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Volume X, Number 339

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Life Sciences Newsletter — October 2020

The October Mintz Life Sciences Newsletter brings the latest developments in life sciences, legal insights, and industry activity straight to your inbox. This edition includes:

USPTO and DOJ Discuss the Role of Intellectual Property in Life Science Sector Innovation

On Sept 23 & 24, the USPTO and DOJ co-hosted a webinar titled, “Promoting Innovation in the Life Science Sector and Supporting Pro-Competitive Collaborations: The Role of Intellectual Property.” The Mintz team attended, and we provide an overview of the event and discussions here. Below are some takeaways:

  • Speakers highlighted the significant impact the life sciences industry has had on life expectancy and other health markers and the importance of limiting barriers while maintaining a system that rewards innovation.

  • The USPTO continues to provide guidance to create an integrated approach to patent subject eligibility following decisions in important cases (AliceAMP, and Mayo, in particular). The 2019 Revised Patent Subject Matter Eligibility Guidance is the most recent from the USPTO.

  • Varying industry perspectives were presented on the strength and value of the current patent system for protecting innovation and providing access to such innovation as a platform for technological advances. (See pages 5–6 for “Are Changes to U.S. Patent Law Needed to Better Support Innovation in Life Sciences and the Development of COVID-19 Solutions?”)

  • Director Andrei Iancu of the USPTO shared that preserving IP rights during a time of crisis, such as the COVID-19 pandemic, is critical. The speed with which the industry has responded is enabled by prior technologies, innovators of which were rewarded at the time for their lengthy efforts to achieve those successes. Our system encourages inventors now and will during future crises.

  • Assistant AG Makan Delrahim of the DOJ shared that IP and antitrust are great complements to each other and that his prior experience in the life sciences and with IP are valuable assets in his current role. He is a believer in a balance between protecting innovation and maintaining an open market.

  • See page 12 for an interesting discussion on “Competition and Collaboration: Examining Competitive Effects and Antitrust Risks Associated with Collaborations,” which features insights from small biotechs, large pharma companies, academic research institutions, and the DOJ.

For more, at this link is an overview of the event, which captures comments from USPTO Director Andrei Iancu and Assistant AG of the DOJ’s Antitrust Division, Makan Delrahim.
 

Bioethics in a Pandemic

The Mintz Health Law team authored a series of blog posts on Bioethics in late August through September. A topic deeply important to the life sciences ecosystem, bioethics is seeing increased visibility in communities throughout the country due to the high profile of vaccination development efforts. The series discusses a number of topics related to vaccine development and distribution, including Operation Warp Speed, the framework for equitable allocation of the COVID-19 vaccine, and an overview of bioethics generally and lessons we’ve learned from the past.
 

5th Annual Pharmacy & Pharmaceutical Industry Summit

Mintz and consulting affiliate ML Strategies are hosting our 5th Annual (and first virtual!) Pharmacy & Pharmaceutical Industry Summit on Tuesday and Wednesday, October 27 & 28. You are invited to join us for sessions including:

  • Addressing Racial and Ethnic Disparities in Health Care

  • 2020 Year in Review: Regulatory and Policy Developments Impacting Pharmacy Benefits and the Pharmaceutical Supply Chain

  • Reimagining Telehealth and Digital Pharmacy Services in the Time of COVID-19 and Beyond

  • The 2020 Presidential Election Outlook and the Impact on Drug Pricing

For more information and to join us, click here.

 

 

Transactional Activity in the Industry

Each quarter, the Mintz transactions team takes a look at activity across several deal types in the US life sciences sectors and presents that data and our thoughts at this link. The 3rd quarter showed a nice increase in VC and IPO deals, with 25% and 10% increases, respectively. PIPE transactions experienced the largest deal volume increase with 65% growth in the number of deals as compared to the 2nd quarter. Secondary Offerings were down approximately 10%, and M&A, after a somewhat surprisingly strong 2nd quarter, settled from 89 deals in the 2nd quarter to 59 in the 3rd quarter. That contrasts a bit with the economy overall, when M&A transactions spiked in the 3rd quarter as many more traditional industries pulled the trigger on delayed deals and made consolidation moves.

