You searched for Patent - Page 11 of 161

Results for "Patent"

USPTO Conducting Patent Eligibility Jurisprudence Study

by Amol Parikh | Jul 15, 2021 | Patents

At the request of Senators Thom Tillis (R-NC), Marie Hirono (D-HI), Tom Cotton (R-AR) and Chris Coons (D-DE), the US Patent & Trademark Office (USPTO) is undertaking a study on the current state of patent eligibility jurisprudence in the United States and how the current jurisprudence has impacted investment and innovation, particularly in critical technologies like quantum computing, artificial intelligence, precision medicine, diagnostic methods and pharmaceutical treatments. On July 9, 2021, the USPTO issued a Federal Register Notice seeking public input on these matters to assist in preparing the study. The deadline for submitting written comments is September 7, 2021.

The Federal Register Notice included 13 concerns on which comments were requested:

Explain how the current state of patent eligibility jurisprudence affects the conduct of business in your technology areas, and identify your technology areas.
Explain what impacts you have experienced as a result of the current state of patent eligibility jurisprudence in the United States. Include impacts on as many of the following areas as you can, identifying concrete examples and supporting facts when possible:
1. patent prosecution strategy and portfolio management;
2. patent enforcement and litigation;
3. patent counseling and opinions;
4. research and development;
5. employment;
6. procurement;
7. marketing;
8. ability to obtain financing from investors or financial institutions;
9. investment strategy;
10. licensing of patents and patent applications;
11. product development;
12. sales, including downstream and upstream sales;
13. innovation and
14. competition.
Explain how the current state of patent eligibility jurisprudence in the United States impacts particular technological fields, including investment and innovation in any of the following technological areas:
1. quantum computing;
2. artificial intelligence;
3. precision medicine;
4. diagnostic methods;
5. pharmaceutical treatments and
6. other computer-related inventions (e.g., software, business methods, computer security, databases and data structures, computer networking, and graphical user interfaces).
Explain how your experiences with the application of subject matter eligibility requirements in other jurisdictions, including China, Japan, Korea, and Europe, differ from your experiences in the United States.
Identify instances where you have been denied patent protection for an invention in the United States solely on the basis of patent subject matter ineligibility, but obtained protection for the same invention in a foreign jurisdiction, or vice versa. Provide specific examples, such as the technologies and jurisdictions involved, and the reason the invention was held ineligible in the United States or other jurisdiction.
Explain whether the state of patent eligibility jurisprudence in the United States has caused you to modify or shift investment, research and development activities, or jobs from the United States to other jurisdictions, or to the United States from other jurisdictions. Identify the relevant modifications and their associated impacts.
Explain whether the state of patent eligibility jurisprudence in the United States has caused you to change business strategies for protecting your intellectual property (e.g., shifting from patents to trade secrets, or vice versa). Identify the changes and their associated impacts.
Explain whether you have changed your behavior with regard to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States as a result of [...]

Continue Reading

Diehr Alice, Yu are Superimposing Novelty onto Patent Eligibility. Love, Newman.

by A. Shane Nichols | Jun 24, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of a Rule 12(b)(6) motion to dismiss on the basis that, under the two-step Alice analysis, the patent claims—directed to a digital camera—were directed to ineligible subject matter under 35 U.S.C. § 101. Yu, et al. v. Apple Inc., et al., Case Nos. 20-1760; -1803 (Fed. Cir. June 11, 2021) (Prost, J.) (Newman, J., dissenting)

The patent claim under consideration recited an “improved digital camera” that has two lenses, two image sensors, an analog-to-digital converter, a memory and a digital image processor for “producing a resultant digital image from said first digital image enhanced with said second digital image.” Yu conceded that “the idea and practice of using multiple pictures to enhance each other has been known by photographers for over a century” and that the components recited in the claim “are themselves generic and conventional.”

