IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Results for "Patent application"
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The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

by | Feb 25, 2021 |

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., Case no.18-1876 (Fed. Cir. Feb. 9, 2021) PER CURIAM. The case concerns communications regarding generic approvals and “skinny labels,” which permit companies to sell pharmaceutical products that omit certain patented uses.

On Oct. 2, 2020, a panel of the Federal Circuit (PROST, C.J ., NEWMAN and MOORE, JJ.) issued an opinion finding that Teva induced infringement of a patent covering GlaxoSmithKline’s (GSK’s) drug Coreg® (carvedilol). In a per curiam Order, the Court has now vacated that opinion and set a new round of oral arguments that was held on February 23.

Teva had requested an en banc rehearing the case, which was denied in the Order vacating the Oct. 2, 2020 opinion while ordering panel rehearing limited to the following issue:

Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011.

Background

GSK’s patent covers a method of using carvedilol, the active ingredient in Coreg®, for the treatment of congestive heart failure. In 2007, the FDA approved Teva’s application to market generic carvedilol tablets. To obtain that approval prior to the expiration of the patent (or prevailing on noninfringement, invalidity, or unenforceability of the patent in litigation), Teva had “carved out” certain patent-protected left ventricular dysfunction uses and only included claims to treat hypertension, i.e., claims not covered by the GSK patent. That original patent expired in 2007, but it was reissued in 2008.

Teva had deliberately omitted congestive heart failure in its label until the FDA made it add that indication in 2011. In accordance with the Order, the February 23 oral argument focued on alleged infringement in the period before the label change, i.e., the period 2008 and 2011. The outcome is expected to turn on associated activities and statements made by Teva that went beyond the approval of the generic drug with skinny labeling, where Teva did not explicitly claim that their product was for the patent-protected uses.



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Patent Extension Requires Board or Court Reversal, Multiple Examiner Actions Not Enough

by | Feb 18, 2021 |

The US Court of Appeals for the Federal Circuit affirmed a grant of summary judgment for the Director of the US Patent and Trademark Office (PTO), holding that the statutory language authorizing so-called “C-delay” patent term adjustment requires an adverse patentability finding that is reversed by a court or the Patent Trial & Appeal Board. Chudik v. Hirshfeld, Case No. 20-1833 (Fed. Cir. Feb. 8, 2021) (Taranto, J.) C-delay adds to a patent’s term to account for delay experienced during appellate review of an adverse patentability finding. C-delay does not apply when the examiner reopens examination after final rejection (in this case, four times over an 11-year period) because appellate review is not triggered when an examiner, and not the Board or a court, undoes a final unpatentability decision by reopening examination.

Chudik filed a patent application, and the examiner rejected all pending claims as unpatentable. Chudik declined to appeal, instead filing a request for continued examination. Over the next eight years, the examiner issued four more final rejections. After each rejection, Chudik filed a notice of appeal and opening brief, and after each notice of appeal, the examiner reopened prosecution rather than answering the appeal. The patent finally issued more than 11 years after Chudik filed the application. The PTO added time to the term of the patent for A-delay (where the PTO fails to meet certain prescribed deadlines) and B-delay (each day that the patent application’s pendency extends beyond three years), but not C-delay.

The C-delay provision of the Patent Act provides for a patent term adjustment where the delay is due to “appellate review by the [Board] or by a Federal Court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability.” Chudik challenged the PTO’s calculation of the patent extension, arguing that he was entitled to C-delay patent term adjustment for the time his four notices of appeal were pending in the PTO. Chudik argued that the C-delay provision’s “appellate review” included the examiner’s decision to undo her final action through a reopening of prosecution. The PTO rejected that argument, concluding that the C-delay provision did not apply because the Board’s jurisdiction over the appeals never attached and no Board or reviewing court reversed an adverse determination of patentability.

Chudik then sued the PTO director in federal district court, again arguing that “appellate review” referred to the Board’s entire review process, starting when the notice of appeal is filed. Chudik also argued that “a decision in the review reversing an adverse determination of patentability” covered an examiner’s own decision, through a reopening of prosecution. Although characterizing it as “based on a reasonable construction of statutory text,” the court rejected Chudik’s challenge. Applying Chevron, the district court held that the PTO’s position must be affirmed because that position was reasonable. Chudik appealed to the Federal Circuit.

