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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Partner

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

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. 

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

Transforming the U.S. Healthcare Industry with Blockchain Technology

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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.

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

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.

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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>

Associate

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

Bu Yin

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

Gordon A. Milner

Gordon Milner

Managing Partner, Shanghai

Chuan focuses his practice on cross-border M&A transactions; sophisticated technology, media, and telecom (TMT) transactions; and complex IP/commercial matters across Greater China.

Chuan Sun

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceu

Janet Xiao Ph.D.

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world.

Janet Xiao

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China Eyes New Export Controls for Life Sciences Technologies

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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”). 

China Eyes New Export Controls for Life Sciences Technologies

The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes and was found to be infringing the intellectual property (IP) rights held by Grapa Varieties Ltd. The case against the farm owner was won by Grapa, which specializes in breeding and licensing premium table grape varieties under the ARRA™ and Early Sweet™ brands. The particular IP right at issue was a plant breeders’ right (PBR) owned by Grapa.PBRs are similar to other forms of IP, such as patents, but are a sui generis form of IP protection available in many countries specifically for plant varieties. Egypt introduced its national plant variety protection system in 2002 under Law 82. Although negotiations regarding an association agreement for Egypt to be considered for membership in the International Union for the Protection of New Varieties of Plants (UPOV) began in 1995, Egypt did not accede to UPOV until 2019, after establishing compliance with the 1991 revised version of the UPOV Convention.  Grapa Varieties Ltd. previously dealt with illegal grape exports into Europe in June 2021 when illegally exported grapes were <a href="https://grapaes.com/the-power-of-enforcement/?utm_source=rss&utm_medium=rss&utm_campaign=the-power-of-enforcement">seized in a port and destroyed</a>. However, the new removal order is the first instance when enforcement has protected the PBRs at the origin of the fruit inside Egypt. The Beni Suef Economic Court ruling thus reflects a significant expansion in the industry protection of PBRs in Egypt, and comes as part of a wider crackdown on illegal fruit exports. This crackdown has been assisted by a decree issued last year by Egypt’s Minister of Agriculture, H.E. El-Sayed El-Quseir, which requires all farms to be registered and assessed before gaining the right to export. Infringements, such as from the propagation, sale, display, or export of the variety without a license, now result in a fine and the possibility of a custodial sentence.The order from the Beni Suef Economic Court demonstrates the commitment of Egypt’s phytosanitary authorities to protect the rights of plant breeders and their legitimate licensees within the country. The outcome of this case is likely to resonate throughout the export industry, as repeated incidents of export seizures incur significant financial losses for exporters, and negatively impact Egypt’s international reputation in the agricultural sector. Given that Egypt exports around 150,000 tonnes of grapes a year and has cornered the market as the world’s largest exporter of fresh oranges, relying on seizures at the export stage to protect plant IP would be worrying and expensive. The protection afforded through PBRs within Egypt is thus instrumental in ensuring that the IP holder does not experience a loss in revenue caused by illegal production and importation. <a href="https://grapaes.com/illegal-early-sweet-grapes-uprooted-in-egypt/">Sources</a> believe the citrus market is next in line for the IP shake-up.The <a href="https://www.freshfruitportal.com/news/2022/07/13/grapa-wins-legal-case-against-illegal-planting-in-egypt/">well-publicized protection</a> of Grapa’s PBRs by the Court will boost breeders’ confidence that pursuing illegal plantations, nurseries, and exporters in Egypt is not only achievable, but is expected of the phytosanitary authorities. This will have the additional benefit of strengthening Egypt’s image in international markets, thus improving Egypt’s ability to access new protected plants and create a healthy climate for breeders to invest in Egypt.

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

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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

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes and was found to be infringing the intellectual property (IP) rights held by Grapa Varieties Ltd. The case against the farm owner was won by Grapa, which specializes in breeding and licensing premium table grape varieties under the ARRA™ and Early Sweet™ brands. The particular IP right at issue was a plant breeders’ right (PBR) owned by Grapa.

Liz Freeman Rosenzweig co-authored an article for China IPR examining China's new and much anticipated Seed Law, which went into effect on March 1, 2022."The new Seed Law reflects a significant expansion in the scope of plant breeders' rights (PRB) protection in China," Liz wrote. "PBRs are a sui generis form of intellectual property protection available in many countries for plant varieties, similar to but distinct from patents or other forms of IP."She added: "The first major change in the Seed Law is the introduction of EDVs [essentially derived varieties], which are required to be protected by China if/when it accedes to UPOV '91, the latest UPOV Convention. As China is currently a member of UPOV '78, the inclusion of EDVs is a major step in the direction of accession. Hinting strongly at exactly that, the definition of EDVs in the new Seed Law closely mirrors UPOV's definitions. This is a positive departure from the Draft PVP Regulations, which were the first to formally float the idea of EDVs into the Chinese PVP system, but did not precisely use UPOV's definition."Read the <a href="https://chinaipr.com/2022/05/09/chinas-new-seed-law-molecular-varieties-and-macro-developments/" target="_blank">full article</a>.

