Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">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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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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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.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

What Makes a Good Cell and Gene Therapy Application?

A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

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On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc.[1] affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB)[2] that invalidated challenged patent claims owned by Monterey Research (“Monterey”) covering an “improved Static Random Access Memory (SRAM) cell design and method of manufacture”[3] for computer memory.U.S. Patent No. 6,534,805 (“U.S. Pat. No. ’805”)Monterey’s U.S. Pat. No. ’805 protects a memory cell having multiple layers of circuit components.[4]  A conventional semiconductor memory device stores information digitally, in the form of bits (e.g., binary digits).  The memory is typically organized as a matrix of memory cells, each of which is capable of storing one bit.  The cells of the memory matrix are accessed by wordlines (that are typically associated with the rows of the memory matrix) and bitlines (that are typically associated with the columns of the memory matrix).[5]  Figure 3 of U.S. Pat. No. ’805 depicts local interconnects that correspond to bitlines (38 and 39) or a global wordline (43 and 44), each of which is associated with a single contact region (15c, 16c, 17c1, and 17c4) within the circuit.[6]<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt2ae0f4d67cb35854/6554028c4d28592649afb1f1/231114-patent-prosecution-trategies.jpg?format=auto&amp;quality=60" alt="Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings"/></div>Inter Partes ReviewPetitions for Inter Partes Review of U.S. Pat. No. ’805 were brought by Advanced Micro Devices, Inc. and STMicroelectronics, Inc.[7] and by Qualcomm Inc., Advanced Micro Devices, Inc., and STMicroelectronics, Inc.[8]  The dispute concerned, inter alia, claim 8, which reads:<blockquote dir="ltr">8. A memory cell comprising a plurality of substantially oblong active regions formed in a semiconductor substrate and arranged substantially in parallel with one another, and a plurality of substantially oblong local interconnects above said substrate that extend only partially across the memory cell and are arranged substantially in parallel with one another and substantially perpendicular to said active regions.</blockquote>Petitioners argued that neither the claim language nor the Specification supported Patent Owner’s proposed claim construction that a single local interconnect layer required lateral routing of signals along the interconnect layer because the word “routing” wasn’t present in the application, and Figure 3 did not illustrate any routing along the local interconnect layer, let alone specific positions that would demonstrate routing.[9]To oppose Petitioners’ assertion, Patent Owner Monterey referenced the underlying prosecution history to support its position that the disputed limitation was limited to the embodiment in Figure 3 showing the type of lateral routing of signals being discussed.  Specifically, Monterey argued that the limitation “single local interconnect layer comprising local interconnects corresponding to bitlines and a global wordline” was added to claim 8 during reexamination to distinguish over a cited prior art reference.[10]The PTAB found that neither the specification nor the prosecution history limited the claim scope to lateral routing[11] because Figure 3 only showed a single contact point on each relevant interconnect, rather than contacts on both ends that would impose lateral routing, and the underlying prosecution history did not disclaim any specific routing.[12]  The challenged claims were found unpatentable as obvious[13] and Monterey appealed.[14]Federal CircuitOn appeal, the Federal Circuit affirmed the PTAB’s conclusion that Monterey’s representations made during prosecution did not restrict the claim limitation to lateral routing because those statements did not require that the local interconnects provide connections between “laterally displaced” components such that signals would have to be horizontally routed.[15]  Even if the disputed “single local interconnect layer” claim term were limited to Figure 3, the majority held that Figure 3 did not restrict the claim as argued by Monterey because Figure 3 only depicts a single contact region for each of the relevant local interconnects required by the disputed limitations,[16] leaving it ambiguous as to whether the second contact region associated with the local interconnects (about which Figure 3 is silent) required lateral and not vertical routing.  As such, the Federal Circuit agreed with the PTAB’s claim construction.Interestingly, in dissenting in part, Judge Dyk disagreed with the majority’s holding that Figure 3 was not limited to the lateral routing construction because the PTAB concluded that “the embodiment shown in Figure 3 of the ’805 patent illustrate[d] routing . . . signals along an interconnect layer to connect laterally displaced bitlines and wordlines.”[17]  Thus, according to Judge Dyk, the PTAB determined that the rest of the claim language and specification did not limit the claim scope to the embodiment disclosed by Figure 3, not that Figure 3 was so limited.[18]  Therefore, under the PTAB’s determination, limiting the scope of the disputed claim term to the embodiment in Figure 3 would limit the claim’s scope to an embodiment connecting laterally displaced components.[19]Practical Tips for ProsecutionTypically, to maintain flexibility for a broad claim construction, patent practitioners seek to put fewer statements and declarations on the record during prosecution.  Patent practitioners may engage in a balancing act and apply a minimalistic approach, placing just enough on the record to support the Applicant’s position, while not placing too much on the record to result in unintentional repudiations of claim scope.  However, this decision emphasizes how this approach may have unintended consequences during post-grant proceedings.Patent practitioners should consider pursuing claims of varying scope during prosecution to protect diverse embodiments of the invention as an alternative to narrowing the claims during prosecution, which could create estoppel issues when attempting to argue for broader claim construction in post-grant proceedings at the PTAB or during litigation.References[1] Monterey Research, LLC v. STMicroelectronics, Inc., No. 2022-1411, 2022-1770 (Fed. Cir. 2023) (“Fed. Cir. Decision”).[2] Advanced Micro Devices, Inc. and STMicroelectronics, Inc. v. Monterey Research, LLC, IPR2020-00990, 2021 WL 6339618 (P.T.A.B. Nov. 23, 2021) (“0990 Decision”); Qualcomm Inc. v. Monterey Research, LLC, No. IPR2020-01491, 2022 WL 682743 (P.T.A.B. Mar. 4, 2022) (“1491 Decision”).[3] U.S. Patent No. 6,534,805 (“U.S. Pat. No. ’805”), 1:7–10.[4] See 1491 Decision, at *2.[5] See U.S. Pat. No. ’805, 1:32–43.[6] See id. at 11:18–21, 13:12–13, 31.[7] See 0990 Decision, at *4 (challenging claims 8, 10, 12, 16, 18, 22, and 23 under 35 U.S.C. § 103(a) in view of U.S. Patent No. 6,417,549 (“Oh”) individually and Oh in view of R. Jacob Baker, et al., CMOS Circuit Design, Layout and Simulation (2011) (“Baker”)).[8] See 1491 Decision, at *4–5 (challenging several claims under 35 U.S.C. § 103(a) in view of U.S. Patent Nos. 6,347,062, 5,702,982, 5,930,163, Oh, and/or Baker).[9] See 1491 Decision, at *17.[10] See id. at *7 and *17.[11] See id. at *8 (“although Figure 3 shows bitline signals can be routed horizontally . . . neither the Specification nor the claims require such routing.”).[12] See id. at *8.[13] See id. at *80–81. See also 0990 Decision, at *45.[14] See Fed. Cir. Decision, at *5.[15] See id. at *18.[16] See id.[17] See id. at *3 (quoting 1491 Decision, at *17) (Dyk, J., dissenting in part, concurring in part).[18] See id. at *3.[19] See id. at *3 and *4.