Applying the Supreme Court’s two-step Alice v. CLS Bank test for determining patent eligible subject matter, the Federal Circuit determined at step one that the claim was “directed to the abstract idea of taking two pictures . . . and using one picture to enhance the other in some way.” At step two, the Court held that the claim failed to otherwise define a patent eligible invention because the digital camera “is recited at a high level of generality and merely invokes well-understood, routine, conventional components to apply the abstract idea of [using one picture to enhance the other in some way].” The Court rejected Yu’s attempts to use portions of the patent’s specification to support eligibility, explaining that the eligibility analysis is limited to the literal recitations of the asserted claims.

Then, along came Judge Pauline Newman. With a chainsaw.

In dissent, Judge Newman argued that the majority was improperly enlarging the § 101 analysis to include other “substantive requirements of patentability.” Judge Newman emphasized (twice) that the claim literally recited an electromechanical camera, not an abstract idea. In her view, the camera recited in the claim met the requirements of § 101 as a new and useful machine, without regard to whether the claimed camera also met the novelty requirements of §§ 102 and 103. Referring to the Supreme Court’s 1981 holding in Diamond v. Diehr, Judge Newman wrote that “[i]n contravention of [Diehr‘s] explicit distinction between Section 101 and Section 102, the majority now holds that the [claimed] camera is an abstract idea because the camera’s components were well-known and conventional and perform only their basic functions.” Judge Newman further proclaimed that “the principle that the majority today invokes was long ago discarded.”

Judge Newman also admonished the majority for the destabilizing effects that similar holdings have already had on US patent policy. She noted that “[i]n the current state of Section 101 jurisprudence, inconsistency and unpredictability of adjudication have destabilized technologic development in important fields of commerce,” and that “[t]he fresh uncertainties engendered by the majority’s revision of Section 101 are contrary to the statute and [...]

Continue Reading

Submarine Sunk: Patent Prosecution Laches Pops GATT Bubble

by Christopher M. Bruno | Jun 10, 2021 | Patents

Addressing for the first time whether the US Patent & Trademark Office (PTO) can assert prosecution laches as a defense in a civil action brought under 35 U.S.C. §145, the US Court of Appeals for the Federal Circuit held that the PTO could assert prosecution laches as a defense against four patent applications in a case where the plaintiff delayed presenting the claims for these applications over a period of at least 10 years. Hyatt v. Hirshfeld, Case Nos. 2018-2390; -2391; -2392; 2019-1038; -1039; -1049; -1070 (Fed. Cir. June 1, 2021) (Reyna, J.)

Gilbert Hyatt is well known for having built a prolific patent application portfolio based on nearly 400 initial filings made just before the United States changed from an issuance-based patent exclusivity system to a filing-based patent exclusivity system under the Uruguay Round of the General Agreement on Tariffs and Trade (GATT). By 2003, those 400 initial filings had exploded into 45,000 independent claims. Hyatt’s applications were so labor intensive that the PTO developed a separate examining unit specifically dedicated to their review. Many of these applications have been rejected.

After the PTO finally rejected four of Hyatt’s computer software patent applications, in 2005 Hyatt filed a § 145 action in the district court. Throughout the litigation, the PTO argued that Hyatt had routinely delayed prosecuting his patent applications and never complied with his verbal agreement with the PTO to streamline each application to apply for only one invention. Ultimately, after a five-day bench trial, the district court found that the PTO failed to prove it had taken sufficient action to advance prosecution of Hyatt’s applications. The PTO appealed.

Resolving the threshold issue on appeal of whether prosecution laches is even available to the PTO in a § 145 action, the Federal Circuit explained that the right to assert laches as an affirmative defense flows naturally from the PTO’s rights to reject applications based on laches and defend such rejections on appeal in the Federal Circuit on the same grounds. Any other conclusion, the Court recognized, would create incongruence and undermine the PTO’s authority. Such a defense is available even if raised for the first time in the district court, as “§145 actions open the door to new evidence.”

The Court found significant errors in the district court’s application of prosecution laches law. First, the Federal Circuit held that the district court too narrowly focused on the PTO’s specific conduct without considering the totality of the circumstances, including delays caused by Hyatt’s sweeping amendments and prosecution of other patent applications, as well as the relative costs and burdens of examining Hyatt’s gargantuan application portfolio. The Court was particularly critical regarding the district court’s assignment of blame to the PTO in its attempts to manage the unwieldy task before it.

