About bwheelock

Education J.D., Washington University in St. Louis B.S.E. in Mechanical Engineering, Duke University

Drug Labeling that Excludes Patented Use Can Still Induce Infringement

In Glaxosmithkline LLC v. Teva Pharmaceuticals USA, Inc., [2018-1976, 2018-2023] (August 5, 2021), the Federal Circuit vacated the grant of JMOL in favor of Teva, and reinstated the jury’s verdict and damages award for infringement of RE40,000, and remanded for appropriate further proceedings.

The ’000 patent claims a method of decreasing mortality caused by chronic heart failure by administering carvedilol with at least one other therapeutic agent.

Teva argued it could not have induced infringement prior to 2011, because it had “carved out” the indication and prescribing information for treatment of congestive heart failure in its 2007 label under section viii, and that it could not be be liable for inducement for any time period because it did not cause others to infringe the method claimed in the ’000 patent. The jury found the ’000 patent was not invalid, that Teva induced infringement of claims 1–3 during the partial label period proir to 2011, and that Teva induced infringement of claims 1–3 and 6–9 during the full label period after 2011. The jury assessed damages based on a combination of lost profits and a reasonable royalty and found Teva’s infringement willful.

The district court granted Teva’s renewed motion for JMOL, finding that substantial evidence did not support the verdict of induced infringement because GSK failed to prove that Teva’s alleged inducement, as opposed to other factors, actually caused physicians to directly infringe by prescribing generic carvedilol for the treatment of mild to severe chronic heart failure.

The Federal Circuit agreed with GSK that substantial evidence supports that Teva actively
induced by marketing a drug with a label encouraging a patented therapeutic use. The Federal Circuit said that the labeling did not omit all patented indications or merely note (without mentioning any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand-name drug. Instead, the Federal Circuit said this was a case in which substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications. The Federal Circuit address the concerns of several amici, nothing that its narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.

35 U.S.C. § 271(b) provides “Whoever actively induces infringement of a patent
shall be liable as an infringer.”The Federal Circuit explained that “[a] finding of inducement requires establishing “that the defendant possessed specific intent to encourage another’s infringement.” This requires a plaintiff to show that the alleged infringer’s actions induced infringing acts and that he knew or should have known his actions would induce actual infringements. The Federal Circuit said that when a plaintiff relies on a drug’s label accompanying the marketing of a drug to prove intent, the label must encourage,
recommend, or promote infringement.

The Federal Circuit found that despite Teva’s purporting to carve out the patented congestive heart failure indication, and its deletion of the indication from its pre-2011 partial label, substantial evidence supports the jury’s finding that Teva induced doctors to infringe the method of use claimed in the ’000 patent. GSK argues that substantial evidence supports
the jury’s verdict that Teva’s partial label encouraged an infringing use (via the post-MI LVD indication) and that Teva’s marketing materials encouraged prescribing carvedilol in a manner that would cause infringement of the ’000 patent, and the Federal Circuit agreed. GSK provided substantial evidence that Teva’s partial label instructed the method of use
claimed in the ’000 patent and thus was not a skinny label, because some of the labeled incidations overlapped the patented process.

Skimpy Proof of a Regular and Established Place of Business Bares Absence of Venue for Corporate Affiliates

In Andra Group, LP v. Victoria’s Secret Stores, LLC, [2020-2009] (August 3, 2021), the Federal Circuit affirmed the dismissal of three defendants for improper venue pursuant to 28 U.S.C. § 1400(b).

Andra sued for infringement of U.S. Patent No. 8,078,498 directed to displaying articles on a webpage, including applying distinctive characteristics to thumbnails and displaying those thumbnails in a “master display field.” Defendants argued that venue
was improper because Victoria’s Secret Stores did not commit acts of infringement
in the District, and the related defendants did not have regular and established places of business in the District.