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Of Counsel

Mark D. McBriar focuses his practice on patent drafting and prosecution, IP due diligence, freedom to operate, patentability evaluations, re-examinations, and litigation support. Dr. McBriar works wit

Mark D. McBriar Ph.D.

Mark McBriar

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On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc.[1] affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB)[2] that invalidated challenged patent claims owned by Monterey Research (“Monterey”) covering an “improved Static Random Access Memory (SRAM) cell design and method of manufacture”[3] for computer memory.

Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings

Licensing + Commercial

Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.Read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltbc857834ffd7f479/64a89947ade08c2fe3cb214e/230705-top-considerations-for-transactions.pdf" target="_self">full article</a>.

Top 10 Considerations for Transactions Involving Alternative Protein Companies

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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Patent Agent

Dr. Sarah Bloch focuses her work on patent drafting and prosecution. Sarah has experience in IP due diligence inquiries, with an emphasis on biotechnology, agriculture, and the food industry.
Sarah ha

Sarah E. Bloch Ph.D.

Sarah Bloch

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Top 10 Considerations for Transactions Involving Alternative Protein Companies

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Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.

Intellectual Property

Agtech

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.What is a CRADA?<a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> are the basis for research collaboration between federal agencies and private sector businesses and organizations. CRADAs are derived from the Stevenson-Wydler Technology Innovation Act of 1980, Public Law 96–480, 94 Stat. 2311 (Oct. 21, 1980), as amended by the Federal Technology Transfer Act of 1986, Public Law 99–502, 100 Stat. 1785 (Oct. 20, 1986) (FTTA). CRADAs are different than grants and procurement contracts in that CRADAs emphasize collaboration between federal laboratories and non-federal parties to undertake joint research as opposed to the transfer of funding.How are rights in inventions developed under CRADAs allocated?The allocation of rights in inventions developed under CRADAs are generally subject to a different and more flexible set of rules (described in 15 U.S.C. § 3710(a)) than those prescribed in the Bayh-Dole Act (35 U.S.C. §§ 200–212), which generally applies to inventions developed with federal government funding under grants and contracts. In contrast, the government generally has wide latitude in negotiating certain aspects of CRADAs, including, in particular, with respect to rights in inventions and subsequent patents related thereto. Overall, the allocations will depend on inventorship: was the invention made in whole or in part by a government employee or solely by a collaborator’s employee?Inventions made by government employee(s) under a CRADAWhere inventions are made either in whole or in part by a government employee (i.e., either government inventions or joint inventions), the government may either assign or license the invention to the collaborator (for reasonable compensation, if appropriate; see 15 U.S.C. § 3710(b)(1)).The collaborator also has the option for an exclusivelicense in a pre-negotiated field of use (see 15 U.S.C. § 3710(b)(1)). Assignments or licenses to the collaborator of government-developed or jointly developed inventions are subject to the government’s retention of a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have it practiced throughout the world by or on behalf of the government. Further, where the government either assigns or grants an exclusive license to the collaborator, the government retains “march-in” rights to force a license to a third party in “exceptional circumstances” (i.e., where necessary to meet health or safety needs or public use requirements) or if collaborator fails to comply with domestic manufacturing requirements, where applicable. Alternatively, if the collaborator has a non-exclusive license, the government could simply give a license to a third party.Inventions made by collaborator’s employee(s) under a CRADAIn contrast, where CRADA inventions are made solely by a collaborator’s employee(s), the collaborator may retain title, but must provide the government with a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced the invention throughout the world for government purposes (see 15 U.S.C. § 3710(b)(2)). While negotiating the terms of the CRADA, the collaborator may want to thoroughly describe all background IP (including any patents) related to the research project and clearly exclude the background IP from the rights scheme that applies to CRADA-subject inventions.USDA CRADA policy and templatesThe USDA Agricultural Research Service (ARS) provides a number of template agreements, including a template CRADA, on its <a href="https://www.ars.usda.gov/ott/templates-agreements/" target="_blank">website</a>.Some CRADA terms are more open to negotiation than others. For instance, collaborators will not be able to negotiate out terms required under the licensing requirements of 35 U.S.C. § 