On August 29, 2019, the Director of the USPTO notified the Trademark Public Advisory Committee (TPAC) of the Office’s intent to set or adjust trademark related fees and submitted a preliminary trademark fee proposal for comment. There are multiple timelines for public debate and comment on the proposed new fees, with a tentative implementation date of August 2020. While most proposed fee changes are relatively modest ($25 – $75 for new electronic filings, per class; $125 for Section 8&15 declarations, per class), many remain unchanged (such as Section 8&9 renewals). Nonetheless, the additional costs could be significant for companies with large portfolios. We will continue to keep you apprised of developments in this area including the exact date for implementation of the new fee schedule if/when the new fees are approved.
On July 23, 2019, the Federal Circuit departed from its utility patent-focused docket to deliver a precedential opinion relating to design patents in Auto. Body Parts Ass’n v. Ford Global Techns., LLC. At issue were the validity and enforceability of design patents on automotive repair and replacement parts. The case arose from a filing by the Automotive Body Parts Association (ABPA) in the Eastern District of Michigan seeking declaratory judgment of invalidity and enforceability of two design patents relating to the hood and vehicle headlamp of the Ford F-150. The ABPA moved for summary judgment, but the District Court entered judgment sua sponte in favor of Ford. The case was taken up on appeal.
The crux of ABPA’s argument rested on the proposition that Ford’s design patents were directed to functional, and not ornamental, aspects of an article, and thus were invalid. Under the law, design patents are authorized if claiming “new, original and ornamental design[s] for an article of manufacture.” 35 U.S.C. § 171(a). Previously, the Federal Circuit has held that an “ornamental design” cannot be “primarily functional.” Sport Dimension, Inc. v. Coleman Co., 820 F.3d 1316, 1320 (Fed. Cir. 2016).
ABPA cited to Best Lock Corp. v. Ilco Unican Corp., 94 F.3d 1563 (Fed. Cir. 1996), in which designs for a blade of a key were determined to be functional based on the admitted fact that no alternatively designed blade would mechanically operate the corresponding lock. The ABPA attempted to analogize the cases, reasoning that because consumers considering F-150 truck replacement parts seek to restore the original appearance of the trucks, replacement parts would not be acceptable and there is a functional benefit to designs that are aesthetically compatible with the vehicles.
The court rejected ABPA’s argument, articulating that, while design patents must claim an ornamental design and not one dictated by function, a valid design may contain some functional elements.
“ABPA argues that Ford’s hood and headlamp designs are functional because they aesthetically match the F-150 truck. But ABPA does not identify, nor can we find, any design patent case ruling aesthetic appeal of this type functional. We hold that, even in this context of a consumer preference for a particular design to match other parts of a whole, the aesthetic appeal of a design to consumers is inadequate to render that design functional.” (Emphasis added).
The court provided several factors to consider when determining if a design is dictated by function, including whether:
- The protected design represents the best design.
- There are any concomitant utility patents.
- Alternative designs would adversely affect the utility of the specified article.
- Advertising touts features of the design as having specific utility.
- There are any elements in the design, or an overall appearance, clearly not dictated by function.
The court also rejected ABPA’s efforts to apply the aesthetic functionality doctrine of trademarks to design patents.
The Federal Circuit addressed two secondary arguments set forth by ABPA. ABPA posited that, under the doctrines of patent exhaustion and right to repair, when an F-150 is sold, the entirety of any design patents embodied in the truck are exhausted and use of Ford’s designs on replacement parts is permitted if the parts are intended for use with Ford’s trucks. The court clarified that patent exhaustion does apply to design patents but does not apply to new replacement parts sold or created by the purchaser. Regarding the right to repair, the court held that it does not permit a complete reconstruction of a patented component, but rather allows replacement of an individual unpatented component of a patented article, or a purchaser of an F-150 truck to repair specific parts on the truck. Ultimately, the District Court’s ruling was affirmed.
