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Store This Element: Lexicography Controls Claim Term Definition Over Plain and Ordinary Meaning

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness finding, determining that the Board properly applied the patentee’s lexicography in construing a disputed claim term and properly treated arguments raised by the parties in the reply and sur-reply briefings. ParkerVision, Inc. v. Vidal, Case No. 22-1548 (Fed. Cir. Dec. 15, 2023) (Prost, Wallach, Chen, JJ.)

Intel filed a petition for inter partes review of a patent owned by ParkerVision. The challenged patent is directed to wireless local area networks (WLANs) that use frequency translation technology and incorporate another patent that describes down-conversion utilizing down-converter modules. The challenged claim is directed to apparatuses for down-converting electromagnetic (EM) signals. Among other things, the claim recites “wherein said first and said second frequency down-conversion modules each comprise a switch and a storage element.” The Board found the challenged claim unpatentable and in doing so, construed the term “storage element” to mean “an element of a system that stores non-negligible energy from an input signal.” The Board based its construction on the description of “storage modules” in a patent incorporated by reference into the challenged patent. ParkerVision appealed.

The Federal Circuit affirmed the Board’s construction, finding that ParkerVision had acted as its own lexicographer when it defined the term “storage element” in the incorporated-by-reference patent. The Court relied on a “critical” paragraph from the incorporated-by-reference patent that states: “[s]torage modules and storage capacitances, on the other hand, refer to systems that store a non-negligible amount of energy from an input EM signal.” The Court reasoned that the term “refer to,” together with the “as used herein” language from a preceding sentence, conveyed an intent for the sentence to be definitional and applicable to the whole patent rather than to a specific embodiment. To that end, the Court reiterated that a patentee may act as its own lexicographer by crafting a definition for a claim term rather than relying on the plain and ordinary meaning of that term, and that when a patentee does so, the definition may act as a disavowal of the full scope of the plain and ordinary meaning of the term.

ParkerVision also argued that the Board impermissibly relied on arguments allegedly raised for the first time in Intel’s reply brief, and that it erred in excluding certain arguments made by ParkerVision on sur-reply. The Federal Circuit rejected both arguments. The Court reasoned that because ParkerVision proposed a new claim construction in its patent owner response, Intel was permitted to argue and present evidence of obviousness under that new construction as long as such evidence relied on the same embodiments for each invalidity ground as were relied on in the petition.

The Federal Circuit also noted that ParkerVision’s arguments on sur-reply exceeded the scope of its patent owner response. While ParkerVision’s patent owner response proposed that the “storage element” be an element of the energy transfer system and store non-negligible amounts of energy from an input EM signal, ParkerVision only argued that the [...]

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If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry of generic drugs in a Hatch-Waxman suit are subject to higher scrutiny than plaintiffs asserting the same theories outside of the Hatch-Waxman context. H. Lundbeck A/S v. Lupin Ltd., Case No. 22-1194 (Fed. Cir. Dec. 7, 2023) (Dyk, Prost, Hughes, JJ.)

Lundbeck owns the approved new drug application (NDA) for Trintellix®, a drug indicated for the treatment of major depressive disorder (MDD), as well as an expired compound patent for the associated active ingredient vortioxetine. Lundbeck also owns a patent that claims the use of vortioxetine as an antidepressant that can be prescribed in place of a traditional antidepressant to alleviate a patient’s negative sexual side effects, and another patent that claims the use of vortioxetine to treat cognitive impairment symptoms in patients with MDD.

Generic pharmaceutical companies filed abbreviated new drug applications (ANDAs) seeking approval to market generic versions of Trintellix® and asserting that Lundbeck’s unexpired patents listed in its NDA were invalid and would not be infringed by the generic companies. As required by the Hatch-Waxman Act (to prevent the entry of a generic on the market), Lundbeck sued the generic companies. At the district court, the defendants prevailed on the finding of noninfringement but lost on invalidity. Lundbeck appealed.