China’s New Seed Law: Molecular Varieties and Macro Developments

Liz Freeman Rosenzweig co-authored an article for China IPR examining China's new and much anticipated Seed Law, which went into effect on March 1, 2022.
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China’s New Seed Law: Molecular Varieties and Macro Developments

On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the Catalog has been revised in 12 years.The amendment of the Catalog as related to certain high-tech industries has attracted much media attention, particularly to the restriction on the export of drone technologies, certain information-processing technologies for artificial intelligence interactive interface and individualized information push services based on data analysis, and technologies related to password security and information defense and countermeasures. This article, however, will focus on the revisions related to the Life Sciences industry, after a brief introduction to China’s technology export regulations.Technology export from China is governed by China’s Technology Import and Export Regulations (TIER). The scope of technology export regulated by TIER is very broad, and includes all acts of technology transfer from within China to outside China, whether by way of trade, investment, or economic and technological cooperation. Specifically, TIER regulates outbound assignments of patents and patent applications, patent licenses, transfers of technological secrets, provision of technological services, and other forms of outbound cross-border technology transfers. TIER categorizes technology exports into three categories: technologies that may be “freely” exported (the “Free Technologies”), technologies the export of which is restricted (the “Restricted Technologies”), and technologies the export of which is prohibited (the “Prohibited Technologies”). The Catalog, jointly promulgated by MOFCOM and MOST, includes the lists of the Restricted Technologies and the Prohibited Technologies. Under TIER, export of the Prohibited Technologies is prohibited, export of the Restricted Technologies is subject to MOFCOM’s prior approval, and the regulatory requirement for the export of the Free Technologies is the after-the-fact registration of the relevant technology export contract, which shall become effective according to its own terms and not conditioned on the registration.MOFCOM’s approval of export of the Restricted Technologies is generally a two-step process before provincial-level branches of MOFCOM (“Local Commerce”). After it receives an application for approval of the export of a Restricted Technology, Local Commerce will conduct a review of the Restricted Technology together with other applicable governmental agencies, e.g., the local branch of China Intellectual Property Administration, the local branch of MOST, the Ministry of Agriculture and Rural Affairs, or the National Forestry and Grassland Administration, depending on the nature of the Restricted Technology. Such review may take up to 30 business days before an approval or disapproval decision can be made. The approval is not the final approval of the technology export, but will be a Provisional License for Technology Export (the “Provisional License”). The technology export applicant may not engage in any substantive negotiation of the technology export or sign any technology export contract until after the issuance of the Provisional License. After the technology export contract is signed, the applicant must apply for the final Technology Export License by submitting to Local Commerce the Provisional License, a copy of the technology export contract, a list of the Restricted Technologies to be exported under the contract, and documents evidencing the legal status of the contracting parties. Local Commerce will conduct an authenticity review of the technology export contract, and will make a decision on whether to approve the technology export within 15 business days after receiving the required documents. The approval decision will be in the form of a Technology Export License. It is worth noting that, regardless of any effective date set forth in a technology export contract, with respect to any Restricted Technology, the contract is effective only upon the issuance of the Technology Export License.As a result of the adjustment of the Catalog, the following Life Sciences-related technologies (categorized into different industries) have been deleted from the Catalog, meaning that their export is no longer prohibited or restricted but will only be subject to after-the-fact registration of the relevant technology export contract:<ul><li>Medicine manufacturing industry <ul><li>Caffeine manufacturing technology using chemical synthesis or semisynthesis</li><li>Riboflavin (VB2) manufacturing techniques</li><li>Chemical synthetic or semisynthetic drug manufacturing technology</li><li>Biotechnology for the manufacturing of penicillin, streptomycin, cephalosporin C, or aureomycin</li><li>Thrombin-like snake venom single-component preparation techniques</li><li>Natural medicine manufacturing technology</li><li>Preparation and processing technologies for functional polymer materials with biological activities</li></ul></li><li>Professional device manufacturing industry <ul><li>Enzyme-labeled monoclonal antibody preparation technology</li></ul></li></ul>The following Life Sciences-related technologies (categorized into different industries) have been added to the Catalog as Restricted Technologies, meaning that their export will be subject to the approval process described earlier in this article:<ul><li>Agriculture <ul><li>Crop (including forage grass) seed resources and their propagation technology, particularly those on the Catalog for the Classification of Crop Seed Resources for Export</li><li>Artificial propagation technology for agricultural wild plants, particularly those listed in the Catalog of Wild Plants Subject to Special State Protection and the Convention on International Trade in Endangered Species of Wild Fauna and Flora</li><li>Genetic engineering (genes and vectors) <ul><li>Newly discovered plant male sterile genes, restoration genes and vectors</li><li>Newly discovered disease- or pest-resistant genes and vectors</li><li>Newly discovered stress-resistant genes and vectors</li><li>Newly discovered quality genes and vectors</li><li>Newly discovered yield-related genes and vectors</li><li>Other newly discovered important genes and vectors</li><li>Unique gene manipulation technology</li></ul></li></ul></li><li>Medicine manufacturing industry <ul><li>All bacterial and viral strains that are obtained using genetic engineering and can be industrially produced, and their culturing technology (this has been an expansion from a limited number of strains specifically identified in the previous version of the Catalog)</li><li>Inactivated vaccine for enterovirus 71 (EV71)</li><li>Rotavirus oral live vaccine</li><li>Viral strains for EV71 vaccine</li><li>Viral strains for CA16 vaccine</li><li>Core techniques and technology for pentavalent and hexavalent rotavirus vaccine production</li><li>Polysaccharide-protein binding technology</li><li>Medical diagnostic devices and equipment manufacturing technology (including domestically made next-generation gene analyzers and third-generation single-molecule sequencers)</li></ul></li></ul>When responding to questions from the press, MOFCOM suggested that the latest amendment to the Catalog was intended to simplify the Catalog. This intention was not clearly reflected in the revisions related to the Life Sciences industry, however. As summarized above, MOFCOM seems to have added an equal or greater number of technologies related to the Life Sciences industry to the Catalog compared to the number deleted. Some of the newly added Restricted Technologies, such as “newly discovered important [plant] genes and vectors,” “bacterial and viral strains obtained using genetic engineering and which can be industrially produced,” and “medical diagnostic devices and equipment manufacturing technology,” appear to have been very broadly defined. MOFCOM also announced that it will further simplify the Catalog in the near future, and whether there will be more deletions from than additions to the Catalog of Life Sciences-related technologies in the next round of amendment to the Catalog remains to be seen.Corresponding to the export Catalog, China also has a Catalog of Technologies the Import of Which is Prohibited or Restricted. MOFCOM further announced that it will significantly simplify that catalog in the near future. For more information on China’s technology import regulations, please refer to the author’s article <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltab5f0746dbcea5cc/627317778e09542a15b7deef/191200-crossing-borders.pdf" target="_blank">here</a>.

