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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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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Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the <a href="https://eur-lex.europa.eu/eli/reg/2017/745/2020-04-24">Medical Device Regulation</a><a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> (MDR) and <a href="http://data.europa.eu/eli/reg/2017/746/2022-01-28">In Vitro Diagnostic Medical Device Regulation</a><a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> (IVDR) :<ol><li>The EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) discussed the outline of an EU Commission (Commission) proposal for targeted amendments of the transition periods under the MDR and IVDR on December 9, 2022, which will be incorporated into a draft legislation by the beginning of 2023.</li><li>In a new position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), which was announced at the EPSCO meeting and published shortly thereafter, the MDCG discusses the use of bridging measures to provide a temporary solution to certificates that are expiring through application of Article 97 MDR.</li></ol>BackgroundDue to the grave shortage of notified body capacity and the sheer amount of medical devices and in-vitro medical devices (IVD), which need to be recertified under the new legislative framework, most manufacturers will not be able to attain MDR or IVDR certification before the end of the respective transition period, which for medical devices ends as early as May 2024.The scope of the problem is immense: there have been 8,120 applications from manufacturers and 1,990 certificates granted under the MDR so far. By contrast, 22,793 valid certificates issued under the <a href="https://eur-lex.europa.eu/eli/dir/1993/42/oj">Medical Devices Directive</a><a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> (MDD) and <a href="https://eur-lex.europa.eu/eli/dir/1990/385/2007-10-11">Active Implantable Medical Devices Directive</a><a href="#_ftn4" target="_self" id="_ftnref4">[4]</a> (AMDD) are due to expire on May 26, 2024, at the latest. If the current rate of certificate issuance continues without change, the number of MDR certificates issued by May 2024 may reach around 7,000. Furthermore, the number of notified bodies remains a bottleneck—36 bodies have been designated under the MDR, but a further 26 applications are currently being processed.Commissions SuggestionsDuring the EPSCO meeting on December 9, 2022, health ministers from the EU member states joined forces to support the Commission’s proposal to extend the transitional provisions in Article 120 MDR, which were already outlined prior to the meeting in a Commission’s <a href="https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf">information note</a> of December 6, 2022. The Commission precipitated this development in response to urgent concerns expressed by several EU member states, members of the European Parliament, stakeholders, the MDCG and feedback from notified bodies.Among other things, the Commission suggests the following MDR amendments (despite the proposal claiming to extend both the MDR and IVDR, the suggested transition period extensions only cover the MDR):To extend the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Class III and class IIb devices (high risk) may extend to 2027 and class IIa and class I devices (medium risk) may extend to 2028 (low risk);If needed for legal and practical reasons, to extend the validity of MDD/AMDD certificates;Set conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. May 26, 2024); and To remove the ‘sell off’ provision in Article 120(4) MDR.The suggested extended transition periods for medical devices under the MDR would be staggered according to risk classes:<table><tbody><tr><td>Device class</td><td>Current transitional period</td><td>Proposed transition period</td></tr><tr><td>I</td><td>May 26, 2024</td><td>2028</td></tr><tr><td>IIa</td><td></td><td>2028</td></tr><tr><td>IIb</td><td></td><td>2027</td></tr><tr><td>III</td><td></td><td>2027</td></tr></tbody></table>The EPSCO unanimously supported extending the transition periods and opted for a swift adoption. The Commission’s proposal will be presented at the beginning of next year, but it’s unknown what it will entail and to which specific dates the transitional periods will be extended. While it is unclear when the changes will become effective, previous corrigenda have demonstrated that adoption can be