Lundbeck pressed its induced infringement and contributory infringement theories on appeal. Lundbeck argued that the generics infringed under the plain text of Hatch-Waxman (35 USC 271(e)(2)(A)) because they filed ANDAs seeking approval to market vortioxetine, and that “some uses of vortioxetine—for the treatment of patients that have previously taken other drugs but had to cease or reduce use due to sexually related adverse events and for the treatment of cognitive impairment—are covered by [Lundbeck’s listed] patents; and the labels do not prohibit prescribing vortioxetine for those uses, even though the defendants do not propose to market the drug for those patented uses.” In other words, Lundbeck argued that in terms of its inducement allegation, it made no difference whether a drug would be sold for a use not covered by Lundberg’s NDA-listed patents because the drug could be prescribed for those patented uses.

The Federal Circuit disagreed, explaining that “‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA” and for which the ANDA was submitted.” The Court emphasized that it is not “an act of infringement under . . . § 271(e)(2)(A) to submit an ANDA for a drug if just any use of that drug were claimed in a patent.” If it were, a brand could “maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA,” which “would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.” As the Court then held, “actions for [...]

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Sound the Alarm: Reasonable Royalty Apportionment Analysis Overlooks “Sleep State”

After a jury found infringement of two patents and awarded almost $2.2 billion in damages, the US Court of Appeals for the Federal Circuit reversed the infringement finding for one asserted patent, vacated the damages award for the other asserted patent, and reversed the district court’s refusal to allow the alleged infringer to add a licensing defense. VLSI Technology LLC v. Intel Corporation, Case No. 22-1906 (Fed. Cir. Dec. 4, 2023) (Lourie, Dyk, Taranto, JJ.)

VLSI sued Intel for infringement of two patents. During the litigation, third party Finjan underwent a change in control after which it was controlled by the same parent entity as VLSI. Intel sought to amend its answer to add a licensing defense based on the broad definition of “affiliates” in its license agreement with Finjan, arguing that as a consequence of the change in control Intel was licensed to patents owned by VLSI. The district court denied the motion to amend.

At trial, the jury found literal infringement of one patent and infringement under the doctrine of equivalents (DoE) for the other patent. The jury awarded $2.2 billion in damages. Intel appealed.

The patent that the jury found infringed under the DoE was directed to devices, such as computer processors, having the ability to operate at a variety of frequencies. Depending on the operating conditions, a master device can provide a trigger input to a controller in response to a desired increase in device performance, and the controller can then adjust the clock frequency accordingly. Intel argued that the evidence of equivalents presented to the jury was legally insufficient to support a finding of infringement.

The Federal Circuit agreed and reversed the jury’s finding under the DoE. The Court stressed that for a patent owner to prevail under a DoE assertion, it must provide “particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the accused device.” While VLSI’s proof of equivalence was limitation specific, the testimony provided during the trial was insufficient to explain the “insubstantiality” of the differences between the claims and the Intel products. The Court specifically cited trial testimony by VLSI’s expert, who characterized the differences as “a difference of where an engineer draws the line . . . it’s a design choice.” In its explanation of why the analysis and testimony was insufficient, the Court explained that “[i]t is not enough [] to say that the different functionality-location placements were a ‘design choice.’ . . . VLSI had to prove—with particularized testimony and linking argument—that the elements of the Intel arrangement were substantially the same as the elements of the claimed arrangement. But VLSI offered no meaningful testimony doing so.”

Intel also appealed the damages award based on the patent that was found to be literally infringed. That patent was directed to certain features that provide separate scalable (as opposed to fixed) power supply voltages for both processors and memory devices, depending on the need of the device. VLSI’s expert presented a calculation of damages based [...]

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PTO Creates Separate Design Patent Bar

The US Patent & Trademark Office (PTO) published its final rule, creating a separate design patent bar where admitted design patent practitioners will practice in design patent proceedings only. (88 Fed. Reg. 78644 (Nov. 16, 2023).)

