related to warehousing, distribution, quality control, sales, and marketing. These expenses were critical to Lashify’s domestic industry case.

The Commission rejected Lashify’s claims, reasoning that it did not demonstrate the establishment of, or effort to establish, a domestic industry. This is known as the “economic prong” of the domestic industry requirement. One way to satisfy this prong is by showing the expenditure of significant labor or capital within the US. Lashify’s domestic expenses were limited to warehousing, distribution, quality control, sales, and marketing costs, and in the Commission’s view, these expenses did not constitute significant “labor or capital” under Section 337 (a)(3)(B). The Commission determined that these expenses were no greater than those any importer would incur once its products arrived in the US. Lashify appealed.

The Federal Circuit reversed, citing the text of the provision recognizing significant labor or capital as a means of establishing a domestic industry and noted that the statutory language did not exclude expenses related to warehousing, distribution, quality control, sales, and marketing. Considering the domestic industry requirement under Section 337(a)(3)(C), the Court noted that the reference to labor and capital in part (B) was analogous to investments in plant and manufacturing in part (C), which similarly did not limit the “enterprise functions” to which the investments must be directed.

The Federal Circuit cited its 2015 decision in Lelo, which defined “labor” as “human activity that produces goods or provides the services in demand in an economy” and “capital” as “a stock of accumulated goods,” not simply money to finance an enterprise. The Court held that complainants may satisfy the economic prong by demonstrating the “employment of a large enough stock of accumulated goods [i.e., capital] or of a significant amount of human activity for production goods or providing the services in demand in an economy [i.e., labor].” The Court determined that Lashify’s warehousing, distribution, quality control, sales, and marketing expenses fit within this definition and should therefore be considered in assessing whether Lashify had employed sufficient labor and capital within the US to satisfy the economic [...]

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Interesting Delay: Prejudgment Interest Accrues Despite Unreasonable Delay

by | Mar 13, 2025 |

The US Court of Appeals for the Federal Circuit upheld a decision on enhanced damages and prejudgment interest, concluding that the district court correctly applied the appropriate standard for enhanced damages in accordance with established precedent. Halo Electronics, Inc. v. Pulse Electronics, Inc., Case Nos. 23-1772; -1966 (Fed. Cir. Feb. 28, 2025) (Prost, Bryson, Reyna, JJ.) (nonprecedential).

In 2013, following a jury verdict in favor of Halo, the district court entered a $1.5 million verdict against Pulse for willful infringement but denied Halo enhanced damages. Halo appealed and, in 2016, engendered a new enhanced damages standard from the Supreme Court. In 2015, while the case was pending before the Supreme Court, Halo filed for an award of supplemental damages for direct infringement between 2012 and 2013, and prejudgment and post-judgment interest on the initial $1.5 million judgment and on the supplemental damages. The district court awarded supplemental damages and prejudgment and post-judgment interest.

In 2017, the district court determined that Halo was not entitled to enhanced damages or attorneys’ fees under the Supreme Court’s new standard. Although the parties still disagreed on which method to use for prejudgment interest calculation – and briefed their positions accordingly – the district court mistakenly ordered the clerk to enter a final judgment and close the case. After the Supreme Court decided WesternGeco v. ION Geophysical in 2018, Halo (in 2020) filed a motion seeking prejudgment interest and a new damages trial, arguing that the district court had not made a final ruling on the issue of prejudgment interest and that WesternGeco was intervening case law that permitted it to seek additional damages for Pulse’s activities outside the United States.

Halo argued that because the final order closing the case ignored an outstanding issue (prejudgment interest), the case was merely administratively closed. Although Pulse argued that the resurrected case should remain closed under Federal Rule of Civil Procedure 41(b), the district court awarded limited prejudgment interest in March 2023. The district court rejected Halo’s request for a new trial regarding additional foreign damages under WesternGeco.