The Federal Circuit affirmed the district court’s decision, finding that the PTO’s interpretation of the C-delay provision’s statutory language was [...]

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2020 IP Law Year in Review: Patents

by and | Jan 28, 2021 |

Executive Summary

In 2020, the US Supreme Court and Court of Appeals for the Federal Circuit continued to refine key aspects of intellectual property law on issues that will have an impact on litigation, patent prosecution and business strategy. This Special Report discusses some of the most important decisions.

The Federal Circuit issued several panel decisions clarifying the bounds of patent-eligible subject matter in the area of life sciences and computer technology. In the life sciences space, the court found several patents satisfied the conditions for patent eligibility. For example, the Federal Circuit found patent-eligible claims directed to preparing a fraction of cell-free DNA enriched in fetal DNA, claims directed to a method of operating a flow cytometry apparatus with a number of detectors to analyze at least two populations of particles in the same sample to be patent eligible, and claims directed to a method of treating type 2 diabetes mellitus using a DPP-IV inhibitor. In the area of computer technology, the court clarified that claims directed to an improvement to computer networks were patent eligible, but that claims directed to applying longstanding commercial practices to generic computer components remain ineligible. Given the uncertainty of patent eligibility law, questions surrounding life sciences and computer-related technology will continue to be raised in cases.

The Supreme Court issued one decision in 2020, in which it found that the Patent Trial and Appeal Board’s application of the time bar for filing a petition for inter partes review (IPR) is not appealable. The Federal Circuit issued two en banc decisions, including one decision confirming discussing the use of the phrase “consisting essentially of” in patent claims and patent eligibility of mechanical inventions.

Following on the heels of the Supreme Court’s 2017 TC Heartland v. Kraft Foods decision addressing patent venue, the Federal Circuit addressed patent venue in Hatch-Waxman litigation. The court explained that for the purposes of determining venue, infringement occurs only in judicial districts where actions related to the submission of an abbreviated new drug application (ANDA) occur, and not in all locations where future distribution of the generic products specified in the ANDA is contemplated. This ruling may have far-reaching consequences, including the ability for ANDA defendants to effectively control venue for litigation.

Patents

  1. § 101 Decisions in 2020
  2. 2020 at the Supreme Court
  3. Arthrex Decision
  4. En Banc at the Federal Circuit – Two Contentious Denials
  5. The Federal Circuit Limits Venue for Hatch-Waxman Litigation

2021 Outlook

The Supreme Court is set to hear at least two patent cases and one copyright case this term. In The United States of America v. Arthrex, Inc., the Court will consider whether PTAB judges are unconstitutionally appointed and the other addressing whether assignor estoppel and in Minerva Surgical, Inc. v. Hologic, Inc., et al., the Court will consider whether the doctrine of assignor estoppel bars an assignor from asserting invalidity of an assigned patent in district court. [...]

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New or Not, Object-Oriented Simulation Patent Ineligible Under § 101

by | Jan 14, 2021 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s pleadings-stage determination that patent claims directed to an object-oriented simulation were subject matter ineligible under 35 USC § 101. Simio, LLC v. FlexSim Software Prod., Inc., Case No. 20-1171 (Fed. Cir. Dec 29, 2020) (Prost, C.J.).

Simio filed suit against FlexSim for infringement of patent claims directed to object-oriented simulations in which one instance of an object may have behaviors assigned to it without changing the generic object’s definition. FlexSim moved to dismiss the complaint under Fed. R. of Civ. P.12(b)(6), arguing that the patent was invalid under 35 USC § 101. The district court granted FlexSim’s motion to dismiss, finding that the asserted claims were directed to the ineligible abstract idea of substituting text-based coding with graphical processing and that FlexSim properly showed there was no inventive concept or alteration sufficient to make the system patent-eligible. Simio appealed.

The Federal Circuit reviewed the dismissal order and its underlying patent eligibility conclusions de novo. Under the two-step Alice/Mayo framework, the Court affirmed. Considering the first step of the Alice/Mayo framework, the Court agreed that the asserted claims were “directed to the abstract idea of using graphics instead of programming to create object-oriented simulations.” The Court rejected Simio’s argument that the “executable process to add a new behavior to an object instance” improved the functionality of the computer on which it ran, concluding that no improvement was made to the computer and that the claim limitation did not change the claim’s “character as a whole.” As to step two of the Alice/Mayo framework, whether the claim limited the abstract idea to an inventive concept, the Federal Circuit concluded that, while the claim may be directed to a new idea, it is still an abstract one lacking any inventive concept or application of the idea. The Court affirmed the district court’s dismissal.