After reviewing the evidence presented by the PTO, the Federal Circuit found that the PTO had amassed significant evidence of Hyatt’s delay of prosecution of his applications—i.e., “patterns of prosecution conduct [that] created a perfect storm that overwhelmed the [...]

Continue Reading

New Perspective on Specific Personal Jurisdiction in Patent DJ Venue

by Paul Devinsky | May 20, 2021 | Patents

The US Court of Appeals for the Federal Circuit concluded that the minimum contacts or purposeful availment test for specific personal jurisdiction was satisfied where a patent owner sent multiple infringement notice letters and other communications to a resident of California who then filed for declaratory judgment of non-infringement in federal district court in California. Trimble Inc. v. PerDiemCo LLC, Case No. 19-2164 (Fed. Cir. May 12, 2021) (Dyk, J.)

PerDiem accused Trimble of infringing several of PerDiem’s patents. PerDiem exchanged 22 communications with Trimble in California over a period of three months, some through Trimble’s subsidiary ISE in Iowa and other communications through its chief IP counsel in Colorado. The communications started with a letter (sent to ISE in Iowa) that had attached an unfiled complaint and which PerDiem used to try to launch license negotiations. This unfiled complaint asserted nine of PerDiem’s patents. After ISE brought Trimble, its parent, into the discussion, PerDiem accused Trimble’s products of infringing 11 patents and sought to enter into binding mediation on its infringement allegations. PerDiem also threatened to sue Trimble in the Eastern District of Texas and identified the counsel it planned to use for this purpose. Trimble filed for a declaratory judgment of non-infringement in the Northern District of California. The district court dismissed the complaint, relying on the Federal Circuit’s 1998 decision in Red Wing Shoe v. Hockerson-Halberstadt, concluding that it would be unreasonable to assert personal jurisdiction over PerDiem based on its communications. Trimble appealed.

The sole issue in the appeal was whether the district court erred in holding that there was no specific personal jurisdiction over PerDiem in the Northern District of California. The Federal Circuit explained that PerDiem’s contacts with California were far more extensive than those in Red Wing, noting the manner in which PerDiem amplified its threats of infringement as the communications continued, asserted more patents, and accused more of Trimble and ISE’s products of infringement. The Court noted that PerDiem even identified the counsel it retained to sue Trimble and the venue in which it planned to file suit. Overall, the Court found that PerDiem’s 22 communications over the course of about three months fell well outside the “sufficient latitude” the Court sought to grant patentees “to inform others of [their] patent rights without subjecting [themselves] to jurisdiction in a foreign forum” on the basis of three letters sent over a similar time period in Red Wing.

Practice Note: It remains to be seen how useful this case may be in the context of obtaining specific personal jurisdiction over non-practicing entities (or other patent owners) based on sending demand letters into a potential declaratory judgment venue viewed as less hospitable to patent owners.

Prosecution History Prevents Patent Owner from “Intercepting” Win on Appeal

by Thomas DaMario | May 20, 2021 | Patents

In reviewing whether the Patent Trial & Appeal Board (Board) correctly interpreted the meaning of “intercepting” in the context of Voice over Internet Protocol (VoIP) technology, the US Court of Appeals for the Federal Circuit found that the claim language and prosecution history supported the Board’s decision. The Court thus affirmed the Board’s construction and subsequent finding of obviousness. Uniloc 2017 LLC v. Apple Inc., Case Nos. 20-1403, -1404 (Fed. Cir. May 12, 2021) (Prost, C.J.)

Uniloc owns a patent directed to a system and method for using various VoIP features, such as caller-ID, call waiting, multi-line service, and different levels of service quality known as the “codec specification.” The patent explains that in order to generate revenue for these features, service providers must maintain control over which subscribers have paid for these additional features. To achieve that control, the system employs an enforcement mechanism that sits between the sender of the communication and the intended recipient. The enforcement mechanism ensures that both parties are authorized to use the particular features by intercepting the signaling message, determining whether the client is authorized, and filtering the signaling message based on the authorization. The majority of the claims require authorization related to only one service type. However, one of the claims (claim 18) requires authorization related to at least two service types.

