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Results for "Patent application"
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Sole Searching: Trade Dress Hopes Booted as Functional, Nondistinctive

by | Apr 25, 2024 |

The US Court of Appeals for the Fourth Circuit affirmed a district court’s summary judgment grant in a trademark dispute, finding that the district court did not err in concluding that a subset of design elements lacked distinctiveness in the public’s view. TBL Licensing, LLC v. Katherine Vidal, Director of the United States Patent and Trademark Office, Case No. 23-1150 (4th Cir. Apr. 15, 2024) (Quattlebaum, Gregory, Benjamin, JJ.)

TBL Licensing is commonly known as Timberland, the prominent footwear manufacturer. Timberland tried to register specific design elements of its popular boot as protected trade dress with the US Patent & Trademark Office (PTO). In its application, Timberland provided a detailed written description of the boot design elements it sought to register as protectable trade dress. Timberland also included a drawing of these design elements.

The PTO rejected Timberland’s application, finding that the design was functional and lacked distinctiveness. Timberland appealed to the Trademark Trial & Appeal Board, which affirmed. Timberland then challenged the Board’s decision in the US District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because Timberland’s design was functional and had not acquired distinctiveness. Timberland appealed.

Timberland argued that the district court improperly segmented the design during its functionality analysis. Timberland argued that the district court failed to meaningfully consider the design as a whole, and even if it did, the court erred in considering specific factors, including the availability of alternative designs and the design’s simplicity in manufacturing. The court also relied on inapposite patents and advertisements as evidence to support its functionality finding, an analysis that Timberland argued was improper.

The Fourth Circuit affirmed the district court’s decision. While acknowledging the potential error in the district court’s failure to analyze the design holistically, the Court ultimately found that the limited design elements Timberland sought to register lacked secondary meaning – a crucial element for trade dress protection. The Court employed a secondary meaning analysis to assess public perception of Timberland’s design and considered various factors, including advertising expenditures, consumer studies, sales success, unsolicited media coverage, attempts at imitation and length of exclusive use.

Applying each factor, the Fourth Circuit determined that the district court did not clearly err in finding that the design elements lacked distinctiveness. The Court explained that the district court highlighted flaws in Timberland’s consumer survey, noting suggestive questions and a lack of focus on the claimed design features. The district court also emphasized that Timberland’s advertising expenditures did not effectively link the claimed design features with Timberland in consumers’ minds. Timberland’s arguments regarding sales success, media coverage and attempts at plagiarism were also found insufficient to establish secondary meaning. Lastly, the presence of similar-looking boots from other manufacturers undermined Timberland’s claim of exclusivity in using the design.

Lacking direct consumer survey evidence, the Fourth Circuit determined that Timberland’s circumstantial evidence failed to [...]

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Drawing Can Teach Claim Limitations If “Clear on Its Face”

by | Apr 18, 2024 |

Addressing when a drawing in a prior art reference includes a teaching that is “clear on its face,” the Director of the US Patent & Trademark Office vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) petition. MAHLE Behr Charleston Inc. v. Catalano, IPR2023-00861 (PTAB Decision Review, Apr. 5, 2024) (Vidal, PTO Dir.)

MAHLE Behr filed a petition requesting institution of an IPR, challenging claims of a patent owned by Catalano. The patent is directed to a device known as a sacrificial anode that prevents corrosion in motor vehicle radiators caused by electrolysis. One of the claim terms at issue requires the anode to be “within 10 inches” of another element. MAHLE argued that a figure in a prior art reference anticipated or rendered obvious several challenged claims.

The Board denied the institution after determining that MAHLE did not establish a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. The Board cited the Federal Circuit’s 2000 decision in Hockerson-Halberstadt v. Avia Group International to explain that “[p]atent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” The Board concluded that the figure relied on by MAHLE did not provide exact dimensions and thus could not be sufficient to render the claims invalid.

MAHLE filed a request for Director Review, which was granted. In its request, MAHLE argued that the Board erred in its application of Federal Circuit case law on the use of patent drawings as prior art teachings. The Director agreed, explaining that “the Board did not adequately address [MAHLE’s] arguments regarding what [the figure in the prior art] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” Federal Circuit case law established that a claim may be anticipated or rendered obvious by a figure in the prior art if the drawing clearly discloses the claim limitation. If “a person of skill in the art could derive the claimed dimensions from the patent’s disclosure, there is no additional requirement that the specification must explicitly disclose the precise proportions or particular sizes.”