The Federal Circuit noted that because each defendant is incorporated in Delaware, no defendant “resides” in Texas for the purpose of patent venue. Thus, to establish venue in this case, Andra must show that each Defendant committed acts of infringement and maintains a regular and established place of business in the Eastern District of Texas. While Victoria’s Secret Stores did have a place of business in the District, the other defenants did not. Andra argued, however, that Victoria’s Secret Stores’ locations are “a regular and established place of business” of the related entities because Victoria’s Secret Stores’ employees are agents of the related defendants, or, alternatively,
because the related defendants have ratified Victoria’s Secret Stores locations as their places of business.

The Federal Circuit examined the relationship between Victoria’s Secret Stores and the related entities, and agreed that none of the facts alleged by Andra are sufficient to
prove that Stores employees are agents of the other defendants. On Andra’s ratification theory, the Federal Circuit noted that “where related companies have maintained corporate separateness, the place of business of one corporation is not imputed
to the other for venue purposes. The Federal Circuit further noted that the fact
that the entities work together in some aspects, is insufficient to show ratification.

Giving reasoned consideration to all relevant factors or attributes of the relationship” between Victoria’s Secret Stores and the related defendants, the Federal Circuit concluded that Andra has not met its burden to related entities have ratified Victoria’s Secret Stores locations as their own places of business such that they may be said to maintain a regular and established place of business in the District.

The Federal Circuit thus affirmed the dismissal of the related entities who did not maintain employees or agents in the District and had not ratified the locations of a related entity as their own.

Following the Rules is Not Enough (Check the Statutes)

In Mondis Technology Ltd. v. LG Electronics Inc., [2020-1812] (August 3, 2021), the Federal Circuit dismissed LG’s appeal from a jury verdict that it infringed U.S. Patent No. 7,475,180, directed to a display unit configured to receive video signals from an external video source .

The jury found that the accused LG televisions infringed claims 14 and 15 of the ’180 patent, that the claims were not invalid, and that LG’s infringement was willful, and awarded plaintiffs $45 million in damages. Following the jury verdict, LG filed several post-trial motions including: (1) a motion for JMOL or new trial of non-infringement, (2) a motion for JMOL or new trial of invalidity, and (3) a motion for JMOL, new trial, or remittitur regarding the damages award and willfulness finding.

On September 24, 2019, the district court denied LG’s motions regarding infringement, invalidity, and willfulness but ordered further briefing on damages. On April 22, 2020, the district court granted LG’s motion for a new trial on damages. Less than 30 days later, on on May 8, 2020, LG filed notice of interlocutory ppeal challenging the district court’s decision denying LG’s post-trial motions regarding infringement, invalidity, and willfulness (all of which were decided in the September 24 Order).

The problem for LG is that its interlocutory appeal is governed by 28 U.S.C. § 1292(c)(2), which provides the Federal Circuit with exclusive jurisdiction over “an appeal from a judgment in a civil action for patent infringement which would otherwise be appealable to the United States Court of Appeals for the Federal Circuit and is final except for an accounting.” 28 U.S.C. § 2107(a) sets the time for appeal as “within thirty days after the entry of such judgment, order or decree.” Under § 1292(c)(2), a judgment is final except for an accounting when all liability issues have been resolved, and only a determination of damages remains.

The September 24 Order resolved all issues of liability, so the appeal was due by October 24, and thus the May 2020 filing was more than six months late, and thus the Federal Circuit had no jurisdiction to consider the appeal.

LG argued that FRAP 4(a)(4) instructs that, if a party timely files any of several enumerated motions, including post-trial motions for judgment under FRCP 50(b) or for a new trial under FRCP 59, “the time to file an appeal runs for all parties from the entry
of the order disposing of the last such remaining motion.”

The Federal Circuit noted that LG’s timeliness arguments focus on the Federal Rules,
rather than the statutory requirements for jurisdiction, observing that the Rules cannot override federal statute, and to the extent that there is any conflict between the Rules and federal statutes, the statutes must prevail.

However, not all is lost for LG. While its interlocutory appeal was dismissed, LG is not precluded from from challenging the liability determinations of the district court under our § 1295 jurisdiction once the damages determination is completed.