The Federal Circuit’s decision reaffirms the strength of design patents’ rights covering article components and replacement parts – eliminating doubt as to whether design patents are enforceable beyond the initial market for patented designs. Considering the decision, inventors and designers of articles of manufacture, even those in industries other than automotive, should consider adding design patents covering components to their portfolio strategies – either as a first line of offense or to complement utility patents on the components or corresponding articles of manufacture.
To illustrate, a manufacturer may obtain a utility patent on an article of manufacture. But a component of the article may not itself be eligible for a utility patent (e.g., may be seen as novel or obvious). A competitor could then make and sell the component without infringing the utility patent on the article. Yet, as seen in ABPA v. Ford, a component may have independent value, such as in the sale of replacement parts in the secondary market. Therefore, the manufacturer may not have recourse against competitors that make and sell replacement components for the article.
However, if the component has an inventive ornamental appearance, it may be eligible for a design patent. Procuring a design patent on the component may give the manufacturer a means to prevent competitors from making or selling replacements of the component. Furthermore, even if the design patent holder does not wish to make or sell replacements for the component, the design patent gives the holder solid grounds on which to enter into license agreements with suppliers of replacement parts. Therefore, a design patent protecting the component may play multiple roles in a portfolio strategy.
The Trump administration, addressing efforts to curb online counterfeiting, has called for heightened collaboration, at times suggesting providing private parties with technological resources to help combat online counterfeiting. At the same time, the administration has bemoaned the lack of accountability among online third-party intermediaries and called for “clean[ing] up this Wild West of counterfeiting and trafficking.”
The president’s Memorandum on Combating Trafficking in Counterfeit and Pirated Goods (“Memo”), issued in April of this year, echoes both these approaches. The Memo has called for an interagency report (“Report”) to be completed by November 2019. In preparation for this Report, the Department of Commerce subsequently issued a Comment Request soliciting feedback from online third-party intermediaries, among others.
II. Blueprint for the Upcoming Report: Both Descriptive and Prescriptive
The Memo calls for a comprehensive analysis of all available data that may shed light on the issue of online counterfeiting. Moreover, it calls for the identification of any market forces that may be facilitating online counterfeiting, as well as an evaluation of foreign strategies—namely those in France and Canada—in combating similar issues.
The prescriptive measures are a bit more amorphous. While one portion of the Memo calls for “enhanced enforcement actions,” other portions call for further collaboration at three levels: among governmental agencies; between the government and third parties; and among third parties themselves. More specifically, the Memo emphasizes “suggestions for increasing the use of effective technologies.” The recently released Comment Request by the Department of Commerce confirms the administration’s interest in utilizing technology to mitigate online counterfeiting in that it specifically solicits further recommendations about how “effective technologies” could be deployed to curb online counterfeiting.
The Comment Request illuminates some of the “best practices” the administration is considering, including an advance vetting of potential sellers/vendors; establishing a “prohibited items” list to bar such goods from being sold in the marketplace; and a number of notification regimes requiring third-party intermediaries to alert customers, and possibly other marketplaces, to any identified counterfeit goods. While some third-party marketplaces have already begun to adopt sophisticated technological systems of their own to curb online counterfeiting, such proposals suggest more burdensome notice requirements, so as to create a solidified front among all online marketplaces.
III. Anticipated Effectiveness of Prospective Policies
Experts in the field note that an ad hoc approach towards online counterfeiting creates room for counterfeiters to evade disciplinary actions by jumping from platform to platform. Thus, proactive collaboration among online platforms appears necessary to ensure counterfeiters have nowhere to go. As Rebecca Mond, vice president of federal government affairs at The Toy Association, testified before Congress, “more must be done to prevent identified illicit sellers that have been taken down from reappearing on marketplaces selling the same products.”
The law is currently in flux with respect to whether online platforms can be held liable for the selling of counterfeit goods on their sites, especially with respect to the question of whether a platform has an obligation to proactively monitor the situation as opposed to merely respond when notified about a counterfeit. Courts have tried to assess the extent to which platforms participate in the selling of these counterfeit goods. If the report calls for executive or congressional action to assist courts in labeling online platforms as active participants, this could subject platforms to trademark infringement liability upon a third-party sale of counterfeit goods.