The Federal Circuit next addressed whether the district court erred in denying Simio’s motion for leave to amend its complaint. The Court concluded that, after disregarding conclusory statements, Simio’s amended complaint just repackaged the same assertions of non-abstractness as the original complaint. Citing its holding in ShoppersChoice.com (IP Update, May 2020), the Court also rejected Simio’s argument that the district court should have conducted claim construction before determining eligibility. In ShoppersChoice.com, the Court held that pleadings-stage patent eligibility decisions may be proper when the patentee does not explain how a term’s construction could affect the analysis.

Finally, the Federal Circuit raised its own independent reasoning for denying Simio’s motion for leave to amend, explaining that it “may affirm on any grounds for which there is a record sufficient to permit conclusions of law, even grounds not relied upon by the district court.” The Court found that Simio failed to show good cause for seeking leave to amend after the scheduling order’s deadline. Namely, Simio’s amended complaint contained no facts that could not have been alleged before the deadline. Nor did Simio demonstrate any relevant [...]

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Printed Matter Is Patentable If It’s Functional, Not Just Communicative

by | Nov 19, 2020 |

In a tour de force of issues related to the printed matter doctrine, the US Court of Appeals for the Federal Circuit reversed various rulings that the patents-in-suit were not infringed, not willfully infringed and invalid as directed to printed matter. Instead, the Court held that there was substantial evidence in the record to support a jury finding of infringement and willfulness, and that the asserted claims were not directed solely to printed matter and thus were patent eligible under 35 USC § 101 (thereby raising a genuine dispute of material fact that precludes summary judgment as to anticipation). C R Bard Inc. v. AngioDynamics, Inc., Case Nos. 19-1756, -1934 (Fed. Cir. Nov. 10, 2020) (Reyna, J.)

This dispute began when Bard sued AngioDynamics for infringing three patents directed to identifying a vascular access port that is suitable for power injection, which is a medical procedure requiring injecting fluids into a patient at a high pressure and flow rate. Generally, the identification was accomplished by certain markings on the vascular access port that can be detected during an x-ray scan.

Prior to trial, AngioDynamics moved for summary judgment on patent eligibility, novelty and enablement. This summary judgment motion was initially denied, but the district court sought a report and recommendation prior to trial regarding whether certain limitations relating to radiographic marker images were entitled to patentable weight under the printed matter doctrine. The magistrate judge concluded that the limitations were not entitled to patentable weight, and the district court adopted the recommendation. At trial and at the end of Bard’s case-in-chief, AngioDynamics moved for judgment as a matter of law (JMOL) on non-infringement and no willfulness. Ultimately, the district court terminated the trial and granted AngioDynamics’ JMOL motion for non-infringement and no willfulness. The district court further held that the claims were invalid because they were directed to printed matter and were not inventive. Bard appealed, challenging each of the district court’s findings.

In reversing the summary judgment of no infringement, the Federal Circuit explained that Bard’s expert’s reliance on an incorrect understanding of the district court’s claim construction was alone insufficient to grant judgment as a matter of law. Instead, the expert’s misunderstanding went to credibility, and the Court found the record reflected that the expert properly testified that the various claim elements were met under the proper claim constructions. The Court further explained that Bard did not have an affirmative duty to test AngioDynamics products, but rather was entitled to rely on AngioDynamics’ representations to the US Food and Drug Administration and to its customers. With regard to induced infringement, the Court explained that if an alleged infringer instructs its users to use the product in an infringing way, there is sufficient evidence for a jury to find infringement. Because the district count found no inducement based on its erroneous summary judgment of no infringement, that ruling was similarly reversed.

The Federal Circuit also reversed the district court on its summary judgment of no willfulness, concluding that Bard [...]

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PTO Seeks Comments on Proposed Rulemaking for Denying Patent Reviews

by | Oct 29, 2020 | ,

The US Patent and Trademark Office (PTO) requested public comments on considerations for instituting trials under the Leahy-Smith America Invents Act (AIA). Comments are due by November 19, 2020.