swift. It will be worth monitoring further developments and details in the coming months.MDCG Position Paper on the Application of Article 97 MDR to Devices with Expired or Expiring CertificatesThe Commission also saw a need for bridging measures before this legislative change can be implemented, which led to the MDCG position paper (MDCG 2022-18) that seeks to ensure the application of Article 97 MDR to legacy devices under the MDD or AMDD. This is in line with prior position papersMDCG 2022-11 and MDCG 2022-14, which had already indicated the use of Article 97 MDR measures.The original purpose of Article 97 MDR was to allow EU member states to issue exemptions for medical devices that do not comply with the requirements of the MDR, but do not pose an unacceptable risk to patients or other individuals. In this case, the competent authorities (usually the national regulatory agency responsible for medical devices) can require the manufacturer or other relevant economic operators to correct the non-compliance within a reasonable amount of time.The MDCG 2002-18 recommends, with a coordinated set of criteria, that EU member states may apply this mechanism to devices that are ‘in transition’ from the MDD or AMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.The major advance of this position paper is that EU member states should recognize Article 97(1) MDR decisions issued by other EU member states, requiring only one application to cover the entire European Union.Manufacturers whose certificates have expired or will expire before receiving their notified body certificate under the MDR are advised to proactively inform the competent authority of the EU member state in which they or their authorized representative have their registered place of business about the forthcoming or incurred non-compliance with the relevant MDR requirements. An evaluation of the risk posed by the device, as well as any other non-compliance requirements, is then required by the competent authority. As long as the competent authority determines that there is no unacceptable risk to health and safety, Article 97(1) MDR will apply.Non-compliance must be resolved within a reasonable and clearly defined timeframe, and the manufacturer should already have undertaken reasonable efforts to transition its device to the MDR. That means, in particular, that the manufacturer’s application for conformity assessment under the MDR should have been accepted by a notified body and a written agreement signed by the notified body and manufacturer in line with section 4.3 of Annex VII MDR.ConclusionBoth developments are to be welcomed, as they have the potential to take an enormous amount of pressure off the market. However, the Commission’s proposal is not final, and there remains a lack of clarity as to the details of the proposed extensions.For example, according to the Commission’s proposal, an extension may only be granted for devices whose manufacturers have already taken steps to initiate certification procedures under the MDR, the uncertainty about what this means poses a problem. Yet it is unclear under which conditions this is the case. Does this require that the manufacturer must only adapt his quality management system, or would the notified body have to have accepted the manufacturer's application for conformity assessment?Moreover, in terms of extensions of MDD certificates, it is unclear when, according to the Commission’s proposal, such an extension is needed for “legal and practical reasons” and whether such an extension would be granted retroactively to already expired certificates.The most significant challenges with respect to the MDCG position paper seem to be that it is unclear how it relates to a proposed extension of the validity period for certificates under Article 120(2) beyond May 26, 2024, and that it remains to be seen how competent authorities will manage the influx of applications for Article 97 MDR exemptions. It is quite conceivable that the competent authorities for Article 97 MDR exemptions turn out to be a bottleneck, just as notified bodies do for MDR certification.Watch this spot for further information on the latest developments in MDR and IVDR implementation.MoFo Research Assistant Nicole Gebert contributed to this article.<hr class="divider"><a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017<a href="#_ftnref3" target="_self" id="_ftn3">[3]</a> Council Directive 93/42/EEC of 14 June 1993<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> Council Directive 90/385/EEC of 20 June 1990