IV. To Cajole to Threaten
The Report may call for the transformation of optional safeguards into mandatory protocols. Peter Navarro’s comments about the need for accountability suggests a heightened enforcement policy that penalizes online marketplaces for allowing the sale of counterfeit goods. At the same time, the memo’s call for collaboration suggests cooperation. Only time will tell whether the latter actually undermines the former.
 The quotation is from Peter Navarro, Director of White House National Trade Council. See Deb Riechmann, Trump Signs Memorandum to Stem Counterfeit Goods Trafficking (Apr. 3, 2019), available at https://www.apnews.com/71d9d74bb31a4447b7a34446cf2410be.
 Presidential Memorandum on Combating Trafficking in Counterfeit and Pirated Goods, Sec. 2 (April 3, 2019)
 Comment Request on the Report on the State of Counterfeit and Pirated Goods Trafficking and Recommendations, 84 Fed. Reg. 132, 32861 (U.S. Dep’t of Commerce, July 10, 2019).
 Memo, Sec. 2(b)(ii).
 Memo, Sec. 2(b)(vii).
 See Comment Request, at 32863.
 Comment Request, at 32863.
 Testimony of Rebecca Mond, Vice President of Federal Government Affairs at The Toy Association, Before the U.S. House of Representatives, Committee on the Judiciary Subcommittee for Courts, Intellectual Property, and the Internet for the Hearing titled “Counterfeits and Cluttering: Emerging Threats to the Integrity of the Trademark System and the Impact on American Consumers and Businesses” (July 18, 2019).
 See Tiffany, Inc. v. eBay Inc., 600 F.3d 93, 103, n. 9 (2d Cir. 2010) (determining that despite having general knowledge about the counterfeit taking place, the online platform would have had to have more specific knowledge to constitute contributory trademark infringement); but see Oberdorf v. Amazon.com Inc, 2019 WL 2849153, at *10 (3d Cir. 2019) (discussing, albeit it in a strict products liability context, how an online market provider can be considered a seller).
 See Spy Optic, Inc. v. Alibaba.Com, Inc., 163 F. Supp.3d 755, 765 (C.D. Cal. 2015) (allowing the trier of fact to determine the extent to which an online platform’s use of metadata to group products on its website constitutes participation with the actual sale).
 Navarro has been quoted as saying: “Right now these third-party online marketplaces . . . together with the ecosystem that supports them . . . have essentially zero liability when it comes to these counterfeit goods. That simply has to stop.” See Clyde Hughes, Trump Signs Memo to Fight Counterfeit Products Online, United Press International (Apr. 3, 2019), available at https://www.upi.com/Top_News/US/2019/04/03/Trump-signs-memo-to-fight-counterfeit-products-online/7681554305512/.
In two opinions issued in the past few weeks, the Federal Circuit has shaken up two requirements of the reissue statute that most practitioners don’t think about much. 35 USC 251(a) authorizes reissue of a patent “for the invention disclosed in the original patent.” 35 USC 251(c) provides that “[t]he provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent,” which includes the written description requirement of 35 USC 112(a). The “conventional” wisdom up to now has held that these requirements are more or less synonymous (and not considered arduous). Now, we aren’t so sure.
In Forum US, Inc. v. Flow Valve, LLC, ___ F.3d ____ 2019 U.S. App. LEXIS 18055 (Fed. Cir., June 17, 2019), the district court invalidated a reissue patent on summary judgment on the ground that the reissue claims did not comply with the “original patent” requirement of the reissue statute. The Federal Circuit affirmed, agreeing on the basis of long-standing precedent under the pre-1952 reissue statute – which referred to the “same invention” as the original patent – that the broadened scope of the reissue claims was not apparent from the face of the original patent specification. Continue Reading
The language of the patent damages statute, 35 U.S.C. § 284, appears straightforward – “[u]pon finding for the claimant the court shall award the claimant damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer” (emphasis added). The common reasonable royalty calculation multiplies a royalty base by a royalty rate to yield a damages award. While the math seems simple, determination of a reasonable royalty in the context of devices that have hundreds, perhaps thousands, of components and functionalities is an endeavor ripe for chicanery. See Grain Processing Corp. v. Am. Maize–Products Co., 185 F.3d 1341, 1350 (Fed. Cir. 1999) (“To prevent the hypothetical from lapsing into pure speculation, [the] court requires sound economic proof of the nature of the market and likely outcomes with infringement factored out of the economic picture.”).