Halo appealed, and Pulse counter appealed. Halo raised two main arguments:

  • Enhanced damages were appropriate because of the jury’s finding of willfulness.
  • The district court should have allowed a limited trial on the issue of foreign infringement.

Pulse argued that FRCP 41(b) should have barred any prejudgment interest because Halo did not address the court’s oversight until 2020.

The Federal Circuit rejected both of Halo’s arguments. It explained that a jury’s finding of willfulness is “but one factor” in an enhanced damages determination under the Supreme Court’s highly discretionary Halo test. Willful infringement does not require the more egregious intent that gives rise to enhanced damages, nor does it merge with enhanced damages analyses procedurally – willfulness is a jury issue, while enhanced damages is an issue for the court.

Addressing Pulse’s argument, the Federal Circuit found no abuse of discretion in either the district court’s refusal of a new trial [...]

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Validity Analysis for Product-by-Process Claim Focuses on Product

by | Mar 13, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board patentability finding, explaining that an anticipation analysis for a product-by-process claim focuses on the product and not the process. Restem, LLC v. Jadi Cell, LLC, Case No. 23-2054 (Fed. Cir. Mar. 4, 2025) (Moore, Schall, Taranto, JJ.)

Jadi Cell owns a patent directed to stem cells that have specific cell markers expressed. These stem cells are obtained from the subepithelial layer of mammalian umbilical cord tissue by first placing the layer in contact with a tissue culture growth substrate and then culturing the layer. The claims of the patent are product-by-process claims. Restem challenged certain claims of the patent in an inter partes review (IPR) petition as being anticipated by the Majore reference or obvious in view of Majore in combination with other references. The Board found that none of the challenged claims were shown to be unpatentable. Restem appealed.

The Board construed the claim term “placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate” to mean “to intentionally place umbilical cord tissue comprising the subepithelial layer so that it touches a growth substrate to permit cell culture.” The Board found that while the prior art references disclosed the two-step process in the claims, the references failed to disclose the claimed cells because the references did not necessarily produce cells with the claimed cell marker expression profile. Restem argued that the Board erred by construing the claims to require steps beyond the claimed two-step process. The Federal Circuit rejected that argument, finding that the Board had made underlying factual findings that supported its anticipation analysis in construing the “placing” step and therefore did not err.

In the underlying proceeding, the Board declined to construe “isolated cell” but construed “expresses/does not express” to mean that “the marker is confirmed present/absent relative to a control sample,” consistent with its interpretation of isolated cell to indicate a cell population. In construing this claim, the Board relied on extrinsic evidence to assess how a person of ordinary skill in the art would determine whether the cell markers were expressed. The Board found that both parties’ experts agreed that cell marker analysis was done at the cell population level at the time of invention. Restem argued that the Board erred in implicitly construing “isolated cell” contrary to the express definition in the challenged patent. However, the Federal Circuit upheld that implicit construction as supported by the intrinsic evidence because the specification consistently described the claimed invention as a cell population and the prosecution history indicated that the examiner only allowed the patentee to claim a cell population.

As for the Board’s finding that the Majore reference did not inherently or expressly anticipate the challenged claims, the Federal Circuit affirmed. The Board found that the cell marker expression profile distinguished the claimed cells from other stem cells and was therefore limiting, and that Majore did not expressly disclose the nonexpression limitations included [...]

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Diamond in the Rough: Federal Circuit Polishes § 101’s Abstract Idea Test

by | Feb 20, 2025 |

The US Court of Appeals for the Federal Circuit reversed and remanded a determination by the US International Trade Commission regarding subject matter ineligibility under 35 U.S.C. § 101. The Court concluded that the Commission’s “loose and generalized” analysis did not adequately consider the specific and technical improvements specified by the claims. US Synthetic Corp. v. International Trade Commission, Case No. 23-1217 (Fed. Cir. Feb. 13, 2025) (Dyk, Chen, Stoll, JJ.)

