Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part III

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.

Mobile Apps

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:

  1. App controls a medical device – FDA considers it an accessory. Example: Software that controls an insulin pump.
  2. 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.
  3. 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.[1]

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.

[1] 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).

CAFC: Patents Enjoy a Presumption of Subject Matter Eligibility

Co-authored by: Phillip Wolfe

In Cellspin Soft, Inc. v. Fitbit, Inc.,[1] 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.[2] 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

Canada: New Trademark Laws Go Into Effect

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

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part II

The Promise of Digital Therapeutics

According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior. The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Sepah et al. defined “digital therapeutics” as “evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care.” See Long-Term Outcomes of a Web-Based Diabetes Prevention Program: 2-Year Results of a Single-Arm Longitudinal Study, J Med Internet Res 2015 | vol. 17 | iss. 4 | e92.

The methods employed by digital therapeutics can be used as a stand-alone therapy or in conjunction with more conventional treatments, such as pharmacological or in-person therapy. Such methods use various digital devices (e.g., smartphones, apps, sensors, computers) to help manage, monitor and prevent illnesses in at-risk patients. These devices are used to collect data from different sources. Such data may include personalized physiological parameters; behavior, social and geographical patterns; and even data indicative of the user’s mood or feelings.

In the mental health area, we believe that digital therapeutic approaches can overcome three of the biggest problems with conventional therapies: lack of access, lack of affordability and stigma. The problems with access and affordability are mainly caused by the relative scarcity of trained counselors as compared to the number of people in need of counseling. Stigma, on the other hand, is a psychological impediment to seeking help based on a person’s feeling of shame about his or her mental afflictions. The field of digital therapeutics offers the promise of delivering behavior therapies safely and effectively via a digital device, and thereby largely overcome the problems of access, affordability and stigma. For this reason, we believe that now is a good time to invest in the digital therapeutics space. Continue Reading

Protected and Unfiltered. Supreme Court Strikes Down the Lanham Act’s Scandalous and Immoral Restrictions.

In April at oral argument, the bench grappled with the issue of viewpoint discrimination based on the literal meaning of the statute and the genuine concern that without regulation, profane and obscene language and images will be imprinted with the ®.

Ultimately, in a unanimous decision, the court held that the statutory language restricting scandalous and immoral speech as drafted and currently interpreted was unconstitutional. The practical implications of the ruling were not considered. Several members of the court considered that there was a possible fix in a limited construction that could satisfy constitutional challenge. However, the majority of the court held that the statute as worded is facially unconstitutional viewpoint discrimination, and that there was no “fix.” Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part I

Introduction

More Americans than ever before are suffering from mental and emotional distress. In the United States, the mental health problem is exacerbated by issues across infrastructure, government and culture. However, because the resources for those living with mental health issues are constrained,[1] startups could have a big impact. In particular, we believe that digital therapeutic approaches offer great promise in overcoming the problems inherent in traditional approaches to mental health and behavioral therapy. Such problems relate to stigma, cost and general inaccessibility of cost-effective treatments for the general population.

We are starting to see new energy behind innovators in the mental health space. Examples include Enlyte (discussed in greater detail below); Talkspace, an online therapy app that connects users with licensed therapists; Calm, a sleep and meditation app; and Feel, a wearable designed to monitor the user’s emotional state.

Each of these companies – whether they aim to provide easy access to mental health professionals, to promote overall mental wellness or to better monitor the user’s mental state – has the potential to be highly impactful as well as profitable. In our view, the time is right to invest in mental health and digital therapeutics. In this paper, we provide an overview of the field of digital therapeutics for mental health, as well as the legal, regulatory and ethical issues that should be considered by entrepreneurs and investors. Continue Reading

Return Mail May Make COFC More Attractive To Patent Holders

This article was first published by Law360 on June 19, 2019.

Authored by: William Bergmann and Michael Anderson

In 2011 the Leahy-Smith America Invents Act created three new types of post-issuance proceedings to challenge patent validity: inter partes review,[1] post-grant review[2] and covered-business-method review.[3] These proceedings have proven to be popular avenues to challenge patent validity among accused infringers and, correspondingly, unpopular among patent holders.

The popularity of these proceedings among accused infringers can be attributed to several factors: (1) the lower burden of proof (preponderance of evidence) needed to prove invalidity, (2) the higher success rates attributed to AIA proceedings, (3) the relative speed of AIA proceedings and (4) the likelihood that related litigation will be stayed.

Last week in Return Mail Inc. v. United States Postal Service, the U.S. Supreme Court held that the federal government cannot avail itself of any of the three post-issuance proceedings created by the AIA. This article examines the effect of the Return Mail decision on future patent-infringement claims against the government.