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China Technology Export Update: Amendment of The Export Technology Catalog

China Patent Eligibility Update: Human Embryonic Stem Cells

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On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s 

China Technology Export Update: Amendment of The Export Technology Catalog

On July 3, 2020, China’s National People’s Congress published the second draft of the latest amendment to China’s Patent Law (the “Draft Amendment”) for public comments, which were allowed to be submitted by August 16, 2020.  The Draft Amendment included proposed revisions to 19 articles from the first draft of the amendment published in 2019, and revisions to more than 30 articles in the current Patent Law.  Of significant interest to the Life Sciences industry among these revisions was the introduction for the first time of patent linkage provisions to the Patent Law (the “Patent Linkage Provisions”).  Below is a brief summary of the key Patent Linkage Provisions:<ul><li>Where a patentee or an interested party believes that a drug that is the subject of a generic drug registration application (the “Generic Application”) falls within the scope of the relevant patent published on China’s approved drug patent information registration platform (the “Platform”), the patentee or the interested party may file a lawsuit before a People’s Court or apply for an administrative ruling by China National Intellectual Property Administration (CNIPA) within thirty days after the date of publication of the Generic Application by China’s National Medical Products Administration (NMPA).</li></ul><ul><li>If the patentee or the interested party fails to file the lawsuit or apply for the administrative ruling within the time limit, the generic drug registration applicant (the “Generic Applicant”) may petition that a People’s Court or CNIPA confirm that the drug does not fall within the scope of the relevant patent.</li></ul><ul><li>If the People’s Court or CNIPA issues an effective adjudication or ruling within nine months after accepting the filing by the patentee or the interested party, with respect to a chemical drug’s Generic Application that has passed technical evaluation, NMPA may decide whether to grant approval of the Generic Application based on such adjudication or ruling.</li></ul>The legislative bases for the Patent Linkage Provisions were two opinions jointly issued by the General Office of the Chinese Communist Party Central Committee and the General Office of the State Council: the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices, issued in October 2017, which provided that “a system linking drug evaluation and approval with drug patents shall be explored and established to protect the lawful rights and interests of patentees, reduce the risks of patent infringement by generic drugs, and encourage the development of generic drugs” (the “First Opinions”), and the Opinions on the Strengthening of Intellectual Property Protection, issued in November 2019 (the “Second Opinions”).  The most recent push for the legislative development has been attributed to the signing of the Economic and Trade Agreement Between the Government of the People’s Republic of China and the Government of the United States of America on January 15, 2020.The Patent Linkage Provisions have provided a procedural framework and have set the stage for NMPA and CNIPA to work together and jointly promulgate detailed regulations that are intended to address many questions left unanswered by the Patent Linkage Provisions.  In its April 2020 plan for the advancement of implementation of the Second Opinions, CNIPA set a goal to “establish an early dispute resolution mechanism for drug patents” by the end of October 2020.  Since then, NMPA and CNIPA have had many discussions with legal experts and experts in the fields of patent and drug administrations, and industrial representatives and associations, resulting in the publication for public comments on September 11, 2020 of the draft Trial Implementing Methods for Early Resolution of Drug Patent Disputes (the “Draft Methods”).  Public comments on the Draft Methods are allowed to be submitted by October 25, 2020.This article will analyze the Patent Linkage Provisions in light of the Draft Methods, focusing on questions left unanswered by the Patent Linkage Provisions and how those questions may have been addressed by the Draft Methods.<h4>Constructive notice to patentee and requirements of patentee to take advantage of the constructive notice</h4>The Patent Linkage Provisions are silent on the obligation of the Generic Applicant to notify the patentee of the branded drug.  Both the First Opinions and the Relevant Policies on Encouraging Drug and Medical Device Innovation and Protecting Innovators’ Rights (Draft for Public Comments), published by NMPA’s predecessor on May 12, 2017 (the “Policies”) have placed the burden on the Generic Applicant to notify the patentee of the Generic Application.  The Policies further required the Generic Applicant to declare that the subject drug of the Generic Application does not infringe the patentee’s patent.  The Generic Application and the Generic Applicant’s declaration would constitute constructive notice to the patentee, but whether the patentee can take advantage of such constructive notice would heavily depend on how much information is included in such constructive notice. The Draft Methods are consistent with the constructive notice mechanism, and have confirmed that the constructive notice will be in the form of declarations by the Generic Applicants.  Specifically, the Draft Methods require the Generic Applicant to submit, together with the Generic Application, a declaration with respect to each relevant branded drug patent registered on the Platform.  Both the Generic Application and the corresponding declaration(s) will be published by NMPA.  The declaration may be in one of four types:<ul><li>That the Platform does not include any relevant branded drug patent information;</li></ul><ul><li>That the relevant branded drug patent registered on the Platform has expired or has been declared invalid;</li></ul><ul><li>That the Platform includes relevant branded drug patent, and the Generic Applicant promises not to market the generic drug prior to the expiration of the patent; or</li></ul><ul><li>That the relevant branded drug patent registered on the Platform should be declared invalid, or the generic drug does not fall within the scope of the patent.