The Director further explained that “the Board did not adequately address MAHLE’s arguments regarding what [the prior art figure] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” While the prior art figure did not disclose the precise proportions or measured quantity specified in the challenged claims, the figure showed the elements being located as claimed (necessarily within the 10 inches recited). The Director explained that the Board should have considered whether a person of ordinary skill in the art would have understood the figure to disclose the claimed elements being within 10 inches of each other.

The Director vacated the Board’s decision and remanded the petition with instructions to consider both what the prior art figure [...]

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What Use Does § 271(e)(1) Safe Harbor “Solely” Protect?

by | Apr 4, 2024 |

The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of transcatheter heart systems while attending a trade conference, finding the importation reasonably related to submitting information to the US Food & Drug Administration (FDA) for medical device approval. Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Case No. 22-1877 (Fed. Cir. Mar. 25, 2024) (Stoll, Cunningham, JJ.) (Lourie, J., dissenting).

The fact pattern in this case is unusual. Meril, a manufacturer of a transcatheter heart system approved for sale in Europe but not in the United States, brought two demonstration samples to San Francisco with lawyer-generated instructions that the samples could not be used, sold or offered for sale in the US. Meril presented at a trade booth during a cardiovascular medical device conference. It was undisputed that the samples never left a bag that was first kept at a hotel and later brought to the conference and placed in a storage room.

Edwards Lifesciences nevertheless sued for infringement based on importation. The district court found that Meril’s importation was reasonably related to its attempts to secure regulatory approval because they were for the purposes of recruiting investigators for a clinical trial Meril had made initial efforts to commence (as required to market this type of device in the US). Accordingly, the district court granted summary judgment of noninfringement on grounds that the safe harbor under § 271(e)(1) applied. Edwards appealed.

Edwards argued that the district court erred by not finding a genuine material dispute of fact relating to Meril’s subjective intent (i.e., whether, notwithstanding some evidence, Meril actually intended the importation to relate to FDA approval). Edwards also challenged whether the importation was solely related to FDA approval and argued that the non-use of the devices to recruit investigators rendered the safe harbor inapplicable.

The Federal Circuit rejected all three challenges. Canvassing the Federal Circuit’s decades of prior case law, the Court concluded that a putative infringer’s intent is irrelevant when determining whether the safe harbor applies. Thus, even if Edwards were correct in challenging Meril’s intent, there would still be no material factual dispute. On the issue of whether the importation activity was solely related to FDA approval, the Court, discussing the use of “solely” in terms of the safe harbor provision, reiterated prior cases’ determination that the uses need not be solely related to FDA approval, but rather, that the only uses that would be protected were those within the safe harbor. Finally, the Court again deemed the non-use of the devices irrelevant, as nothing in the statute required actual use.

Judge Lourie dissented, not because he necessarily viewed the district court’s or the majority’s application as squarely incorrect under existing precedent, but because he believed that existing precedent did not expressly give proper weight to the statute’s use of the word “solely.” Applying a plain text analysis, Judge Lourie argued that the safe harbor [...]

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New PTAB Claim Construction? Give the Parties Review Opportunity

by | Mar 28, 2024 |

The US Patent & Trademark Office (PTO) Director vacated Final Written Decisions issued by the Patent Trial & Appeal Board that presented a sua sponte construction of a claim term in dispute, holding that the parties were not provided adequate notice of the Board’s new construction. Assa Abloy AB v. CPC Patent Technologies Pty., Ltd., IPR2022-01006, -01045, -01089 (PTAB Decision Review Mar. 15, 2024) (Vidal, PTO Dir.)

The Board issued Final Written Decisions in three inter partes reviews (IPRs), holding that the petitioner failed to demonstrate that any of the challenged claims were unpatentable. The petitioner requested Director Review, raising three issues concerning the Final Written Decisions’ treatment of the claim term “biometric signal”:

  1. The Board’s construction newly added a limitation that neither the petitioner nor the patent owner proposed
  2. The Board’s construction was erroneous
  3. The Board inconsistently addressed this claim limitation among the IPRs at issue.

The Director decided that review was appropriate.

The Director explained that in view of the petitioner’s and patent owner’s divergent post-institution positions regarding this limitation, the Board had authority to construe “biometric signal” even though its institution decisions indicated that the Board would give this claim term its plain and ordinary meaning. The petitioner argued that the term meant “the input and output of the biometric sensor,” and the patent owner argued that the term meant a “physical attribute of the user” (i.e., a fingerprint, facial pattern, iris, retina or voice). The Board held that it meant “a physical or behavioral biometric attribute that provides secure access to a controlled item.”

