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.

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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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Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated guidelines to add a framework for analysis of antibody patentability. Although not all countries have written guidelines, this framework generally aligns with standards in other countries.New sections 8.192-8.193 were introduced to the <a href="https://www.ipos.gov.sg/docs/default-source/resources-library/patents/guidelines-and-useful-information/examination-guidelines-for-patent-applications.pdf" target="_blank" dir="ltr">Examination Guidelines</a> by the Intellectual Property Office of Singapore (IPOS) and set out an examination framework for assessing novelty and inventive step of antibody inventions. In particular, the guidance states that “for an antibody binding the same antigen as known antibodies, inventive step is not acknowledged based solely on its characterization by its CDR sequences.” Instead, the IPOS guidelines require that the specific amino acid sequence of an antibody must impart an additional surprising property compared to known antibodies binding the same antigen for it to be non-obvious. Description in the specification of a surprising technical effect associated with the claimed antibody is helpful to finding an antibody sequence inventive.The new guidelines issued in Singapore reflects a trend seen in other jurisdictions.In the United States, although there is no specific issued guidance for consistent examination of antibody claims, some examiners find claims obvious if the only difference from the prior art is the sequence, in which case data showing a superior activity may be helpful. Other examiners may consider sequence difference sufficient to confer non-obviousness. In contrast to the lack of standards for assessing non‑obviousness of antibodies in the United States, there is a more consistent and higher standard for written support for antibodies, making it challenging to obtain claims broader than exact sequences. For instance, claiming sequence identity (for example, to CDRs or the variable regions) is unlikely to be patentable unless the application discloses a sufficient number of examples that can support the breadth of the claims.To establish inventive step of novel antibody sequences, the European Patent Office (EPO) requires a surprising technical effect is shown by the application, or that there is no reasonable expectation of success of obtaining antibodies having the required properties (Section G-II.5.6.2 of Guidelines for Examination). In contrast to the United States, standards for establishing support for antibody claims are generally not as strict at the EPO. Nevertheless, it is generally required to define the antibodies by reference to the CDRs, but often examiners will also ask for full variable sequences to be included (e.g., if binding affinity is the technical effect).In China, the applicant needs to show that the claimed antibody has beneficial technical effects (rather than unexpected technical effects) compared to the known antibody. This may mean that it is not necessarily required to show that there is a special technical effect (e.g., binding affinity) and/or to have comparative data over the known antibody. Regarding the level of disclosure required for obtaining a genus claim, an antibody claim is required to be defined by at least the sequences of the six CDRs of the antibody. It is difficult to obtain a genus claim (e.g., antibodies defined by an epitope or only some CDRs of the heavy chain and/or light chain), and it is nearly impossible to obtain functional claims that are not limited to specific antibody sequences.Similar to all the jurisdictions above, applicants in Japan can rely on unexpected superior properties to overcome an obviousness rejection. Such unexpected superior property can be shown by the demonstrative data in the application as filed. The written description and enablement requirements in Japan generally align with those in the United States and China, in that a sufficient number of embodiments needs to be described in order to pursue a genus claim. Notably, the presence of any negative data in an application in Japan can evidence inoperative embodiments and—if such is within the scope of the claim—may also limit the ability to claim a broad genus.While the standard to inventiveness and written support for antibodies vary across jurisdictions, the trend toward tightening patentability standards is clear, making it even more important to have data characterizing the antibody of interest in the specification. The data in the specification can do double duty—providing both fodder for inventive step (especially if data comparing to the prior art are available) and evidence to support enablement and written description.

Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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. 

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Scientific Analyst

Dr. Paige Zhang focuses on patent preparation and prosecution, with an emphasis on cellular and molecular biology, antibody therapeutics, and gene therapy.
Prior to joining the firm, Paige was a Life 

Paige Zhang Ph.D.

Paige Zhang

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Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

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Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents.

In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. This is especially true in the life sciences, where data can be imperative for securing a patent but difficult to obtain as a result of long development cycles, clinical trial periods, and financial limitations. The submission of post-filing-date data can be a mechanism by which additional evidence in support of patentability can be provided once prosecution has begun.The United States Patent Office (USPTO) has long allowed post-filing-date data in the form of an affidavit or declaration to provide objective evidence to demonstrate non-obviousness (e.g., by showing unexpected results) or for establishing enablement. To be accepted, the presented data must be commensurate in scope with the claims sought to be patented. For a showing of enablement, the objective evidence also must be consistent with the supporting teachings of the specification.Last week, the European Patent Office confirmed that post-published evidence may be used to support a technical effect in the assessment of inventive step in the <a href="https://documents.epo.org/projects/babylon/eponet.nsf/0/C620B61029205275C125897B002BEDCF/$File/G2_21_Decision_%20of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf" target="_blank">decision of the Enlarged Board of Appeal in G 2/21</a>. The decision states that evidence submitted to prove the technical effect may not be disregarded solely because it had not been public before the filing date. However, for post-published data to be considered to establish inventive step, the skilled person must be able to derive the technical effect as being encompassed by the teaching and embodied by the originally disclosed invention.Recent guidelines implemented by the Chinese National Intellectual Property Administration (CNIPA) in January 2021 also allow post-filing data to be considered in support of both inventive step and sufficiency of disclosure, if the technical effect to be proved by the supplementary data is obtainable by the disclosure of the specification. The Japan Patent Office’s Examination Guidelines also permit submission of post-filing data of experimental results to address inventive step, enablement, and written description, but such data may not be a substitute for the detailed description of the invention. Accordingly, in our experience, post-filing data in Japan is allowed as evidence if it supports and reinforces data already present in the originally filed specification.While jurisdictions differ on whether and how post-filing data can be considered, data generated after filing may still be submitted in some cases when it is not possible to include at filing. However, to increase the likelihood that post-filing data will be considered, applicants should ensure that their patent specification includes teachings that provide a nexus between the claimed subject matter and the technical effect achieved. While this may not always require actual working examples, at least some in vitro data may be required and—for the case of therapeutic methods—in vivo animal model data may be necessary or helpful.

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Patent Agent

Dr. Elizabeth (Liz) Newman focuses her work on patent  drafting and assisting prosecution. She also has experience in IP due diligence  inquiries, including freedom-to-operate analyses, with an emphas

Liz Newman Ph.D.

Liz Newman

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Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

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In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. 

Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

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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Of Counsel

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

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Gordon is a partner whose practice focuses on advising clients about intellectual property, licensing, outsourcing, and technology transactions.
He has advised clients in the IT, telecommunications, f