Prior to this rulemaking, there was a single patent bar for those who practice in patent matters before the PTO, including in utility, plant and design patent proceedings. PTO regulations previously required that all patent bar practitioners pass a registration exam and possess specific and stringent scientific and technical qualifications, such as an engineering degree or substantial course work in physics, biology, chemistry or the like.

The new rule creates a separate design patent bar that still requires members to pass the current registration exam but permits applicants to have a bachelor’s degree, master’s degree or PhD in any of the following areas from an accredited college or university:

  • Industrial design
  • Product design
  • Architecture
  • Applied arts
  • Graphic design
  • Fine/studio arts
  • Art teacher education.

The new rules expanding the patent bar admission criteria are intended to encourage broader participation and to keep up with the ever-evolving technology and related teachings that qualify someone to practice before the PTO. Practitioners currently admitted before the PTO will not be impacted by the change and can continue to prosecute utility, plant and design patents.

The rule will take effect on January 2, 2024.




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Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding after the statutory deadline has passed. Purdue Pharma L.P. v. Collegium Pharm., Inc., Case No. 22-1482 (Fed. Cir. Nov. 21, 2023) (Dyk, Hughes, Stoll, JJ.)

Purdue owns a patent directed to a pharmaceutical formulation meant to prevent or deter the abuse of opioid analgesics through the use of an aversive agent. On March 13, 2018, Collegium filed a PGR petition asserting that the patent claims were invalid. On September 24, 2019, Purdue filed a notice of bankruptcy and imposition of automatic stay, after which the Board stayed the PGR proceeding. The Board’s one-year deadline to issue an FWD under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) expired on October 4, 2019. After the bankruptcy court lifted the stay on the PGR proceeding on September 1, 2020, Purdue argued that the Board no longer had the authority to issue an FWD because the 18-month statutory deadline to do so had passed. The Board disagreed and issued an FWD finding the challenged claims unpatentable. Purdue appealed.

Purdue argued that the Board did not have authority to issue an FWD after the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) had passed. Purdue advanced four arguments in favor of its proposed interpretation of § 326(a)(11):

  1. The use of “shall” and “requiring” deprives the Board of the authority to issue an FWD.
  2. The “negative words” of “not later than 1 year” and “by not more than 6 months” indicate a loss of authority.
  3. The statutory language in § 326(a)(11) requires PGR proceedings to be conducted “in accordance with” the Board’s jurisdictional grant in 35 U.S.C. § 6, and therefore the Board’s jurisdiction expires when the deadline in § 326(a)(11) expires.
  4. The exceptions in § 326(a)(11) for “good cause” and “joinder” demonstrate that those are the only limited instances where the Board may issue an FWD after the statutory deadline.

None of Purdue’s arguments persuaded the Federal Circuit. The Court reasoned that § 328(a) plainly requires the issuance of an FWD and that “[h]ad Congress meant to deprive the agency of power in § 326(a)(11), it knew how to do it” vis-à-vis the use of specific language, like the language it used in other sections of the America Invents Act (AIA), such as 35 U.S.C. § 315(b) and 35 U.S.C. § 321(c), both of which specifically deny agency power after a temporal deadline.

The Federal Circuit also considered the legislative history of § 316(a)(11), recognizing that Congress created PGR and inter partes review (IPR) proceedings when enacting the AIA to, among other things, replace the “lengthy and inefficient” reexamination proceeding. The Court reasoned that prohibiting an FWD after the statutory deadline would “force” parties to commence district court litigation—an act contrary to the purpose of the AIA, which [...]

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PTO Provides Guidance for Computer-Related Design Patent Applications

The US Patent & Trademark Office (PTO) published a notice regarding supplemental guidance for PTO personnel examining design patent claims containing computer-generated images. 88 Fed. Reg. 80277 (Nov. 17, 2023).