The Director vacated and remanded the Final Written Decisions, explaining that the Board failed to provide the petitioner and the patent owner reasonable notice of its new construction or the opportunity to present arguments concerning it, as required under the Administrative Procedure Act (APA). The Director noted that neither party requested the Board’s inclusion of a construction that required an attribute of the claimed signal to “provide[] secure access to a controlled item” and concluded this was the sort of “difficult to imagine” sua sponte construction that the US Court of Appeals for the Federal Circuit held (in its 2021 decision in Qualcomm v. Intel) lacked sufficient notice if appearing for the first time in a Final Written Decision.

The Director instructed that on remand the Board should authorize the petitioner to file a supplemental briefing that addresses the Board’s construction and its application to the asserted prior art and authorize the patent owner to respond to the petitioner’s supplemental briefing.

The Director also noted that the patent owner’s proposed claim construction in the IPRs was similar to the construction that the Board adopted in its institution decisions in other IPRs challenging two of the patents at issue. In recognition of this situation, the Director also invited the petitioner, in its supplemental briefing, to address the perceived inconsistencies in these claim constructions.



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District Court Subpoena Power Plays “Supporting Role” to PTO Rules

by | Mar 21, 2024 |

Addressing the subpoena power of district courts to compel evidence for use in US Patent & Trademark Office (PTO) proceedings, the US Court of Appeals for the Fourth Circuit upheld a district court’s decision (albeit on alternative grounds), holding that district courts’ authority to issue subpoenas in support of PTO proceedings is limited by the PTO Rules of Procedure. Xactware Solutions, Inc. v. Buildxact Software Ltd., Case No. 22-1871 (4th Cir. March 13, 2024) (Gregory, Harris, Floyd, JJ.)

Buildxact, an Australian company, filed a trademark application at the PTO for BUILDXACT. Xactware opposed the BUILDXACT application at the Trademark Trial & Appeal Board and requested to depose three of Buildxact’s officers via video. When Buildxact objected indicating it would only allow written depositions (citing the PTO rules, which state that foreign depositions must be in writing unless the parties stipulate otherwise or the deposing party shows good cause), Xactware subpoenaed Buildxact through service on Buildxact’s default agent – the PTO Director – for an in-person deposition of a Buildxact corporate representative.

Buildxact filed a motion in the district court to quash the subpoena. The district court magistrate judge granted Buildxact’s motion, finding that Buildxact, which has no office, employees, or regular business in or near Virginia, did not have sufficient contacts to qualify as “being within” the district. Xactware moved for a review of the order, but the district court agreed with the magistrate judge’s ruling. Xactware appealed.

Pursuant to 35 U.S.C. § 23, the PTO may establish its own rules for depositions in cases before the Board. Additionally, 35 U.S.C. § 24 grants the “clerk of any United States court for the district wherein testimony is to be taken for use in any contested case in the Patent and Trademark Office” the power to “issue a subpoena for any witness residing or being within such district, commanding him to appear and testify before an officer in such district authorized to take depositions and affidavits.”

Xactware argued that Buildxact is “within” the district because it has an agent designated to receive service of process there (i.e., the PTO Director). The PTO argued that even if Buildxact were “within” the district, the subpoena must still be quashed as the deposition was improper under the PTO rules. The Fourth Circuit agreed, noting that it consequently need not address whether Buildxact was “within” the district or not.

The Fourth Circuit held that the district court lacked the authority to issue a subpoena compelling Buildxact’s deposition because the deposition being sought was prohibited by PTO rules and would not be admissible in any PTO proceeding. Looking at the legislative history, the Fourth Circuit noted that the district court’s subpoena power under § 24 is only available to the extent the courts are empowered to aid the PTO: “Section 24 assigns a supportive role to the district courts to ensure the smooth functioning of the [PTO] procedures.” Moreover, the explicit language of § 24 requires that a district court can only subpoena testimony “for use [...]

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Be Cool: Don’t Construe the Construction

by | Mar 21, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision after concluding that the patent owner’s proposed construction would require the parties to construe the construction. CoolIT Systems, Inc. v. Katherine Vidal, Director of the United States Patent & Trademark Office, Case No. 22-1221 (Fed. Cir. March 7, 2024) (Lourie, Bryson, Stark, JJ.) (nonprecedential).

CoolIT Systems owns a patent directed to a system for fluid heat transfer to cool electronic devices. The patent focuses on a heat exchange system comprising various components including a heat sink, a housing member and a compliant member. The patent claims priority from two provisional applications. Asetek Danmark petitioned for inter partes review (IPR) of the patent based on anticipation and obviousness. During the IPR proceeding, the parties disputed the meaning of the term “matingly engaged,” a term introduced in the later provisional application. To preserve validity, CoolIT argued that the term should be construed narrowly to mean “mechanically joined or fitted together to interlock.” Asetek sought a broader construction of “joined or fitted together to make contact,” which would encompass all methods of joining two surfaces.