 

Life Sciences Deals July - September 2020

 

Intellectual Property in the Industry

In this edition, we continue the quarterly review of Patent Grants in the USPTO’s Art Unit 1600 begun in our inaugural edition. Art Unit 1600 covers most biological and chemical innovations, and we use it here as an imperfect corollary for patent activity in the Life Sciences industry. Our review is a year-over-year comparison of patents granted by month each year between 2017 and 2020. The data is presented in charts by quarter for ease of review.

 

3rd Quarter Patent Grants - Art Unit 1600

 

M2D2 $200K Challenge – the Results Are In!

On October 1, the winners of this year’s Annual M2D2 $200K Challenge were announced! We are proud to recognize the winners of the competition in this newsletter. Mintz has been a leading sponsor of the Challenge for years, and we annually host the awards night. More than 200 applications were received in February for the competition, which is usually held in person in the spring. After hoping for the best, M2D2 elected to go with virtual competition and award events this year. Fifteen entrepreneurs and executives pitched their companies on September 17, and they all reconvened on the first day of October to learn the results. Corporate sponsors awarded prizes to the following competitors:

 

Award Recipient

Profligen
Navigation Sciences
AiM Medical Robotics
RBI Medical
CranioSense
ExoNanoRNA

Sponsor

Amgen
Asahi-Intecc
Boston Scientific
Hologic
Johnson & Johnson
Sarepta Therapeutics

And, for the first time, the competition had a cash prize of $50,000, provided by the Mass Life Sciences Center and presented by Jennifer Griffin, MLSC’s VP of Industry Strategy & Investments. Congratulations to Cx Therapeutics for receiving this award!

 

 

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume X, Number 294
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Adam C. Lenain, Member, Mergers & Acquisitions Licensing & Technology Transactions Securities & Capital Markets
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Adam assists life sciences and information technology companies navigate complex legal and business issues.  With a practical and creative focus on his clients’ intended business results, he often functions as an outside general counsel and is regularly consulted by management teams for guidance on strategic matters.  His clients are both public companies and emerging growth companies. 

Adam has over twenty years of experience representing issuers and investment banks in connection with public and private financing transactions, SEC regulatory compliance and ’34 Act reporting.  He...

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William Whelan M&A Attorney Mintz Levin
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Bill applies his extensive mergers and acquisitions and venture capital financing experience primarily to deal work for life sciences companies. He helps clients thrive at every stage of the corporate life cycle by piloting them through the initial organization phase, stock and debt financings, IPOs, alliances, and business combinations. He ably advises biotechnology, medical technology, healthcare IT, and other types of technology companies. Bill also counsels venture capital firms about their portfolio investments.

Bill currently serves as Co-chair of the firm’s Life Sciences...

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Susan Benson Health Attorney Mintz Law Firm
Member / Managing Member, DC Office; Chair, Health Law, Communications, Antitrust & ML Strategies Division

Susan’s clients depend on her in-depth industry knowledge and strategic insights. Her in-house experience informs her pragmatic, business-savvy counsel to health care industry clients. She regularly advises pharmaceutical services providers, managed care organizations, post-acute and long term care providers, and those who invest in the industry on the risks and potential benefits of strategic affiliations, complex service agreements, and due diligence in high profile transactions. She also provides counsel on government programs such as Medicare and Medicaid, and...

202-661-8715
Jonathan Kravetz, Mintz Levin, Securities & Capital Markets, Mergers & Acquisitions International Law Firm Network, Life Sciences
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Jon is Chair of the Securities & Capital Markets Practice Group and Co-chair of the Life Sciences Practice Group. He represents clients in both public and privately placed equity and debt financings under the Securities Act of 1933, provides counseling for public companies with respect to the full range of securities compliance issues under the Securities Exchange Act of 1934, and advises high-technology, biotechnology, and medical device companies in numerous contractual and strategic matters.

Jon has an active international practice, representing European companies in merger...

617-348-1674
Terri Shieh-Newton, Mintz Levin Law Firm, San Francisco, Intellectual Property and Life Sciences Attorney
Member

Dr. Shieh-Newton has significant experience in a wide range of life sciences and clean technology industries that allows her to provide creative solutions and render business-savvy advice to her clients. Her practice focuses on patent strategy, comprehensive portfolio management, construction of valuable portfolios, preparation and prosecution of patent applications, interferences, and post-grant proceedings in the life sciences and clean technology sectors. She manages and conducts due diligences for both private and public companies and investors. Dr. Shieh-Newton has...

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