Claims Against the Government in the Court of Federal Claims

The U.S. Court of Federal Claims was established in 1855 under Article I of the Constitution to hear claims against the federal government. All of its trials are bench trials, and its nickname, “the People’s Court,” is reflected by a quote from President Abraham Lincoln displayed in the lobby of the courthouse: “It is as much the duty of government to render prompt justice against itself, in favor of citizens, as it is to administer the same, between private individuals.” The federal government is a defendant in every case, and it is represented by the U.S. Department of Justice. All appeals from actions in the COFC are taken to the U.S. Court of Appeals for the Federal Circuit.

Pursuant to 28 U.S.C. § 1498(a), the COFC has exclusive jurisdiction to hear claims against the United States for the unauthorized manufacture or use of a patented invention.[4] This jurisdiction extends to infringing acts committed by government contractors and subcontractors if they are acting with the authorization or consent of the United States.[5] As the dissent in the Return Mail case noted, the cases can be complex and can potentially lead to large damages awards because of the large procurements of accused items made by the federal government.[6]

On its surface, the holding of the Return Mail case would appear to make the COFC an attractive place for patentees to enforce their rights, as it may be the only court in the country in which a patentee could bring suit without fear of the defendant’s requesting an IPR, PGR or CBM review — or possibly even an ex parte reexamination — of the patent(s)-in-suit and subsequently filing a motion to stay the litigation pending that review.[7]

For example, even in cases before the U.S. International Trade Commission, which generally does not stay its proceedings, a patentee may still have to contend with the effects of co-pending IPRs that respondents may file.[8] As in to district court patent infringement actions, the government must prove patent invalidity in COFC cases under the clear and convincing standard.[9]

On the other hand, cases filed in the COFC are limited to claims against the United States, and since the government’s unauthorized use of a patented invention is in the nature of an act of eminent domain rather than a tort, the COFC will not enjoin the government nor award enhanced damages against it for willful infringement, as noted by the Return Mail court.[10]

Government Contractor Intervention and Use of America Invents Act Proceedings

One factor complicating the effect of the Return Mail decision is that government contractors often intervene in COFC patent cases pursuant to Court of Federal Claims Rule 14, to protect their interests. Under Rule 14 the government may formally notify contractors of COFC litigation affecting the contractor’s interests, and in response the contractor can intervene in the action to protect those interests.

Such an interest could arise if the government contract under which the accused items were purchased included a patent indemnity clause, such as Federal Acquisition Regulation 52.227-3 on patent indemnity. This potentially makes the contractor liable for any infringement, which then provides the contractor with incentive to challenge any asserted patents using the AIA proceedings.

Government contractors involved in COFC patent cases have already challenged patents asserted against the United States in AIA proceedings, and obtained stays of the COFC litigation, over the objections of the patentees.[11] Questions have arisen in these cases relating to the requirement that a petition requesting IPR proceedings correctly identify “all real parties in interest” pursuant to Section 312(a)(2) of the Patent Act and whether a government contractor is subject to the one-year time bar contained in Section 315(b).

If a petition fails to correctly identify all real parties in interest, it may be denied pursuant to the requirements of Section 312(a)(2), and under Section 315(b), “inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.”

Some of these questions have been answered, at least by the Patent Trial and Appeal Board, but others remain or have been created by the Return Mail case. In Department of Justice v. Discovery Patents LLC, the PTAB held that seven government contractors that had intervened in the related COFC case and that were subject to FAR patent indemnity obligations to the United States were not considered “real parties in interest” solely based on the indemnification obligation.[12]

In BAE Systems Information v. Cheetah Omni LLC, the PTAB held that the contractual relationship between the government and its contractor did not constitute a privity relationship that would trigger the one-year time-bar provision of Section 315(b), and the contractor was allowed to proceed with an AIA review even though the corresponding COFC case had been filed more than one year ago.[13]

The panel did note, however, that the petition was filed within one year of the date upon which the contractor was served with formal notice of the litigation pursuant to Court of Federal Claims Rule 14.[14] The panel did not address whether this places a time limit on government contractors for filing petitions for AIA reviews, or whether there are no time limits on contractors whatsoever.

Recent decisions from the Federal Circuit have stated that the PTAB should examine the facts of each case in determining whether an entity is a real party in interest.[15] Should the PTAB decide based on a particular set of facts that the federal government is a real party in interest to a patent validity challenge filed by a contractor, will that preclude the contractor’s ability to challenge the patent in AIA proceedings altogether? In view of the Return Mail case it is likely that patentees will remain vigorous in their challenges to AIA proceedings brought by government contractors.

Conclusion

The Return Mail decision removes an arrow in the Department of Justice’s quiver in defending patent infringement actions in the Court of Federal Claims. The effect of this may be alleviated in cases in which affected government contractors decide to file petitions for AIA proceedings on their own.


