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Silence May Be Sufficient Written Description Disclosure for Negative Limitation

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and no-loading dose negative limitation. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. Jan. 3, 2022) (Linn, O’Malley, JJ.) (Moore, CJ, dissenting).

Novartis’s Gilenya is a 0.5 mg daily dose of fingolimod hydrochloride medication used to treat relapsing remitting multiple sclerosis (RRMS). HEC filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringed a patent directed to methods of treating RRMS with fingolimod or a fingolimod salt at a daily dosage of 0.5 mg without an immediately preceding loading dose.

The specification described the results of an Experimental Autoimmune Encephalomyelitis (EAE) experiment induced in Lewis rats showing that fingolimod hydrochloride inhibited disease relapse when administered daily at a dose of 0.3 mg/kg or administered orally at 0.3 mg/kg every second or third day or once a week, and a prophetic human clinical trial in which RRMS patients would receive 0.5, 1.25 or 2.5 mg of fingolimod hydrochloride per day for two to six months. The specification did not mention a loading dose associated with either the EAE experiment or the prophetic trial. It was undisputed that loading doses were well known in the prior art and used in some medications for the treatment of multiple sclerosis.

The district court found that HEC had not shown that the patent was invalid for insufficient written description for the claimed 0.5 mg daily dose or the no-loading dose negative limitation. The district court also found sufficient written description in the EAE experiment and/or prophetic trial and credited the testimony of two of Novartis’s expert witnesses. HEC appealed.

The Federal Circuit affirmed the district court’s decision. Turning first to the daily dose limitation, the majority held that the prophetic trial described daily dosages of 0.5, 1.25 or 2.5 mg and found no clear error by the district court in crediting expert testimony converting the lowest daily rat dose described in the EAE experiment to arrive at the claimed 0.5 mg daily human dose. Reciting Ariad, the Court explained that a “disclosure need not recite the claimed invention in haec verba” and further, that “[b]laze marks” are not necessary where the claimed species is expressly described in the specification, as the 0.5 mg daily dose was here.

Turning to the no-loading dose negative limitation, the majority disagreed with HEC’s arguments that there was no written description because the specification contained zero recitation of a loading dose or its potential benefits or disadvantages, and because the district court inconsistently found that a prior art abstract (Kappos 2006) did not anticipate the claims because it was silent as to loading doses. The Court explained that there is no “new and heightened standard for negative claim limitations.” The majority acknowledged that silence alone is insufficient disclosure but emphasized that [...]

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PTO’s Financial Benefits from IPR Don’t Render PTAB Unconstitutional

A split panel of the US Court of Appeals for the Federal Circuit concluded that the structure and functions of the Patent Trial & Appeal Board (PTAB) survived yet another constitutional challenge, this time based on the PTAB’s fee and compensation structure, lack of director review over the institution decision and applicability of the Takings Clause. Mobility WorkX, LLC v. Unified Patents LLC, Case No. 20-1441 (Fed. Cir.) (Dyk, J.) (Newman, J., dissenting).

With the dust barely settled after the Supreme Court’s ruling in US v. Arthrex, Inc. that the PTAB’s rendering of final written decisions without director review violated the Appointments Clause, this case presented a whole new slate of potential deficiencies with the PTAB. Although none of these deficiencies were initially raised with the PTAB, the Court exercised its discretion to nonetheless consider the challenges based on publicly available records that it could judicially notice.

The first challenge, already made in many other cases, was that the Federal Circuit remand for the director to consider a rehearing petition in view of Arthrex. This remedy, already afforded in other post-Arthrex challenges, was a simple grant. Yet, here, Mobility asked for something more, arguing that because the director did not resolve the inter partes review (IPR) within the 12-month statutory period, the director must confirm the claims or dismiss the IPR. The Court declined to rule on this issue, instructing Mobility to raise the issue on remand.

The issue receiving the most attention by the Federal Circuit was Mobility’s claims that the PTAB’s fee structure and bonus payments to administrative patent judges (APJs) based on their workload violated the Due Process Clause. According to Mobility, the APJs have a financial incentive to institute IPRs (i.e., significant fees), which provide a significant benefit to the agency. But the Court concluded that the APJs (even the leadership APJs) have only an attenuated role in budget control and thus have an insignificant interest in the financial health of the US Patent & Trademark Office as a whole. Because Congress holds the purse strings and the more significant budget responsibilities fall on the director and the president, the majority held that little connection existed between institution decisions and the agency’s overall financial health, which was consistent with the Court’s own precedent regarding reexaminations and other circuits’ precedents regarding executive agency fee collection. This attenuated connection differentiated the PTAB’s collected fees from Supreme Court cases that found due process violations based on the structure of certain executive courts presided over by a mayor who also held concomitant budget responsibilities.