US Synthetic Corp. (USS) filed a complaint with the Commission, alleging that several entities (intervenors) violated § 337 of the Tariff Act by importing and selling certain products that infringed five of USS’s patents. The patent at issue concerned a composition of a polycrystalline diamond compact (PDC) and disclosed an improved method for manufacturing PDCs.

An administrative law judge (ALJ) determined that several claims of the patent were valid and infringed under 35 U.S.C. §§ 102, 103, and 112. However, the ALJ found the claims patent-ineligible under § 101, deeming them directed to an abstract idea. The Commission affirmed this finding while rejecting the intervenors’ argument that the claims lacked enablement under § 112. Consequently, the only bar to a § 337 violation was the § 101 ruling. USS appealed, challenging the Commission’s patent ineligibility determination, while the intervenors argued that the claims were not enabled.

The Federal Circuit determined that the patent claims were directed to a specific technological improvement rather than an abstract idea. The Court had consistently explained that claims that provide a concrete technological solution to a recognized problem in the field are patent-eligible under § 101. Here, the claimed invention was not merely an implementation of an abstract idea on a generic computer; rather, it provided a particularized solution rooted in the physical composition of matter defined by constituent elements, dimensional information, and inherent material properties.

Applying the Supreme Court’s two-step Alice framework, the Federal Circuit reasoned that, under Alice step one, courts must determine whether the claims are directed to an abstract idea or a patent-eligible improvement. In this case, the Court found that the patent claims were not directed to an abstract idea because they recited a specific solution that was directed to a non-abstract composition of matter: PDC. Unlike claims found ineligible in prior cases, USS’s patent did not merely recite a mathematical algorithm or fundamental economic practice but instead provided a tangible technological advancement for an improved method for manufacturing PDCs.

The Federal Circuit noted that even if the claims were directed to an abstract idea under Alice step one, the claimed invention contained an inventive concept sufficient to transform the nature of the claim into patent-eligible subject matter under Alice step two. The Court explained that an inventive concept exists when the claims recite a specific, unconventional solution that goes beyond well-understood, routine, and conventional activities previously known in the field. Here, the Court determined that the claimed invention included an innovative combination of components (diamond, cobalt catalyst, and substrate) in conjunction with particular dimensional information (grain size) and [...]

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Small-Market Segment Can Still Satisfy Domestic Industry Requirement

by | Feb 20, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a US International Trade Commission finding, explaining that small-market segments can be significant and substantial enough to support the Commission’s domestic industry requirement. Wuhan Healthgen Biotechnology Corp. v. International Trade Commission, Case No. 23-1389, (Fed. Cir. Feb. 7, 2025) (Moore, Chen, Murphy, JJ.)

Ventria Bioscience Inc. owns a patent directed to cell-culture media, which supplies nutrients to cells grown in artificial environments. Ventria filed a complaint at the Commission alleging that Wuhan Healthgen Biotechnology violated § 337 of the Tariff Act by importing products that infringed the patent. The Commission ultimately found that Healthgen imported infringing products and that Ventria had satisfied the domestic industry requirement. Healthgen appealed.

The Federal Circuit affirmed the Commission’s domestic industry finding. The Court began by explaining the long-standing principle that patent infringement-based violations of § 337, which establishes unlawful import practices, require that “an industry in the United States, relating to the articles protected by the patent…exists or is in the process of being established.” This requirement is divided into economic and technical prongs. Here, Healthgen conceded that the technical prong was satisfied by a Ventria product (Optibumin) that practiced the patent.

The economic prong considers three factors, any of which are sufficient to satisfy the prong. As identified by the subsections of § 337(a)(3), “there is in the United States, with respect to the articles of the patent…(A) significant investment in plant and equipment; (B) significant employment of labor or capital; or (C) substantial investment in its exploitation, including engineering, research and development, or licensing.” The Commission found that each of these factors was met because, among other things, Ventria had 100% of its relevant investments in Optibumin located within the United States. The conclusion was further supported by a comparison of the investments to Obtibumin’s revenue.