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

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Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

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

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EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation(MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)

EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products. In the new and final CDS Guidance, FDA modified its interpretation of each of the four criteria in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, significantly narrowing what FDA considers exempt from regulatory authority.Read the <a href="https://mofotech.mofo.com/topics/ai-trends-for-2023-fda-regulatory" target="_self">full blog post</a>.

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AI Trends for 2023 - FDA Regulatory

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program.

AI Trends for 2023 - FDA Regulatory

In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based on European Union trademark law, the drug manufacturers can stop parallel importers from distributing their medicinal products if they have been repackaged in new outer packaging with the corresponding trademark of their medicinal product affixed.The practice of parallel importers in the medical sectorDue to differing price levels on the pharmaceutical markets in various EU member states, parallel importers buy drugs for a lower price in one market (e.g., Eastern Europe) and sell them at higher prices in other markets (e.g., Germany). The products are either relabeled or the outer packaging is replaced in its entirety in order to change the packaging language. In the latter case, the trademark of the reference product is affixed to such repackaging by the parallel importer. In the current cases, pharmaceutical companies Bayer and Novartis have opposed this repackaging practice of parallel importers kohlpharma and Abacus.Legal framework shaped by CJEU case lawThe CJEU has dealt with parallel imports of medicinal products in several landmark decisions. The starting point is the right of the drug manufacturer to prohibit third parties from using its trademark during trade (Art. 9 para. 2 of the EU trademark regulation 2017/1001). However, due to the principle of free movement of goods within the EU and the fact that the trademark proprietor’s rights are generally exhausted for the entire EU once an individual product bearing the mark has been placed on the EU market (Art. 15 of the EU trademark regulation 2017/1001), it is settled case law that parallel imports of medicinal products are generally permissible (case no. C-16/74). For repackaged products, this is only the case if the conditions carved out by the CJEU in previous decisions (joined case nos. C-427/93, C-429/93, and C-436/93) are fulfilled. The conditions require that (i) repackaging is necessary for commercializing the goods in the import market, (ii) the condition of the goods is not affected, (iii) the repackaging is made transparent on the goods, (iv) the importer informs the manufacturer about the repackaging, and (v) the new presentation does not cause damage to the reputation of the trademark.Repackaging v. relabeling of pharmaceutical productsIn the decisions at hand, the CJEU focuses more closely on the necessity of repackaging over pure relabeling. The court recognizes that repackaging has a stronger impact on the rights of the trademark proprietor than mere relabeling. The court emphasizes that the repackaging must therefore be a necessary means for the importing of the product. This, according to the court, would be the case, if regulations or practices in the importing EU member state prevent the distribution of that product on the market of that EU member state in the same packaging in which the product is distributed in the exporting EU member state. However, it would not be the case if the repackaging of the product is based exclusively on the parallel importer’s desire to obtain an economic advantage.The parallel importers argue that repackaging is necessary due to the requirements of the <a href="https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview#:~:text=The%20European%20Union%20%28EU%29%20has%20a%20strong%20legal,for%20sale%2C%20including%20legitimate%20sale%20via%20the%20internet." target="_blank">EU falsified medicines laws</a>, which provide that all medicinal products sold in the EU must have a unique identifier (i.e., a barcode) and an anti-tampering device (i.e., a security seal to verify whether the packaging of a medicinal product has been opened or altered) to ensure that their content is authentic (see Art. 47a of Directive 2001/81, inserted by Directive 2011/62/EU and Art. 4 Regulation 2016/161). In order to replace the package leaflet of the original product with a package leaflet in the language of the import market, the anti-tampering device will have to be broken. If the packaging would only be relabeled and a new anti-tampering device added, the traces of the damaged original security seal may still remain visible. Parallel importers claim that this would be a major barrier to importing the products into other EU member states as medicinal products with damaged packaging are less likely to be accepted, especially by consumers.In the decisions at hand, the CJEU considered these risks to be less significant. It held that the aforementioned Article 47a(1)(b) of Directive 2001/81 allows reuse only on the condition that the original security features can be replaced by those that are equally suitable for verifying the authenticity and identity of the medicinal products concerned and for providing evidence of their tampering. The fact that wholesalers or consumers may be irritated by traces of a broken anti-tampering device has no bearing, as it only had to be made clear to them that these traces were made by the parallel importer. A general presumption of consumer resistance to relabeled drugs is not sufficient to require repackaging. This may only be different if it was clearly demonstrated that a significant proportion of consumers decided against purchasing the relabeled products. Under these circumstances, the repackaging of the products in new packaging would not be aimed exclusively at an economic advantage, but at gaining effective access to the market.ConclusionThe two CJEU decisions are good news for manufacturers, as they raise the bar for repackaging of parallel imported drugs. Importers will now have to provide proof for each market that the majority of consumers are less likely to buy relabeled products over repackaged products, even when they are informed that relabeling was done by the parallel importer. Otherwise, only relabeling will be permissible.MoFo research assistant Tim Stripling contributed to this article.

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

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In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging practices of parallel importers. 