Similarly, the Federal Circuit held that the APJs’ incentive to render a certain number of decisions—i.e., APJs receive bonus payments if they earn at least 84 decisional units, and the number of decisions is part of performance evaluation—did not provide an unconstitutional incentive to institute. The majority reasoned that ample alternative means existed for the APJs to earn their bonuses, namely, the ability to volunteer for non-America Invents Act (AIA) decisions (such as [...]

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Party May Not Veil EU Individual’s Information under GDPR at the TTAB

In a rare precedential opinion, the Trademark Trial & Appeal Board (TTAB, Board) ruled that the EU General Data Protection Regulation (GDPR) does not apply in Board proceedings. Chicago Mercantile Exchange, Inc. v. Intercontinental Exchange Holdings, Inc., Opposition Nos. 91235909; 91254514 (T.T.A.B. Sept. 27, 2021) (Faint, Interlocutory Attorney).

This was a consolidated proceeding between Chicago Mercantile Exchange and New York Mercantile Exchange (collectively, CME) and Intercontinental Exchange Holdings (ICE) and brought before the TTAB. CME sought to amend the Board’s standard protective order (SPO) to allow in-house access to information and materials designated by ICE as “Confidential – Attorney’s Eyes Only” and asked the TTAB to find that the EU GDPR does not apply in the proceedings.

The Board’s SPO is automatically imposed in all inter partes proceedings. In order for the Board to disturb their SPO, CME needed to show that protection of ICE’s trade secrets will impair CME’s prosecution of its claims. ICE asserted that CME failed to show good cause for modification of the SPO and the Board agreed. As an initial matter, CME failed to provide information sufficient for the Board to determine in-house counsel’s responsibilities, including whether those responsibilities included competitive decision-making such that disclosure to in-house counsel would competitively harm ICE. Secondly, CME failed to clearly demonstrate that there was a need for access to the highly sensitive competitive information to adequately prepare its case. Accordingly, the Board denied CME’s motion to amend the protective order.

CME next raised the issue of whether ICE may redact names, email addresses and other information from documents and electronically stored information (ESI) originating in the European Union prior to its production on the basis that the GDPR requires such redaction. CME argued that because ICE waited more than 18 months to assert this objection, the objection is waived, that CME will be severely prejudiced if ICE’s objection stands and that the GDPR does not apply in inter partes Board proceedings.

For background, the GDPR is an EU regulation made effective May 25, 2018, in order to protect the privacy and security of EU citizens’ personal data by limiting the transfer of such information among member states of the European Union, as well as between the European Union and other countries, including the United States. The broad definition given to “personal data” in the GDPR encompasses “any information relating to an identified or identifiable person.” However, this class of information (an individual’s name, position, job title and email address) is generally required to be produced in discovery pursuant to the Fed. R. Civ. Pro. 26(b)(1).

In this precedential decision, the Board, citing the 1987 Supreme Court case Societe Nationale Industrielle Aerospatiale v. U.S. Dist. Court, established that a foreign country’s law precluding disclosure of evidence in US courts and tribunals will generally not deprive those courts and tribunals of “the power to order a party subject to its jurisdiction to produce evidence even though the act of production may violate that statute.”. Additionally, the GDPR does not per [...]

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Federal Circuit Lacks Appellate Jurisdiction over Standalone Walker Process Claims

The US Court of Appeals for the Federal Circuit ordered the transfer of a case asserting standalone Walker Process antitrust claims involving an unenforceable patent to the regional circuit, in this case the US Court of Appeals for the Fifth Circuit. Chandler v. Phoenix Services LLC, Case No. 20-1848 (Fed Cir. June 10, 2021) (Hughes, J.) The case originated in the US District Court for the Northern District of Texas, over which the Fifth Circuit has appellate jurisdiction. The decision to transfer was based on a subject matter jurisdiction analysis for Walker Process claims. The Federal Circuit reiterated that its precedent does not mandate exclusive Federal Circuit jurisdiction over all Walker Process cases.

