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

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Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office requirements for the written descriptions and disclosures that are necessary to obtain a patent for biologic products. The sequence listings are used by patent offices during examinations to search for identical or similar sequences when assessing novelty and nonobviousness of the invention sought to be patented. Sequence listings also become publicly available when a patent application is published, allowing the public to access the sequence information. This is especially important when reviewing the patent landscape for freedom to operate analyses for third-party patents.Starting July 1, 2022, all World Intellectual Property Organization (WIPO) member patent offices, including the U.S. Patent and Trademark Office (USPTO), will transition to new sequence listing procedures that will require sequence information be provided in .xml format. Since 1992 – the first year the USPTO required a separate sequence listing – the format for sequence listings has been ASCII .txt.The new format, designated WIPO standard ST.26, is intended to synchronize sequence listings among different patent offices and various international sequence repositories and therefore enable better sequence searches. Where ASCII .txt files are generally smaller in size and easier to interpret, XML files allow for more in-depth annotation via computer tags that also expedite structured information retrieval.More information about the sequence listing changes is available from WIPO and can be found <a target="_blank" href="https://www.wipo.int/standards/en/sequence/faq.html">here</a>. In order to comply with the new standards, WIPO has developed a software tool (“<a target="_blank" href="https://www.wipo.int/standards/en/sequence/?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term">WIPO Sequence</a> tool”) that both generates and validates sequence listings. The WIPO Sequence tool can also be used to convert the previous WIPO standard ASCII ST.25 listings from .txt format to .xml format. There is no transition period in the new rules, and the ability to file a sequence listing in the previous ST.25 format will disappear as of July 1, 2022.The new sequence listing standard will apply to any patent application filed on or after July 1, 2022, including any continuation or divisional application in which the original sequence listing had been prepared in the ST.25 ASCII .txt format. If an applicant desires to continue prosecution of an application family with a new patent filing, the preparation of the sequence listings must be made or converted to the new format. Practitioners and applicants should be aware of the extra time that may be needed to implement the new format. In addition, due to the format differences under the new rules, care also should be taken to ensure that a new matter is not being added when a sequence listing is converted to the new ST.26 format. The sequence listing changes may also have a profound negative impact on the ease with which patent sequences from any published application can be reviewed by the public. XML files are not instantly readable and will require a dedicated display program in order to interpret the sequence input. When downloaded, XML listings will include various coding elements, and it will be necessary to upload an XML file on the WIPO Sequence tool (or another XML viewing platform) in order to decipher the information. While WIPO has indicated that Patent Cooperation Treaty (PCT) applications will have their listings available as XML files, it is not clear how individual patent offices will publish listings under the new standards. Producing a PDF copy of the XML file will most likely present a very difficult task for any practitioner or applicant because there is no way to convert the file via the WIPO Sequence tool.These changes are significant and will impact the accessibility and ease with which applicants and practitioners alike approach the preparation and analysis of sequence listings. Life sciences patentees are encouraged to seek input from counsel to discuss the sequence listing changes in order to ensure compliance with the new rules.

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

Liz Newman Ph.D.

Liz Newman

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

Karen G Potter Ph.D.

Karen Potter

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The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

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Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in 