Apple filed a petition for inter partes review (IPR), alleging that all claims of the patent were invalid as obvious over a prior art patent referred to as Kalmanek. Kalmanek discloses signaling messages that are routed through at least one “gate controller,” which can authenticate the identity of the calling party and authorize the services sought. The services include at least caller-ID and enhanced levels of call quality. Kalmanek’s process is accomplished by sending a SETUP message, which the calling party sends to the gate controllers and then to the intended recipient. After receipt, the called party sends a SETUPACK message along a return path to the gate controllers and then to the caller.

During the IPR, Apple asserted that the term “intercepting” a signaling message associated with the call, as recited in all independent claims, should be interpreted to mean “the signaling [message] is received by a network entity located between the endpoints of the call.” Uniloc disagreed and argued that the term should be interpreted as excluding the receipt of a signaling message by the intended recipient of the message. The Board agreed with Apple’s construction and subsequently found that all terms were invalid as obvious with the exception of claim 18. With respect to claim 18, the Board concluded that Apple failed to meet its burden to show that Kalmanek disclosed authorization related to a codec service. Furthermore, the Board opined that even assuming Apple had properly advanced such an argument, it would have lost on the merits.

On appeal, Uniloc challenged the Board’s construction of the “intercepting” term, and Apple cross-appealed the Board’s finding with respect to the non-obviousness of claim 18. The Federal Circuit affirmed [...]

Continue Reading

Targeted Advertising Still Patent Ineligible Subject Matter

by Paul Devinsky | May 20, 2021 | Patents

The US Court of Appeals for the Federal Circuit found that targeted advertising is still an abstract idea and that a system providing targeted advertising must utilize something more than generic features and routine functions to be eligible for patent protection. Free Stream Media Corp. v. Alphonso Inc., Case No. 19-1506 (Fed. Cir. May 11, 2021) (Reyna, J.)

Free Stream Media, d.b.a. Samba, owns a patent directed to “a system providing a mobile phone user with targeted information (i.e., advertisements) that is deemed relevant to the user based on data gathered from the user’s television.” The system has three main components: (1) a networked device (e.g., a smart TV) that collects primary data, including program information, location, weather information or identification information; (2) a client device (e.g., a mobile device) on which applications run and advertisements may be shown; and (3) a relevancy-matching server that uses the primary data to select advertisement or other targeted data based on a relevancy factor associated with the user. Specifically, the relevancy-matching server “may also be configured to render the targeted data to the user through the networked device and/or the sandboxed application of the client device.”

Samba asserted infringement of the patent against Alphonso. In response, Alphonso filed a motion to dismiss on grounds that the asserted claims of the patent were directed to patent ineligible subject matter under 35 USC § 101. Alphonso subsequently filed a motion for summary judgment of non-infringement. The district court denied the § 101 motion but granted the summary judgment motion. Samba appealed the non-infringement finding, and Alphonso cross-appealed the § 101 finding.

The Federal Circuit started with the § 101 finding by first addressing Alice step 1 (abstract idea). The Court rejected the district court’s finding that the asserted claims were directed to “systems and methods for addressing barriers to certain types of information exchange between various technological devices . . . being used in the same place at the same time,” i.e., to bypass the security sandbox, and not an abstract idea of tailored advertising. To the contrary, the Court found that the asserted claims were directed precisely to the abstract idea of tailored advertising—specifically, gathering information about television users’ viewing habits, matching the information with other content and sending that content to a second device. Reiterating its prior holdings with respect to Alice step 1, the Court explained that the asserted claims only provided for the result of overcoming a security sandbox, and did not at all describe how that result is achieved. The Court also explained that even if the claims did recite a method for bypassing a security sandbox, Samba failed to demonstrate that this was anything more than a mere use of a computer as a tool, or that it somehow “improves the operability of these devices beyond providing a user with targeted content using generic processes and machinery.”