In 2006, Phoenix Services and Mark Fisher (collectively, Phoenix) acquired a company called Heat On-The-Fly and its patent to protect a purported proprietary fracking process. Heat-On-The-Fly, and later Phoenix, sought to enforce the patent against numerous parties. During the patent application process, however, Heat On-The-Fly had failed to disclose numerous public uses of the fracking process prior to the application filing. In 2018, in an unrelated case, Energy Heating, LLC v. Heat On-The-Fly, the Federal Circuit, held that “failure to disclose prior uses of the fracking process rendered the . . . patent unenforceable due to inequitable conduct.” The plaintiffs in the case at hand, Ronald Chandler, Chandler MFG., Newco Enterprises and Supertherm Heating Services (collectively, Chandler), alleged that Phoenix’s continued enforcement of the patent violated Walker Process pursuant to § 2 of the Sherman Act.

Walker Process monopolization claims originate from a 1965 Supreme Court decision that recognized an antitrust cause of action under the Sherman and Clayton Acts when a party fraudulently obtains a patent for the purpose of attempted monopolization. Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp. To succeed on a Walker Process claim, a plaintiff must satisfy two elements:

  • The plaintiff must show that the defendant obtained the patent through knowing and willful fraud on the US Patent & Trademark Office and enforced that patent with knowledge of its fraudulent procurement.
  • The plaintiff must be able to satisfy all other elements for a Sherman Act monopolization claim.

Pursuant to 28 U.S.C. § 1295(a)(1), the Federal Circuit retains jurisdiction over any civil case arising under any act of Congress relating to patents. In this instance, the Federal Circuit stated that Walker Process antitrust claims may relate to patents “in the colloquial use of the term,” but under 1988 Supreme Court precedent, Christianson v. Colt Indus., the Federal Circuit’s jurisdiction only extends to cases where the cause of action is created under federal patent law, or where the plaintiff’s right to relief “necessarily depends on resolution of a substantial question of federal patent law.”

Here, the Federal Circuit relied on its own 2018 precedent where it analyzed subject matter jurisdiction for Walker Process claims. Xitronix Corp v. KLA-Tencor Corp. (Xitronix I). Xitronix I involved alleged fraud by the defendants to obtain a patent. The Court acknowledged [...]

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Initial Confusion? Relax, Eighth Circuit Has Your Number

Addressing a novel issue regarding when confusion must occur for it to be actionable, the US Court of Appeals for the Eighth Circuit concluded that initial-interest confusion was a viable infringement theory. Select Comfort Corp. v. Baxter, Case No. 19-1113 (8th Cir. May 11, 2021) (Melloy, J.)

Select Comfort owns registered trademarks, including “SELECT COMFORT,” “SLEEP NUMBER” and “WHAT’S YOUR SLEEP NUMBER,” for adjustable air mattresses, which it sells online and in stores across the United States. Baxter sells competing air mattresses online and through a call center. Select Comfort brought a suit asserting trademark infringement, trademark dilution and false advertising theories against Baxter. Select Comfort alleged that Baxter used Select Comfort’s registered trademarks in an identical or confusingly similar manner to advertise Baxter’s mattresses and divert consumers to its website and phone lines instead of Select Comfort’s. Select Comfort also alleged that Baxter made false representations about its products and failed to dispel consumer confusion about the products. At trial, Select Comfort pointed to similar terms in Baxter’s online advertising text, graphics and domain addresses, in addition to examples of actual confusion about the products in Baxter’s call-center transcripts.

Earlier in the case, in connection with summary judgment, the district court found that the relevant consumers were sophisticated as a matter of law, and, citing Eight Circuit precedent, rejected application of a theory of initial-interest confusion. The district court instead instructed the jury that in order to prevail on its trademark infringement claim, Select Comfort had to prove likelihood of confusion at the time of purchase. Based on this limiting instruction, the jury rejected Select Comfort’s trademark infringement claims. Select Comfort appealed.

The Eighth Circuit reversed. The Court explained that the district court erred on the availability of an initial-interest confusion as an infringement theory. For trademark infringement claims, the likelihood of confusion test is a fact-intensive inquiry with many factors. However, circuit courts have not definitively agreed on when confusion must exist. Must confusion occur only at the time of ultimate purchase, or can it also exist during pre-sale? The theory of initial-interest confusion involves the latter scenario, namely, when confusion about a product’s ownership causes a customer to have initial interest in the product, even if there is no actual sale at the time of the confusion. Actionable initial infringement protects competitors from getting a free ride on the goodwill of an established mark if a consumer falsely infers an affiliation between the companies.

