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Method for Determining Haplotype Phase Found Subject Matter Ineligible

by | Mar 17, 2021 |

In an appeal from a final rejection of a pending application, the US Court of Appeals for the Federal Circuit held that claims directed to methods for determining “haplotype phase” were correctly rejected under 35 USC § 101 as subject matter ineligible. In Re Board of Trustees of The Leland Stanford Junior University, Case No. 20-1012 (Fed. Cir. Mar. 11, 2021) (Reyna, J.)

Haplotype phase is a scientific way of describing the methodology of determining from which parent a particular allele (or gene) is inherited. The representative claim involved (i) receiving allele data, (ii) receiving pedigree data, (iii) determining an inheritance state based on the allele data, (iv) receiving transition probability data; (v) receiving linkage disequilibrium data and then- determining a haplotype phase based on the pedigree data, the inheritance state for the information described in the allele data, the transition probability data and the population linkage disequilibrium data; and storing the haplotype phase in a computer system and providing the stored haplotype phase in response to a request.

Steps (i) through (iii) were known in the art for determining haplotype phase. The crux of the improved process depended on steps (iv) and (v). The additional data provided as “linkage disequilibrium data” and “transition probability data” allegedly enable haplotype phase to be inferred in regions of the gene where “inheritance state” may be uninformative. The additional data in the claimed method resulted in an increase in the number of haplotype phase predictions made.

The examiner, and then the Patent Trial & Appeal Board, found that the claimed process was directed toward patent eligible subject matter—a mathematical algorithm. Stanford appealed.

Applying the two-step framework established by the 2014 Supreme Court decision in Alice Corp. v. CLS Bank, the Federal Circuit first determined that the claims were directed to an abstract mathematical calculation under Alice step one.

Under step two of the Alice inquiry, the Federal Circuit found that the claims did not include additional limitations that, taken as a whole, provide an inventive concept that transforms the abstract idea into patent eligible subject matter. The Court reasoned that the representative claim “recites no steps that practically apply the claimed mathematical algorithm; instead [the claim] ends at storing the haplotype phase and ‘providing’ it ‘in response to a request.'” These steps alone were not enough to transform the abstract idea into patent eligible subject matter.

Stanford argued that the claimed process was directed to patent eligible subject matter and represented an improvement on a technological process—namely, an improvement in the number of haplotype phase predictions that this mathematical algorithm could yield. The Federal Circuit was unpersuaded that the pending claims did anything other than “merely enhance[] an ineligible concept.”

The Federal Circuit concluded that the claims only recited the conventional haplotype phase algorithm and then instruct: “apply it,” similar to the claimed subject matter prohibited by the Supreme Court in Alice. Accordingly, the Court affirmed the Board’s decision.



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Doctrine of Equivalents Analysis Should Not Be Simple Binary Comparison

by | Mar 17, 2021 |

The US Court of Appeals for the Federal Circuit remanded a district court’s claim construction and grant of a defendant’s summary judgment motion of non-infringement under the doctrine of equivalents, finding that a reasonable juror could find that the accused products performed substantially the same function in substantially the same way to achieve substantially the same result as the claimed invention. Edgewell Personal Care Brands, LLC v. Munchkin, Inc., Case No. 20-1203 (Fed. Cir. Mar. 9, 2021) (Moore, J.)

Edgewell manufactures and sells the “Diaper Genie,” a diaper pail system with a replaceable cassette placed inside the pail for soiled diaper collection, forming a wrapper around the diapers. Munchkin marketed a refill cassette as compatible with Edgewell’s pails. Edgewell’s two patents at issue relate to improvements in the cassette. After claim construction, Edgewell asserted literal infringement of one patent and infringement under the doctrine of equivalents of the other patent. The district court granted Munchkin’s summary judgment motion of non-infringement against both patents. Edgewell appealed.

Edgewell’s first patent is directed to a cassette with a clearance at its bottom portion. The claim construction dispute turned on whether the claims required a clearance space after the cassette was installed. The district court construed the claim to require a space and to require that the claimed “clearance” cannot be filled by an unclaimed interfering member. The district court granted Munchkin summary judgment because Munchkin’s refill cassette had no space after the cassette was installed. The Federal Circuit reversed, explaining that an “apparatus claim is generally to be construed according to what the apparatus is, not what the apparatus does.” The Court found that without an express limitation, “clearance” should be construed to cover all uses of the claimed cassette. The Court determined that the specification and purpose of the “clearance” supported the notion that the claim does not require a clearance after insertion.

The second patent is directed to a cassette with a cover that includes a “tear-off” section. The district court’s construction of an annular cover was of a single, ring-shaped cover. Munchkin’s cassettes each include a two-part cover, and the district court granted Munchkin’s motion for summary judgment of non-infringement. Although the Federal Circuit agreed with the claim constructions, the Court found that the district court erred in granting summary judgment to Munchkin under the doctrine of equivalents for claim element vitiation on the basis that “annular cover” and “tear-off” limitations §§would be rendered meaningless.