The principle of apportionment is supposed to corral flimflam economic analysis from stampeding past a justified damages award. Garretson v. Clark, 111 U.S. 120 (1884) (requiring the patentee to provide “evidence tending to separate or apportion the defendant’s profits and the patentee’s damages between the patented feature and the unpatented features”).
On April 23, the Thirteenth Standing Committee of the National People’s Congress passed the fourth amendment to the Trademark Law of China. The new trademark law will come into effect Nov. 1, 2019. The revisions are designed to curb bad faith filings, willful infringements and counterfeit commodities. Businesses with brand interests in China will have stronger grounds to oppose and cancel bad faith applications and registrations under the new law; they will also be able to more effectively enforce their trademark rights in China. The most significant of the new revisions are described here. Continue Reading
On Aug. 3, a new regulation promulgated by the U.S. Patent and Trademark Office (USPTO) will take effect and require all trademark applicants, registrants and parties to trademark proceedings that are domiciled outside the United States to be represented by an attorney who has a license to practice law in the U.S. Consequently, individuals and entities with a permanent legal address or a principal place of business (i.e., headquarters) located outside the United States or its territories, respectively, will no longer be permitted to file any trademark-related submissions with the USPTO, either without an attorney or through an attorney who is not licensed in good standing in the United States. Moreover, under the new rule, U.S.-licensed attorneys who represent someone in a trademark matter, regardless of where domiciled, will now need to provide their U.S. state bar membership information along with an attestation that they are active members in good standing of the bar. Continue Reading
Legislative Exclusions of Software (21st Century Cures Act)
The 21st Century Cures Act (Cures Act), signed into law on Dec. 13, 2016, was designed to accelerate medical product development and bring new innovations faster and more efficiently to patients who need them. Interesting aspects of the Cures Act include that it
- streamlines FDA procedures to prioritize Breakthrough Devices;
- reduces or eliminates review of medical devices deemed to be low risk; and
- removes five categories of software from FDA review.
Under the Cures Act, the categories of software excluded from FDA review include:
- Category A: Software for administrative support of healthcare facilities, e.g., processing and maintaining financial records, claims and billing information, appointment schedules.
- Category B: “Healthy lifestyle” software that provides no diagnostic, prevention or treatment function.
- Category C: Electronic patient records, but not intended to interpret or analyze patient records.
- Category D: Software for transferring, storing, converting formats, or displaying test data lab tests or med device data, but not intended to interpret or analyze patient records.
- Category E: Clinical Decision Support Software (CDSS), i.e., software that provides recommendations based on medical information (e.g., peer review). The software must enable independent review of the basis of the recommendations and does not include medical imaging or in vitro testing.
It should be noted that the FDA is authorized to bring Categories C, D and E back under regulation with a showing of likelihood and severity of patient harm, the extent to which the software function is intended to support clinical judgment, a reasonable opportunity for a healthcare professional to review the basis of the information, and the intended user and use environment.
The FDA website includes a page concerning Mobile Medical Applications and notes that mobile apps can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on Sept. 25, 2013, which explains the agency’s oversight of mobile medical apps. The FDA defines three broad categories that are regulated:
- App controls a medical device – FDA considers it an accessory. Example: Software that controls an insulin pump.
- App that transforms the mobile device into a regulated device. May include attachment for standard mobile device. App may be labeled for medical-specific uses. Example: App that allows for control of attached transducer that converts a smartphone into a glucose meter.
- App that performs patient-specific analysis and provides patient-specific diagnosis or treatment recommendations. Example: App that calculates dosage or creates a dosage plan for radiation therapy.
