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PTO Asks Whether Legislative Action for Experimental Use Exception Is Warranted

by Peter Brunovskis, PhD | Jul 18, 2024 | Patents

The US Patent & Trademark Office (PTO) issued a request for comments concerning the public’s views on the common law experimental use exception and whether Congress should enact a statutory experimental use exception. 89 Fed. Reg. 53963 (June 28, 2024).

The experimental use defense for alleged patent infringement has been part of US jurisprudence for more than 200 years. The current state of experimental use exception jurisprudence in the United States is set forth in Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002). In that case, the Federal Circuit proffered a “very narrow and strictly limited experimental use defense” prohibiting an alleged infringer from invoking such a defense for “use that is in any way commercial in nature” or “any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications.”

The Madey decision has been met with a mix of opinions, some arguing that the Federal Circuit’s construction encourages innovation and others arguing that it impedes innovation. Limited exemptions have been carved out in the US. For example, 35 U.S.C. § 271(e)(1) established a safe harbor (the Bolar exemption) allowing for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices or drugs. The Plant Variety Protection Act also provides for exemptions allowing the use of protected plant varieties for research and breeding of new varieties.

While many European and Asian nations have statutory experimental use exceptions in place, legislative efforts for codifying a statutory experimental use exception in the US have thus far failed. With the intent to promote fair competition and innovation, the PTO seeks to revisit this issue by collecting the public’s views on the impact of the experimental use exception in all technology areas. Of particular interest, the PTO seeks comments on one or more topics, including:

How current US experimental use exception jurisprudence impacts investment and/or research and development in any field of technology.
Whether certain technologies are negatively affected by the current experimental use exception jurisprudence.
The impact that a statutory experimental use exception would have on the innovation and commercialization of new technologies with respect to research and development, ability to obtain funding, investment strategy, licensing of patents and patent applications, product development, sales (including downstream and upstream sales), competition, and patent enforcement and litigation.
The impact of current experimental use exception jurisprudence on decisions made with respect to filing, purchasing, licensing, selling or maintaining patent applications and patents in the US.
Reasons for adopting a statutory experimental use exception or maintaining the status quo.
How a statutory experimental use exception should be defined to ensure that patent rights are preserved.
Recommendations for enhancing and facilitating experimental research on patent inventions in the US.

When responding to the questions, commenters are further asked to identify whether they represent, for example:

An inventor, patent owner or investor.
A licensee or user of patented technology.
An entity representing inventors or patent owners (g., law firms).
A recipient of [...]

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European UPC Issues Its First Decisions on the Merits

by Dr. Laura Katharina Woll, LL.M. | Jul 18, 2024 | EU Update, Patents

Franz Kaldewei GmbH & Co. KG v. Bette GmbH & Co. KG

The Unified Patent Court (UPC) issued its first decision on the merits, granting the first-ever permanent injunction covering seven UPC member states. Franz Kaldewei GmbH & Co. KG v. Bette GmbH & Co. KG (Düsseldorf Local Division, July 3, 2024).

The UPC found that the asserted patent was invalid in its granted form due to obviousness but upheld as valid an auxiliary request on which the injunction is based. Among other things, the Düsseldorf Local Division discussed procedural lapses around a missed deadline (denying the defendant a submission of certain documents one day prior to the oral hearing), jointly hearing the infringement case, and a counterclaim for revocation and inventive step. In this regard, the Court proceeded pragmatically and flexibly, as the UPC Court of Appeal (CoA) did in 10x Genomics, but unlike the European Patent Office (EPO) with its focus on the closest prior art and building a problem-solution approach thereon.

The decision further dealt with claims for information on the scope of infringement, claims for recall or removal from the channels of commerce, and considerations against requiring security for enforcement of a judgment on the merits in the given case.

Regarding so-called contributory infringement (i.e., indirect use of the invention), the UPC held that there is a double territorial requirement: the offer and/or delivery of the essential element must take place within UPC territory, and the invention must also be used within UPC territory. The Court left open the question of whether it is sufficient that the offering/delivery exists in a member state and the invention is intended for direct use in another, different member state. Further case law will have to clarify this point. Regarding the prior use defense, it follows from the decision that there is no “UPC/European” prior use. The existence of a right of prior use must be asserted for each member state according to its national law, and the respective defendant must provide the relevant information for each country individually.