Patent practitioners have grown accustomed to reviewing the PTO Patent Trial and Appeal Board (Board) administrative guide, precedential or informative opinions, and other published filings and decisions to discern best practices for filing petitions for and defending against inter partes review, post-grant review, covered business method and derivation proceedings before the Board. For example, the latest Board Consolidated Trial Practice Guide (Nov. 2019) (CTPG) is available here. The PTO is considering codifying or modifying its current policies and practices through formal rulemaking and wishes to gather public comments on its current approach and other approaches suggested by stakeholders.

PTO policies and Board decisions such as General Plastic, Valve Corp. I, Valve Corp. II, NHK Spring and Fintiv set forth factors for analyzing whether to institute an AIA proceeding (and particularly a follow-on or serial petition) or issue a discretionary denial due to the timeline for parallel district court proceedings. Many of these policies and cases are also discussed in the CTPG. The PTO already has received input from stakeholders on these policies that expand on the PTO director’s discretionary authority to institute an AIA trial. Most stakeholder comments suggested that the case-specific analysis outlined in precedential opinions and the CTPG achieves the appropriate balance and reduces gamesmanship—for example, by ensuring that AIA proceedings do not create excessive costs and uncertainty for the patent owner or the system, while allowing meritorious challenges to patents to be heard. However, some stakeholders have proposed that the PTO adopt brightline rules, regardless of the case-specific circumstances, to:

  • Use its discretion to preclude claims from being subject to more than one AIA proceeding
  • Permit more than one AIA proceeding only if the follow-on petitioner is unrelated to the prior petitioner
  • Place no limits on the number of petitions that can be filed or the number of AIA trials that can be instituted against the claims of a patent, so long as the petition complies with statutory timing requirements and the institution threshold of showing that at least one claim of the patent is unpatentable
  • Preclude institution of an AIA trial against challenged claims if the patent owner opposes institution and a related district court or US International Trade Commission (ITC) action (in which any of the challenged claims are or have been asserted against the petitioner, the petitioner’s real-party-in-interest or a privy of the petitioner) is unlikely to be stayed
  • Eliminate any consideration of the status of any district court or ITC actions involving the challenged patent, so long as the petition complies with statutory timing requirements and the institution threshold.

These contrasting views prompted the PTO to issue a request for comments on the factors that should be considered as part of a balanced assessment of the relevant circumstances when exercising its discretion to institute an AIA trial. The PTO [...]

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Only Human: Broadest Reasonable Interpretation Standard Applies to Intentionally Expired Patent

by | Oct 22, 2020 | ,

Affirming an invalidity finding by the Patent and Trial Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit found that the claims of the now-expired patent should be construed under the broadest reasonable interpretation (BRI) standard, and not under the Phillips standard, because the patent owner intentionally gave up the remainder of the patent term only after the appeal was fully briefed. Immunex Corp. v. Sanofi-Aventis U.S. LLC, Case Nos. 19-1749, -1777 (Fed. Cir. Oct. 13, 2020) (Prost, C.J.).

Immunex owns a patent directed to human antibodies that inhabit certain receptors to treat inflammatory diseases such as arthritis. After being sued for infringement, Sanofi and Regeneron (collectively, Sanofi) requested inter partes review (IPR) of the patent, which the PTAB instituted. Based on the IPR filing date and because the patent was unexpired during the pendency of the IPR proceeding, the PTAB used the BRI standard to construe various claim terms. Had the patent been expired, the PTAB would have used the more stringent Phillips standard to construe the claims. Ultimately, the PTAB found all of the challenged claims unpatentable. Immunex appealed.

After appellate briefing was complete, Immunex filed a terminal disclaimer of its patent. The US Patent and Trademark Office accepted the terminal disclaimer, and as a result the patent term expired approximately two months before oral argument. Immunex then filed a citation of supplemental authority informing the Federal Circuit of the terminal disclaimer and asking the Court to change the applicable claim construction standard from BRI to Phillips.

The Federal Circuit found that the application of the BRI standard to Immunex’s patent was appropriate. Although the PTAB currently applies the Phillips claim construction standard in all newly filed IPRs, at the time that Sanofi filed its IPRs, the PTAB applied the Phillips standard only to expired patents. For unexpired patents, it applied the BRI standard. The Court noted that the use of the Phillips standard in cases where the patent expired during the appellate process should not be an absolute, particularly when the patent term expired at an unexpected early date, such as through the filing of a terminal disclaimer.