</li></ul>The Generic Applicant is not obligated to make any declaration with respect to a branded drug patent that is not registered on the Platform, and the Draft Methods have made it clear that the early dispute resolution mechanism does not apply to patents not listed on the Platform.  Therefore, in order to take advantage of the constructive notice and the early dispute resolution mechanism offered by the Draft Methods, an obvious task for the branded drug patentees/branded drug registration applicants is to register the relevant branded drug patents on the Platform.  The Draft Methods have provided detailed requirements on the timing of the registration (at the time the branded drug registration application (the “Branded Application”) is submitted, within 30 days after publication of the issuance of the patent during the pendency of the Branded Application, or within 30 days after information on a patent registered on the Platform is changed), and the types of drug patents that are registrable on the Platform.  Specifically, (i) chemical drug patents registrable on the Platform include patents directed to active pharmaceutical ingredient (API) compounds, compositions comprising APIs, and their medical uses, (ii) biologics patents registrable on the Platform include patents directed to the sequences or structures of the biologics, and (iii) traditional Chinese medicine (TCM) patents registrable on the Platform include patents directed to TCM compositions, TCM extracts, and their medical uses.  Branded drug registration applicants or patent owners are obviously encouraged to register as many registrable patents on the Platform as possible, so that they may be included in the Generic Applicants’ declarations that constitute constructive notice to the patentees and serve as basis for the patentees to file a lawsuit or apply for an administrative ruling against the Generic Applicant.<h4>30-day time limit and its preclusive effect?</h4>The legal significance of the 30-day time limit provided by the Patent Linkage Provisions remains to be clarified.  For example, will the patentee be precluded from filing patent infringement lawsuit against the Generic Applicant later during the pendency of the Generic Application in the event the patentee fails to file the lawsuit or initiate the administrative proceeding against the Generic Applicant within the 30-day time limit?  Will the fact that the Generic Applicant petitions or fails to petition that the Court or CNIPA confirm that the generic drug does not fall within the scope of the relevant patent make a difference in any potential preclusive effect?The Draft Methods extended the 30-day time limit set forth in the Patent Linkage Provisions to 45 days, a discrepancy that will ultimately need to be resolved, and clarified that in the event the patentee or the interested party fails to file the lawsuit or initiate the administrative proceeding within the 45-day time limit, NMPA can make a decision whether to approve the Generic Application based directly on the conclusion of the technical evaluation and the Generic Applicant’s declaration(s).  This does not answer the preclusive questions discussed above.  In addition, the Draft Methods require that the patentee or interested party submit to NMPA the notice of acceptance of the lawsuit or the administrative proceeding within 10 days after such notice is issued by the People’s Court or CNIPA, respectively, but do not spell out any consequences of failure to submit the notice within the 10-day time limit.<h4>CNIPA’s role in resolving patent disputes</h4>The Patent Linkage Provisions provide that the patentee may file an infringement lawsuit against a Generic Applicant or seek an administrative ruling on the same issue by CNIPA and, failing that, the Generic Applicant may petition the Court or CNIPA to confirm that the generic drug does not fall within the scope of the relevant patent.  These provisions seem to empower CNIPA to both adjudicate infringement and declare non-infringement to the same extent a People’s Court is empowered to do.  This seems to be an unorthodox legislative move.  The issue of empowerment aside, CNIPA proceedings do not necessarily take a shorter time than Court proceedings, and the Patent Linkage Provisions will inevitably prolong the entire adjudication process in the event CNIPA’s rulings are appealed to the Courts, which often occurs.  It is worth noting that under the Policies, filing for a CNIPA ruling of infringement upon notice of a Generic Application and the Generic Applicant’s non-infringement declaration is not an option.In addition, the Patent Linkage Provisions are silent on CNIPA’s established jurisdiction over the validity of issued patents.  It is unclear whether the Generic Applicant’s right to petition that a People’s Court or CNIPA confirm that the drug does not fall within the scope of the relevant patent includes the right to seek invalidation of the relevant patent or is limited to seeking a declaration of non-infringement.According to the Draft Methods, one of the outcomes of the Court or CNIPA proceeding initiated by the patentee or the interested party is the invalidation of the relevant patent.  It appears that the Draft Methods have already contemplated a prolonged battle, perhaps in multiple venues, between the patentee and the Generic Applicant, such that a proceeding by which the patentee seeks to enforce its patent rights may ultimately result in the invalidation of the patent.<h4>Waiting period and NMPA’s role</h4>According to the Patent Linkage Provisions, NMPA may decide whether to approve a chemical drug’s Generic Application based on the People’s Court’s adjudication over the patentee’s filing of the infringement lawsuit or CNIPA’s ruling in the administrative proceeding.  Such provisions appear to be an attempt to regulate NMPA’s conduct by way of the Patent Law, and are inconsistent with the Policies, which provided that NMPA could prescribe an approval waiting period of up to 24 months after receiving proof of the filing of the patent infringement lawsuit.  