Practice Notes:

The UPC has shown that it is capable of dealing efficiently with both infringement and invalidity questions within the short timeframe it has set itself. The UPC delivered on its promise to issue a decision on the merits in just over a year and only a few weeks after the oral hearing.
Regarding claim interpretation, the Düsseldorf Local Division referred to the CoA’s decisions on February 26, 2024, and May 13, 2024, stating that the principles of Article 69 EPC apply to both validity and infringement proceedings.

DexCom, Inc. v. Abbott et al.

The day after the UPC’s decision on the merits in Franz Kaldewei granting a permanent injunction, the Paris Local Division delivered its first decision on the merits and declared the patent in suit invalid in 17 UPC member states. DexCom, Inc. v. Abbott et al. (Paris Local Division, July 4, 2024).

The Paris Local Division also ruled on both infringement and validity questions and [...]

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Is Pleading “Generic” Enough to Plead Inducement?

by Christopher M. Bruno | Jul 11, 2024 | Patents

The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded product and referred to the branded product’s sales for patented uses. Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., Case No. 23-1169 (Fed. Cir. June 25, 2024) (Moore, Lourie, Albright, JJ.)

Amarin Pharmaceuticals sells the drug Vascepa, which the US Food and Drug Administration (FDA) approved for two uses:

To treat severe hypertriglyceridemia.
As an adjunct therapy to reduce certain cardiovascular risks.

In 2016, Hikma submitted an abbreviated new drug application (ANDA) to market a generic version of Vascepa, which at the time was only approved for treatment of severe hypertriglyceridemia. Hikma and Amarin then litigated patents covering Vascepa under the Hatch-Waxman Act, with Hikma invalidating the patent claims covering the severe hypertriglyceridemia indication. After Amarin obtained approval for its second indication, Hikma submitted to the FDA a “section viii carve out” (i.e., prescribing information that purposedly did not include the second indication). The FDA approved Hikma’s product, which was sold with a “skinny label.” After Hikma’s ANDA was approved, Hikma issued a series of press releases that referred to its product as a “generic” version of Vascepa, even though the product was not approved for the cardiovascular risk indication. The press releases also referred to Vascepa’s annual sales as approximately $1.1 billion – the amount of Vascepa scales for all uses – as well as its usage information.

Amarin sued Hikma again for patent infringement, this time claiming that Hikma induced infringement of patents covering the cardiovascular risk indication. The district court overruled the magistrate judge’s recommendation and concluded that Amarin’s complaint did not plead a plausible case of induced infringement. Amarin appealed.

The Federal Circuit reversed. First, it explained its view that the case was a “run-of-the-mill” inducement infringement case, rather than one governed by the Hatch-Waxman Act framework. Emphasizing the deferential plausibility standard applicable at the pleadings stage, the Court held that, combined with allegations that Hikma’s label included warnings that would promote infringement, Amarin’s averments about Hikma’s press releases were sufficient at this stage to plausibly claim that Hikma induced infringement of the cardiovascular risk limitation by its references to the branded product.

The Federal Circuit also rejected Hikma’s claim that a ruling in Amarin’s favor would “effectively eviscerate section viii carve-outs.” The Court explained that its ruling was an ordinary application of induced infringement that promotes scrutiny of generic companies’ communications for clarity and consistency.

Practice Note: This case continues the trend of inducement cases that has received renewed interest after GlaxoSmithKline v. Teva Pharmaceuticals. Branded pharmaceutical manufacturers may be emboldened to sue after launch based on theories of inducement where section viii carveouts were employed.