In the precedential 2010 Eighth Circuit case Sensient Techs. v. Sensory Effects Flavor, the Court neither rejected nor adopted the initial-interest/pre-sale confusion theory. Instead, it merely found that the theory did not apply where consumers were sophisticated (i.e., where they exercise a high degree of care in purchasing products, a factor weighing against likelihood of confusion). Here, influenced by Lanham Act amendments and other circuit courts, the Court addressed the issue previously left open: whether the initial-interest confusion may be actionable in the Eighth Circuit in cases where the jury is left to [...]

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Zero Hero: Disclaiming Disputed Term Renders Dispute Moot

The Trademark Trial & Appeal Board redesignated as precedential a decision dismissing a beverage company’s opposition to trademarks using the term “ZERO” for zero-calorie drinks after the trademark applicant disclaimed the term ZERO in its pending applications, the sole remedy requested in the opposition. Royal Crown Co., Inc. v. The Coca-Cola Co., Opposition Nos. 91178927 (Parent Case); 91180771; 91180772; 91183482; 91185755; 91186579; and 91190658 (TTAB May 3, 2019) (redesignated precedential Mar. 30, 2021) (Hightower, ATJ). The US Court of Appeals for the Federal Circuit agreed with the Board’s decision, holding that disclaiming the term ZERO rendered the dispute moot. Royal Crown Co., Inc. v. Coca-Cola Co., Case No. 19-2088 (Fed. Cir. Aug. 3, 2020) (Lourie, J.)

Royal Crown and Coca-Cola are competitors in the beverage market. Coca-Cola filed 16 applications to register marks appending the term ZERO to some of its existing beverage brands, such as Coke Zero, Coke Cherry Zero and Sprite Zero. Royal Crown filed oppositions to each of the 16 applications (later consolidated), arguing that the marks were generic or merely descriptive of the beverages’ zero-calorie attributes, and that the registrations should be denied without a disclaimer of the term ZERO. The Board initially held that Coca-Cola’s applications could be registered without a disclaimer of the term ZERO, finding that Royal Crown failed to show that ZERO was generic for zero-calorie products in the genus of soft drinks, sports drinks and energy drinks, and that Coca-Cola proved that the term ZERO had acquired distinctiveness for soft drinks and sports drinks, although not for energy drinks. On appeal, the Federal Circuit vacated the decision and remanded the case back to the Board with instructions to apply the correct legal standard for genericness of the term ZERO, including examining whether the term ZERO referred to a key aspect of the genus when appended to a beverage mark, and to make an express finding regarding the degree of the mark’s descriptiveness.

On remand, the Board ordered the parties to rebrief certain issues. Instead, Coca-Cola filed an unconsented motion to amend each of its applications to disclaim the term ZERO. Coca-Cola argued that the disclaimer rendered the remaining issues in the case moot and that no further action was required by the Board. Although disclaimer was the sole remedy Royal Crown originally sought in its oppositions, Royal Crown protested that the disclaimer was procedurally improper and not case-dispositive. Royal Crown argued that its requested relief included a determination that ZERO was generic or merely descriptive, and that while a disclaimer was the manner in which that relief was demonstrated, a disclaimer did not moot the legal issues raised. Royal Crown asked the Board to defer ruling on the motion to amend until it had issued a full decision on the merits.

Agreeing with Coca-Cola, the Board found that since the disclaimer was the relief sought by Royal Crown and the form of the disclaimer was acceptable, entered the disclaimer and dismissed Royal Crown’s opposition.

Practice Note: In the original appeal from [...]

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Collaterally Estopped: Do Not Re-Examine the Same Issues

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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IP Implications of the Consolidated Appropriations Act, 2021

On December 27, 2020, Congress signed the Consolidated Appropriations Act, 2021, into law. The omnibus act includes new legislation affecting patent, copyright and trademark law. A brief summary of key provisions is provided below.

Patents – Section 325 Biological Product Patent Transparency

42 USC § 262(k) was amended to require that the US Food and Drug Administration (FDA) provide the public with more information about patented biological products. Within six months, the FDA must make the following information available to the public on its Database of Licensed Biological Products or “Purple Book,” and it must update the list every 30 days:

  • A list of each biological product, by nonproprietary name, for which a biologics license is in effect
  • The license date and application number
  • The license and marketing status (as available)
  • Exclusivity periods

The amendment requires that the holders of a license to market a biologic drug now disclose all patents believed to be covering that drug. The new law is designed to prevent errors that could delay biosimilars from coming to the market.