It is impractical to expect the People’s Court or CNIPA to render any enforceable adjudication or ruling of infringement or non-infringement within nine months, so an obvious question is: What if no adjudication or ruling is made within the nine-month waiting period?  In addition, the Patent Linkage Provisions are silent on whether the technical evaluation of the generic drug will be suspended during the nine-month waiting period.  The Policies are clearer and consistent with the Opinions in both aspects, providing that NMPA may approve the Generic Application in the event the People’s Court fails to find infringement within the 24-month waiting period, and that NMPA will not suspend the technical evaluation during such period.  It is also interesting to note that the 9-month waiting period apparently only applies to chemical drugs, and the Patent Linkage Provisions are silent on how long a waiting period, if any, is applicable to biologics.The Draft Methods have maintained the 9-month waiting period for chemical generic drugs, starting from the date the People’s Court or CNIPA accepts the lawsuit or the administrative proceeding, respectively, and clarified that technical evaluation of the chemical generic drug is not suspended during the 9-month period.  The Draft Methods obligate the patentee or interested party to submit the adjudication of the Court or the ruling of CNIPA to NMPA within 10 days after receipt of the adjudication or ruling.  In the event the adjudication or ruling is that the Generic Application falls within the scope of the relevant patent, NMPA will suspend the administrative approval process of the chemical drug’s Generic Application until 20 business days prior to the expiration of the relevant patent.  In the event the adjudication or ruling is that the Generic Application does not fall within the scope of the relevant patent or that the parties settle, or the relevant patent has been declared invalid, the Generic Application will continue its administrative approval process.  The Draft Methods also clarified that in the event the Court or CNIPA has not made a valid adjudication or ruling and the parties have not settled, the chemical drug’s Generic Application will continue its administrative approval process.  However, if later during the pendency of the Generic Application an adjudication or ruling is made that the Generic Application falls within the scope of the relevant patent, the administrative approval process will be suspended as if the ruling was made within the 9-month waiting period.  Any suspension of the administrative approval process, whether within or after the 9-month waiting period, may be lifted in the event the original Court adjudication or CNIPA ruling has been overruled by a final Court order.It is worth noting that the Draft Methods have provided no waiting period for the Generic Applications of biologics and “same name, same prescription” TCMs, and state that NMPA can make its approval directly based on the conclusion of the technical evaluation.  In the event a patentee or interested party initiates a Court or CNIPA proceeding, the adjudication or ruling from such proceeding is that the biologic or TCM Generic Application falls within the scope of the relevant patent, and the adjudication or ruling is made during the pendency of the Generic Application, NMPA will require as part of its marketing approval (assuming technical evaluation has been passed) that the biologic or TCM may be marketed only after the expiration of the relevant patent.<h4>Other noteworthy provisions of the Draft Methods in favor of Generic Applicants</h4>According to Articles 9 and 10 of the Draft Methods, the patentee/interested party’s right to initiate a Court or CNIPA proceeding seems to be limited to the circumstance where the Generic Applicant has submitted a declaration that the relevant branded drug patent registered on the Platform should be declared invalid, or the generic drug does not fall within the scope of the patent, i.e., the fourth type of declaration discussed above, and in the event a declaration of the first or the second types is submitted by the Generic Applicant, the corresponding Generic Application will go through the regular administrative approval process and be approved based on the conclusion of the technical evaluation.  This apparently prejudices against the patentee because it is possible that a declaration of the first or the second types is submitted by the Generic Applicant negligently, and the Draft Methods only seek to punish against intentionally fraudulent declarations filed by the Generic Applicant, where the punishment is the prohibition for one year of submitting the same type of Generic Application and not any remedy to the patentee.  In the event a patentee thinks that a generic drug infringes its relevant patent right after the generic drug has received marketing authorization, the patentee may still file infringement lawsuit.  The marketing authorization will not be revoked by NMPA, however, and its validity is not affected by the infringement lawsuit.The Draft Methods incentivize the first approved generic drug that has successfully challenged a branded drug patent by giving the generic drug a 12-month market exclusivity period since its approval, during which time NMPA will not approve the marketing of any generic drug of the same type, provided that the period of market exclusivity does not go beyond the challenged patent’s expiration date.  NMPA will not suspend the technical evaluation of other Generic Applications of the same type as the generic drug during its market exclusivity period, but will suspend the administrative approval process of the other Generic Applications until 20 business days before the expiration of the market exclusivity period.With the proposed codification of the Patent Linkage Provisions into the Patent Law and the proposed rulemaking by NMPA and CNIPA, China’s patent linkage legislation is moving full steam ahead.  The Supreme People’s Court also hopes to issue its judicial interpretation on trials involving drug patent linkage issues by the end of 2020, hopefully further addressing questions left unanswered by the Patent Linkage Provisions and the Draft Methods.  China’s patent linkage legislation and rulemaking are happening at multiple governmental branches, and certainly worthy of close monitoring and careful analysis.