Turning to Alice step 2 (inventive concept), the Federal Circuit explained that the claimed abstract idea of providing targeted advertisements was not [...]

Continue Reading

Federal Circuit Puts Patent Infringement Award/Injunction Back in the Box

by Jodi Benassi | May 13, 2021 | Patents

The US Court of Appeals for the Federal Circuit, exploring the use of Federal Rule of Civil Procedure 60(b)(3) under Ninth Circuit law, affirmed a district court’s ruling setting aside a monetary damages judgment and an injunction for fraudulent misrepresentations by a corporate patent owner’s president concerning prior art. Cap Export, LLC, et al. v. Zinus, Inc., et al., Case No. 20-2087 (Fed. Cir. May 5, 2021) (Dyk, J.)

In 2016, Cap Export sued Zinus seeking a declaratory judgment that claims of a patent owned by Zinus were invalid and not infringed. Zinus countersued, alleging that Cap Export infringed its patent covering a bed frame that can be packed into the headboard for compact shipping (known as a “bed in a box”). Zinus filed a motion for partial summary judgment of no invalidity of certain claims, and the court allowed Cap Export to depose Zinus’s then-president and “testifying technical expert,” Colin Lawrie. During the deposition, Lawrie denied knowledge of the existence of prior art. The district court concluded that the claims were not invalid and entered a judgment and permanent injunction against Cap Export.

Shortly thereafter, Zinus sued another company for patent infringement, and Cap Export discovered an exhibit on the docket describing a sale to Zinus of a bed that had all of the components of the bed (except the headboard) packed inside a zippered compartment in the headboard. Cap Export contacted the third party that sold the prior art beds to Zinus and obtained an invoice bearing the signature of Lawrie, the same witness who denied knowledge of such beds during his deposition. Cap Export moved to vacate the judgment and injunction on the grounds of fraud and misrepresentation under Rule 60(b)(3). After the district court granted the motion, Zinus appealed.

The Federal Circuit analyzed the issue under Ninth Circuit law, which requires evidence that the verdict was obtained through fraud, misrepresentation or other misconduct, and that the conduct prevented the losing party from fully and fairly presenting its defense. Ninth Circuit law further requires that the fraud was not discoverable by due diligence before or during the proceedings. Zinus argued that Cap Export’s counsel should have discovered the emails if they had exercised due diligence and propounded standard document requests for a patent case. Cap Export did not dispute that its written discovery served on Zinus did not specifically seek prior art and that it did not depose the inventor of the patent. Cap Export also did not dispute that although Lawrie’s deposition was taken, it was not taken under Federal Rule of Civil Procedure 30(b)(6).

The Federal Circuit explained that the issue was not whether Cap Export’s conduct fell below the standard of care for attorneys practicing patent litigation, but rather whether a reasonable company in Cap Export’s position should have had reason to suspect the fraud—i.e., that Lawrie had testified falsely—and, if so, whether it took reasonable steps to investigate. The Court found no showing that there was reason to suspect that Lawrie’s statements were [...]

Continue Reading

Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

by Paul Devinsky | Mar 11, 2021 | Patents

Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.)

Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient. Adding polyethylene glycol (a process known as PEGylating) to FVIII at random sites was found to increase the protein’s half-life but reduce its function. Bayer invented FVIII that is PEGylated in a specific region (the B-domain) so that it retains its function and maintains the longer half-life.

After Baxalta developed a PEGylated FVIII therapeutic, Adynovate®, Bayer sued Baxalta for infringement of its patent. During claim construction, the district court construed the claim preamble “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random,” finding that Bayer had disclaimed conjugates with random PEGylation. The district court also construed “at the B-domain” to mean “attachment at the B-domain such that the resulting conjugate retains functional FVIII activity,” rejecting Baxalta’s proposal of “at a site that is not any amine or carboxy site in FVIII and is in the B-domain” because Bayer had not disclaimed PEGylation at amine or carboxy sites. Before trial, Baxalta moved for clarification of the term “random” in the construction of the preamble, but the district court “again” rejected Baxalta’s argument that Bayer defined “random” conjugation as “any conjugation at amines or carboxy sites.”