209, which apply to both joint inventions and government inventions licensed by a collaborator and are outlined in Section 7.1 of the USDA template. Under this statute, wholly government inventions and joint inventions (by the government and the collaborator) are treated the same.Key takeawaysOverall, <a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> can offer collaborators potential advantages over competitors by, for example, facilitating confidential access to USDA’s research capacity, license negotiations, and global network of partners, while also helping USDA scientists contribute more directly to economic development and facilitating licensing of USDA technologies. Potential collaborators should be aware that they have some degree of latitude in negotiating CRADAs and should take care to consider the implications of inventorship on title of resulting IP, among other considerations. Our government contracts and IP teams have negotiated CRADAs with USDA in the past and can provide assistance with CRADA negotiations. Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/government-contracts-public-procurement" target="_blank">Government Contracts + Public Procurement</a> or <a href="https://www.mofo.com/capabilities/patent-strategy-prosecution" target="_blank">Patent Strategy + Prosecution</a> teams if you have any questions or if you are interested in learning more about how MoFo could help your company navigate CRADAs with USDA.

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Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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Associate

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.

IP Implications of USDA Research Collaborations

United States

While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new biological targets associated with a particular disease, screening known compounds for new applications and designing new therapeutic compounds, among other applications.In this article, originally published in Law360, we explain the top 10 considerations for AI transactions involving use in drug discovery, which are:<ol><li>Consider the nature of the services being provided.</li><li>Be mindful of IP ownership.</li><li>Consider quality and privacy issues for training data.</li><li>Consider exclusivity.</li><li>Account for infringement risk.</li><li>Be reasonable with royalties.</li><li>Evaluate confidentiality and competitive use.</li><li>Plan for uncertainty.</li><li>Scrutinize contractual risk allocation.</li><li>Beware of an evolving regulatory landscape.</li></ol>For more detail on each of the considerations, read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltc9412c34b10121da/64499b26d57e320df0d8163a/230425-considerations-licensing-ai-drug-discovery.pdf">full article</a>.

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Stephanie assists companies with technology and life sciences transactions, representing both private and public companies, from emerging growth through the Fortune 50. In particular, Stephanie focuses on helping companies that leverage data through technology in structuring their business and commercial transactions.

Stephanie Sharron

Stephanie Sharron is partner in the Palo Alto office and a member of the firm’s Technology Transactions Group. Clients turn to Ms. Sharron for advice on how to leverage data through technology and the related issues that apply to their business models in light of the rapid changes in business, technology and law.

Stephanie Lynn Sharron

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.

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10 Considerations When Licensing AI for Drug Discovery

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While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process.

10 Considerations When Licensing AI for Drug Discovery

Regulatory

China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the “Export Catalogue”) for public consultation (the “Proposed Amendment”). The Proposed Amendment is subject to change but, once finalized, would be another significant revamp after two other major amendments of the Export Catalogue, first in 2008 and then again in 2020. The amended Export Catalogue seeks to introduce “cell cloning and gene editing for human use,” “CRISPR gene editing,” and “synthetic biology” to the control list.China’s biopharmaceutical industry has been facing increased pressure in recent years from various directions, such as practical challenges in access to advanced technologies and certain Chinese companies being placed on the Entity List under the U.S. Export Administration Regulations. In response, China has been strengthening its own export control over China-originated cutting-edge biotechnologies, highlighting concerns over national security and public interest and also the redirected focus on domestic markets.For more information and insights on this topic, read MoFo’s full <a href="https://www2.mofo.com/e/323401/eyes-new-export-controls-email/8tg89/566349410?h=j01MklwE1Klh2BmSQhR6j-jwxYg3CiKXWLJiofJ_190" target="_blank">client alert</a>.<div></div>

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Tyler’s experience encompasses various aspects of transactional and contentious IP matters, including cross-border M&A transactions, technology transfer and licensing, IP and data-driven strategic coo

Tyler Xiu

China Eyes New Export Controls for Life Sciences Technologies