China Patent Linkage Update: Codification and Rulemaking

On July 3, 2020, China’s National People’s Congress published the second draft of the latest amendment to China’s Patent Law (the “Draft Amendment”) for public 

China Patent Linkage Update: Codification and Rulemaking

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic Resources Regulations (the “Regulations”) and its draft Biosecurity Law, and sends a strong signal that China’s legislature is determined to strengthen the penalties and punishments for the protection of China’s biosecurity. The Draft has been published for public comments, which may be submitted by August 16, 2020.China’s current Criminal Law includes a number of crimes for violation of other laws and aimed for the prevention and control of infectious diseases and bioterrorism, e.g., certain crimes in violation of China’s Law on Prevention and Treatment of Infectious Diseases and causing the spread of, or a serious risk of spreading, a Category A infectious disease determined by that law, crimes for causing the spread of bacterial or viral agents for infectious diseases resulting in serious consequences, and crimes for violating health and quarantine regulations at the national border. The current Criminal Law also includes a number of crimes aimed at the prevention and control of biological invasions and for biological resource conservation, e.g., crimes for violation of certain national regulations on animal and plant epidemic prevention and quarantine. The current Criminal Law, however, lacks provisions on misuse of biotechnology, illegal use of human genetic resources (HGR), and other acts resulting in the destruction of ecological environment or biological resources. This is in part due to the slow legislation in other areas of law, because the Criminal Law, in the context of biosecurity, rather than defining crimes from scratch, typically provides for penalties and punishments against serious violations of other laws or regulations. The legislative progress in China’s Biosecurity Law provides the motivation for speeding up the corresponding legislative update to China’s Criminal Law.The Draft proposed to add the following provisions to the crimes in connection with the collection and supply of blood and the production and supply of blood products:Any person committing any of the following acts, in violation of relevant State regulations and endangering public health or social public interest, shall be sentenced to, in cases of serious circumstances, not more than 3 years of fixed-term imprisonment or criminal detention or control, and/or a fine, and, in cases of especially serious circumstances, imprisonment of not less than 3 years but not more than 7 years, and a fine: (i) illegally collecting China’s human genetic resources; (ii) illegally transporting, mailing or carrying China’s human genetic resources materials abroad; and (iii) supplying or providing open access to China’s human genetic resources information to foreign organizations or individuals or institutions established or actually controlled thereby.Although proposed to be added to the existing provisions related to blood and blood products, the new provisions related to HGR have far broader implications than curbing mishandling of blood products. Human genetic resources, as defined in the Regulations and the draft Biosecurity Law, include not only HGR materials, of which blood is but one example, but also the data and other information generated from the utilization of those materials, which is broad enough to cover medical images and laboratory test results. Both the Regulations and the draft Biosecurity Law, which is intended to codify significant portions of the Regulations, prohibit foreign organizations and individuals and institutions established or actually controlled thereby (collectively, “Foreign Persons”) from collecting or preserving China’s HGR within China, or providing China’s HGR abroad. Therefore, Foreign Persons are subject to the punishments provided for in items (i) and (ii) of the newly proposed HGR-related Criminal Law provisions.The Draft also includes punishments of up to seven years of imprisonment and a fine against the implant of genetically edited embryos or cloned embryos into humans or animals in violation of relevant State regulations, as crimes of illegal medical practice. This is an obvious countermeasure taken by the legislators in light of the gene-edited babies scandal that broke out in China in 2018.The inclusion of HGR-related crimes in the Draft is hardly surprising. Both the Regulations and the draft Biosecurity Law state that any violation thereof that constitutes a crime shall be prosecuted according to the law, and in the absence of the corresponding crimes in the Criminal Law, those provisions have so far been toothless when it comes to HGR. Foreign Persons should pay special attention to the Criminal Law’s legislative progress, because in addition to the economic consequences that they may have to bear for violating the Regulations and the Biosecurity Law, they may face criminal prosecution for the same violations in the event the circumstances are serious, which the courts in China will have considerable discretion to determine when imposing sentences.For a summary and analysis of the Regulations, please refer to this <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html" target="_blank">author’s article</a>, and for a summary and analysis of select provisions of the draft Biosecurity Law, please refer to this <a href="https://lifesciences.mofo.com/topics/Chinas-Biosecurity-Law-will-cover-Human-Genetic-Resources.html" target="_blank">author’s article</a>.