Copyrights – The CASE Act of 2020

The Consolidated Appropriations Act incorporates the Copyright Alternative in Small-Claims Enforcement (CASE) Act of 2020, as well as legislation designed to increase criminal penalties for the unauthorized digital streaming of copyright-protected content. The CASE Act includes revisions to the Copyright Act, 17 USC §§ 101 et seq., with the goal of creating a new venue for copyright owners to enforce their rights instead of having to file an action in federal court.

The Copyright Claims Board

The CASE Act established the Copyright Claims Board (a small claims court), which is designed to serve as an alternative forum where parties may voluntarily seek to resolve certain copyright claims regarding any category of copyrighted work. A party may opt out upon being served with a claim, choosing instead to resolve the dispute in federal court. A party to a proceeding before the Board may, but is not required to, be represented by a lawyer. A party may also be represented by a law student who is qualified under applicable law, and who provides such representation on a pro bono basis. The Board consists of three copyright claims officers who may conduct individualized proceedings to resolve disputes and must issue written decisions setting forth their factual findings and legal conclusions.

Procedural Matters

The Board must follow the law in the federal jurisdiction in which the action could have been brought if filed in federal court. Because jurisdictional conflicts may arise where a dispute may have been brought in multiple jurisdictions, the CASE Act provides that the Board may apply the law of the jurisdiction that the Board determines has the most significant ties to the parties and the conduct at issue.

Although formal motion practice is not permitted, discovery is allowed on a limited basis, including requests for documents, written interrogatories and written requests for admission. The Board may consider evidence, documentary and (non-expert) testimony, without the application of formal [...]

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Federal Circuit Will Not Second-Guess IPR Institution Denials

In a series of non-precedential orders, the US Court of Appeals for the Federal Circuit reiterated that it lacks jurisdiction to hear appeals on whether the Patent Trial and Appeal Board properly decided to deny inter partes review (IPR) petitions based on parallel district court litigation. Cisco Systems Inc. v. Ramot at Tel Aviv University, Case Nos. 20-2047, -2049 (Fed. Cir. Oct. 30, 2020); Google LLC v. Uniloc 2017 LLC, Case No. 20-2040 (Oct. 30, 2020); In re: Cisco Systems Inc., Case No. 2020-148 (Fed. Cir. Oct. 30, 2020); Apple Inc. v. Maxell, Ltd., Case No. 20-2132, -2211, -2212, -2213, 21-1033 (Fed. Cir. Oct. 30, 2020).

The 2011 Leahy-Smith America Invents Act (AIA) created various mechanisms for challenging the validity of issued patents in post-grant proceedings before the US Patent and Trademark Office PTO) by adding transitional covered business method and post-grant review proceedings to existing ex parte re-examination, and expanding and renaming inter partes re-examination to inter partes review (IPR).

Under 35 USC §§ 311, 312, a petition for IPR must identify all real parties in interest, identify and support the prior art grounds for challenges to the claims, and provide “such other information as the Director may require by regulation.” Under 35 USC § 314 and 37 CFR 42.4(a), the Board institutes a trial on behalf of the PTO Director, and a “determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.” In deciding whether to institute the trial, the Board considers, at a minimum, whether a petitioner has satisfied the relevant statutory institution standard. Even when a petitioner has satisfied the institution standard, the Director has statutory discretion under 35 USC 314(a) and 324(a) to deny a petition.

In 2016, the Supreme Court of the United States held in Cuozzo Speed Techs. v. Lee that “the agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion,” and that there is “no mandate to institute review.” The Supreme Court also found that the Director is given broad discretion under 35 USC 315(d) and 325(d) to determine the manner in which “multiple proceedings” before the PTO involving the same patent may proceed, “including providing for stay, transfer, consolidation, or termination of any such matter or proceeding.” Subsequent PTO policies and precedential Board decisions set forth factors affecting the case-specific analysis of whether to institute an AIA proceeding, and particularly a follow-on or serial petition, or discretionary denial due to the timing of parallel district court proceedings.

In Cisco v. Ramot, the Board denied Cisco’s petitions to institute IPRs against two patents that Ramot had asserted against it in a district court case. The decisions denying Cisco’s petitions cited the Board’s discretion under 35 USC § 314(a) not to institute review and relied on the factors determining whether efficiency, fairness and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding. Specifically, the Board [...]

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PTO Seeks Comments on Proposed Rulemaking for Denying Patent Reviews

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

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

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

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

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

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