Now more than ever, technology is influencing the way we do business, communicate, move through and around the world, access and manage our homes, receive and administer healthcare, make purchases, secure information, and protect our most valuable property. Morrison Foerster keeps pace with this rapidly evolving landscape across our internationally recognized corporate, finance, intellectual property, and litigation practices. MoFo Tech brings together our insights relating to fields such as blockchain and distributed ledger, cloud and as-a-service technologies, driverless cars, drones, fintech, computer hardware and software, the Internet of Things, semiconductors, and telecommunications. The MoFo Tech blog offers real-time, in-depth analyses of the trends and complex issues shaping the global technology industry.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Scott Llewellyn’s practice focuses on complex litigation in federal and state courts around the country, with an emphasis on patent and trade secret disputes. Over the past decade, he has worked on some of the most significant, high–profile IP cases involving technology for televisions, smartphones, and self–driving cars, relying on 40 years of experience with computer hardware and software. Scott also has significant experience with business divorce cases before courts and arbitrators, involving a mix of trade secret, patent, tort, and contract claims relating to technology development and implementation.Scott also has successfully tried general commercial arbitration and agency matters, briefed and argued various appeals in federal appellate court, and tried more than 20 cases for the Denver City Attorney’s office, most of them jury trials.Scott also has an active pro bono practice, having worked on a variety of criminal and immigration appeals, and having represented Colorado criminal defense and mental health organizations in high–profile suits against the state of Colorado for violations of the constitutional rights of defendants.At MoFo, Scott serves on the board of the Morrison & Foerster Foundation. In the broader legal community, he serves on the boards of the Colorado Lawyers Committee and Drop in the Bucket (a charity that builds wells and sanitation systems in sub–Saharan Africa).After law school, Scott clerked for the Honorable Clarence A. Brimmer, District of Wyoming, and the Honorable Diarmuid F. O’Scannlain, Ninth Circuit. He was also previously an adjunct professor at the Georgetown University Law Center.

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Scott Llewellyn’s practice involves complex litigation before state and federal courts around the country, with an emphasis on patent and trade secret disputes for high-tech companies, to which he brings more than 35 years of experience with computer hardware and software, in particular relating to the processing and transmission of audio, video, voice, and other types of data. Mr. Llewellyn has also tried commercial arbitration and agency matters; briefed and argued various appeals in federal appellate court; and tried more than 20 cases for the Denver city attorney’s office, most of them jury trials.

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MoFo Tech brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry, covering fields such as blockchain and distributed ledger, cloud and SaaS technologies, driverless cars, drones, FinTech, computer hardware and software, the IoT, semiconductors, and telecommunications.

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MoFo Tech brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry, covering fields such as blockchain and distributed ledger, cloud and SaaS technologies, driverless cars, drones, FinTech, computer hardware and software, the IoT, semiconductors, and telecommunications.

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Current State of the AI VC Financing Market

MoFo Tech Law Summit – Tech and Antitrust: Policy Shifts in the Second Trump Administration

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AI Dynamics: Regulatory Landscape and Industry Insights