The Federal Circuit further affirmed the PTAB’s claim construction under the BRI standard and the invalidity finding predicated on that claim construction. The issue on appeal was whether a “human antibody” must be entirely human (as asserted by Immunex) or whether it may also be “partially human,” including “humanized” (as asserted by Sanofi and construed by the PTAB). The Court agreed with the PTAB and found that the patent’s specification supported the conclusion that the BRI of “human antibody” “includes both fully human and partially human antibodies.” The Court also found that “human antibodies” in the context of the patent-in-suit is a broad category that encompasses both partially and completely human antibodies. The Court therefore affirmed the PTAB’s finding.

The Federal Circuit also commented on the PTAB’s departure from an earlier claim construction ruling by a district court in which “human” was construed to mean “fully [...]

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Senator Tillis Urges USPTO to Adopt Patent Reform Proposals

by | Aug 18, 2020 |

On August 10, 2020, Senator Thom Tillis of North Carolina urged the Director of the United States Patent and Trademark Office (USPTO), Andrei Iancu, to adopt two patent reform proposals suggested by Lisa Larrimore Ouellete and Heidi Williams. Senator Tillis is the Chairman of the Senate Judiciary Committee’s Subcommittee on Intellectual Property. Stanford University professors Lisa Larrimore Ouellete and Heidi Williams proposed the reforms in a paper, Reforming the Patent System, The Hamilton Project, Policy Proposal 2020-12 (June 2020).

The first proposed reform would require patent applicants to more clearly distinguish between hypothetical experimental results and actual experimental results. The USPTO allows applicants to include so-called “prophetic examples” in a patent application. The patent applicant is supposed to distinguish between prophetic examples and actual working examples by the verb tense used to describe the example. Prophetic examples should be described in the present or future tense, while working examples should be described in the past tense. However, the verb tense is not always clear. Moreover, the verb tense distinction may not be appreciated by foreign language translators, scientists and engineers, especially in countries where prophetic examples are not allowed. Ouellette and Williams proposed that prophetic examples in patent applications be clearly labeled. This would reduce confusion by the public. Senator Tillis noted that confusing data in patent applications could be used to mislead the public and pump up profits for a company that has little to offer the economy or the public.

The second proposed reform would require patent owners to disclose ownership of patents in a more transparent and standardized manner. The lack of a transparent and standardized recording of patent assignments increases the costs and uncertainties of freedom-to-operate searches, licensing, negotiations and patent litigation. There is currently no requirement by the USPTO that the assignment records be updated when there is an ownership change of a patent. There is no requirement that hidden owners of patents be listed in an assignment record. Moreover, a single patent owner can be referred to by different names in different patents. Ouellette and Williams proposed: 1) Congress or the USPTO should require standardization of entity and inventor names across patent records, 2) Congress or the USPTO should increase incentives to record changes in patent assignments, and 3) at least for patents involved in litigation, parties having ownership interests in the patents should be identified.

Ouellette and Williams also proposed adjusting patent terms for pharmaceuticals so that pharmaceuticals that have to undergo a lengthy clinical trial would still have a sufficient patent term once they are approved by the Food and Drug Administration. However, patent term changes require a change to the patent statute, and therefore this proposal needs to be approved by Congress.

Senator Tillis explained that the two proposed reforms would enhance “the patent system so that it provides optimal incentives for innovators and inventors while also minimizing transactional costs that may discourage the development of new products.” Senator Tillis noted the two proposed reforms could be implemented by the USPTO [...]

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“Method of Preparation” Claims Still Patent Eligible Under § 101 in Modified Opinion

by | Aug 13, 2020 |

The US Court of Appeals for the Federal Circuit denied an accused infringer’s petition for rehearing en banc and issued a modified opinion with additional analysis maintaining its prior finding that patent claims directed to a method of preparation were patent eligible. Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419 (Fed. Cir. Aug. 3, 2020) (Lourie, J.) (Reyna, J., dissenting).