The vitiation doctrine ensures that applying the doctrine of equivalents “does not effectively eliminate a claim element in its entirety.” The Federal Circuit found that the district court erred in evaluating this element as a binary choice—single-component structure versus a multi-component structure. Instead, the Court explained that the district court should have evaluated the evidence to determine whether a reasonable juror could find that the accused products perform substantially the same function, in substantially the same way, achieving substantially the same result as the corresponding claim elements. Edgewell’s expert opined that Munchkin’s products performed the [...]

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First-to-File Rule Requires That Action Could Have Been Brought in Transferee Forum

by | Mar 11, 2021 |

After issuing a rare grant of a mandamus petition directing a district court to stay proceedings until ruling on a pending motion to transfer, the US Court of Appeals for the Federal Circuit denied a subsequent mandamus petition to compel transfer after that district court denied the transfer. In re SK hynix Inc., Case No. 21-114 (Fed. Cir. Feb. 25, 2021) (Taranto, J.) (non-precedential). The Federal Circuit found that the doctrine of forum non conveniens and the first-to-file rule did not establish a basis for transfer because the action could not have initially been brought in the transferee forum and the patentee’s prior filings in that forum did not give consent for subsequently filed actions.

Netlist and SK hynix are competitors in the memory semiconductor space. Netlist sued SK hynix for patent infringement in the US District Court for the Western District of Texas. SK hynix moved to transfer the case to the US District Court for the Central District of California. With no ruling after eight months (while the case continued to move forward), SK hynix sought mandamus from the Federal Circuit to compel the district court to transfer the case. The Federal Circuit declined to transfer the case and instead stayed the district court proceedings until the district court ruled on the transfer motion. The district court then denied the transfer motion, rejecting SK hynix’s arguments that the doctrine of forum non conveniens and the first-to-file rule required transfer to the Central District of California. The district court also advanced the Markman hearing and trial dates. SK hynix again sought mandamus from the Federal Circuit to compel transfer and requested a stay of the district court proceedings because of the advanced Markman and trial dates.

Applying Fifth Circuit law, the Federal Circuit denied the mandamus petition, concluding that SK hynix had not shown that the district court clearly abused its discretion in denying the transfer motion. On the forum non conveniens issue, the Court found no clear abuse in the district court’s determination that SK hynix did not meet the threshold conditions for transfer under 28 USC § 1404(a), namely that the action “might have been brought” in the Central District of California or that, in the alternative, all the parties had consented to that venue for the action. As to the “might have been brought” inquiry, the Court found that the district court properly focused on whether the action might have been brought against SK hynix America, a domestic entity subject to the venue requirements of 28 USC § 1404(b) and headquartered in the Northern District of California, rather than SK hynix, a foreign entity not subject to the same venue requirements. The Court also found that SK hynix did not differentiate between the foreign and domestic SK hynix entities in its transfer motion. This was not an action that might have been brought against SK hynix in the Central District of California because SK hynix America lacked sufficient presence there to confer venue under [...]

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

by | Mar 11, 2021 |

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. [...]

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Corresponding Structure Necessary to Support ‘Module’ Claim Element

by | Mar 11, 2021 |

In determining whether a claim element invoked 35 USC § 112, ¶ 6, the US Court of Appeals for the Federal Circuit concluded that “module” was a nonce term and required sufficient corresponding structure in the patent specification to avoid indefiniteness under 35 USC § 112, ¶ 2. Rain Computing, Inc. v. Samsung Electronics Co., Ltd., Case Nos. 20-1646, -1656 (Fed. Cir. Mar. 2, 2021) (Moore, J.)

Rain sued Samsung for infringement of a patent directed to a method for delivering software application packages to user terminals over a network. The claims at issue included an element that recited a “user identification module configured to control access [to] software application packages.” The district court determined that the “user identification module” was a means-plus-function term subject to 35 USC § 112, ¶ 6, but that the specification disclosed sufficient corresponding structure such that the term was not indefinite. Rain appealed the judgment of non-infringement.

Reviewing de novo, the Federal Circuit first addressed whether the claim language invoked § 112, ¶ 6. While there is a rebuttable presumption that ¶ 6 does not apply to claims lacking “means” language, the Court noted that “module” does not provide any indication of structure and is a well-known substitute for “means.” No other claim language, including the “user identification” prefix, imparted any structure onto the term. For purposes of claim construction, the specification also did not impart any structure to the claimed user identification module. Rain argued that amendments and examiner arguments during prosecution were proof of sufficient structure, and that, as the examiner noted, a means-plus-function term cannot be nested within a method claim. The Federal Circuit disagreed, noting that the examiner’s statement that a means-plus-function claim element cannot be nested within a method step was simply incorrect as a matter of law. Thus the Court found that “user identification module” was a means-plus-function claim term.