I will Gladly Assign to You Today, an Invention I will Make Tomorrow

In Omni Medsci, Inc. v. Apple, Inc., [2020-1715, 2020-1716] (August 2, 2021), the Federal Circuit affirmed the district court’s holding that the University of Michigan bylaws did not effectuate a present automatic assignment of Dr. Islam’s patent rights and therefore affirm the district court’s denial of Apple’s motion to dismiss on the ground that Omni, Dr. Islam’s assignee, had standing.

The University of Michigan’s by laws provide that:

Patents and copyrights issued or acquired as a result of or in connection with administration, research, or other educational activities conducted by members of the University staff and supported directly or indirectly (e.g., through the use of University resources or facilities) by funds administered by the University regardless of the source of such funds, and all royalties or other revenues derived therefrom shall be the property of the University.

Slip Op. 2-3.

If this language worked an immediate assignment of rights, then Dr. Islam’s assignment to Omni was a nullity, and Omni lacked standing, as Apple contended. The majority reviewed this language and agreed with the district court that it did not presently automatically assign
Dr. Islam’s rights to the patent but rather, at most, “reflects a future agreement to assign rather than a present assignment.” This conclusion was supported by a comparison of the language with Federal Circuit precedent; the fact tht the same language was used in other parts of the document that could not possibly be considered to be a present assignment; the fact that the language did not use “present tense words of execution;” and the fact the language was different than assignment language used by the University in other forms.

Judge Newman dissented, finding that the language in the by laws was an assignment, which meant the assignment to Omni was ineffective, and thus Omni lacked standing.

Regardless of whether you side agree the majority or with Judge Newman, both sides continue to accept without question that it is possible to make a present assignment of something that does not exist. It would foolish not to recognize that this is the law, and to use clear language of present assignment in employee agreements. However it is equally foolish not to get a confirmatory assignment once something is actually invented.

PTAB Departure from Agreed Claim Construction Required Notice and Opportunity to be Heard

In Qualcomm Inc. v. Intel Corp., [2020-1589, 2020-1590, 2020-1591, 2020-1592, 2020-1593,
2020-1594] (July 27, 2021), the Federal Circuit vacated and remanded six inter partes review final written decisions determining that claims 1–15, 17–25, and 27–33 of U.S. Patent
No. 9,608,675 would have been obvious.

The ’675 patent relates to techniques for generating a power tracking supply voltage for a circuit that processes multiple radio frequency signals simultaneously, using one power amplifier and one power tracking supply generator. During the IPR’s the parties never disputed that the signals were required to increase user bandwidth, and in the International Trade Commission, the Commission’s construction of the term also included the increased
bandwidth requirement.

The Board issued six final written decisions concluding that all challenged claims were unpatentable. In reaching its conclusion, the Board construed the term “a plurality of carrier aggregated transmit signals” in each asserted claim to mean “signals for transmission on multiple carriers,” omitting any requirement that the signals increase or extend bandwidth.

Qualcomm argued that it was not afforded notice of, or an adequate opportunity to respond to, the Board’s construction of “a plurality of carrier aggregated transmit signals,” and the Federal Circuit agreed. The Federal Circuit began by noting that “[a] patent owner in [an IPR] is undoubtedly entitled to notice of and a fair opportunity to meet the grounds of rejection,”
based on due process and Administrative Procedure Act (APA) guarantees.

The Board may adopt a claim construction of a disputed term that neither party proposes
without running afoul of the APA. Parties are well aware that the Board may stray from disputed, proposed constructions, however, but in the instant case the issue of whether increased bandwidth was a required part of the claim construction was not in dispute. The Federal Circuit noted that the patent owner owner agreed with the increased bandwidth requirement proposed by the petitioner. While the Board did not change theories midstream or depart from a construction it previously adopted, it is still difficult to imagine either party anticipating that this agreed-upon matter of claim construction was a moving target. The Federal Circuit said that unlike with disputed terms, it is unreasonable to expect parties to brief or argue agreed-upon matters of claim construction. Thus the Federal Circuit found that in the
the circumstances of this case, the Board needed to provide notice of, and an adequate opportunity to respond to, its construction. The Federal Circuit further found that Qualcomm did not receive notice or an opportunity to be heard regarding the Board’s construction that departed from the agreed-upon increased bandwidth requirement, and thus, the Board violated Qualcomm’s procedural rights under the APA.