Healthgen argued that the investments were too small to be significant or substantial, and that Optibumin’s revenue was low, which inflated investment-to-revenue ratios. The Federal Circuit rejected Healthgen’s argument, stating that “[s]mall market segments can still be significant and substantial enough to satisfy the domestic industry requirement.” The Court continued, stating that a domestic industry analysis “cannot hinge on a threshold dollar value or require a rigid formula; rather, the analysis requires a holistic review of all relevant considerations that is very context dependent.” Here, the Court found that “[t]hough the dollar amounts of Ventria’s Optibumin investments are small, the Commission found all of the investments are domestic, all market activities occur within the United States, and the high investment-to-revenue ratios indicate this is a valuable market.” The Court found that the Commission’s findings were supported by substantial evidence and affirmed the Commission.



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Collateral Estoppel Doesn’t Apply to Unchallenged IPR Claims

by | Feb 20, 2025 |

The US Court Appeals for the Federal Circuit found that despite a Patent Trial & Appeal Board determination that certain challenged patent claims were unpatentable based on a preponderance of the evidence standard, the patent owner is not collaterally estopped from asserting other, unreviewed claims of that patent in district court litigation. Kroy IP Holdings, LLC v. Groupon, Inc., Case No. 23-1359 (Fed. Cir. Feb. 10, 2025) (Prost, Reyna, Taranto JJ.)

Kroy sued Groupon for patent infringement. In response, Groupon filed two inter partes review (IPR) petitions challenging 21 claims of the patent at issue. After Groupon’s IPR deadline passed, Kroy amended its complaint to add additional claims from the challenged patent. The Board found all 21 challenged claims unpatentable. Kroy amended its complaint again, this time removing the 21 unpatentable claims and including only claims that were not at issue in the IPR proceedings.

In response, Groupon moved to dismiss the complaint, arguing that the Board’s prior IPR rulings on the unpatentable claims collaterally estopped Kroy from asserting the new claims. The district court agreed, finding that if the Board issues final judgment that a patent claim is unpatentable and another claim is immaterially different, then collateral estoppel applies to that other claim for purposes of invalidity. Applying that standard, the district court determined that the new claims were not materially different from the unpatentable claims in terms of invalidity and granted Groupon’s motion to dismiss with prejudice. Kroy appealed.

Kroy argued that collateral estoppel should not apply because the burden of proof for invalidity in an IPR proceeding (preponderance of the evidence) is lower than in the district court (clear and convincing). The Federal Circuit noted that this case presents a distinct question of collateral estoppel law; that is, whether a prior final written decision of the Board that certain patent claims are unpatentable precludes a patentee from asserting other claims from the same patent, even assuming the asserted claims are immaterially different from the unpatentable claims for purposes of invalidity.

Referring to its recent 2024 decision in ParkerVision v. Qualcomm, the Federal Circuit clarified that collateral estoppel does not apply to new claims that have not yet been adjudicated. The Court explained that Groupon must prove the invalidity of these new claims in the district court by clear and convincing evidence. The Court dismissed Groupon’s reliance on the 2013 Ohio Willow Wood decision, noting that this case addressed whether a prior district court’s invalidity ruling estopped the patentee from asserting claims in the district court that are immaterially different for purposes of invalidity. On the other hand, the Ohio Willow Wood estoppel scenario occurred in district courts involving the same burden of proof. Because the Board determined unpatentability on separate patent claims based on a preponderance of the evidence standard, courts cannot collaterally estop a patentee from asserting other, unadjudicated patent claims in district court litigation.