Before trial, Baxalta moved to exclude the testimony of Bayer’s damages expert regarding his proposed reasonable-royalty rate. The expert had defined a bargaining range and proposed to testify that the royalty rate should be the midpoint of the range based on the Nash Bargaining Solution. The district court permitted the expert to testify as to the bargaining range but excluded the opinions regarding the midpoint as insufficiently tied to the facts of the case.

After trial, the district court granted Baxalta’s pre-verdict motion for judgment as a matter of law (JMOL) of no willful infringement. Subsequently, the jury returned a verdict that the claims were infringed and not invalid for non-enablement, and awarded damages based on an approximately 18% royalty rate for the period for which the parties had presented sales information. Baxalta moved for JMOL or a new trial on infringement, enablement and damages. Bayer moved for pre-verdict supplemental damages for the period between the presented sales data and the date of judgment, and for a new trial on the issue of willfulness. The district court denied all of Baxalta’s motions and Bayer’s motion for new trial, but granted Bayer’s motion for supplemental damages, applying the jury’s ~18% rate to sales data for the later period. [...]

Continue Reading

Impossible; Cloud Storage Patent Claims Invalid for Indefiniteness or Not Infringed

by Paul Devinsky | Feb 25, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s determination that three patents directed to data synchronization were indefinite as lacking sufficient disclosed structure to support a means plus function claim element, as impossible in terms of claim scope or not infringed. Synchronoss Technologies, Inc. v. Dropbox. Inc., Case Nos. 19-2196, -2199 (Fed. Cir. Feb. 12, 2021) (Reyna, J.)

Synchronoss filed suit against Dropbox for infringement of three patents relating to synchronizing data across multiple devices connected via internet, a synchronization agent management server, and transferring media data to a network coupled device. As to the first patent, the district court found that Dropbox did not infringe because the claims, as construed, required hardware, whereas Dropbox’s accused product existed entirely in software. The district court then found that all of the claims of the second patent were invalid as indefinite under § 112, paragraph 6, since various claim terms, including “user identifier module,” did not correspond to adequate structure in the specification. Finally, the district court found that the third patent was invalid under § 112 for including within its scope an impossibility, namely, “generating a [single] media file” that “compris[es] a directory of digital media files.” Synchronoss appealed all three findings.

The Federal Circuit first addressed the claim that the district court found to include impossible scope. The Court agreed with the district court, noting that Synchronoss’s expert admitted that it was impossible for a media file to contain a directory of media files. The Court rejected Synchronoss’s argument that a person of ordinary skill in the art would understand that the invention actually meant something different, and noted that Synchronoss’s proposal would result in re-writing the claims to preserve their validity.

The Federal Circuit next addressed the claim including the means plus function element found to contain terms lacking adequate structure antecedent in the specification. The Court applied a two-step process to construe the “user identifier module” term, first identifying the claimed function and then determining whether the specification disclosed sufficient structure for performing the claimed function. Adopting Synchronoss’s position that the claimed function was “identifying a user,” the Court found that the specification did not disclose sufficient structure corresponding to the claimed user identifier module. The Court noted that although Dropbox’s expert identified more than 20 different possible structures that could perform the claimed function, “it is not enough that a means-plus-function claim term correspond to every known way of achieving the claimed function; instead, the term must correspond to ‘adequate’ structure disclosed in the specification such that a person of ordinary skill in the art would be able to recognize and associate the structure with the claimed function.”

Finally, the Federal Circuit addressed the district court’s finding of non-infringement. At the district court, Synchronoss proposed a construction of the claim term “device” to include “software . . . residing on . . . hardware” and conceded that its claims could not cover “software completely detached from hardware.” The Court concluded that the [...]

Continue Reading

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

by Paul Devinsky | Feb 25, 2021 | Patents

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.

Older Posts »

« Newer Posts

BLOG EDITORS

Paul Devinsky

Amol Parikh

Jodi Benassi

BLOG EDITORS

STAY CONNECTED

TOPICS

ARCHIVES

RECENT POSTS