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims. The recent BASF v. CSIRO[1] decision provides yet another data point on how the Federal Circuit thinks about this issue. Although broad genus claims continue to be disfavored, this case demonstrates how applicants can maximize the effect of their early-stage data and, by extension, the scope of their patent claims.The patents at issue in this case concern transgenic plants that express a series of enzymes not native to land plants. When introduced in oilseed crops (e.g., canola), these enzymes would allow the plants to transform a short-chain fatty acid they naturally produce (ALA) into the nutritionally beneficial long-chain polyunsaturated fatty acids found in fish and other marine life (EPA and DHA).When it submitted its initial patent filings, the patentee had successfully implemented the technology in the model organism Arabidopsis, but it had not yet implemented the invention in canola or other oilseed plants.In BASF, the Federal Circuit upheld a jury determination that three claims directed to a transgenic canola plant capable of producing long chain polyunsaturated fatty acids were adequately supported by working examples in the model organism Arabidopsis, but invalidated three genus claims covering all plants because they lacked sufficient written description.In upholding the canola claims, the Federal Circuit cited the Arabidopsis working examples together with the prominence of canola in the specification. Three portions of the specification that expressly identify canola were particularly relevant: a list of preferred oilseed plants, a list of “plants of the invention,” and a list of oilseed crop plants.The disclosure in the specification was supplementethd by trial evidence explaining the connection between the model organism Arabidopsis and the claimed plant, canola. Expert testimony established that (1) Arabidopsis and canola are both oilseeds (i.e., they store oil in the cotyledons), (2) the two species both naturally produce ALA, and (3) their shared ability to metabolize oils is due to their low evolutionary distance.The Federal Circuit credited this testimony as demonstrating that proof of concept attained in Arabidopsis was “more than just a stepping stone” and “highly predictive of” achieving production of the desired oils in canola.[2]But the court’s reasoning could logically extend to additional plants. Other plants appear in the preferred embodiment lists and share relevant characteristics with Arabidopsis. The court’s discussion suggests that the Arabidopsis working examples, the specification, and the information explaining the connection between Arabidopsis and other oilseeds could support a subgenus claim covering at least canola, soy, and flax.[3] Of course, there was no such subgenus claim examined by the court, so we cannot say for sure.We do know that the court was unwilling to extend its reasoning to all plants. Despite its willingness to recognize the Arabidopsis data in support of the canola claims, the court clearly rejected the broad genus claim covering all plants: it found nothing in the specification or presented through expert testimony to suggest that success in Arabidopsis meant possession of the invention in all plant cells.[4]Although it invalidates yet another genus claim, BASF is not all bad news for patent applicants in the life sciences field. In fact, patent applicants should look to BASF as a guide for maximizing the power of proof of concept data obtained in model organisms.From prior case law we know that proof of concept in one species can “serve as a stepping stone” to support patent claims directed towards different species, and that actual reduction to practice is not a requirement.[5] But applicants would be wise to enhance the effectiveness of their data, creating “more than just a stepping stone,” by explicitly laying out the connection in the specification between the model organism and the desired species. BASF also provides a lesson on the importance of drafting multiple layers of claims, particularly when an independent claim is directed to a large genus, such as “all plants.” Applicants should present subgenus and species claims of varying and overlapping scope to provide backup positions if a broad genus claim is found to be invalid.By maximizing the power of model organism data through proper disclosure, and by including subgenus claims in an application, a savvy prosecutor can strategically avoid the two extremes of either narrowly claiming the exemplified subject matter or claiming a broad, unsupported genus.  [1] BASF Plant Sci., LP v. Commonwealth Sci. & Indus. Rsch. Org., 28 F.4th 1247 (Fed. Cir. 2022). The opinion was also featured as a “case of the week” on our Federal Circuity blog for its discussion of co-ownership issues arising from a collaboration agreement: <a href="https://federalcircuitry.mofo.com/topics/Last-Week-In-The-Federal-Circuit-March-21-2022-Federal-Circuit-Says-Go-Fish.html">https://federalcircuitry.mofo.com/topics/Last-Week-In-The-Federal-Circuit-March-21-2022-Federal-Circuit-Says-Go-Fish.html</a>.[2] Id. at 1267.[3] Id. at 1265.[4] Id. at 1268-69 (noting that CSIRO did not argue that success in Arabidopsis automatically mean success in all plant cells).[5] Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1349, 1353 (Fed. Cir. 2011).

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

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Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.

Owen Grayson Hosseinzadeh

Owen Hosseinzadeh

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Stepping Stones to Success: Supporting Claims in the Life Sciences

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Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.
The standard for written description in the life sciences seems to 