The above discussion is intended to be a useful guide helping entrepreneurs and investors understand whether a given digital therapeutic approach is likely to require FDA review and approval. For obvious reasons, legal counsel should be consulted when needed.
Intellectual Property Protection
In the United States, a medical device invention (including a software-based medical device) can be protected by patent, provided the invention is novel and non-obvious (the conditions for patentability) and does not fall within an excluded category of subject matter. The excluded categories include natural phenomena and abstract ideas. A full discussion of the topic of patent eligibility is beyond the scope of this paper. For our purposes, it suffices to say that software-based inventions that simply diagnose but do not treat a patient are more difficult to patent. On the other hand, devices that include a treatment function are more clearly eligible for protection. The interested reader is invited to review the articles cited in the notes below.
Reasons to Invest in Digital Therapeutics
The mental healthcare market is huge, and growing. It’s not an exaggeration to say that the market is proportional to the human population worldwide. Moreover, in the United States and other developed countries, it is becoming more common for mental health treatments to be reimbursed through employer-based health plans. At the same time, there is significant friction in the market, making it overly difficult and expensive for individuals to get the help they need. And the stigma associated with mental health issues acts as a further barrier to treatment.
Digital therapeutic approaches offer the promise to overcome all these problems in a highly scalable and profitable way. In addition, the FDA regulatory hurdles are relatively low compared to other medical device and pharmaceutical-based therapies. In today’s highly mobile society, digital therapies are more efficient than in-person or telephone counseling, and they offer opportunities for therapists to efficiently manage patients and gain insights from big data analytics and AI. The authors can envision a future (in the next five to 10 years) where hundreds of millions of users worldwide will have ready access to effective mental health therapies wherever and whenever they need them, through their smartphones.
 See, e.g., The Federal Circuit Deals Another Blow to Diagnostic Method Patents (April 11, 2019); Federal Circuit Holds That Claims Directed to Methods of Treating Pain in a Renally Impaired Patient Are Patent-Eligible Under Section 101 (March 29, 2019); The Federal Circuit Opens the Door Wider for the Subject Matter Eligibility of Methods of Treatment, Compositions and Methods of Manufacturing (March 18, 2019); Federal Circuit holds that claims directed to diagnosing neurotransmission or developmental disorders are invalid for failing to recite patent eligible subject matter (February 11, 2019); and, last but not least, The ‘Integrated Into a Practical Application’ Test of the 2019 Revised Patent Subject Matter Eligibility Guidance (January 7, 2019).
Co-authored by: Phillip Wolfe
In Cellspin Soft, Inc. v. Fitbit, Inc., the Court of Appeals for the Federal Circuit (CAFC) rendered an important decision declaring that the presumption of validity under § 282 includes the presumption that claims are patent eligible under § 101.
Claimed Invention and Procedural Posture
Cellspin sued several companies for infringing various claims of four different patents related to connecting a data capture device, e.g., a digital camera, to a mobile device so that a user can automatically publish content from the data capture device to a website. The accused infringers moved to dismiss, arguing that the patents were ineligible under § 101. The district court granted these motions and subsequently awarded attorneys’ fees under § 285. In this case, the Federal Circuit vacated both the district court’s dismissal and its subsequent award of attorneys’ fees, and remanded the case to the district court. Continue Reading
On June 17, Canada implemented long-awaited changes to its trademark laws. These updates are designed to modernize Canadian trademark practice and bring Canada more in line with international practice. Businesses with brand interests in Canada will want to be aware of these important changes, the most significant of which are described here.
Madrid Protocol: Canada has now acceded to the International Registration system, known as the Madrid Protocol, joining 100+ member countries around the world. The Madrid Protocol can simplify trademark filings and save money, allowing your U.S. attorney to initiate applications in multiple jurisdictions worldwide by filing one international application through the World Intellectual Property Organization (WIPO). Businesses that use a Madrid filing strategy will no longer need to file an independent national registration for protection in Canada. Continue Reading