China to Criminalize Human Genetic Resources Violations

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for r

China to Criminalize Human Genetic Resources Violations

During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for public comments, which may be submitted by June 13, 2020.The draft Biosecurity Law was first brought to the Standing Committee’s review in October 2019. As a comprehensive and ambitious set of laws covering multiple areas under the overarching name “biosecurity,” the draft legislation was an attempt to address the absence of legal punishments against biotechnology misuses in China in recent years, an infamous example of which is the gene-edited babies scandal that broke out in late 2018.The Draft covers the following major areas: the establishment of a biosecurity risk prevention and control system, the prevention and control of major new or sudden infectious diseases or animal or plant epidemics, the security of biotechnology R&D and application, laboratory biosecurity, the security of human genetic resources (HGR) and biological resources, countermeasures against the threat of bioterrorism and biological weapons, the buildup of biosecurity capabilities, and the legal liability in the event of violation of relevant provisions of the Biosecurity Law. This article will summarize and analyze certain provisions in the Draft applicable to, and their potential impact on, foreign entities and individuals.The broad scope of the Draft can first be seen by the vague definition it has ascribed to “biosecurity,” which includes the following “capabilities” of the State: to effectively respond to threats from animals, plants, microorganisms, biotoxins, and other bioactive substances (collectively, “Biological Factors”) and relevant elements, to maintain stable and sound development of the biological field and a danger-free and threat-free status, and to guarantee sustainable development and security. Because of such vagueness, and because the Draft prohibits any individual and any entity from harming State biosecurity, the potential scope of violation of the Biosecurity Law appears extremely broad.Biosecurity risk prevention and control system            According to the Draft, China will implement a unified system to issue biosecurity information. The biosecurity information that is considered to be “necessary to be uniformly released” must be issued at the State level or at the local government level as necessary and authorized by the State. No unauthorized entity or individual may issue such information. This prohibition potentially covers the publication of research articles that includes biosecurity information, e.g., the sequence of a newly discovered virus with the potential to cause an epidemic.            As part of the biosecurity risk prevention and control system, China will publish and amend from time to time State directories and lists of entry and exit items related to biosecurity, which will be used by China Customs. The Draft gives Customs a wide latitude of authority related to biosecurity, which extends to inbound and outbound persons, transportation tools, containers, goods, articles, packaging materials, and the discharge of ballast water of international navigation ships. As necessary and approved by the State Council, Customs may temporarily close a port or the relevant border.Prevention and control of major new or sudden infectious diseases or animal or plant epidemics            According to the Draft, any entity or individual that finds any infectious disease or animal or plant epidemic must report it to a medical institution or a relevant professional institution or department. China will also strengthen the construction of border and port protection and control capabilities for infectious diseases and animal and plant epidemics, support international communication and cooperation, take part in international rescue and assistance as needed, and establish an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemics.Security of biotechnology R&D and application; laboratory biosecurity            The Draft includes a number of provisions governing biotechnology R&D and application. For example, the State Council will promulgate a list of important equipment and special Biological Factors involving biosecurity, any purchase or import of items on the list by any entity engaging in biotechnology R&D or application will be subject to registration, and no individual will be allowed to purchase or hold such items. The State Council will also categorize biotechnology R&D activities into high, medium or low risk categories. Foreign entities are prohibited from conducting high or medium risk biotechnology R&D activities in China.            The Draft includes a whole chapter on laboratory biosecurity, particularly with respect to laboratories of pathogenic microorganisms. The establishment of such labs is subject to approval or registration, depending on the circumstances. The establishment of such labs with foreign investment will be subject to an additional security review. If the security review determines that any pathogenic microorganism laboratory may affect public health, state security or public benefits, it may not be established. In addition, individuals will be prohibited from establishing a biosecurity laboratory.            