It is not Obvious to Ignore the Teachings of the Prior Art

In Chemours Company FC, LLC v. Daikin Industries, LTD., [2020-1289, 2020-1290] (July 22, 2021), the Federal Circuit concluded that the Board’s decision on obviousness is not supported by substantial evidence and that the Board erred in its analysis of objective indicia of nonobviousness, and reversed.

U.S. Patent No. 7,122,609 relates to a unique polymer for insulating communication cables formed by pulling wires through melted polymer to coat and insulate the wires, a process
known as “extrusion.”

Chemours argues that the Board’s final written decision on obviousness is erroneous because its factual findings on motivation to combine were unsupported by substantial evidence, and specifically that Daikin did not meet its burden of proof because it failed to show that a person of ordinary skill in the art would modify the polymer of the prior art reference to achieve the claimed invention. However the reference also taught that a narrow distribution of molecular weights was important, while the claimed invention did not use the narrow distribution of molecular weights.

The Federal CIrcuit found that Board’s obviousness findings are not supported by substantial evidence. The Federal Circuit said the Board appears to have ignored the express disclosure in the reference that teaches away from the claimed invention and relied on teachings from other references that were not concerned with the particular problems the reference sought to solve. More specifically, the Board did not explain why one would be motivated to increase the melt flow rate to the claimed range, when doing so would necessarily involve altering the inventive concept of a narrow molecular weight distribution polymer. The Federal Circuit cited Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) where it found no motivation to modify the prior art where doing so “would destroy the basic objective” of the prior art).

The Federal Circuit found that this was particularly true in light of the fact that the reference appears to teach away from broadening molecular weight distribution and the known methods for increasing melt flow rate. The Federal Circuit said that the Board relied on an inadequate evidentiary basis and failed to articulate a satisfactory explanation that is based on substantial evidence for why one would have been motivated to modify the reference.

The Federal Circuit also agreed that the Board erred in its analysis of objective indicia. The Board found no nexus between the claimed invention and the alleged commercial success because all the features were disclosed in the prior art. The Federal Circuit instructed that contrary to the Board’s decision, the separate disclosure of individual limitations, where the invention is a unique combination of three interdependent properties, does not negate a nexus, explaining that concluding otherwise would mean that nexus could never exist where the claimed invention is a unique combination of known elements from the prior art.

The Federal Circuit also agreed that the Board erred in its demand that market share evidence is necessary to sustain a finding of commercial success. Chemours contended that sales data
alone should be enough for commercial success, and the Federal Circuit agreed. The Federal Circuit said that market share data, though potentially useful, is not required to show commercial success. While the Board was entitled to weigh evidence and find, if appropriate, that Chemours’s gross sales data were insufficient to show commercial success without market
share data, the Board, erred in its analysis that gross sales figures, absent market share data, “are inadequate to establish commercial success.”

Lastly, the Federal Circuit agreed that the Board erred when it found that the patents in suit were blocking patents. A blocking patent is an earlier patent that prevents practice of a later invention—the invention of the patent-in-dispute. The Board concluded that the evidence proffered to establish commercial success was weak because the patent-in-suit blocked others
from entering the market. The Federal Circuit said that the challenged patent, which covers the claimed invention at issue, cannot act as a blocking patent.

A Patent Infringement Complaint Simply Must State a Plausible Claim to Relief

In Bot M8 LLC v. Sony Corporation of America, [2020-2218] (July 13, 2021), the Federal Circuit found no error in the district court’s “directing” Bot M8 to file a first amended complaint, or in dismissing Bot M8’s claims of infringement of U.S. Patent Nos. 8,078,540 and 8,095,990 for failure to state a plausible claim of infringement. However, the Federal Circuit held that the district court erred in finding Bot M8’s allegations as to U.S. Patent Nos. 7,664,988 and 8,112,670 were insufficient. The Federal Circuit found that the district court acted within its discretion in denying Bot M8’s motion to file a second amended complaint, as well as the subsequent order denying leave to move for reconsideration. Finally the Federal Circuit affirmed the granting summary judgment as to the invalidity of the U.S. Patent No. 7,338,363 under 35 USC 101. The asserted patents all relate to gaming machines and are directed to casino, arcade, and video games generally.