Citing to its 2015 en banc ruling in Williamson v. Citrix Online, the Court turned to the term’s construction under §112, ¶ 6, applying the same two-step process it used just a few weeks earlier in Synchronoss Technologies v. Dropbox. In the first step, the Court simply used the district court’s undisputed finding that the function was “to control access to . . . software packages to which the user has a subscription.” In the second step, the Court attempted to identify corresponding structure in the specification. Here the Court noted that structure in a specification corresponds only if there is a clear link or association, and that the specification must also disclose an actual algorithm when the function is performed by a general-purpose computer.

The Federal Circuit concluded that the district court erred in finding that the disclosure of a storage device provided sufficient structure, explaining that such devices are nothing more than general purpose computers not capable of performing the access control function without specialized software—an algorithm. Rain’s patent specification disclosed no such algorithm, without which the “user identification module” lacked sufficient structure. Thus [...]

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Chill: Full Recoupment of Investment Not a Bar to Equitable Intervening Rights

by | Mar 4, 2021 |

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of equitable intervening rights, protecting an alleged infringer from liability for activity that would otherwise infringe patent claims that were substantively and substantially altered during re-examination of the patent. John Bean Technologies Corp. v. Morris & Associates, Inc., Case No. 20-1090, -1148 (Fed. Cir. Feb. 19, 2021) (Reyna, J.)

John Bean and its only domestic competitor, Morris, manufacture chillers for processing poultry. John Bean told its customers that Morris’s competing chillers infringed John Bean’s patent. Morris sent John Bean a letter demanding that it stop making infringement allegations, and identifying prior art that Morris contended rendered the patent invalid. John Bean never responded to Morris’s demand letter, and Morris continued to manufacture and sell its competing poultry chillers.

Eleven years later, John Bean submitted its patent for ex parte re-examination. During reexamination, John Bean’s only original claims were substantively and substantially amended. After its reexamination certificate issued, John Bean sued Morris for infringement.

In 2016, the district court granted Morris’s motion for summary judgment with respect to the affirmative defense of equitable estoppel. The Federal Circuit reversed on appeal, holding that equitable estoppel did not apply because Morris’s unanswered demand letter related solely to the patent’s original claims and not to the altered and new claims that Morris was accused of infringing in the later-filed suit.

On remand, the district court granted Morris’s motion for summary judgment that John Bean’s infringement claims were barred by equitable intervening rights. The district court weighed seven factors in analyzing Morris’s equitable intervening rights defense and found that Morris engaged in substantial preparation prior to the re-examination, including years of research and development, and the conversion of almost two-thirds of its business to selling the accused chillers. The district court also found that John Bean acted in bad faith by failing to dispute Morris’s contentions of invalidity until after Morris had built its business manufacturing and selling the chillers accused of infringement. John Beam appealed.

Under 35 USC § 252, a court has the discretion to permit an accused infringer to continue to manufacture and sell an otherwise infringing product if the accused infringer made substantial preparation to commercialize the product prior to the re-examination of the patent. The policy rationale underlying equitable intervening rights is that the public has a right to use anything that is not specifically claimed in the original patent. John Bean’s suit only accused Morris of infringing claims that were added or substantially altered during re-examination.

In the present appeal, John Bean argued that the district court improperly weighed several of the equitable intervening rights factors. In particular, John Bean argued that the district court failed to give sufficient weight to the fact that Morris had already recouped the cost of its substantial preparations through sales of its otherwise infringing chiller, and was thus not entitled to the equitable remedy Morris sought from the court.

The Federal Circuit rejected John Bean’s [...]

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Collaterally Estopped: Do Not Re-Examine the Same Issues

by | Mar 4, 2021 |

In an appeal from an inter partes re-examination of a patent having both original and newly presented claims, the US Court of Appeals for the Federal Circuit ruled that a decision in earlier inter partes reexaminations of related patents had a preclusive effect that collaterally estopped the Patent Trial and Appeal Board from making new findings on the same issue that was determined in the prior re-examinations. SynQor, Inc. v. Vicor Corp, Case No. 19-1704 (Fed. Cir. Feb. 22, 2021) (Hughes, J.), (Dyk, J., dissenting).

Background

In 2011, SynQor asserted several patents, including the ‘190 patent, the ‘702 patent and the ‘290 patent, against Vicor. Vicor petitioned for reexamination of the ‘190, ‘702 and ‘290 patents, arguing that the claims of the ‘190 patent were unpatentable over two references: Steigerwald and Cobos. SynQor argued that an artisan would not have combined Steigerwald and Cobos because they taught circuits that operated at incompatible frequencies.