New Arguments Yield Same Unpatentability Outcome

by Karen Gover | Jun 13, 2024 | Patents

On remand from the US Court of Appeals for the Federal Circuit in connection with inter partes review (IPR) proceedings, the Patent Trial & Appeal Board considered the petitioner’s reply arguments and evidence regarding the claim constructions that were first proposed in the patent owner’s response but again found that the claims were not unpatentable. Axonics, Inc. v. Medtronic, Inc., IPR2020-00712; -00680 (May 30, 2024) (Tartal, Jeschke, Dougal, APJ)

Axonics filed IPR petitions challenging two patents owned by Medtronic that are directed to the transcutaneous charging of implanted medical devices. In its petitions, Axonics did not propose any express claim constructions. In its preliminary response, Medtronic agreed that claim construction was not necessary. In its patent owner response, however, Medtronic – for the first time – advanced a new claim construction that differed from the interpretation of the relevant claims implied in Axonics’s claim charts. Axonics defended its own implicit construction but also offered new arguments and evidence that the prior art anticipated the patents even under the alternative construction. The Board adopted Medtronic’s new claim construction but refused to consider Axonics’s new arguments and evidence because they were first presented in the reply. The Board then found that Axonics failed to show by a preponderance of the evidence that the challenged claims were unpatentable. Axonics appealed.

Axonics did not dispute the new claim construction first introduced by Medtronic in its response and adopted by the Board; it argued only that the Board erred in refusing to consider its reply arguments and evidence under the new construction. The Federal Circuit agreed, concluding that in such a situation, “a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction, at least where it relies on the same embodiments for each invalidity ground as were relied on in the petition.” The Court remanded for the Board to consider Axonics’s new arguments.

On remand, the Board considered Axonics’s new arguments and evidence that the challenged claims were unpatentable over the prior art under the new construction. It also considered Medtronic’s amended sur-reply. The Board again determined that none of the challenged claims were unpatentable. In its analysis, the Board pointed out that some of Axonics’s new arguments and evidence regarding what the prior art disclosed in light of the new claim construction were inconsistent with the arguments and evidence it initially offered in its petition. In particular, the Board observed that the declaration testimony of Axonics’s expert regarding the prior art, on which Axonics relied in its petition, did not support the new claim construction, even considering the expert’s supplemental declaration. The Board also rejected Axonics’s attempts in its post-remand brief to discredit Medtronic’s arguments as “untimely and wrong,” “incorrect” and “contradictory of the positions on infringement it has taken in district court.” Citing the Federal Circuit, the Board pointed out that in an IPR, the burden of persuasion to prove unpatentability by a preponderance of the evidence [...]

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PTO Collaborates With UK Counterpart to Address Standard-Essential Patents

by Thomas DaMario | Jun 13, 2024 | Patents

On June 3, 2024, Under Secretary of Commerce for Intellectual Property and US Patent & Trademark Office (PTO) Director Kathi Vidal and Chief Executive Officer of the UK Intellectual Property Office (IPO) Adam Williams signed a memorandum of understanding (MOU) designed to tackle various issues related to standard-essential patents (SEPs).

SEPs are patents that have been declared essential to a particular technical standard. Common examples of technical standards with active SEP bases include cellular communication and other wireless standards, such as LTE, 5G and Wi-Fi. Standards are typically adopted by Standard Setting Organizations (SSOs). To have input on standard adoption, many SSOs require participants agree to license any patents that result from discussions with potential licensees on Fair, Reasonable and Non-Discriminatory (FRAND) terms (See e.g., ETSI Intellectual Property Rights Policy).

But what are FRAND terms, and who gets to decide whether they issue? While individual patents are territorial (e.g., a US-issued patent is only enforceable in the United States), patent owners often obtain patent coverage in multiple jurisdictions. This can lead to challenges wherein a court in one jurisdiction may determine FRAND terms for a patent in that jurisdiction, which may then set or significantly influence the FRAND rate for the patent owner’s corresponding patents in other jurisdictions.