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Judicial Bias and Erroneous Admission of Expert Testimony Prompt Case Reassignment

by | Feb 13, 2025 |

The US Court of Appeals for the Federal Circuit reversed a district court’s decision to admit expert testimony and remanded the case to a different judge, noting that “from the moment this case fell in his lap, the trial judge’s statements indicate that he did not intend to manage a fair trial with respect to the issues in this case.” Trudell Medical Intl., Inc. v. D R Burton Healthcare, LLC, Case Nos. 23-1777; -1779 (Fed. Cir. Feb. 7, 2025) (Moore, C.J.; Chen, Stoll, JJ.)

Trudell Medical sued D R Burton Healthcare for infringement of a patent directed to respiratory treatment devices. Leading up to trial, Trudell filed a motion in limine seeking to exclude testimony from Dr. John Collins on invalidity and noninfringement. At the pre-trial conference, the court denied the motion in limine. A few days later, however, on the first day of trial, the district court reversed itself and granted the motion in limine after Trudell filed a motion for reconsideration. Moments later, the district court indicated that it would reserve a ruling on the motion until the end of Trudell’s case.

On the third and final day of trial, the district court ruled that Collins was allowed to testify. After trial, the jury returned a verdict that the asserted claims were valid but not infringed. Trudell appealed.

Trudell argued that the district court erred in allowing Collins to testify. The Federal Circuit indicated that it reviews a district court’s decision to admit or exclude evidence under the law of the regional circuit – here, the Fourth Circuit, which applies an abuse of discretion standard. Trudell argued that because Collins did not timely serve an expert report on noninfringement and the failure to do so was neither substantially justified nor harmless, the district court abused its discretion in allowing the testimony. Although D R Burton had filed a seven-page declaration from Collins in support of its opposition to summary judgment of infringement, Trudell argued that it was afforded no opportunity to depose Collins regarding the declaration and was therefore prejudiced by the allowance of the testimony. Trudell argued that the admitted testimony also exceeded the scope of the declaration and was “untethered from the district court’s claim constructions.”

The Federal Circuit agreed, finding that the district court abused its discretion in allowing Collins’s noninfringement testimony because D R Burton did not disclose Collins’ noninfringement opinion in a timely expert report as required by Rule 26. Regarding the declaration, the Court found that it was submitted a month after the close of discovery and therefore was not timely served. The Court concluded that the proper remedy was exclusion of Collins’ noninfringement testimony absent a showing that the failure to disclose was either substantially justified or harmless.

The Federal Circuit affirmed the denial of Trudell’s post-trial motion seeking a finding of infringement. While the Court agreed that without Collins’ testimony there was minimal evidence to support noninfringement, the jury would still have been free to discredit the testimony of Trudell’s [...]

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It’s Obvious: Erroneous Claim Construction Can Be Harmless

by | Feb 13, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness determination even though it found the Board had improperly construed a claim term, because the Court found the error harmless in the context of the prior art. HD Silicon Solutions LLC v. Microchip Technology Inc., Case No. 23-1397 (Fed. Cir. Feb. 6, 2025) (Lourie, Stoll, Cunningham, JJ.)

During a 2022 inter partes review (IPR), the Board determined that all but one of the 17 challenged patent claims were unpatentable as obvious in light of a prior patent (Trivedi) and other secondary prior art. The patent described methods of creating “a local interconnect layer in an integrated circuit” using two films. The independent claim recited a first film composed of titanium nitride and a second film as “comprising tungsten.” The Board construed “comprising tungsten” to include either elemental tungsten or tungsten-based compounds. The Board also found that the Trivedi patent disclosed films comprising either elemental tungsten or tungsten compounds. Thus, the Board held that all claims except one were obvious in light of Trivedi and that a person of ordinary skill in the art would have been motivated to combine Trivedi with other prior art. The patent owner appealed, arguing that the Board’s obviousness finding was dependent on the Board’s incorrect construction of the phrase “comprising tungsten.”