The Board found both interpretations extreme and partially construed the term as being satisfied when at least a portion of the compliant member fits within the recessed region of the housing member. Despite agreement on the term “mate” to mean “join or fit together,” there was disagreement on the term “engage.” However, the Board did not determine whether “matingly engaged” could encompass forms of engagement beyond fitting.

The Board found that the cited prior art suggested a compliant member fitting the housing, thus rendering the claims obvious. CoolIT appealed. The US Patent & Trademark Office (PTO) intervened after Asetek withdrew from the appeal based on settlement.

CoolIT argued that the Board’s interpretation was flawed, and that the prior art did not meet the requirements of the “matingly engaged” limitation irrespective of the interpretation adopted. CoolIT contended that its proposed construction aligned with the invention’s purpose and properly distinguished between the 2007 and 2011 provisional applications. CoolIT also argued that the compliant member must partition features to control coolant flow, necessitating a specific type of joining or fitting.

In response, the PTO argued that CoolIT’s proposed construction read limitations from the specification into the claim. The PTO contended that neither the claims nor the specification required “interlock” and disputed CoolIT’s interpretation of the 2007 provisional application. The PTO did not propose an alternative construction, however.

The Federal Circuit concluded that “matingly engaged” should properly be construed as “mechanically joined or fitted together,” as that construction accurately reflected the term’s meaning and aligned with arguments presented by both parties. The Court rejected CoolIT’s proposal to add the word “interlock” because it would cause more confusion than clarity, noting that even CoolIT and the PTO still disagreed over what the term “interlock” meant and thus adding that term to the construction would provide little guidance.

The Federal Circuit found that the Board [...]

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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

by | Mar 7, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

  • The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
  • Ikan’s counsel [...]

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Uncle Sam Can March In: Government Licenses Under Bayh-Dole Aren’t Subject to “Strict Timing Requirements”

by | Feb 22, 2024 |

In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the government for federally funded research based on work that occurred prior to the effective date of a funding agreement. University of South Fl. Board of Trustees v. United States, Case No. 22-2248 (Fed. Cir. Feb. 9, 2024) (Reyna, Taranto, Stoll, JJ.)

University of South Florida (USF) owns a now-expired patent directed to transgenic mice expressing a certain gene causing an accelerated pathology for Alzheimer’s disease. The patent’s subject matter was conceived while the two named inventors worked at USF, but both inventors transitioned their work to the Mayo Clinic prior to the first actual reduction to practice of the claimed invention. The mice remained at USF, under the care of USF professors, while the named inventors continued to oversee the project from Mayo. The first actual reduction to practice occurred while the inventors were at Mayo.

While the named inventors were still at USF, one inventor submitted a grant application to the National Institutes of Health (NIH). The NIH awarded the inventors (while they were still at USF) a grant covering the mouse project. After the inventors moved to Mayo but prior to the award grant, the designated grantee changed from USF to Mayo. In November 1997, Mayo and USF entered into a subcontract whereby Mayo would pay USF for grant-covered work occurring at USF.

USF sued the United States alleging infringement of the mouse patent by a third party with the government’s authorization and consent. The third party was producing and using mice covered by the patent for the government. The US asserted a license defense under the Bayh-Dole Act, which gives the government a license to practice certain federally funded inventions. The Claims Court granted judgment to the US under its license defense, determining that USF operated pursuant to an implied contract with Mayo based on the understanding that Mayo would use funding from the NIH grant to pay USF for work done there. The Claims Court therefore determined that USF was a contactor with an implied subcontract that was a funding agreement under Bayh-Dole. Since the invention was therefore invented by a government contractor operating under a funding agreement, it was a “subject invention” that was first actually reduced to practice under a government contract. Therefore, under Bayh-Dole, the government was entitled to a license. USF appealed, arguing that the invention was not a “subject invention” within the meaning of § 202(c)(4) of Bayh-Dole.

USF argued that to trigger § 202(c)(4), a funding agreement must be in place at the time of the relevant work and there was no implied agreement in April 1997, the time the work that led to the reduction to practice commenced. The Federal Circuit determined that the November 1997 subcontract was adequate to support entitlement to claim a government license under § [...]

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No Home Away From Home: Federal Circuit Confirms PTO Domicile Requirements

by | Feb 22, 2024 |

The US Court of Appeals for the Federal Circuit confirmed the US Patent & Trademark Office’s (PTO) refusal to register a trademark based on the applicant’s failure to comply with the domicile address requirement of 37 C.F.R. §§ 2.32(a)(2) and 2.189. In re Chestek PLLC, Case No. 22-1843 (Fed. Cir. Feb. 13. 2024) (Lourie, Chen, Stoll, JJ.)