Food Traceability Final Rule OverviewOn November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its <a href="https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods" target="_blank">Final Rule: Requirements for Additional Traceability Records for Certain Foods</a> (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for subject entities that manufacture, process, pack, or hold foods that are included on the <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list" target="_blank">Food Traceability List</a> (FTL). FDA’s ultimate goal in these efforts is to reduce the time it takes to respond to foodborne illness outbreaks. These additional recordkeeping requirements are intended to enable FDA to quickly and efficiently track down potentially hazardous foods and ultimately reduce the number of people who are exposed and get sick.The Final Rule identifies critical tracking events (CTEs) along the supply chain where records containing key data elements (KDEs) must be created and maintained for foods on the FTL. KDEs will vary for different CTEs but will contain information needed to effectively trace a product based on the CTE performed. CTEs include: <ul><li>Harvesting</li><li>Cooling (before initial packing)</li><li>Initial packing of raw agricultural commodities (other than food obtained from fishing vessel)</li><li>First land-based receiving of food from fishing vessel</li><li>Shipping</li><li>Receiving</li><li>Transforming</li></ul>The Final Rule also requires subject entities to establish and maintain a traceability plan, which details how the traceability program records are maintained, how traceability lot codes are assigned, and other key information needed to understand the records. Five Takeaways from the FDA WebinarOn Wednesday, December 7, 2022, FDA held an informational <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-food-traceability-final-rule-12072022" target="_blank">webinar</a> on the recently released Food Traceability Final Rule issued pursuant to the FDA Food Safety Modernization Act (FSMA). <ol><li>All entities subject to the Final Rule must comply with its requirements by January 20, 2026. Because of the need for all entities to share information to achieve effective traceability, the compliance date for all entities is the same. To prepare for compliance with the Final Rule, FDA recommends that subject entities begin talking to their supply chain partners to better understand existing recordkeeping systems and efficient communication pathways. </li><li>While the rule does not require subject entities to keep electronic records, for many companies the requirement to [describe the requirement to produce records to FDA in three days] will likely require a sophisticated and interoperable software solution to comply. The Final Rule does not prescribe software specifications or requirements for recordkeeping, and it is the responsibility of the subject entities to meet the requirements under the Final Rule with whatever technology they choose to use. FDA will not be validating or endorsing software systems. </li><li>FDA anticipates updating the Food Traceability List (FTL) every five years. Updates to the FTL will be made through notice and comment rulemaking, and industry stakeholders will have opportunities to submit information for FDA to consider when contemplating updates. Any deletions of foods on the FTL will be effective immediately after the Final Rule updating the list is in effect, and any additions to the FTL will be effective two years after the Final Rule. </li><li>FDA has begun the implementation planning phase for the Final Rule and is planning on incorporating stakeholder engagement throughout the process. It is actively working on ways for stakeholders to submit traceability information to it and is contemplating a database that allows subject entities to upload information. FDA intends to issue additional guidance in the future.</li><li>In implementing and enforcing the Final Rule, FDA anticipates that education of industry stakeholders will go hand in hand with regulation. It understands that this is a new paradigm and that the industry will have questions going forward. It has stated it will continue to update the FAQs as more questions are received and emphasized that industry stakeholders may continue to submit questions to FDA’s Food and Cosmetics Information Center (FCIC) through its online <a href="https://cfsan.secure.force.com/Inquirypage/" target="_blank">inquiry page</a>. </li></ol>

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FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar

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On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register.  The Final Rule establishes additional traceability recordkeeping requirements for subject entities that manufacture, process, pack, or hold foods that are included on the Food Traceability List (FTL).

FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar

This article is Part B of the fifth alert in our series of alerts focussed on the alternative protein industry. While Part A provided an overview of financing options in the industry, this Part B considers a variety of key financing options in more detail, including important considerations for nascent companies.Read the <a href="https://www.mofo.com/resources/insights/221207-financing-options-in-the-alternative-protein-industry" target="_self">full client alert</a>.

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Simon Arlington is a partner based in the Corporate Group focusing on M&A and private equity.

Simon Arlington

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Associate

Michelle Luo is an associate in the firm’s London office and a member of the Technology Transactions, Intellectual Property and Global Privacy Groups.

Michelle Si-Ting Luo

Michelle Luo

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Financing Options in the Alternative Protein Industry

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This article is Part B of the fifth alert in our series of alerts focussed on the alternative protein industry. While Part A provided an overview of financing options in the industry, this Part B considers a variety of key financing options in more detail, including important considerations for nascent companies.