The Federal Circuit agreed that the Board’s claim construction was erroneous, because the term “comprising tungsten” required elemental tungsten. The Court explained that the claims explicitly used compound names when referring to compounds, such as “titanium nitride.” Thus, when the drafters wrote “comprising tungsten” without more, they clearly intended to exclude non-elemental tungsten options. The Court also noted that the patent specification used “tungsten” to reference only elemental tungsten and used the word “based” to encompass both elements and their compounds. For example, the patent discussed “chlorine-based” and “fluorine-based” components. Thus, the Court concluded that the claim drafters knew how to delineate when terms should include compounds, and that there was no such delineation in the term “comprising tungsten.”

The Board relied on a single sentence in the patent that stated: “the second film may comprise tungsten, for example,” to support its construction. The Federal Circuit rejected such a broad reading of this language, explaining that it only provided for impurities mixed among the elemental tungsten in the second film, rather than the film comprising a tungsten compound. The Board also cited a European Union (EU) patent in support of the construction that “comprising tungsten” explicitly included tungsten compounds. The Court stated that such extrinsic evidence was insufficient to overcome the asserted patent’s intrinsic teachings.

The Federal Circuit analyzed whether the Board’s obviousness holding could stand given its erroneous construction. The Court found that because the Board determined that Trivedi disclosed layers made of a tungsten compound and elemental tungsten, the patent claims were obvious when the disputed term was properly construed to be limited to elemental tungsten. Thus, the Board’s error was harmless.



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Eye-Catching: Biosimilars Injunction Prevails

by | Feb 6, 2025 |

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a preliminary injunction, finding that there was a proper exercise of personal jurisdiction and that no substantial question of invalidity had been raised for the patents at issue that would prevent the injunction from issuing. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 24-1965 (Fed. Cir. Jan. 29, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)

Regeneron holds a Biologics License Application for Eylea®, a therapeutic product containing aflibercept (a VEGF antagonist used in various treatments for eye diseases). Regeneron owns multiple patents related to its Eylea® product, including a patent directed to intravitreal injections using VEGF formulations. Mylan, Samsung Bioepis (SB), and other companies filed abbreviated Biologics License Applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval to market Eylea® biosimilars. Regeneron brought suit against these parties asserting infringement of its patent and filed a motion for a preliminary injunction.

The district court granted the preliminary injunction against SB, enjoining it from offering for sale or selling the subject of its aBLA without a license from Regeneron. SB appealed, arguing that:

  • The exercise of personal jurisdiction over it was improper.
  • There was a substantial question of invalidity of the patent under either obviousness-type double patenting or lack of adequate written description.
  • There was no causal nexus established.

The Federal Circuit upheld the exercise of personal jurisdiction on SB, finding that SB had minimum contacts with the state of West Virginia. SB is headquartered in South Korea and entered into a development and commercialization agreement with Biogen for a biosimilar to Eylea®, SB15, that gives SB continuing rights and responsibilities as the agreement is implemented. The Court found that SB did not have to distribute the product itself under the agreement for it to be subject to personal jurisdiction. Further, the Court found that SB’s aBLA and internal documentation indicated an intent to distribute SB15 US-wide, which was sufficient to establish intent to distribute the product in West Virginia.

The Federal Circuit also upheld the district court’s grant of the preliminary injunction. SB invoked another patent in the same family as the asserted patent that was directed to an intravitreal injection containing a VEGF trap as the reference patent for an obviousness-type double patenting theory. The Federal Circuit upheld the district court’s findings that the stability requirement, the “glycosylated” requirement, and the “vial” limitations in the claims of the asserted patent were all patentably distinct from the reference patent. The Court found that the stability requirement recited in the asserted patent was more specific than, and not inherent within, the reference patent. The Court further agreed that the reference patent embraced both non-glycosylated and glycosylated aflibercept, not only the glycosylated aflibercept contained in the asserted patent claims.

The Federal Circuit then addressed SB’s arguments that the specification lacked sufficient written description for the claimed [...]

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