Stepping Stones to Success: Supporting Claims in the Life Sciences

After a myriad of <a href="https://www.mofo.com/resources/insights/200334-europes-unified-patent-court.html?utm_source=publication&utm_medium=email" target="_blank">challenges</a>, <a href="https://www.linkedin.com/pulse/unified-patent-courtunexpected-roadblocks-ahead-germany-sch%C3%B6nig/" target="_blank">delays</a>, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an international organization. This date marks the beginning of the Provisional Application Period (PAP), which was triggered by the thirteenth member state’s ratification of the PAP Protocol. The Administrative Committee, one of three governing bodies of the UPC, had no time to lose and took up its preparatory work with an <a href="https://www.unified-patent-court.org/news/announcement-unified-patent-court-administrative-committees-inaugural-meeting" target="_blank">inaugural meeting</a> on February 22, 2022.  Since then, preparatory measures seem to be in full swing. The interview process for candidate judges began at the end of March 2022. As soon as the Court will be deemed functional, which is expected to take about eight months of preparations, Germany will deposit its ratification of the Unified Patent Court Agreement (UPCA), a final step which it is – in agreement with the other member states – currently holding back in order to control the timeline.  From that moment, the final countdown of three months will be initiated until the UPCA will enter into force and the UPC will open its doors.With the UPC having reached the home stretch, Supplementary Protection Certificates (SPCs) have come into the limelight as the fundamental area of intellectual property (IP) protection that remains fragmented among the member states.SPCs are sui generis IP rights. They grant up to five years (and in cases of pediatric extensions, five and one half years) of additional protection for a medicinal or veterinary product or a plant protection product that has gained market authorization. SPCs were introduced to offset the lengthy process of regulatory proceedings. Protection is based on EU regulation No. 1610/96 (concerning SPCs for plant protection products) and No. 469/2009 (concerning SPCs for medicinal products) (“SPC Regulations”) and is available in all EU member states. However, application and approval is handled on the member state level.  This remained the same despite the advent of the European Patent Package, which introduced the Unitary Patent (UP) and the UPC, but did not provide for unitary SPCs.[The European Patent Package introduced the Unitary Patent (UP), a single patent having effect in all participating EU member states, and the Unified Patent Court (UPC), a court system having jurisdiction over UPs with its decisions having effect in all participating member states.]As a consequence, UPs can only be extended by national SPCs.During an evaluation in 2020, the <a href="https://ec.europa.eu/docsroom/documents/43847" target="_blank">European Commission (EC) found</a> that the SPC system in general provides effective incentives for innovations, and the EC ascertained that the main shortcomings are rooted in the national administration and management of SPCs. Therefore, the EU Parliament called on the EC to address this SPC fragmentation. In the course of its legislative work, the EC has launched a so-called “Call for Evidence” to gather feedback on how to tackle that issue. The Call for Evidence brings up three topics for discussion:a) The baseline scenario with no policy change. The SPC system would continue to operate on the basis of existing EU and national rules. Member states might continue in an uncoordinated manner to recalibrate their SPC practices, with different approaches persisting across the single market.b) Non-legislative instruments, including guidelines based on the best practices of national patent offices and the case law of the Court of Justice of the European Union (CJEU), aimed at further harmonizing the current SPC system.c) Legislative changes, which would possibly be combined with non-legislative changes, including:1) Creation of a centralized system for SPC protection in the EU, with a view to reducing the cost and burden and making the procedure for granting SPCs more predictable. A centralized system would facilitate the setting up of standardized, common, and publicly available digital databases. This centralized system could consist of: (i) a unitary SPC, complementing the future unitary patent; (ii) a unified procedure for granting bundles of national SPCs, without creating a unitary SPC; or (iii) a combination of the two. The detailed features of a centralized SPC system will be assessed in an impact assessment (e.g., an examining and granting authority (a virtual authority comprising SPC experts from Member States, or an EU authority), language arrangements (English-only or multilingual), and judicial review); and2) Targeted amendments of the SPC Regulations on the basis of the best practices of national patent offices and CJEU case law aimed at further harmonizing the current SPC system.The Call for Evidence is open for feedback until April 5, 2022. Any members of the public may provide their feedback and comments. Submissions will be published <a href="https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13353-Medicinal-&-plant-protection-products-single-procedure-for-the-granting-of-SPCs_en">here</a>.Meanwhile, the UPC committees will continue their preparatory work. A fully operational UPC is expected to open its doors in early 2023, if not in late 2022. From that moment, a seven-year transitional period, during which patent holders may opt out of the exclusive jurisdiction of the UPC, will kick off. It is crucial for holders and applicants of UPs to make well-balanced decisions and keep an eye on the UPC strategies of other market participants.On the one hand, the exclusive jurisdiction of the UPC comes with the advantage of a cost-effective litigation system. To participate in the UPC could be seen as an opportunity to shape this new system. On the other hand, being at the mercy of a newly set up court might be daunting, as outcomes could be perceived as less predictable than in the more familiar systems. This might particularly be the case in light of the fact that a declaration of invalidity would stretch to all participating member states.Therefore, the right strategy can only be tailored in view of the risks or strengths attached to specific patent portfolio and its market environment. Owners and applicants should use the home stretch of the UPC to become familiar with the UPC system and its procedures and get advice on UPC strategy, where needed.

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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A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

Healthcare, Biologics, and Severability: Will the ACA—and the BPCIA—Survive the Latest Challenge?

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After a myriad of challenges, delays, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction.