Financing Options in the Alternative Protein Industry

This is an excerpt from a longer piece. For more information on the history and landscape of PVPs on transgenic plants, <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt97cae3869531ab98/638e0c0ab660b4108abd0411/221205-usdas-pvp-system-embraces-transgenic-and-gene-edited-plants.pdf" target="_blank">read more</a>.Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants. PVP certificates (PVPs), which have been available in the U.S. since the enactment of the Plant Variety Protection Act of 1970 (PVPA; 7 U.S.C. §§ 2321-2582), have historically been associated with traditional breeding. However, there are actually numerous granted PVPs covering transgenic plant varieties, and the USDA is now also granting PVPs to gene edited plants. This article describes a recently granted PVP for a gene edited plant, contextualizing this example PVP in the broader landscape of PVP certificates that are directed to plant varieties created using modern biotechnology.As of this writing, there have been at least 1,952 granted PVPs covering transgenic plant varieties since 1998, when the USDA started collecting this information (Figure 1a). This represents roughly 20% of all PVPs granted during this time frame. PVPs covering transgenic varieties are identifiable by an affirmative answer in field 18 in the PVP ST-470 application form (Figure 1b). These transgenes are often used to confer traits that do not usually occur in a crop’s gene pool, such as herbicide tolerance or insecticidal protein synthesis.Figure 1a<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltffce86eee8e0fe31/638f828d035f1065512a8764/221206-figure1a.jpg?format=auto&amp;quality=60" alt="figure1a"/></div>Figure 1a: PVP grants covering transgenic plant varieties by year. Data source: USDA, AMS, S&T, Plant Variety Protection Office, July 2022. The raw data consists of all PVP varieties where the answer to the question “Does the variety contain any transgenes?” is “Yes.” The bar graph was generated by filtering this raw data for records with an issue date, then sorting by issue year.Figure 1b<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltf36b755087f71e6a/638f82b1c1672c63e5e71d77/221206-figure1b.jpg?format=auto&amp;quality=60" alt="figure1b"/></div>Figure 1b: Field 18 of a PVP certificate, indicating the presence of inserted nucleic acids. Source: <a href="https://apps.ams.usda.gov/CMS/AdobeImages/201800533.pdf" target="_blank">PVP application form</a> for rape variety ‘KSR4652’. Note that the USDA changed the language in this field around 2018; an earlier version referred to “transgenes” rather than “biotechnology events” (for an example of the previous language, see field 18 in the <a href="https://apps.ams.usda.gov/CMS/AdobeImages/201700290.pdf" target="_blank">PVP application form</a> for rape variety ‘Cara’). According to the USDA, AMS, S&T, and Plant Variety Protection Office, this change was due to industry pressure for the field to be written more broadly, in order to better encompass newer methods of genetic modification (personal communication, July 2022). USDA-AMS, for its part, views the use of “transgenes” and “biotechnology events” in this context as synonymous, and it collects the information in field 18 in order to assist the National Laboratory for Genetic Resource Preservation in handling seed deposits after expiration (USDA, AMS, S&T, and Plant Variety Protection Office; personal communication, July 2022).In addition to PVPs on transgenic varieties, which contain foreign DNA by definition, the USDA has also recently begun granting PVPs on gene edited plant varieties. Gene editing is a form of modern biotechnology used to make precise genetic changes, but which does not necessarily entail insertion of foreign DNA.For example, the USDA recently granted a PVP certificate to GreenVenus, LLC for the ‘GVR-108XL’ lettuce variety, which was created using gene editing without transgene insertion. Thus, in contrast to the PVPs discussed above, field 18 in this Certificate is marked as “No.” The table below summarizes the bibliographic information of the ‘GVR-108XL’ lettuce PVP, including links to relevant documents.<table><tbody><tr><td>PVP certificate</td><td>No. <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">202000361</a></td></tr><tr><td>Crop</td><td>Lettuce (Lactuca sativa L.)