The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] 35 U.S.C. § 301
[2] 35 U.S.C. § 321.
[3] AIA §§18(a)(1), (d)(1), 125 Stat. 329
[4] Zoltek Corp. v. United States, 672 F.3d 1309, 1318 (Fed. Cir. 2012) (en banc)
[5] Zoltek, at 1318; Richmond Screw Anchor Co. v. United States, 275 U.S. 331, 343-44, (1928).
[6] Return Mail Inc. v. United States Postal Service, dissent at 6-7.
[7] Although the majority in Return Mail concedes that the Patent Office’s Manual of Patent Examining Procedures (MPEP) permits the Government to request that a patent be reexamined in ex parte proceedings, their additional comments leave open the question of whether this procedure is still available to the Government. (“We might take account of this ‘executive interpretation’ if we were determining whether Congress meant to include the Government as a “person” for purposes of the ex parte reexamination procedures themselves. Here, however, the Patent Office’s statement in the 1981 MPEP has no direct relevance. [citation omitted].” Slip Op. at 13-14. As the dissent further points out, ex parte reexamination is not always desirable and AIA proceedings are regarded as an easier way for parties to challenge questionable patents. Dissent at 5.
[8] See Certain Three-Dimensional Cinema Systems and Components Thereof, Inv. No. 337-TA-939, Notice of Commission Determination to Extend the Target Date (April 18, 2016) (extending the target date to permit parties to brief the impact that a PTAB final written decision invalidating certain claims should have on the investigation)
[9] CANVS Corp. v. United States, 114 Fed. Cl. 59, 66 (2013).
[10] Decca Limited v. United States, 544 F.2d 1070, 1167 (1976); Motorola, Inc. v. United States, 729 F.2d 765, 768 (Fed. Cir. 1984).
[11] E.g., Cheetah Omni, LLC v. United States, No. 1:11-cv-00255 (Ct. Fed. Cl. June 7, 2013) (order granting in part motion to stay litigation pending AIA review of patent-in-suit); BAE Sys. Info. v. Cheetah Omni, LLC, IPR2013-00175 (Paper 15)(PTAB July 3, 2013)(instituting inter partes review of patent involved in CFC litigation based on petition filed by government contractor).
[12] Department of Justice v. Discovery Patents, LLC, IPR2016-01035, Slip. Op. at 3-5.
[13] BAE Sys. Info. v. Cheetah Omni, LLC, IPR2013-00175, Slip. Op. at 5-6 (Paper 15) (PTAB July 3, 2013)
[14] Id.
[15] Applications in Internet Time v. RPX Corp, 987 F.3d 1336 (Fed. Cir. 2018); Worlds Inc. v. Bungie, Inc. 903 F.3d 1237 (Fed. Cir. 2018).

Read more at: https://www.law360.com/ip/articles/1170592/return-mail-may-make-cofc-more-attractive-to-patent-holders

Update: Patent and Trademark Fees in Venezuela

As previously reported on this blog, the issue of payment of fees related to trademark applications/registrations in Venezuela is currently in a state of flux. Specifically, given the current U.S. sanctions generally forbidding U.S. corporations from transacting business with the Venezuelan government, it has been difficult for these U.S. entities to pay fees associated with their Venezuelan trademark applications/registrations. As a result, the Venezuelan Patent and Trademark Office (VPTO) recently pushed back all renewal deadlines from February 2, 2018 until May 23, 2019 (although there is a currently pending petition to extend that deadline). Further, the VPTO has stated that it will allow for payment in dollars or euros (cash only) into the VPTO accounts at the Banco Del Tesoro. The VPTO and several trademark experts in Venezuela believe these payments should not be subject to current US sanctions as the Banco Del Tesoro has not been designated as an entity whose property and interests in property are blocked by the US Office of Foreign Assets Control. Please note, however, that as of now, the US government has not taken an official position as to this proposed workaround. We will continue to keep you informed of further developments in this area.

Mission Products v. Tempnology: The Supreme Court Speaks

In February, following oral argument before the U.S. Supreme Court in Mission Product Holdings, Inc. v. Tempnology, LLC,[1] we wrote about the hugely important trademark law issue presented by this case, namely: If a bankrupt trademark licensor “rejects” an executory trademark license agreement, does that bankruptcy action terminate the licensee’s right to continue using the licensed trademark for the remaining term of the agreement? Continue Reading

Scout Me Out? Girl Scouts Challenge Boy Scouts’ SCOUTS Trademark

A trademark case to keep an eye on this year is Girl Scouts of the USA v. Boy Scouts of America, case no. 1:18-cv-10287, which was filed last November in the United States District Court for the Southern District of New York and is currently in the discovery phase.

Being familiar organizations to many of us, the Girl Scouts and Boy Scouts have peacefully coexisted for decades in the U.S. for their respective leadership development services traditionally offered exclusively to girls or boys. Although both are congressionally chartered organizations, they are not affiliated or associated with each other. Each owns numerous federal trademark registrations for their GIRL SCOUTS and BOY SCOUTS brands.

Now, in light of a recent policy change by the Boy Scouts of America (BSA) to begin enrolling girls as well as boys, the Girl Scouts of the United States of America (GSUSA) contends that BSA has crossed the line into its protected trademark space. Continue Reading

LexBlog