A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit <a target="_blank" href="https://cafc.uscourts.gov/opinions-orders/20-1933.ORDER.3-16-2022_1922220.pdf">denied Biogen International’s petition for panel rehearing and rehearing en banc</a>, following a November split decision discussed below.Judges Lourie, Moore, and Newman dissented on the denial of en banc rehearing. Judge O’Malley had dissented from the November panel decision, but retired on March 11, 2022 and only participated in the decision on panel rehearing, not the decision on rehearing en banc.The dissent indicates that the court remains divided regarding application of the written description requirement to the facts in this case.________________________________When does an applicant have “enough” to file a patent application and be granted a patent?That question continues to dog applicants in the biopharmaceutical industry, particularly in view of recent Federal Circuit decisions concerning whether a patent application provides adequate written description for claims requiring functional limitations, such as administering an “effective” amount of a therapy.Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021).In this <a href="https://cafc.uscourts.gov/opinions-orders/20-1933.OPINION.11-30-2021_1871902.pdf" target="_blank">recent split decision from the Federal Circuit</a>, the majority affirmed a District Court decision that Biogen failed to demonstrate possession of a method of treating Multiple Sclerosis (MS) with a therapeutically effective dose of dimethyl fumarate (DMF) of about 480 mg per day claimed in Biogen’s U.S. patent 8,399,514 (the ’514 patent).Claim 1 of the ’514 patent is representative and recites:A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 [milligrams] per day [(mg/day)].In its decision, the majority focused on the fact that the DMF480 dose is listed only once in the specification, and that the sole reference to DMF480 appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day. In addition, the majority observed that the specification defines the term “effective” within a therapeutic, rather than drug-discovery, context, and the sole DMF-dosage paragraph is not linked to treatment of any specific disease, much less a neurological disorder including MS. The majority contrasted this disclosure with the description of DMF720, which is referenced independently as one dose and was known to be effective in treating MS as of the February 2007 priority date. The majority agreed with the district court that it was not necessary to distinguish between clinical efficacy and therapeutic efficacy, particularly because the specification’s definition of “therapeutically effective dose” indisputably featured both clinical and therapeutic insignia.Judge O’Malley dissented, arguing that the District Court erred by disregarding Biogen’s explanations of the distinction between clinical efficacy and therapeutic efficacy, and that “the district court’s conflation of therapeutic and clinical efficacy caused it to erroneously require clinical data, rather than therapeutic effects.” Judge O’Malley further argued that the District Court erred in applying the Court’s “blaze marks” precedent to the claimed DMF480 dose, because the specification does not provide a “laundry list” of therapeutically effective doses, and begins one of several disclosed ranges with the exact DMF480 dose that is claimed.Biogen filed a petition for rehearing en banc, saying the majority incorrectly created a heightened written description standard to “require that Biogen prove the efficacy of its claimed method, rather than describe the claimed invention.” It also objected to the majority’s “insistence on further repetition or singling out” of the DMF480 dose, saying that there is “no requirement that a specification repeat or single out a claimed embodiment.”Several industry groups have urged the Federal Circuit to review the decision.[1] After Mylan filed a response on February 3, it remains to be seen whether the court will provide additional clarity to applicants regarding what is “enough” for written description.Practice TipsPatentees must balance competing factors for timing disclosure of inventions. Filing a patent application too late risks being beaten by a competitor. Filing too soon risks not adequately describing the claimed invention, while potentially poisoning the well for future filings. In particular, care should be taken in the timing for describing specific dosing regimen. The majority noted in Biogen that an inventor need not prove that a claimed pharmaceutical compound actually achieves a certain result, but when that result is expressed claimed in the claims, “our case law provides that [such] result must be supported by adequate disclosure in the specification.” Nuvo, 923 F.3d at 1384. Thus, applicants may want to avoid early disclosure of specific dosing regimens and pursue tailored dosing claims in later filings.When disclosing a series of ranges, applicants should consider providing “blaze marks” to the ranges or values that are more likely to be effective. As highlighted in Biogen, even a short list of ranges may not be considered adequate support for claiming a particular endpoint within the ranges that is later proven to be effective. For example, calling out DMF480 individually or specifically connecting DMF480 (or even a range covering DMF480) to therapeutic efficacy for MS would have strengthened Biogen’s case for written description.Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of biotech and biopharmaceutical industries. [1] Biotechnology Innovation Organization, a division of the American Chemical Society, and Pharmaceutical Research and Manufacturers of America all filed amicus briefs on January 19, 2022, supporting Biogen’s petition for rehearing en banc.

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Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

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Dr. Bu Yin has nearly 10 years of experience in life sciences patent application drafting, global portfolio management, and strategic counseling. Dr. Yin frequently counsels on issues relating to pate

Bu Yin Ph.D.