Introducing the MoFo Tech Law Summit – Innovation Under Regulation

I. IntroductionOn November 26, the Dusseldorf Regional Court handed down a long awaited decision in the so-called automotive patent wars (case ID 4c O 17/19). The court referred heatedly debated questions in connection with the enforcement of standard essential patents (“SEPs”) to the Court of Justice of the European Union (“CJEU”). The detailed set of questions addresses two main issues: 1. Whether the entity selling a device (here a car) that includes a component that implements the technology protected  by the SEP would be in compliance with the FRAND procedure set out by the CJEU in Huawei v. ZTE if it were  to refer  the SEP holder to the upstream component supplier rather than making a fair reasonable and non- discriminatory  (“FRAND”) offer itself; and 2. Certain clarifications on the Huawai v. ZTE requirements regarding the timing of the steps in what is often referred to as the “FRAND dance.”Although the outcome of an order for reference cannot be foretold, the CJEU decision is expected to be the most influential decision on FRAND licensing since the 2015 Huawei v. ZTE ruling (case ID <a href="http://curia.europa.eu/juris/document/document.jsf;jsessionid=6331314A3F81E1AED9537BAA8E87A934?text=&docid=165911&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=17464359">C-170/13</a>). It may create a more predictable framework of licensing negotiations for both SEP holders and implementers. In addition, it may encourage national courts to finally take a clear stance on the FRAND compliance of an offer in certain cases.In this article we will give a short overview of the background of the current SEP battles and an outlook of the practical consequences of the CJEU ruling. II. Uncertainties following Huawei v. ZTEIn Huawei v. ZTE, the CJEU ruled that the SEP holder must first alert a party of its alleged infringement before bringing an action. If the alleged infringer expresses a willingness to take a license, the SEP holder must provide a written licensing offer on FRAND terms. Only if the alleged infringer continues to use the SEPs in question and fails to respond diligently to the SEP holder’s offer may the SEP holder seek an injunction. A diligent response may include a counter-offer on FRAND terms.This landmark decision did not curb litigation on FRAND considerably. For one thing, it left courts with significant leeway to interpret each party’s obligations, particularly as to timing. For example, it is unclear how swiftly the offeree must reply before it is deemed unwilling. As a result, SEP cases are often tactically protracted. Furthermore, the CJEU decision did not cover all aspects of SEP enforcement. Important questions such as the actual terms fulfilling the FRAND requirement remained open. Hence, it is difficult for the parties to assess what license terms and royalties are substantively FRAND.The European Commission (“EC”) tried to provide guidance on those issues with its 2017 communication “Setting out the EU approach to Standard Essential Patents” <a href="https://ec.europa.eu/docsroom/documents/26583">(available here)</a>. Because its initial guidance left open many issues, the EC recently announced that it will encourage industry-led initiatives and possibly enact reforms as part of its action plan on IP (available here).III. Automotive WarsMeanwhile, the connected cars battle in Germany took off. In the advent of 5G and the IoT, the car industry, among many others, increasingly implemented mobile communication technology. Thus, their products moved gradually from the area of classic automotive engineering toward the area of mobile communications. This pursuit for connectivity of automated and digitalized products naturally calls for interoperable technical solutions based on standards. This potentially gives SEP holders a whole new field to reap.Members of the Avanci patent pool, such as Nokia and Conversant, did not want to play by the long-established rules of the car industry and grant licenses at the component level. This is because final product licensing provides a much more attractive royalty base than component-level licensing, as the market value of the smallest salable patent practicing unit is far lower than one of the end products. Accordingly, they launched a wider litigation campaign against car makers, including Daimler, and Volkswagen and other OEMs.Nokia brought 10 proceedings against Daimler before German courts in Munich, Mannheim, and Dusseldorf. In turn, Daimler and four of its suppliers launched antitrust complaints against Nokia before the Commission’s Directorate-General for Competition, claiming that Nokia abused its dominant market position by not granting a license to the suppliers. One of the suppliers, Huawei, followed suit and brought an action before the Dusseldorf Regional Court, seeking to obligate Nokia to grant a license.The order for reference by the Dusseldorf court is the latest striking, yet not unexpected, event in the connected cars proceedings. In the present case, Nokia has offered a license only to Daimler and not to Daimler’s suppliers. Daimler, on the other hand, always wanted its suppliers to take a license and the suppliers have emphasized that they are, in fact, willing to do so. Positions/ ArgumentsNokia claims it is more efficient to only deal with OEMs like Daimler. They also argue that exhaustion dynamics would have unacceptable practical consequences. On the other side, OEMs argue that injunctions against them are not proportionate in light of Art. 3 of the Enforcement Directive (<a href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32004L0048R(01)&from=EN">2004/48/EC</a>). Because suppliers implement the SEP first, OEMs contend that suppliers should be first in line to receive a license. OEMs also invoke efficiency arguments, noting that there are fewer suppliers than OEMs.Controversy on WillingnessFor a long time, the SEP holder’s offer appeared to be the pivotal event. At least before the Dusseldorf courts—the forum that hears the most SEP cases in Germany—it was relatively safe to assume that the SEP holder’s offer signaled the start of the FRAND dance only if the offer was in fact FRAND. In other words, the implementer’s steps under Huawei v. ZTE did not matter, so long as the implementer did not reject any attempt to engage in negotiations and thus render it “unwilling.”On May 5, 2020, the German Federal Court of Justice (“GFCJ”) specified that the implementer must clearly and unequivocally declare its willingness to conclude a license agreement with the SEP holder on reasonable and non-discriminatory terms. The GFCJ further required that the implementer subsequently participate in the license agreement negotiations in a deliberate manner (case ID KZR 36/17). For support, the GFCJ referred to the High Court of England and Wales’ holding in Unwired Planet vs. Huawei that “a willing licensee must be one willing to take a FRAND license on whatever terms are in fact FRAND.”Applying these standards, the Munich Regional Court (case ID 7 O 8818/19) and the Mannheim Regional Court (case ID 2 O 34/19) recently held that an SEP implementer does not indicate its unconditional willingness to accept a FRAND license by referring the SEP holder to its suppliers.  