In its original decision in Illumina v. Ariosa, the Federal Circuit found that claims directed to methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA were not directed to a patent-ineligible natural phenomenon. In its modified opinion, the Court again concluded that the claims were patent eligible under § 101 because they were not directed to a natural phenomenon, but to an exploitation of that natural phenomenon, by inventing a method for preparing a mixture enriched in fetal DNA that selectively removed maternal DNA. In the modified opinion, the majority further explained that the claimed size thresholds were not dictated by any natural phenomenon, but were “human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture in order to create an improved end product that is more useful for genetic testing than the original natural extracted blood sample.” The Court emphasized that the claimed methods achieve more than an observation or detection of a natural phenomenon because the claims include “physical process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood.” The Court distinguished Myriad by stating that the claims were ineligible in that case because they covered a gene that the inventors isolated but did not invent, whereas in this case, the inventors claimed an innovative method using human-engineered size parameters to perform the separation—not the separated DNA itself. The Court concluded that the claimed methods were patent eligible under § 101 because they “utilize the natural phenomenon that the inventors discovered by employing physical process steps and human-engineered size parameters to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.”

Judge Reyna again dissented, arguing that the claims were patent ineligible under § 101 because they were directed to an undisputed natural phenomenon (i.e., the “surprising” discovery of size discrepancy of cff-DNA in a mother’s blood), and the application of the natural phenomenon used routine steps and conventional procedures that are well known in the art. He explained that “[l]ike in Alice, the claims here are directed to a natural phenomenon because they involve a fundamental natural phenomenon, that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood, to produce a ‘mixture’ of naturally-occurring substances.” Judge Reyna argued that the majority ignored the Court’s “claimed advance precedent” by reasoning that the claims belong in a distinct category of “method of preparation” claims, but such characterization should be treated [...]

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Glass Half Empty: Patent Reciting “Half Liquid” Is Indefinite

by | Aug 13, 2020 |

The US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the asserted patent claims were invalid as indefinite because the meaning of the term “half-liquid” was not reasonably clear from the record. IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., Case No. 19-2400 (Fed. Cir. July 31, 2020) (Prost, C.J.).

IBSA owns a patent directed to pharmaceutical formulations for thyroid hormones that enable a safe and stable oral administration. IBSA listed in the Orange Book the patent for Tirosint®, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva filed an abbreviated new drug application to market a generic version of Tirosint®, and IBSA responded by filing a lawsuit for patent infringement against Teva.

During claim construction, the parties disputed the construction of the term “half-liquid.” IBSA proposed that “half-liquid” should be construed to mean “semi-liquid,” while Teva argued that the term was indefinite or should be construed as “a non-solid, non-paste, non-gel, non-slurry, non-gas substance.” The district court began its analysis by acknowledging that the parties “agree that the intrinsic record does not define ‘half-liquid.’” IBSA argued that a priority Italian patent application’s use of the word “semiliquido” (translation: semi-liquid) in the same places where “half-liquid” was used in the patent at issue supported its position that the two terms were synonyms. The district court disagreed, noting several differences in the two patents that indicated that the different choice of terms was intentional. Further, the district court noted that the applicant originally used the term “semi-liquid” in a dependent claim during prosecution, but later removed this term, indicating that the applicant understood the terms to be different and intentionally chose not to use “semi-liquid” in the asserted claims. The district court also found IBSA’s extrinsic evidence (e.g., reliance on dictionary definitions, other patents and expert testimony) unpersuasive. The district court accordingly found the asserted patent claims invalid as indefinite because the meaning of “half-liquid” was not reasonably ascertainable from the record. IBSA appealed.

The Federal Circuit affirmed. The Court first found that the intrinsic record failed to establish the boundaries of the term “half-liquid.” The Court agreed with the district court’s analysis, finding that neither the claims nor the specification supported IBSA’s proposed construction. The Court also explained that the prosecution history reinforced the conclusion that the applicant understood “half-liquid” to be different from “semi-liquid,” because the applicant intentionally removed the term “semi-liquid” in a dependent claim during prosecution. The Court disagreed with IBSA’s suggestion that the district court refused to consider the foreign Italian priority document—rather, “when discrepancies between a foreign priority document and the U.S. filing exist, it may be proper to view the discrepancies as intentional.”

Turning to the extrinsic record, the Federal Circuit found that the district court did not clearly err in its analysis of the presented dictionary definitions, other patents and expert testimony. The Court noted that IBSA identified no scientific dictionaries containing the term despite IBSA’s argument that “half-liquid” would be a recognizable term [...]

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