To survive a motion to dismiss under Rule 12(b)(6), the Federal Circuit said a complaint must “contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. The district court instructed counsel for Bot M8 that it must explain in the complaint every element of every claim that you say is infringed and/or explain why it can’t be done. The Federal Circuit disagreed with the district court’s approach and reiterate that a plaintiff need not ‘prove its case at the pleading stage. The Federal Circuit said a plaintiff is not required to plead infringement on an element-by-element basis. Instead, it is enough that a complaint place the alleged infringer on notice of what activity is being accused of infringement.

The relevant inquiry under Iqbal/Twombly is whether the factual allegations in the complaint are sufficient to show that the plaintiff has a plausible claim for relief. The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully. In other words, a plausible claim must do more than merely allege entitlement to relief; it must support the grounds for that entitlement with sufficient factual content.

The Federal Circuit agreed with the district court that Bot M8’s allegations as to the ’540 and ’990 patents were conclusory and at times contradictory, but found that the court erred in dismissing the allegations as to the ’988 and ’670 patents. With respect to the ’988 and ’670 patents, the court simply required too much.

With respect to the ‘363 Patent, and Federal Circuit agreed that the claims recite the abstract idea of increasing or decreasing the risk-to-reward ratio, or more broadly the difficulty, of a multiplayer game based upon previous aggregate results. The Federal Circuit further found that the claims leave open how to accomplish this, and the specification provides hardly any more direction. The district court said, and the Federal CIrcuit further found that the claim merely recites result-oriented uses of conventional computer devices and that, at bottom, nei-ther the patent specification, patent owner, or patent owner’s experts articulate a technological problem solved by the ’363 patent.” After careful consideration, the Federal Circuit discerned no error in the district court’s § 101 analysis, and found no need to discuss that analysis in any detail.

Father’s Day 2021

America’s ingenuity for celebrating is well documented in the U.S. patent collection, and technology for celebrating our Fathers is not an exception.

Take, for instance, the Expectant Father System patented by Ashley Svopa on June 1, 1999 as U.S. Patent No. 5,908,108:

Then there’s literally a Father Figure in U.S. Patent No. D803720, patented by Eytan and Irina Silboni on November 28, 2017:

Juneteenth

Congress has passed, and President Biden has now signed, legislation making June 19th — Juneteenth — a national holiday. June 19th is the anniversary of the June 19, 1865, announcement of General Order No. 3 by Union Army general Gordon Granger, proclaiming freedom from slavery in Texas. President Lincoln’s January 1, 1863, Emancipation Proclamation officially outlawed slavery in the rebelling states, but enforcement in remote Texas was spotty at best. Ironically, after June 19th 1865, slavery remained legal in two Union states – Delaware and Kentucky – for another six months until the December 6, 1865, ratification of the Thirteenth Amendment to the Constitution abolished slavery nationwide.

Only one U.S. patent to date references Juneteenth — Ivy Antrinette Marlonia’s U.S. Patent No. 8,136,962, on Remote Controlled Hideaway Holiday and Party Lighting. According to Ivy, her party lighting can be used to celebrate a number of occasions, including Juneteenth:

Flag Day 2021

June 14th is Flag Day, the anniversary of the adoption of the flag of the United States on June 14, 1777, by resolution of the Second Continental Congress. President Woodrow Wilson issued a proclamation that officially established June 14 as Flag Day in 1916, and on August 3, 1949, Congress established June 14 as National Flag Day, although it was not made an official federal holiday. The U.S. patent collection provides a number of suggestions of ways to display your flag:

U.S. Patent No. 1,571,581, issued February 2, 1926 discloses a Holder for Flags or the Like
U.S. Patent No. 1,374,921, issued April 19, 1921, disc;loses a Mechanically Waved Flag
U.S. Patent No. 696597, issued April 8, 1902, discloses a Flag Cane.
U.S> Patent No. D22035, issued December 6, 1892, discloses a Handle for Spoon with a flag motif.

However you decide to display the flag today, have a great day.