To the contrary, such a referral indicates that the SEP implementer is “unwilling” regardless of whether the SEP holder’s offer was FRAND.The controversial nature of this issue is evident by the Federal Cartel Office’s involvement.  In the Mannheim proceedings, the Federal Cartel Office weighed in to encourage the Regional Courts to stay the proceedings and providing a set of questions for referral to the CJEU.  The Mannheim court did not follow these suggestions, however, and instead issued its ruling with little delay.  Its decision is the second grant of an injunction to Nokia prohibiting Daimler sales, if enforced.Against this backdrop, the Dusseldorf Courts’ decision to focus on the issue provides hope to OEMs that wish to refer SEP holders to suppliers IV. The questions referred to the CJEUThe Dusseldorf Regional Court’s referral to the CJEU suggests the possibility of a different approach to this question favoring OEMs.  Loosely translated, the referred questions are: A. Must the SEP holder prioritize licensing of suppliers? 1. Can a downstream company impede an action for injunctive relief for infringement of a standards-essential patent   for which the patentee has irrevocably undertaken to grant FRAND licenses on the basis that the SEP holder is abusing   its dominant market position under Art. 102 TFEU by refusing to grant an unrestricted FRAND license to the upstream supplier? a. If common practice in an end-product manufacturer’s sector is that a part supplier’s license clears the   manufacturer of infringement, does this support the defense against injunctive relief? b. Must the SEP holder prioritize licensing of all suppliers regardless of their level in the supply chain, or only the   one supplier immediately upstream of the distributor of the final product? Does this also depend on industry practice? 2. Does Art. 102 TFEU require that the supplier be granted its own unrestricted license for all types of use relevant under patent law on FRAND terms for products implementing the standard with the result that end-product manufacturers (and, as applicable, intermediaries) no longer need to take their own, separate licenses from the SEP holder to avoid patent infringement for using the respective parts per their intended use? 3. If the first question is answered in the negative: does Art. 102 TFEU impose particular qualitative, quantitative, and/or other requirements on the criteria by which a SEP holder must decide which potential infringers at different levels of the supply chain it can sue for injunctive relief?B. Clarifications of the Huawei v. ZTE requirements 1. Putting aside the SEP holder’s and implementer’s pre-litigation obligations (infringement notice, request for license, FRAND licensing offer; license offer to suppliers to be licensed on a priority basis), is it still possible to satisfy   obligations not previously met during the course of court action to the effect that the rights are preserved? 2. Should a license request only to be deemed substantial if a comprehensive assessment of all circumstances clearly and unequivocally shows the SEP user’s willingness and readiness to conclude a license agreement with the SEP holder under FRAND terms, irrespective of what those terms (which, due to the non-existence of an offer at that time are not foreseeable) might be? a. Does an infringer’s silence for several months after receiving an infringement notice indicate its disinterest in a license, so that - despite a verbally formulated request for a license - there is no such license and the SEP holder's injunction request must be granted? b. Can the terms of an SEP user’s counteroffer be interpreted to mean that it has not actually requested a license,  such that the SEP holder's injunction request should be granted regardless of whether its initial license offer was FRAND-compliant? c. Is such a conclusion unwarranted if the counteroffer’s license terms, which shall imply that the SEP user has actually not submitted a substantial license request, are either incompatible with high court precedents or otherwise facially non-FRAND?V.  Nokia’s ReactionThe decision of the CJEU could take up to two years. But for Nokia, time is of the essence. After injunctions obtained in Munich and Mannheim were not sufficient to force Daimler into a license deal, Nokia cannot afford to lose any time and needs another victory fast. In an attempt to prevent the case from actually being heard by the CJEU, Nokia thus appealed the Dusseldorf Court’s decision. This move is not only unusual but also not very likely to succeed, as the Dusseldorf Regional Court’s referral was orchestrated with the Dusseldorf Higher Regional Court, the very same Court which will now have to decide on the appeal. VI. OutlookThe referral offers a glimmer of hope to Daimler and other OEMs that their recent run of unfavorable outcomes before German courts may come to an end. But the outcome of the actual decision, how the national courts will implement it, and its actual benefit to SEP implementers remain to be seen. For example, the Munich Regional Court may be reluctant to rely on industry practices regardless of the CJEU’s ruling, in view of its prior decision that a car manufacturer may not rely on car industry’s licensing practices when implementing technology from the mobile communications sector.The CJEU’s ruling likely will have effects beyond SEP cases involving complex supply chains. Its clarification of issues could accelerate licensing discussions, minimize tactical delays during litigation, and reduce costs overall. Its ruling also may encourage national courts to rule on FRAND terms.Morrison & Foerster Associate Jacqueline Feigl contributed to the writing of this blog post.