The guidance clarifies how to satisfy the article of manufacture requirement under 35 U.S.C. 171 for ornamental designs relating to computer-generated icons shown on a display panel, as discussed in Section 1505.01(a)(I) of the Manual of Patent Examining Procedure (MPEP). According to the guidance, “the mere display of a computer-generated electronic image . . . on a display panel does not constitute statutory subject matter under 35 U.S.C. 171.” However, a computer icon or a graphical user interface (GUI) shown on a display panel (e.g., a computer screen, monitor, computer display system, mobile phone screen or virtual/augmented reality goggles) is more than a mere display of a picture on a screen because it constitutes an integral and active component in the operation that is embodied in and/or applied to a programmed computer displaying the computer icon or the GUI. Thus, if a computer icon or GUI is properly presented and claimed (e.g., the drawing fully discloses the design as embodied in the article of manufacture), it is eligible under 35 U.S.C. 171.

In addressing the foregoing distinctions, the guidance sets forth specific standards for PTO personnel, including consideration of the complete disclosure when evaluating whether a design claim containing a computer-generated electronic image complies with the article of manufacture requirement. For example, given that computer icons or GUIs are considered to be two-dimensional images, which standing alone are surface ornamentation (i.e., an ornament, impression, print or picture), the guidance stipulates that the title and the claim should not be for a computer icon or a GUI alone, but rather an article of manufacture, such as a “display panel with a computer icon.” The guidance further provides examples of acceptable claim language and specific examination scenarios for evaluation.




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Wave Goodbye: Arguments Incorporated by Reference Are Waived

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s patentability determination, finding that the patent challenger waived an argument it attempted to incorporate by reference to another brief. Medtronic, Inc. v. Teleflex Life Scis. Ltd., Case No. 2022-1721 (Fed. Cir. Nov. 16, 2023) (Lourie, Prost, Chen, JJ.)

Teleflex owns a patent directed to a method for using a guide extension catheter with a guide catheter. Medtronic challenged the patent in two inter partes review (IPR) proceedings, arguing that certain claims were obvious in light of Ressemann and Itou and that another claim was obvious in light of Ressemann, Itou and Kataishi. Teleflex argued that Itou was not prior art because the claimed invention was conceived prior to Itou’s filing date and was either actually reduced to practice before the critical date or diligently pursued until its constructive reduction to practice date. Medtronic did not contest Teleflex’s demonstration of conception but instead challenged Teleflex’s alleged showings of both actual reduction to practice and diligence until constructive reduction to practice.

The Board ultimately found that Itou did not qualify as prior art and that Medtronic therefore had not shown that the challenged claims were unpatentable. One of the issues before the Board was whether in vivo testing was required for actual reduction to practice because the claims at issue were method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board ultimately found that no such testing was required, explaining that Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” According to the Board, actual reduction to practice could “be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.” Medtronic appealed.

Medtronic challenged the Board’s determination regarding constructive reduction to practice, arguing as follows:

In addressing diligence, the Board simply adopted its earlier erroneous diligence analysis in IPR2020-00132. Appx61–62. Therefore, if this Court vacates the Board’s diligence holding in No. 21-2356, it should likewise vacate the Board’s decision here. Appellant’s Br. at 41.

The Federal Circuit explained that it did not vacate the diligence holding in the prior decision, so Medtronic’s condition precedent had not been met. Medtronic nevertheless urged the Court to decide the diligence question. The Court refused, finding that Medtronic improperly incorporated by reference an argument from another brief. The Court explained that it would be fundamentally unfair to allow Medtronic to use incorporation by reference to exceed the word limit on briefs. The Court observed that parties pursuing appeals must make certain strategic decisions concerning what material to include in their opening briefs, and here, Medtronic affirmatively chose not to include developed arguments on diligence. The Court therefore found that Medtronic waived its challenge to the Board’s diligence finding. With the diligence issue waived and conception stipulated, the Court affirmed [...]

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Distinguishing Drinkware—Provisional Priority Determined Differently in Pre- and Post-AIA Patents

In a precedential final written decision, the Patent Trial & Appeal Board concluded that a patent does not need to contain a claim supported by a provisional application’s disclosure to draw priority to that provisional for prior art purposes post America Invents Act (AIA). Penumbra, Inc. v. RapidPulse, Inc., IPR2021-01466, paper 34 (PTAB Mar. 10, 2023) (designated precedential Nov. 15, 2023) (Melvin, Cotta, Wisz, APJs).

