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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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Bottling the Truth: Equivalence and Reverse Equivalence

by | Jan 30, 2025 |

The US Court of Appeals for the Federal Circuit ruled that the “substantially the same way” comparison in connection with a doctrine of equivalents (DOE) analysis involving a means-plus-function claim limitation should focus on the overall structure corresponding to the claimed function, not on unclaimed structure. Steuben Foods, Inc. v. Shibuya Hoppmann Corp., Case No. 23-1790 (Fed. Cir. Jan. 24, 2025) (Moore, Hughes, Cunningham, JJ.)

Steuben Foods holds patents for an aseptic bottling system designed to sterilize and fill bottles with foodstuffs at speeds exceeding 100 bottles per minute, making the technology suitable for high-volume food production. Steuben sued Shibuya for infringing its patents. At trial, Steuben successfully demonstrated that Shibuya’s aseptic bottling system infringed a patent claim related to a “second sterile region,” a feature designed to pre-sterilize a valve mechanism and prevent contamination. The jury awarded Steuben more than $38 million in damages and, in doing so, rejected Shibuya’s defense under the reverse doctrine of equivalents (RDOE). The RDOE is a rarely invoked defense that is asserted when an accused product, although meeting the literal terms of a claim, operates on fundamentally different principles and thus does not infringe. Despite the jury’s verdict, the district court granted judgment as a matter of law (JMOL) of noninfringement, holding that Shibuya’s RDOE defense precluded infringement. Steuben appealed.

The Federal Circuit reversed the JMOL based on the RDOE, finding that the district court improperly weighed evidence that should have been left to the jury. The Court emphasized that Steuben’s expert testimony constituted substantial evidence supporting the jury’s findings and warranted deference. The Court also rejected Shibuya’s narrow construction of the claimed “second sterile region,” which would have excluded food flow, and affirmed the broader interpretation adopted by the district court (an interpretation the Court noted better aligned with the claim language).

The Federal Circuit noted that it had “previously described RDOE as an ‘anachronistic exception, long mentioned but rarely applied.’” While the Court declined to definitively rule on the RDOE’s continued viability under the Patent Act of 1952, it favorably noted Steuben’s argument that “if a device literally falls within the scope of a claim, but the accused infringer believes the claim is too broad and its device should not infringe, the appropriate recourse is a § 112 challenge, not a claim of noninfringement under RDOE.” In this case, the Federal Circuit concluded that even if Shibuya had made a prima facie case under RDOE that the principle of operation of the accused product was so far removed from the asserted claim, “the jury’s verdict should not have been overturned under RDOE because [Steuben’s expert] provided rebuttal testimony that the jury was entitled to credit. JMOL of noninfringement was therefore improper.”

The district court had also analyzed whether, under the DOE, claimed structures, such as conveyor plates and systems, were equivalent to Shibuya’s rotary wheels and neck grippers. The district court concluded they were not. The district court had construed the term “means for filling the aseptically disinfected plurality of bottles [...]

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Complex or Not Written Description Is Evaluated Against Claims

by | Jan 23, 2025 |

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents must be evaluated based on the claims themselves, not on their construction. In re Entresto, Case No. 23-2218 (Fed. Cir. Jan. 10, 2025) (Lourie, Prost, Reyna, JJ.)

Novartis owns an approved new drug application (NDA) for a combination therapy of valsartan and sacubitril that Novartis markets under the brand name Entresto®. The term “combination therapy” is used to describe pharmaceuticals where two or more active pharmaceutical ingredients are combined in a single method of treatment. Entresto® is protected by several patents, including the patent at issue. Several generic pharmaceutical manufacturers, including MSN, filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Entresto® prior to the expiration of Novartis’ patent. Novartis sued for infringement.

A unique property of Entresto® is the specific form taken by the active pharmaceutical ingredients, valsartan and sacubitril. The valsartan and sacubitril in Entresto® are present in what is known as a “complex,” meaning the two drugs are bonded together by weak, noncovalent bonds. At issue before the district court was the construction of the claim term “wherein said [valsartan and sacubitril] are administered in combination.” The inquiry focused on whether “in combination” required the valsartan and sacubitril to be chemically separated molecules (not in the form of a complex). The district court adopted Novartis’ proposal to give the term its plain and ordinary meaning because the intrinsic record was silent as to whether the molecules must be separate and not complexed. The complexed form of valsartan and sacubitril was not developed until four years after the priority date of the patent.

After the district court declined to adopt MSN’s “complexed” claim construction, MSN stipulated to infringement. The case proceeded to a bench trial on the issue of validity. The district court found the patent not invalid for obviousness, lack of enablement, and indefiniteness. However, the district court ruled that because the patent did not disclose the complexed form of valsartan and sacubitril, it was invalid for lack of written description. Novartis appealed.