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Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

Wolfgang Schönig

Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

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Counsel

Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Huawei v. ZTE revisited – German automotive patent wars to reshape SEP litigation in Europe

Digital Compliance in Europe: Regulatory Alignment Post-Brexit

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I. Introduction
On November 26, the Dusseldorf Regional Court handed down a long awaited decision in the so-called automotive patent wars (case ID 4c O 17/19). 

Huawei v. ZTE revisited – German automotive patent wars to reshape SEP litigation in Europe

<p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements:  a new Digital Health Center of Excellence and an update on its Software Precertification Program.  Manufacturers developing mobile medical devices, software as a medical device (SaMD), artificial intelligence (AI), and wearables when used as a medical device may want to become involved with new center and/or keep the components of the Software Precertification Program in mind. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">Digital Health Center of Excellence <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">The FDA recently created the Digital Health Center of Excellence, a group of digital health experts assigned with providing technical advice to help accelerate access to safe and effective digital tools.  The new center aims to connect and build partnerships among stakeholders by accelerating digital health advancements, sharing knowledge, and innovating regulatory approaches.  The center is currently in Phase 1, where the focus is on raising awareness and engaging stakeholders.  Phase 2, set to begin at the end of the year, will focus on building partnerships. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">Update on Software Precertification Program <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">The FDA also released an update on its Software Precertification (“Pre-Cert”) Program.  The goal of the Pre-Cert pilot is to develop a streamlined premarket review process for SaMDs, reducing unnecessary regulatory burden for both the medical device manufacturers and the FDA.  SaMDs range from apps on smartphones to computer-aided detection software.  With the Pre-Cert Program, the FDA first examines the medical software manufacturer rather than the medical device.  The companies that meet the criteria through the Pre-Cert process can seek a streamlined review of SaMD products.<p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;"> Essential Components in the Software Pre-Cert Program <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">The Pre-Cert pilot project implements the Total Product Lifecycle Approach (TPLC), which the update outlined.  Four essential components are designed to reflect the total lifecycle of a product:  <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">(1) Excellence Appraisal – The FDA uses five main criteria (patient safety, project quality, clinical responsibility, cybersecurity responsibility, and proactive culture) to determine whether the medical software manufacturer demonstrates a robust culture of quality and organizational excellence. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">(2) Review Determination – The medical software manufacturer itself would be allowed to determine the regulatory pathway for its own products.  Low-risk software products could be placed on the market with a simplified notification procedure. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">(3) Streamlined Review – The FDA will develop a special approach to determine the scope of information to be provided by the medical software manufacturer when filing the initial submission. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">(4) Real-World Approach – The medical software manufacturer shall collect and analyze information related to the actual performance of the software placed on the market to determine safety concerns and risks. <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">Although the development of the Software Pre-Cert Program involves nine (out of over 100) selected companies, it is still early in its development stage.  Additionally, the FDA may face major regulatory hurdles as it will need to ask Congress for the legislative authority to proceed.  <p style="background-color: transparent;box-sizing: border-box;color: rgb(82, 83, 87);font-size: 16.93px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 27.08px;margin-top: 0px;margin-right: 0px;margin-bottom: 20px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;overflow-wrap: normal;">We will continue to monitor the efficacy of the Digital Health Center of Excellence and the trajectory of the Pre-Cert Program and update this post with any new developments.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Associate