Penumbra filed an inter partes review (IPR) petition targeting a patent directed to a “thrombectomy system,” which is a system for removing blood clots in the brain. Penumbra challenged the claims on four different grounds, and each included the Tiegen reference. Therefore, the petition would fail if the Tiegen reference was not prior art.

The challenged patent was filed on July 18, 2019, and drew priority to a provisional application filed on October 24, 2018. Tiegen drew priority to two provisional applications—one dated December 12, 2018, and another dated July 24, 2018. Whether Tiegen was prior art thus depended on whether the challenged patent could draw priority to its provisional application, and whether Tiegen could draw priority to its July 24, 2018, provisional. RapidPulse challenged Tiegen on both bases.

First, the Board assessed the proper priority date for the challenged patent. The Board explained that in order for the patent to draw priority to its provisional application, that provisional application had to provide written support for the challenged patent’s claims. Penumbra argued that the challenged patent’s provisional application did not have written support for the claimed “prevent[ing] forward flow.” RapidPulse responded, arguing that the disclosure of a “minimal amount of momentum from the fluid column” disclosed the claimed “preventing forward flow.” Forward flow generates momentum from the fluid column, so minimizing momentum required preventing fluid flow, according to RapidPulse. RapidPulse also pointed to embodiments that had substantially no forward flow from the distal end of the system.

Penumbra responded by explaining that the provisional application required forward flow in some embodiments, and nothing in the specification stated that the flow should be prevented. The Board agreed, explaining that the provisional application included embodiments with forward flow, and while the provisional recited some embodiments with small amounts of forward flow, the provisional did not indicate that the low forward flow was significant. The Board observed that “one cannot disclose a forest in the original application, and then later pick a tree out of the forest.”

Having determined that the priority date of the challenged patent was July 18, 2019, the Board turned to the priority date of Tiegen. The Board distinguished the present case over Dynamic Drinkware, a 2015 US Court of Appeals for the Federal Circuit case. Dynamic Drinkware states that for prior art purposes, a prior art patent can only draw priority to a provisional application if the prior art patent contains a claim supported by that provisional application. The Board explained that Dynamic Drinkware does not apply post-AIA. Instead, the Board found that, based on the language of AIA 35 [...]

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Resorting to Extrinsic Evidence Is Necessary When Intrinsic Evidence Is Muddied

The US Court of Appeals for the Federal Circuit determined that the limitation “a pH of 13 or higher” could not be construed using the asserted patents’ intrinsic evidence and therefore remanded to the district court with instructions to consider the extrinsic evidence and its impact on claim construction. Actelion Pharms. Ltd v. Mylan Pharms. Inc., Case No. 22-1889 (Fed. Cir. Nov. 6, 2023) (Reyna, Stoll, Stark, JJ.)

Mylan Pharmaceuticals sought market entry for its generic epoprostenol—a small molecule hypertension drug—via an abbreviated new drug application (ANDA). Mylan certified under Paragraph IV with respect to two Orange Book-listed patents that Actelion Pharmaceuticals owned. Actelion timely asserted both patents and achieved a favorable claim construction for the term “a pH of 13 or higher.” This limitation is central to the pharmaceutical breakthrough that the asserted patents disclose, which is stably solubilizing the otherwise unstable epoprostenol. The asserted patents teach that epoprostenol bulk solutions’ pH should preferably be adjusted to about 12.5 to 13.5. Mylan contended that this language meant the claim should not encompass anything below pH 13 (i.e., leaving only a fraction of the disclosure’s preferred range within the scope of the issued claims). The district court disagreed, adopting Actelion’s position that the limitation encompassed values that “rounded” to pH 13 (i.e., pH 12.5 and above). This prompted a stipulated infringement judgment. Mylan appealed.

The Federal Circuit reviewed the district court’s construction de novo, explaining that the district court’s construction was a ruling as a matter of law because no extrinsic evidence was considered. The Court then examined the claim language, specifications and prosecution histories in turn.