</td></tr><tr><td>Variety name</td><td>‘GVR-108XL’</td></tr><tr><td>Applicant and owner</td><td>GreenVenus, LLC</td></tr><tr><td>Filing date</td><td>August 24, 2020</td></tr><tr><td>Issue date</td><td>May 13, 2022</td></tr><tr><td>Related applications</td><td>1) US Provisional Patent <a href="https://patentcenter.uspto.gov/applications/62925853" target="_blank">62/925,853</a> (filed October 25, 2019);2) International patent application <a href="https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021080761" target="_blank">PCT/US2020/54082</a> (published April 29, 2021)</td></tr></tbody></table>GreenVenus, LLC’s romaine lettuce variety ‘GVR-108XL’ has edits to five polyphenol oxidase (PPO) genes, which are enzymes responsible for damage-related browning in fruits and vegetables, and negatively affect the shelf life of products such as pre-cut salads. As described in the publicly available description and data included with the published <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">PVP application</a>, the genetic edits in ‘GVR-108XL’ lettuce lower the activity of PPOs to delay browning, without the presence of transgenes in the plant’s genome. These edits were accomplished using a nuclease and guide RNAs to target multiple PPO genes. The nuclease and guide RNAs were originally introduced on a T-DNA using Agrobacterium-mediated transformation. This foreign DNA was integrated into the lettuce genome, thereby producing a transgenic lettuce plant that mediated its own gene editing. Once the transgenic nuclease and guide RNAs accomplished the desired edits to the PPO genes, the transgenic DNA was segregated out in subsequent generations by traditional breeding. The final ‘GVR-108XL’ lettuce plants thus include the PPO edits, but do not include foreign DNA (for more information, see pg. 8 and Exhibit B of the <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">‘GVR-108XL’ PVP application</a>).Options for plant IP protection and changes to PVPsAlthough this post focuses on PVPs, it is useful to keep in mind that PVPs are one of three non-mutually exclusive forms of IP available for plants in the United States. The other two forms are utility patents and plant patents. Utility patents can have any number of claims, and can cover many different aspects a plant, including but not limited to plant lineages, parts, cells, varieties, and even sometimes traits. Plant patents are restricted to asexually propagated plants, and contain only one claim, which is limited to the particular plant described in the plant patent and clones thereof. Somewhat similarly, PVPs are limited to the protected variety, but have slightly broader coverage than plant patents in that they contain provisions regarding essentially derived varieties (EDVs). This means that permission must be granted by the Certificate holder in order to sell varieties deemed to be “essentially derived” from the protected variety, so long as the protected variety is not itself an EDV. Read a more <a href="https://chinaipr.com/2020/04/02/essentially-derived-varieties-and-the-role-of-leading-cases-in-chinese-plant-variety-protection/" target="_blank">in-depth discussion of EDVs</a>.What do we expect going forward?We expect the number of PVPs granted on plants produced using biotechnology—whether transgenic or not—to only increase going forward. Given the recent updates to USDA’s regulatory process for assessing plants developed using genetic engineering under the SECURE rule, which we have summarized in a <a href="https://www.mofo.com/resources/insights/220912-purple-tomato-first-genetically-engineered-plant-to-be-deregulated" target="_blank">previous post</a>, and the increasing technological ease with which such edits may be made, it is likely that there will be an increase in development of such plants in the US. This is likely to be particularly true for certain “simple” types of gene editing, such as targeted DNA breaks that are repaired without a template, and targeted single base pair substitutions, both of which are exempt from regulation under the SECURE rule.Not only will significantly more GE plants likely be produced going forward, but the recent expansion in PVP coverage to also include asexually reproduced plants (summarized in a <a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants" target="_blank">previous post</a>) means that nearly all such plants are now potentially eligible for PVP coverage. We expect that the combination of these two factors will lead to a significant increase in both the number and proportion of PVPs granted on transgenic and gene edited plant varieties—though it remains to be seen how closely USDA will publicly track each of these categories.As these technological and regulatory changes continue to settle in, it will be interesting to see how the industry adapts to the new regulatory atmosphere, and how use of the various forms of plant IP available in the United States continues to morph in parallel.

USDA’s PVP System Embraces Transgenic and Gene Edited Plants

Liz Freeman Rosenzweig

Scientific Specialist

Christopher Lew is a scientific specialist in the Intellectual Property Group. The scientific specialist team conducts patent and non-patent literature searches for patentability, freedom to operate, 

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Christopher Lew