Chestek included only a PO box for its domicile address in its trademark application. The PTO found this information noncompliant with the domicile address rule, which requires trademark applicants to either have a domicile within the United States or be represented by US counsel. The PTO implemented the requirement in 2019 following a notice-and-comment period. Chestek appealed the PTO’s refusal to register based on the Administrative Procedure Act (APA) and challenged the processes surrounding implementation of the domicile address requirement.

Chestek first argued that the requirement was improperly instituted because the PTO failed to comply with the notice-and-comment rulemaking requirement under 5 U.S.C. § 533 by failing to provide notice of the domicile address requirement adopted in the final rule. However, the Federal Circuit held that the formalities of the notice-and-comment were not required under § 533(b)(A) because the rule was procedural, not substantive (i.e., effecting a change in existing law or policy that affects individual rights and obligations). As the Court explained, the rule did not affect the substantive trademark standards used during examination to evaluate applications but was simply an applicant information requirement.

Chestek next argued that the domicile address requirement was arbitrary and capricious because in implementing the final rule, the PTO “offered an insufficient justification for the domicile address requirement” and failed to consider important repercussions of the requirement, such as its effects on privacy. The Federal Circuit rebuffed that argument, explaining that the domicile requirement and the explanations given for it (determining whether the US attorney requirement applied) were “at least reasonably discernable.” The Court stated that as long as an agency does not give “almost no reason at all” for a new policy, the change is sufficiently justified and not arbitrary or capricious. The Court also noted that the APA does not require an agency to consider and respond to every impact of a proposed policy change.



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Rules of Evidence Require Weighing Relevance of Evidence Against Potential Prejudice

by | Feb 8, 2024 | ,

The US Court of Appeals for the First Circuit affirmed the exclusion of a drug patent in a medical malpractice case, finding that the highly technical language of the patent would more likely confuse a lay jury than be probative of the issues in the case. Ward v. Schaefer, Case No. 22-1547 (1st Cir. Jan. 29, 2024) (per curiam).

In 2018 Edmund Ward sued his doctor, Ernst Schaefer, claiming that Dr. Schaefer had fraudulently induced Ward to participate in an experimental drug protocol and had otherwise failed to obtain his informed consent. Ward was born with a rare genetic disorder that caused his body to not produce a blood enzyme, lecithin-cholesterol acyltransferase (LCAT), that is critical for cholesterol production. As a result, Ward was at risk of kidney failure and would require either regular dialysis or a kidney transplant. When Ward met Dr. Schaefer, Ward’s condition was deteriorating. Dr. Schaefer suggested that Ward might be a suitable candidate for an experimental enzyme therapy with a drug called ACP-501, and Ward, under an expanded access application, was granted permission to start an experimental protocol.

Ward traveled from his home in Massachusetts to a National Institutes of Health (NIH) facility in Bethesda, Maryland, to receive infusions of ACP-501 and was monitored by Dr. Schaefer in Massachusetts. Unfortunately, Ward’s condition did not improve under the experimental protocol but instead worsened because he was compelled to delay dialysis treatments while using ACP-501. Ward stopped the experimental protocol; began regular dialysis; and sued Dr. Schaefer, the NIH doctors and the drug manufacturer. The district court dismissed the claims against most of the plaintiffs, but the claims of fraud and failure to obtain informed consent against Dr. Schaefer went to trial. Ward’s signed consent form was admitted into evidence at trial, but he claimed he had no memory of discussing it with his doctors or signing it. The jury found in favor of Dr. Schaefer on all claims. Ward appealed.

Ward argued that the court erred in refusing to allow the introduction of the patent for ACP-501 because the patent specified that it was a method for reducing arterial cholesterol in patients not suffering from LCAT deficiency. Ward argued that this language in the patent made clear that the drug was not appropriate for patients like him. The district court ruled that the patent was inadmissible because it had been offered without foundation, and that it had nothing to do with the issues of fraud and informed consent. On appeal, the First Circuit offered a different analysis but arrived at the same outcome, holding that the Fed. R. Evid. 403 balancing test “disposes of the matter.”

The First Circuit noted that the patent’s description of ACT-501 “is of absolutely no relevance to Dr. Schaefer’s alleged failure to apprise Ward of the potential risks and rewards of taking the drug through expanded access.” The Court went on to point out that even if the single sentence in the patent pointing to its exclusion for patients with LCAT [...]

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