While the MOU is not public at this time, the PTO indicated that the MOU sets forth a framework for the following action items:

Cooperate on activities to facilitate collaboration and exchange of information on policy matters concerning SEPs to better ensure a balanced standards ecosystem.
Explore means to educate small- and medium-sized enterprises seeking to implement or contribute to the development of technical interoperability standards on FRAND terms.
Examine ways of improving transparency in the FRAND licensing of technical interoperability standards.
Engage in outreach to stakeholders to raise awareness of issues related to SEPs.
Discuss means to incorporate additional jurisdictions into the PTO and IPO’s activities concerning SEPs, including exploring a venue for broader discussions.

The agreement remains in place through June 3, 2029. PTO Director Vidal emphasized that “[t]his important collaboration with UKIPO will help us work together toward a fair and balanced international standard essential patent ecosystem that benefits all businesses in our two countries, including small and medium-sized enterprises and new market entrants.”

The $X Factor: Demystifying Damages Calculations

by Keval Amin | Jun 13, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s decision to deny a defendant’s motion for a new trial on damages, finding that the plaintiff’s damages expert sufficiently showed that prior license agreements were economically comparable to a hypothetically negotiated agreement between the parties. EcoFactor, Inc. v. Google LLC, Case No. 23-1101 (Fed. Cir. June 3, 2024) (Reyna, Lourie, JJ.) (Prost, J., dissenting).

EcoFactor owns a patent directed to mitigating strain on the electricity grid by adjusting thermostat settings within HVAC systems. The patent describes a system where thermostats collect internal temperature readings and use them alongside external temperatures to estimate internal temperature change rates, including future predictions. EcoFactor sued Google alleging infringement based on Google’s Nest smart thermostat products.

After discovery, Google sought summary judgment, arguing that claims of EcoFactor’s patent were invalid as abstract ideas under 35 U.S.C. § 101. The district court denied this motion as well as Google’s Daubert motion to exclude the testimony of EcoFactor’s damages expert. At trial the jury found that Google infringed EcoFactor’s patent and awarded damages. The district court denied Google’s subsequent motions for judgment as a matter of law on noninfringement and for a new trial on damages. Google appealed.

Google raised three key issues. First, it argued that the district court erred in denying its motion for summary judgment. Second, Google asserted that the district court erred in denying its motion for judgment as a matter of law concerning the noninfringement of EcoFactor’s patent. Third, Google claimed that the district court wrongly denied its motion for a new trial on damages, arguing that EcoFactor’s damages expert opinion was based on unreliable methodology.

The Federal Circuit upheld the district court’s decision to deny summary judgment because there were genuine issues of material fact warranting a trial. The Court also affirmed the jury’s infringement verdict against Google, finding that it was supported by substantial evidence. Despite Google’s argument that its Nest thermostats did not meet the claims of EcoFactor’s patent, the Court concluded that expert testimony and corroborating documentation demonstrated otherwise.

On the damages issue, Google argued that EcoFactor’s expert testimony was unreliable because there was no evidence that the parties to the three license agreements used by the expert actually applied the royalty rate stated in the agreement. While Google acknowledged that each of the license agreements include a specified royalty rate, Google argued that each also included a “whereas” clause indicating that the licensee would pay EcoFactor a lump sum amount “set forth in this Agreement based on what EcoFactor believes is a reasonable royalty calculation of [$X] per-unit for . . . estimated past and [] projected future sales of products accused of infringement in the Litigation.” Google asserted that while the agreements may have included a stated rate, there was no evidence that the agreements actually applied the rate in calculating the lump sum payment.

The Federal Circuit rejected Google’s argument. The Court explained that the proposed royalty rate was derived from three [...]

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PTO Reopens Comment Period for AI Inventorship Guidance

by Peter Brunovskis, PhD | Jun 13, 2024 | Patents

The US Patent & Trademark Office (PTO) reopened and extended until June 20, 2024, the period for public comment on the guidance regarding inventorship in applications involving artificial intelligence (AI) assisted inventions. The guidance was published on February 13, 2024, at 89 FR 10043. The PTO will also treat as timely any comments received between May 13, 2024, and the notice’s June 6, 2024, publication date.

Comments on the inventorship guidance must be submitted via the Federal Rulemaking Portal.

For more information, see our previous report on the February 13 PTO notice and related examination guidance.