Past Appeals of Related Patents

On appeals from the reexaminations of the ‘702 and ‘290 patents, the Board affirmed that the challenged claims of the ‘702 patent were not unpatentable, because “there are incompatibilities in frequency between [Cobos and Steigerwald].” Similarly, after finding SynQor’s evidence that Steigerwald and Cobos operated at incompatible frequencies more credible than Vicor’s opposing evidence, the Board found the challenged claims of the ‘290 patent not unpatentable based on a combination of Steigerwald, Cobos and a third reference.

SynQor and Vicor had previously appealed the Board’s decisions in the reexaminations of the ‘702 and ‘290 patents to the Federal Circuit. As to the ‘290 patent, the Federal Circuit had affirmed the patentability of the challenged claims, holding that substantial evidence supported the Board’s finding that an artisan would not combine Steigerwald and Cobos because of their frequency incompatibility. The Court had also affirmed the Board’s decision finding the ‘702 patent not unpatentable, but did not (and was not asked to) reach the Board’s finding that Steigerwald and Cobos were incompatible.

Board Re-xamination of the ‘190 Patent

As to the ‘190 patent (at issue in this appeal), the Board found that Steigerwald and Cobos were not incompatible. In concluding that the challenged claims of the ‘190 patent were unpatentable over Steigerwald and Cobos, the Board was “not persuaded that the switching frequency differential is sufficient to render the combination unsuitable.” It found a new claim unpatentable based on a new ground of rejection, and SynQor opted to re-open prosecution of the new claim.

The ‘190 patent expired in January 2018. In February 2019, the Board issued its decision regarding the claims in the ‘190 reexamination, again rejecting SynQor’s argument that Steigerwald and Cobos had incompatible frequencies, and concluded that “the evidence points strongly to the lack of a frequency range discrepancy between Cobos and Steigerwald.” SynQor appealed.

Appeal as to the ‘190 Patent

On appeal, SynQor argued that common law issue preclusion arising from the ‘702 and ‘290 patent re-examinations should have collaterally estopped the Board from finding that an artisan would be [...]

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Doesn’t Scan: Skin Cancer Detection Device Just Combination of Familiar Elements

by | Feb 25, 2021 |

The US Court of Appeals for the Federal Circuit overturned a finding of non-obviousness of certain claims relating to a device for the detection of skin cancer, finding that the Patent Trial & Appeal Board erred in applying the law of obviousness. Canfield Scientific, Inc. v. Melanoscan, LLC, Case No. 19-1927 (Fed. Cir. Feb. 18, 2021) (Newman, J.)

Canfield Scientific filed a petition for inter partes review challenging the validity of claims of a Melanoscan patent as obvious in view of several prior art references. After the Board upheld the validity of the challenged claims, Canfield appealed.

The device disclosed in the patent is “an enclosure fitted with cameras and lights arranged in a manner that allows for imaging of [all or part] of non-occluded body surfaces in order to detect health and cosmetic disease.” The two challenged independent claims both required:

  • An enclosure configured to receive a person or portion thereof, wherein the enclosure defines a specified imaging position for placing the person or portion thereof within the enclosure
  • A plurality of imaging devices, wherein the plurality of imaging devices are vertically spaced relative to each other, a plurality of the imaging devices are located on opposite sides of the centerline of the specified imaging position
  • A plurality of light sources spaced relative to each other and peripheral to the plurality of imaging devices.

Canfield listed four references in support of its obviousness argument—Voigt, Hurley, Crampton and Daanen. Voigt disclosed an enclosure containing cameras and lights for analyzing and measuring images on the skin of a patient. Voigt did not disclose imaging devices (cameras) vertically and laterally spaced and on opposite sides of the center line. Instead, Voigt taught positioning the subject along the wall and positioning the cameras in a single direction.

Hurley, Crampton and Daanen each taught placement of a subject in the center of the enclosure, with cameras arranged vertically, laterally and on opposite sides of the centerline.

Canfield argued that the combined teachings of the prior art would have reasonably suggested the subject matter of the challenged claims. The Board found this argument unpersuasive, concluding that “Voigt’s rear wall would have blocked the view of the two rear-facing cameras, and Voigt’s horizontally adjustable sliders would have partially blocked the views of the remaining cameras.” Thus a person of skill in the art would not have been motivated to combine “the unmodified Voigt system with Hurley’s arrangement of imaging devices.” The Board did not discuss Crampton or Daanen.

The Federal Circuit disagreed with the Board’s conclusion and stated that the references showed the subject being imaged placed against a wall in Voigt, and centrally placed within the framework in Hurley, Crampton and Daanen. The references showed the cameras laterally and vertically spaced to each other about a center line. Citing the seminal Supreme Court KSR obviousness decision, the Federal Circuit noted that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable [...]

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

by | Feb 25, 2021 |

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 [...]

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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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