Novartis argued that a complex of valsartan and sacubitril was an after-arising invention that need not have been enabled or described. The Federal Circuit agreed, finding that because the patent did not claim the complexed form of valsartan and sacubitril, those complexes need not have been described. The Court cited its “long-recognized” rule that “the invention is, for purposes of the written description inquiry, whatever is now claimed.” All that was required to meet the written description requirement was a disclosure sufficient to show that the inventors possessed a pharmaceutical composition comprising valsartan and sacubitril administered in combination. The Federal Circuit found that by considering what the claims were “construed to cover,” the district court improperly conflated the distinct issues of patentability and infringement. The Federal Circuit reversed the district court’s finding of invalidity for lack [...]

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A Lynk to the Past: Published Applications Are Prior Art as of Filing Date

by | Jan 23, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision finding challenged claims invalid based on a published patent application that, in an inter partes review (IPR) proceeding, was found to be prior art as of its filing date rather than its publication date. Lynk Labs, Inc. v. Samsung Electronics Co., Ltd., Case No. 23-2346 (Fed. Cir. Jan. 14, 2025) (Prost, Lourie, Stark, JJ.)

Samsung filed a petition for IPR challenging claims of a Lynk Labs patent. Samsung’s challenge relied on a patent application filed before the priority date of the challenged patent. However, the application was not published until after the priority date of the challenged patent. The Board rejected Lynk Labs’ argument that the application could not serve as prior art and determined the challenged claims to be unpatentable. Lynk Labs appealed to the Federal Circuit, raising three arguments.

Lynk Labs’ first argument was that the application could not serve as prior art because the publication date meant that it was not publicly available until after the priority date of the challenged patent. Pre-America Invents Act (AIA) law applied. Lynk Labs cited 35 U.S.C. § 311(b), restricting IPR petitioners to challenges “on the basis of prior art consisting of patents or printed publications.” While Lynk Labs admitted that the published application was a printed application, it denied that it was a prior art printed publication.

The Federal Circuit reviewed the issue de novo as a question of statutory interpretation. The Court noted that §§ 102(e)(1) and (2) carve out a different rule for published patent applications than the test for §§ 102(a) and (b) prior art. Under the statute, a patent application filed in the United States before an invention claimed in a later filed application qualifies as prior art if the application is published or a patent is granted on it.

Lynk Labs did not dispute that, under § 102(e)(2), an application resulting in an issued patent can be prior art, even if the patent is granted after an invention’s priority date, as long as the application is filed before the challenged invention priority date. However, Lynk Labs took issue with the fact that the Board applied the same principle, under § 102(e)(1), to applications that are published but do not become patents.

The Federal Circuit explained that the plain language of the statute permitted IPR challenges based on such applications and rejected Lynk Labs’ arguments that the statute should be interpreted differently. Lynk Labs argued that when Congress enacted § 311(b), it transplanted the term “printed publications” from case law, along with that case law’s “old soil” that established that the application would not be prior art.

In support of its argument, Lynk Labs cited case law that in its view suggested that patent applications are never prior art printed publications. However, the Federal Circuit distinguished those cases on the basis they were decided at a time before applications were published and therefore did not address published applications. Lynk [...]

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No Co-Inventorship Absent Corroborated Conception

by | Jan 23, 2025 |

In a patent case concerning cryptocurrency data mining, the US Court of Appeals for the Federal Circuit affirmed a district court’s grant of summary judgment and its ruling that a state law conversion claim was preempted by patent law of inventorship. The Court also affirmed the denial of a correction to the inventorship claim. BearBox LLC v. Lancium LLC, Case No. 23-1922 (Fed. Cir. Jan. 13, 2025) (Stoll, Chen, Bryson, JJ.)

BearBox was an entity founded by Austin Storms that developed and designed mobile cryptocurrency data centers. It operated a half-megawatt data center but was unprofitable as a consequence of the high cost of electricity and the data center’s high energy requirements. Lancium was an entity that aimed to co-locate data centers at wind farms to use the highly variable power generated for data mining but sell excess electricity to the grid when electricity cost was high. BearBox and Lancium met in 2019 at a cryptocurrency mining summit. At that time, BearBox was looking to find customers for its newly developed BearBox containers, and Lancium was in the market for those containers. Both BearBox and Lancium had developed similar software to detect profitable time periods for cryptocurrency mining. Their systems aimed to mine cryptocurrency during periods when electricity prices were low, while selling the energy to the grid when prices were high. Lancium disclosed these concepts in an international patent application filed 15 months before Storms met anyone at Lancium.