Interference Analysis Is a Two-Way Street

by Jacob Michael Bass | Jun 6, 2024 | Patents

On appeal from an interference proceeding, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision that found the claims of the senior party’s patent were not invalid as time-barred under 35 U.S.C. § 135(b)(1). The Federal Circuit concluded that the “two-way test” requires looking to see if either set of pre-critical and post-critical date claims contains a material limitation not found in the other and not just looking to see if the post-critical date claims have additional material limitations. Speck et al. v. Bates et al., Case No. 22-1905 (Fed. Cir. May 23, 2024) (Dyk, Bryson, Stoll, JJ.)

35 U.S.C. § 135(b)(1), pre-AIA, provides that “a claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.” This has been described as a statute of repose that places a time limit on a patentee’s exposure to an interference, the deadline for which is referred to as the “critical date.” At issue in this appeal was the “long-standing” exception to § 135(b)(1) for instances where the applicant files its claim after the critical period but has already been claiming substantially the same invention as the patentee during the critical period.

This case involves drug-coated balloon catheter technology. Bates is the senior party that filed a patent application, and Speck is the junior party that owns an issued patent. Speck’s patent issued on September 4, 2012, whereas Bates filed his application on August 29, 2013, six days before the critical date of Speck’s patent (i.e., one year after the filing date). Bates amended the application on August 30, 2013 (still before the critical date), and canceled all of the original claims and replaced them with new claims. Bates later amended the claims after the critical date to add a requirement that the device be “free of a containment material atop the drug layer.” The amendment was made to overcome a rejection from the examiner during prosecution.

Speck filed a motion to terminate the interference on the ground that the claims of Bates’s application were time-barred under § 135(b)(1) because Bates amended the claims more than one year after Speck’s patent issued. Speck also moved the Board to find that the claims of Bates’s application were unpatentable for lack of written description.

The Board denied Speck’s motion to terminate under § 135(b)(1), finding that the later-amended claims did not differ materially from the claims in other patents and patent applications Bates owned that were filed prior to the critical date, because “Speck ha[d] not directed [the Board] to a material limitation of the Bates involved claims that is not present in the earlier Bates claims.” Speck filed a motion for rehearing, which the Board denied. The Board also denied Speck’s motion to find that Bates’s claims lacked [...]

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For Statutory Equivalents, Even One Means May Be Enough

by Ian J. Howard | Jun 6, 2024 | Patents

A US Patent & Trademark Office (PTO) appeals review panel decided that a means-plus-function (M+F) claim element supported by the disclosure of only a single species is not invalid for indefiniteness or lack of written description, even if the specification lacks other disclosed statutory corresponding equivalents. Ex parte Chamberlain, Appeal No. 22-001944 (App. Review Panel, May 21, 2024) (Vidal, Dir.; Udupa, Boalick, APJs) (per curiam).

The independent claims of the patent application at issue involved methods of treating patients with “anti-C5 antibod[ies]” that include amino acid substitutions devised to increase the in vivo half-life of the antibody. Each claim involved similar preambles: “A method of treating a patient by administering an anti-C5 antibody comprising . . . .” One of the independent claims was in Jepson form, whereas the other included a M+F limitation.

Following rejections by the examiner and the applicant’s appeal to the Patent Trial & Appeal Board, the Board entered new grounds of rejection finding both claims invalid under 35 U.S.C. § 112, ¶1 (written description) and affirmed the examiner’s rejection of the claims for obviousness-type double patenting. The Board also entered a new ground of rejection finding the claim including the M+F claim element indefinite under 35 U.S.C. § 112, ¶2. Following the applicant’s appeal to the Federal Circuit, the PTO took the unusual step of petitioning the Federal Circuit to “administratively remand [the case] to the Office in order to convene an Appeals Review Panel to clarify the Office’s position on the proper analysis of ‘Jepson-format and means-plus-function claims in the field of biotechnology, and particularly in the antibody art’ and ‘to issue a revised decision.’”