Bu Yin

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Possession of an "Effective" Dose

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Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc, f

Possession of an "Effective" Dose

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for PTE, a patent must claim a drug product, a method of using a drug product, or a method of manufacturing a drug product, and PTE is only available for the first approval of an “active ingredient.”The Federal Circuit has addressed the question of what constitutes an active ingredient[1] several times in the context of small molecules. For example, claims directed to a metabolite do not cover the active ingredient,[2] enantiomers of the same compound are different active ingredients,[3] and different salts of the same compound are considered the same active ingredient for purposes of PTE.[4] Although the Federal Circuit case law on small molecules is more developed, it is not clear how the court will apply the current case law and statutory framework to biologics including cell-based therapies and gene therapies.Recent approval of a cell therapy, YESCARTA®, provides insight into considerations from the U.S. Patent & Trademark Office (USPTO) on what constitutes the active ingredient in the context of biologics. The YESCARTA PTE application illustrates two challenges for defining the active ingredient in cell-based therapies to meet the first approval requirement.[5] One challenge is how to define the active ingredient for certain cell-based therapies, where the product differs from patient to patient. Moreover, there is the related challenge of providing a detailed enough description of the active ingredient in the PTE application to allow the USPTO to distinguish the active ingredient of the product from previously approved active ingredients.YESCARTA (Axicabtagene ciloleucel) is an immunotherapy approved to treat B-cell lymphomas. YESCARTA comprises autologous T cells (a type of immune cell that plays a crucial role in detecting and killing cancer cells) derived from an individual patient and engineered specifically to target the patient’s cancer cells. The engineered T cells comprise: (1) T cells harvested from a patient and (2) a foreign protein (i.e., a chimeric antigen receptor (CAR)) specifically targeting a cell-surface protein. The T cells vary from patient to patient, but the CAR is the same for all patients. The T cells containing the CAR are responsible for the anti-tumor activity. All of this raises the question of whether the active ingredient is the T cells and/or the CAR.In the YESCARTA PTE application, applicant Cabaret Biotech Ltd. (“Cabaret”) defined the active ingredient as the engineered T cells. After reviewing the PTE application, the USPTO issued a letter to Cabaret, stating that (a) the cells could not be the active ingredient because the cells differ from patient to patient and (b) the CAR was not an active ingredient because it was not defined in the application as filed. Aside from the challenge surrounding the question “What is the active ingredient?” the USPTO also indicated that the applicant’s description of the structure of YESCARTA was insufficient. The USPTO requested that the applicant comment on whether an earlier approved antibody that targeted the same cell-surface protein was actually the first approval for the active ingredient in YESCARTA.The USPTO never squarely addressed what it considered the active ingredient of YESCARTA to be. After multiple communications between the USPTO and Cabaret, and between the USPTO and FDA, the USPTO approved the YESCARTA PTE application. The information the USPTO finally relied upon for determining that YESCARTA was eligible for PTE was the DNA sequence encoding the CAR. It appears that, based upon the differences in sequences between the YESCARTA CAR and the previously approved antibody, the USPTO determined that YESCARTA contained a new active ingredient.Interestingly, YESCARTA is not the first cell-based product with patient-to-patient variability to receive a grant of PTE. LAVIV® (Azficel-T) is an autologous cell product used for treating moderate to severe wrinkles. In its PTE application, Fibrocell Technologies, Inc. described the active ingredient of LAVIV as an autologous cellular product composed of fibroblasts suspended in a particular cell medium, and listed the active ingredient as “fibroblast cells.”[6] Although LAVIV shares the patient-to-patient variability seen in CAR T cells, the USPTO accepted this designation without further comment.The YESCARTA PTE application illustrates the challenges in applying the active ingredient analysis developed in the small molecule realm to biologics technologies. Precisely how the USPTO views the question of what constitutes an active ingredient in cell-based therapies remains an open question that will most likely be resolved by the courts. This uncertainty, however, has not impeded the grant of PTE for these cell-based therapies. Thus, patentees should not be deterred from filing PTE applications to secure an additional patent term for biologics products, but should keep these challenges in mind when drafting the description of the active ingredient in the PTE application.Follow us to stay up to date on developments regarding PTE. [1] Title 21 of the Code of Federal Regulations defines an “active ingredient” as any component that is “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.”[2] Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990).[3] Ortho McNeil Pharm. v. Lupin Pharm., 603 F.3d 1377 (Fed. Cir. 2010).[4] Pfizer Inc. v. Dr. Reddy Labs. Ltd., 359 F.3d 1361 (Fed. Cir. 2004).[5] U.S. Patent No. 7,741,465; received at the USPTO on December 14, 2017.[6] U.S. Patent No. 5,591,444; received at the USPTO on August 17, 2011.

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Dr. Kate You is a member of the firm’s Patent  Group and focuses her practice on patent prosecution and counseling, including  domestic and international patent preparation and prosecution, and litiga