BearBox’s system was discussed over dinner at the summit and in a single email exchange afterwards. However, BearBox never disclosed any source code associated with the BearBox system to Lancium. The email exchange was the last communication between the two parties. About five months after the meeting, Lancium filed a patent application that related to a set of computing systems configured to perform computational operations using electricity from a power grid and to a control system that monitored a set of conditions and received power option data based at least in part on a power option algorithm. After that application matured into a patent, BearBox filed suit asserting sole or joint inventorship of the patent and conversion under Louisiana state law.

Lancium moved for summary judgment on the conversion claim. The district court granted the motion, noting that federal patent law preempted the claim. However, the district court denied Lancium’s motion for summary judgment on the inventorship claims – claims that were then heard at a bench trial. At trial, the district court concluded that BearBox failed to prove by clear and convincing evidence that BearBox’s founder, Storms, conceived any part of the claimed invention. BearBox appealed.

The Federal Circuit began by assessing the ruling on preemption of BearBox’s conversion claim. Relying on its 2005 decision in Ultra-Precision Mfg. v. Ford Motor, the Court noted that although the state law of conversion does not squarely implicate federal patent law, the way a conversion claim is pled may “[stand] as an obstacle to the accomplishment and execution of the full purposes [...]

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Bit Swap: Motivation to Modify Prior Art Needn’t Be Inventor’s Motivation

by | Jan 16, 2025 |

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision, finding that the challenged patent claims were obvious because a person of ordinary skill in the art (POSITA) would have been motivated to switch two specific information bits in a 20-bit codeword to improve performance. Honeywell Int’l Inc. v. 3G Licensing, S.A., Case Nos. 23-1354; -1384; -1407 (Fed. Cir. Jan. 2, 2025) (Dyk, Chen, JJ.) (Stoll, J., dissenting).

3G Licensing owns a patent concerning a coding method for transmitting a channel quality indicator (CQI) in mobile communication systems. The CQI, a five-bit binary integer (0 to 30) is sent from user equipment, such as a cell phone, to a base station to indicate cellular connection quality. Base stations adjust data rates using adaptive modulation and coding, assigning higher rates to strong signals and lower rates to weaker ones. CQI accuracy is critical for maximizing data transmission efficiency and ensuring recovery of the original message despite transmission errors.

The challenged claims of the 3G patent relate to a CQI code designed to maximize protection of the most significant bit (MSB) to reduce the impact of transmission errors. The prior art disclosed a method and a basis sequence table that provided additional protection to the MSB, minimizing root-mean-square error. However, the claimed invention differed in that it required swapping the last two bits of the basis sequence table. The Board found that a skilled artisan would not have been motivated to make this modification to enhance MSB protection, nor would a skilled artisan have deemed it desirable. Honeywell appealed.

The Federal Circuit reversed, finding the claims obvious for four primary reasons. First, the Court determined that the Board incorrectly concluded that a POSITA would not have been motivated to swap the last two bits to improve MSB protection. The Court emphasized that the motivation to modify prior art does not need to align with the inventor’s motivation. As a result, the Board’s reasoning that minimizing root-mean-square error was not the patent’s primary purpose should not have been a primary consideration.

Second, the Federal Circuit found that prior art explicitly taught the importance of protecting the MSB through redundancy. A skilled artisan would have understood that swapping the two bits, as claimed, would add redundancy and enhance protection. Honeywell’s expert testimony further supported the conclusion that the prior art would have provided the requisite motivation to arrive at the claimed invention, and 3G’s expert did not dispute that the swap increased MSB protection.

Third, the Federal Circuit concluded that the Board improperly conflated obviousness with anticipation by requiring that the prior art disclose swapping the two bits. Anticipation requires the prior art to specifically disclose the claimed modification, but obviousness does not. The Court found that the Board erroneously treated the two standards as interchangeable.

Finally, the Federal Circuit found that the Board wrongly required that the claimed basis sequence table represent the preferred or most optimal combination. As the Court [...]

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Skilled Artisan’s View Is Decisive in Assessing Asserted Claim Drafting Error

by | Jan 16, 2025 | ,

The Court of Appeal (CoA) of the Unified Patent Court (UPC) clarified the legal standard for correcting obvious type inaccuracies in patent claims, explaining that the view of a skilled person at the filing date is decisive when assessing whether a patent claim contains an obvious error. Alexion Pharmaceuticals, Inc. v. Samsung Bioepis NL B.V., Case No. UPC_CoA_402/2024; APL_40470/2024 (CoA Luxembourg Dec. 20, 2024) (Grabinski, Blok, Gougé, JJ.; Enderlin, Hedberg, TJ.)