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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Recent Digital Health-Related FDA Announcements

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The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements:  a new Digi

Recent Digital Health-Related FDA Announcements

As the dust settles on the 2020 election, one result is clear: California voters have approved Proposition 24, and the California Privacy Rights Act of 2020 (CPRA) will become law. Pending official certification of the results, the initiative’s “yes” votes outnumber “no” votes by an approximately 56–44% margin. Covered businesses have just over two years to prepare for any compliance challenges that the CPRA’s passage may pose, as most of its provisions become operative on January 1, 2023.The CPRA will significantly amend the California Consumer Privacy Act of 2018 (CCPA) and create the California Privacy Protection Agency to enforce the CCPA, making California the first state with its own privacy regulator. For more, read our client alert.Read our <a href="https://protect-us.mimecast.com/s/h4KiC9rLGjHyNBp9tEPU6E?domain=www2.mofo.com">client alert.</a>

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CPRA Passes: California Voters Approve Proposition 24

CPRA Passes: California Voters Approve Proposition 24

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As the dust settles on the 2020 election, one result is clear: California voters have approved Proposition 24, and the California Privacy Rights Act of 2020 (CP

Dario de Martino authored the chapter, "<a href="https://www.globallegalinsights.com/practice-areas/blockchain-laws-and-regulations/14-blockchain-manda-the-next-link-in-the-chain" target="_blank">Blockchain M&A: The next link in the chain</a>," in GLI's Blockchain & Cryptocurrency Regulation guide for 2021.In this chapter, Dario discusses how blockchain market participants have remained steadfast and are continuing to ride the wave of M&A, despite having experienced the “crypto winter” and being in the middle of a rare combination of public health, political, social, and economic uncertainties plaguing the global business landscape.

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Blockchain M&A: The Next Link in the Chain

Understanding Blockchain - Blockchain and Securities Law - Part 4

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Dario de Martino authored the chapter, "Blockchain M&A: The next link in the chain," in GLI's Blockchain & Cryptocurrency Regulation guide for 2021.
In this cha

Blockchain M&A: The Next Link in the Chain

Our new Life Sciences MoFo Perspectives podcast is available now. In this episode, several of our Life Sciences Group partners unpack the science, regulatory framework, commercial transactions, and privacy and data security considerations of <a href="https://protect-us.mimecast.com/s/yptHCG6QzAUMMEPNcp_e3o?domain=www2.mofo.com">applying AI and data science to the fight against COVID-19</a>. We cover topics such as:<ul><li>How are companies using AI and machine learning to combat the COVID-19?</li><li>How might this technology be helpful in predicting the potential spread of COVID-19 or any other virus?</li><li>What are privacy issues involved in contact tracing?</li><li>What kind of government guidelines are being put in place regarding how the data are collected?</li><li>How are companies collaborating to use cloud computing and AI data in the fight against COVID-19?</li><li>What are some of the legal issues companies should be aware of when negotiating deals involving data and AI?</li><li>What are some of the ways the FDA is addressing the use of AI and software in fighting COVID-19?</li></ul>Listen to our <a href="https://protect-us.mimecast.com/s/yptHCG6QzAUMMEPNcp_e3o?domain=www2.mofo.com">podcast</a>. Follow our <a href="https://protect-us.mimecast.com/s/fofyCJ67z1UYYl2WuLTSBw?domain=www2.mofo.com">MoFo Life Sciences</a> blog.

CSPC Pharmaceutical Group Limited

ACEA Therapeutics

Kindred Biosciences

Sanuwave Health

MyChem

Special New Fruist Licensing (SNFL)

Sequlite Genomics

Arbutus Biopharma

OpenInvest

LIVEKINDLY

Adagene

Vizgen, Inc.