On remand, the panel affirmed the Board’s determinations that written description was lacking but overturned the Board’s finding of indefiniteness for the claim including the M+F element. In doing so, the panel offered useful commentary on the invalidity standard for M+F claim elements as well as the implications that a limiting preamble may have on invalidity.

The panel found the “treating a patient” preamble recitation limiting in both claims. For the Jepson claim, the preamble was per se limiting. However, the panel went on to find that, even independent of the Jepson claim format, the “treating a patient” phrase would be limiting. Outside the Jepson context, the panel characterized the inquiry of determining whether a preamble limits the body of the claim as a highly contextual one. According to the panel, the “treating a patient” term did not merely provide “circumstances in which the method may be useful” but instead constituted “the raison d’être of the claimed method itself.” The “treating a patient” language was necessary to “give life, meaning, and vitality” to limitations in the body of the claim involving increasing the in vivo half-life of the antibodies and administering the antibodies.

Having determined that the “treating a patient” recitation was limiting, the panel found that the limitation was overbroad compared to the scope of the patent’s disclosure, and thus the Jepson format claim lacked adequate written description. Read in light of [...]

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No Attorneys’ Fees Available for Successful IPR in Parallel Court Proceedings

by Lillian Spetrino | May 30, 2024 | Patents

The US Court of Appeals for the Federal Circuit concluded that a party that voluntarily elects to pursue parallel proceedings before the Patent Trial & Appeal Board and the district court is not entitled to recover attorneys’ fees under 35 U.S.C. § 285 (exceptional case doctrine) in connection with the Board proceedings, nor does § 285 entitle a party to hold opposing counsel jointly and severally liable for fees. Dragon Intellectual Property LLC v. Dish Network L.L.C., Case Nos. 2022-1621; -1777; -1622; -1779 (Fed. Cir. May 20, 2024) (Moore, C.J.; Stoll, J.) (Bencivengo, J., dissenting).

Dragon sued DISH Network, Sirius XM Radio (SXM) and eight others for patent infringement. The district court stayed proceedings as to DISH and SXM while they pursued inter partes review (IPR) but proceeded with claim construction for the other defendants. Following claim construction, all parties stipulated to noninfringement, and the district court accordingly entered a noninfringement judgment that was subsequently vacated following appeal to the Federal Circuit. Following the Board’s determination that the asserted claims were unpatentable, DISH and SXM filed a motion for attorneys’ fees in the district court proceeding. The district court granted the motion for time spent litigating the district court case but denied for fees incurred solely during the IPR proceedings and recovery from Dragon’s former counsel. DISH and SXM appealed the denial-in-part, and Dragon cross-appealed the grant-in-part.

The Federal Circuit affirmed the district court’s grant-in-part, finding that the district court did not abuse its discretion in declaring these cases exceptional. The Federal Circuit explained that the vacated noninfringement judgment did not require the district court to ignore its claim construction order in determining exceptionality. The Court further explained that even though Dragon was not entitled to a claim construction “do-over,” the prosecution history disclaimer issue was independently considered during the exceptionality inquiry, and Dragon did not provide any grounds for the conclusion that this constituted an inadequate inquiry.

The Federal Circuit also affirmed the denial of attorneys’ fees with regard to fees incurred during the IPR proceedings and Dragon’s former counsel’s liability for fee awards under § 285.

First, the Federal Circuit rejected DISH and SXM’s argument that § 285 allows recovery of fees incurred during parallel IPR proceedings, principally on the grounds that the IPR proceedings were pursued voluntarily. The Court reasoned that there are many advantages to leveraging IPR proceedings and, therefore, “where a party voluntarily elects to pursue an invalidity challenge through IPR proceedings, we see no basis for awarding IPR fees under § 285.”

Second, the Federal Circuit relied on the statutory text and determined that liability for attorneys’ fees awarded under § 285 does not extend to a party’s counsel. The Court explained that while other statutes explicitly allow parties to recover costs and fees from counsel, § 285 is silent as to who can be liable for a fee award, and therefore it is reasonable to conclude that fees cannot be assessed against counsel.

Sitting by designation, Judge Bencivengo of the US District Court for the Southern District of California dissented [...]

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