Alexion owns a European patent directed to a drug comprising an antibody that includes the “SEQ ID NO:4” amino acid sequence and that binds “complement component 5” (C5). The description refers to SEQ ID NO:4 as a sequence of 236 amino acids, and the claims also refer to SEQ ID NO:4. It is known in the state of the art that an antibody comprising the entire amino acid sequence, including amino acids forming a “signal peptide,” is unlikely to bind C5. Alexion sought provisional measures, arguing that Samsung infringed Alexion’s patent even though Samsung’s drug did not include the first 22 amino acids (i.e., the signal peptide in this case) of SEQ ID NO:4.

Originally, Alexion applied for the patent as granted but later requested to amend the claims to exclude the first 22 amino acids because of an obvious error during prosecution. The Technical Board of Appeal (TBA) of the European Patent Office (EPO) rejected the request and found that the requested amendment was not a correction of an obvious error.

The Court of First Instance similarly rejected Alexion’s request, although it found that Samsung made literal use of the patent. The Court of First Instance argued, contrary to the TBA, that the first 22 amino acids were meant to be excluded from SEQ ID NO:4 in the patent claim, and that this sequence was obviously not correctly reproduced in the view of a skilled person because otherwise the claimed drug would be unsuitable to bind to C5 (as was undisputed by the parties). However, the Court of First Instance rejected Alexion’s request for provisional measures against Samsung. The Court of First Instance clarified that it must consider not only its own claim interpretation but also the TBA’s different interpretation. Its rationale was that because it is the infringement-focused court, the Court of First Instance  should, before ordering provisional measures, consider whether the TBA, based on its interpretation, would revoke the patent in parallel proceedings because of insufficient disclosure under Article 83 of the European Patent Convention. Ultimately, considering the TBA’s claim interpretation, the Court of First Instance found that the patent’s validity was not certain to the extent required to provide provisional measures. Alexion appealed.

The CoA rejected Alexion’s appeal, finding that the Court of First Instance’s claim interpretation (i.e.,  excluding the first 22 amino acids from the claim ) was legally flawed. The CoA instead adopted the TBA’s claim interpretation and argued (on this point, not much different from the Court of First Instance) that the EPO was likely to revoke the patent. The [...]

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Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing

by | Jan 9, 2025 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or the active ingredient of the drug that was approved. Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al., Case No. 24-1936 (Fed. Cir. Dec. 20, 2024) (Prost, Taranto, Hughes, JJ.)

Teva owns the product that Amneal sought to delist, ProAir® HFA Inhalation Aerosol. The ProAir® HFA combines albuterol sulfate (the active ingredient) with a propellant and an inhaler device to administer the drug. Although the US Food and Drug Administration (FDA) approved Teva’s ProAir® HFA as a drug, the ProAir® HFA contains both drug and device components (the device components being the physical machinery of the inhaler). Teva lists nine nonexpired patents in the Orange Book for its ProAir® HFA.

Amneal filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of the ProAir® HFA that uses the same active ingredient. Amneal asserted that it did not infringe Teva’s nine patents listed for the ProAir® HFA. Teva sued for infringement of six of those patents. Amneal filed counterclaims for antitrust and for a declaratory judgment of noninfringement and invalidity and sought an order requiring Teva to delist the five patents that it asserted against Amneal. Amneal moved for judgment on the pleadings on the ground that Teva improperly listed the asserted patents. The district court granted Amneal’s motion, concluding that Teva’s patents “do not claim the drug for which the applicant submitted the application.” The district court ordered Teva to delist its patents from the Orange Book. Teva appealed.

On appeal, Teva argued that a patent can be listed in the Orange Book if the claimed invention is found in any part of its new drug application (NDA) product. Teva argued that a patent “claims the drug” if the claim reads on the approved drug (i.e., if the NDA product infringes that claim). Teva also argued that according to the Federal Food, Drug, and Cosmetic Act’s broad definition of the word “drug,” any component of an article that can treat disease meets the statutory definition of a “drug.” With this interpretation, Teva’s patents “claim the drug” as the claim dose counter and canister components of the ProAir® HFA.

The Federal Circuit rejected Teva’s interpretation as overbroad because it would allow the “listing of far more patents than Congress has indicated.” The Court rejected Teva’s argument that a patent claiming any component of a drug is listable, explaining that Teva cannot list its patents just because they claim the dose counter and canister parts of the ProAir® HFA.

The Federal Circuit also rejected Teva’s argument that even if Teva’s statutory arguments were rejected, the Federal Circuit must remand the case to the district court to construe the claims. In doing so, the Court rejected Teva’s interpretation of the word “claims” in the listing and counterclaim/delisting provisions, [...]

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