CareDx

Colleges and Universities

BluesphereBio

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Matt Karlyn has 23 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensi

Matt Karlyn

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

In the Public Eye: USPTO Issues Report on AI

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Our new Life Sciences MoFo Perspectives podcast is available now. In this episode, several of our Life Sciences Group partners unpack the science, regulatory fr

Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

Just two months after the final implementing regulations under the California Consumer Privacy Act of 2018 (CCPA) (“the Regulations”) were approved and took effect, California’s Department of Justice (DOJ) has issued another set of proposed modifications and invited written comments from interested stakeholders.  The modifications, which re-introduce provisions that California’s Office of Administrative Law (OAL) withdrew before finalizing the Regulations in August 2020, could impact covered businesses’ CCPA compliance programs, particularly with respect to their provision of notices regarding consumers’ right to opt out of the sale of their personal information, as well as the submission of consumers’ opt-out requests. Please read our summary of the proposed modifications.Read our <a href="https://protect-us.mimecast.com/s/pAcFCYElrZFx2kEJFGI3n8?domain=www2.mofo.com">client alert.</a>

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October Surprise: California DOJ Proposes Additional Modifications to CCPA’s Implementing Regulations

Recent Decision Compelling Disclosure of Data Breach Incident Response Report Highlights the Importance of Preserving Privilege and Protecting Work Product

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Just two months after the final implementing regulations under the California Consumer Privacy Act of 2018 (CCPA) (“the Regulations”) were approved and took eff

October Surprise: California DOJ Proposes Additional Modifications to CCPA’s Implementing Regulations

The USPTO recently released the report “Public Views on Artificial Intelligence and Intellectual Property Policy”. The report is part of the USPTO’s effort to engage with the innovation community and experts on AI and to promote innovation of AI through appropriate intellectual property incentives. The report includes the analysis of nearly 200 responses received from individuals and organizations to federal notices published in August and October 2019 to solicit public comments on patenting AI inventions and the impact of AI on other areas of intellectual property policy. The USPTO requested feedback on issues such as whether current laws and regulations regarding patent inventorship and authorship of copyrighted work should be revised to take into account contributions other than by natural persons.Read our <a href="https://www.mofo.com/resources/insights/201012-uspto-report-on-ai.html">client alert</a>.

Tessa J. Schwartz, partner, has extensive experience in complex intellectual property and technology law, copyright law, and patent litigation.

Tessa Schwartz

Tessa Schwartz has an active practice counseling companies on intellectual property and technology transactions issues, and negotiating complex intellectual property and commercial agreements.

In the Public Eye: USPTO Issues Report on AI

The USPTO recently released the report “Public Views on Artificial Intelligence and Intellectual Property Policy”. The report is part of the USPTO’s effort to e

<p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">In this episode of “Understanding Blockchain,” Morrison & Foerster’s Susan Gault-Brown and Dario de Martino discuss cryptocurrencies, if they are commodities, and if it is possible they're also securities. <p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">This ongoing series is dedicated to providing an overall understanding of blockchain technology and how companies can use it to share, store, and record valuable data through a secure, immutable network.<p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">Watch our video <a href="https://www.mofo.com/resources/video-audio/200915-blockchain-securities-law-part-7.html">here</a>.

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Understanding Blockchain - Blockchain and Securities Law - Part 7

Understanding Blockchain - Blockchain and Securities Law - Part 3

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In this episode of “Understanding Blockchain,” Morrison & Foerster’s Susan Gault-Brown and Dario de Martino discuss cryptocurrencies, if they are commodities, a

Understanding Blockchain - Blockchain and Securities Law - Part 7

In this episode of “Understanding Blockchain,” Morrison & Foerster’s Susan Gault-Brown and Dario de Martino discuss the limits on the transferability of cryptocurrencies.This ongoing series is dedicated to providing an overall understanding of blockchain technology and how companies can use it to share, store, and record valuable data through a secure, immutable network.Watch our video <a href="https://www.mofo.com/resources/video-audio/200908-blockchain-securities-law.html">here</a>.

Understanding Blockchain - Blockchain and Securities Law - Part 6

In this episode of “Understanding Blockchain,” Morrison & Foerster’s Susan Gault-Brown and Dario de Martino discuss the limits on the transferability of cryptoc

Understanding Blockchain - Blockchain and Securities Law - Part 6

<p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">In this episode of “Understanding Blockchain,” Morrison & Foerster’s Susan Gault-Brown and Dario de Martino discuss how to determine whether "utility tokens" are securities or not. <p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">This ongoing series is dedicated to providing an overall understanding of blockchain technology and how companies can use it to share, store, and record valuable data through a secure, immutable network.<p style="background-color: transparent;box-sizing: border-box;color: rgb(33, 37, 41);font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;line-height: 26.4px;margin-bottom: 16px;margin-top: 0px;">Watch our video <a href="https://www.mofo.com/resources/video-audio/200831-blockchain-securities-law.html">here</a>.