Regarding the claim language, the Federal Circuit rejected the parties’ invitations to acknowledge certain prior decisions as articulating bright-line rules. Instead, the Court appeared to endorse analyzing the intrinsic evidence on a case-by-case basis when construing similar range limitations. For example, the Court explained that “there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.” The Court also rejected the following rules concerning range precision:

  • Avoiding rounding requires terms of precision, such as “precisely” or “exactly.”
  • The absence of approximation language dictates a precise value.

In contrast, the Federal Circuit signaled that district courts should properly account for a range’s technical implications (or at least ranges concerning the pH scale) even if that means looking to extrinsic evidence.

Regarding the specifications and prosecution histories, the Federal Circuit disagreed with the district court’s finding that both were inconsistent with Mylan’s position that the disputed limitation reflected a higher degree of precision. The Court concluded that there was little to glean from either, finding that the specifications were as clear as “muddied water” and the prosecution histories provided no insight into the relevant pH range—between pH 12 and pH 13.

The Federal Circuit ultimately concluded that this was an instance in which properly construing a claim limitation required the aid of extrinsic evidence, invoking the Supreme Court of the United States’ guidance from Teva v. Sandoz that extrinsic evidence [...]

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Still Exceptional: Fee-Shift Appropriate in View of Noninfringement Stipulation

In a split decision, the US Court of Appeals for the Federal Circuit affirmed a district court’s award of more than $5 million in attorneys’ fees, finding that the district court did not abuse its discretion in finding the underlying case “exceptional” under 35 U.S.C. § 285 or in calculating the total fees awarded. In re PersonalWeb Tech., Case No. 21-1858 (Fed. Cir. Nov. 3, 2023) (Reyna, Lourie, JJ.) (Dyk, J., dissenting).

Under 35 U.S.C. § 285, a “court in exceptional cases may award reasonable attorney fees to the prevailing party.” In Octane Fitness (2014), the Supreme Court of the United States held that an exceptional case is “simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated,” and the court considers the totality of the circumstances in making this determination.

PersonalWeb’s litigation positions at issue date back to 2011, when PersonalWeb first asserted five patents against an e-commerce company. After an unfavorable claim construction ruling, PersonalWeb stipulated to dismiss the action, and the district court entered the dismissal with prejudice.

In 2018, PersonalWeb asserted the patents against customers of the e-commerce company. The e-commerce company intervened and filed a new action against PersonalWeb seeking a declaratory judgment to bar the infringement actions against the customers based on the 2011 dismissal. Some of the cases proceeded while others were stayed. The district court granted summary judgment against PersonalWeb on claims directed to two allegedly infringing products for two separate reasons: because of the Kessler doctrine and claim preclusion, and because PersonalWeb conceded that it could not prevail after an unfavorable claim construction order.

The district court also entered an award of attorneys’ fees and costs against PersonalWeb, finding the case to be “exceptional” for the following reasons:

  • The infringement claims were “objectively baseless and not reasonable when brought because they were barred due to a final judgment in the [2011 action].”
  • PersonalWeb frequently changed its infringement positions to overcome the hurdle of the day.
  • PersonalWeb unnecessarily prolonged this litigation after claim construction foreclosed its infringement theories.
  • PersonalWeb’s conduct and positions regarding the customer cases were unreasonable.
  • PersonalWeb submitted declarations that it should have known were inaccurate.

The district court calculated the attorneys’ fees to be more than $5 million and costs to be more than $200,000. PersonalWeb appealed.

PersonalWeb argued that the district court erred in awarding fees and, even if fees were warranted, the court erred in assessing almost $2 million of the $5 million award. The Federal Circuit found that the district court did not abuse its discretion in any of its findings related to the fee grant, agreeing with the district court’s application of the Kessler doctrine. In Kessler, the Supreme Court ruled that after a final judgment of noninfringement, follow-up suits by the same patentee over the same non-infringing product against customers of the party [...]

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