China will classify pathogenic microorganism laboratories on four levels, based on the biosecurity protection levels. These are largely consistent with the biological safety levels established by the U.S. Centers for Disease Control and Prevention. The Draft also includes a series of provisions on the management of such laboratories, lab animals, accountability, safety and security, and emergency measures. It is worth noting that these provisions apply not only to pathogenic microorganism labs, but also to manufacturing enterprises involving pathogenic microorganism processing, and to laboratories involving other Biological Factors.Security of biological resources            The Draft has put provisions for biological resources in the same chapter as provisions for HGR, but does not provide a definition for “biological resources.” The biological resources provisions are obviously watered down compared to the HGR provisions, presumably because the legislators intend that the collection, preservation, use and outbound transportation of biological resources will be regulated by other laws and regulations. Interestingly, the only substantive provisions on biological resources in the Draft all relate to foreign entities or individuals, or alien species. For example, the acquisition or use of China’s biological resources by any overseas organization or individual or any institution established or actually controlled thereby (collectively, “Foreign Persons”), or any international scientific research collaboration using China’s biological resources, must each be approved by the relevant department according to the law. Such collaboration must ensure that the Chinese entity and its researchers are involved in a substantial part of the whole research process, and the relevant rights and interests are shared according to the law, although the Draft does not specify how exactly they should be allocated. The State Council will promulgate a directory of alien invasive species, and will strengthen the investigation, monitoring, early warning, control, evaluation and elimination of alien invasive species set out in the directory in the name of protection of biodiversity. No entity or individual may import, release or discard alien species.Security of human genetic resourcesThe Draft has included a number of provisions of China’s Administrative Regulations on Human Genetic Resources (the “Regulations”), in many instances, almost verbatim, particularly with respect to Foreign Persons. Specifically, the Biosecurity Law, according to the Draft, will prohibit Foreign Persons from collecting or preserving China HGR in China, or providing China HGR abroad. International scientific research collaboration using China HGR is permitted but must be approved by China’s Ministry of Science and Technology (MOST) in advance on a project-by-project basis. The only exception to the approval requirement is “international collaboration in clinical trials” at clinical trial institutions that do not involve the outbound transfer of China HGR materials (which has the same definition in the Draft as in the Regulations). Such clinical trial collaboration, however, must still be pre-registered with MOST and, as part of the pre-registration, the types and numbers of HGR proposed to be used and the actual proposed uses must be disclosed to MOST.The Biosecurity Law, according to the Draft, will require that the permitted international collaboration must ensure that the relevant Chinese entities and their research personnel “can take part in the research substantially in the whole process of the collaboration,” and that the relevant rights and interests resulting from the collaboration be shared in accordance with relevant laws, most likely the Regulations, which dictate that any patent rights based on scientific research results obtained in the collaboration must be jointly owned by the participating Foreign Person and Chinese entity, among other benefit-sharing provisions.Penalties for violation of the HGR provisions by Foreign Persons, according to the Draft, include injunction; confiscation of any China HGR illegally collected or preserved and of any relevant illegal income; and a fine of more than RMB 1 million but less than RMB 10 million. If the illegal income is more than RMB 1 million, the fine will be five to ten times that of the illegal income. These penalties are consistent with the ones imposed on Foreign Persons in the Regulations.The Biosecurity Law, according to the Draft, will permit the provision of, or open access to, China HGR information (which also has the same definition in the Draft as in the Regulations) to Foreign Persons, subject only to registration with MOST; provided, however, that, in the event such provision or access could endanger China’s public health, national security or public interests, MOST’s security examination will be required. This is also consistent with the Regulations.The Draft will obviously need further revisions before its final promulgation. Given the breadth of the Draft, this article does not attempt to address many other areas covered by it, some of which may seem to have more relevance to the current COVID-19 pandemic. In fact, the Regulations (and the corresponding provisions in the Draft) have already played an important role in the global battle against COVID-19. Because the certification or authorization by foreign regulatory authorities of the testing kits developed in China requires the cross-border transfer of development data, which constitutes China HGR information, the data transfer and the product development itself, which involves the use of China HGR materials, are both subject to the Regulations.The Draft’s inclusion of some of the key provisions of the Regulations related to Foreign Persons has sent a strong signal that Chinese legislators intend to codify a significant portion of the Regulations into law. The Biosecurity Law’s legislative progress undoubtedly warrants close monitoring and careful analysis.This article is not a comprehensive review of the Draft, but provides a brief summary and analysis of select provisions in the Draft that may be applicable to foreign entities or individuals. For an in-depth analysis of specific provisions or an English translation of the Draft, please contact the <a href="mailto:CCui@mofo.com?subject=MoFo%20Life%20Sciences%20blog%20post" target="_blank">author</a>. The author’s previous article on the Regulations may be accessed <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html">here</a>.

China’s Biosecurity Law will cover Human Genetic Resources

During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Bi

China’s Biosecurity Law will cover Human Genetic Resources