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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On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled “The USPTO‑FDA Collaboration: A Discussion of Recent Activity and Possible Next Steps,” included two representatives from the USPTO—Deputy Commissioner Bob Bahr and Acting Vice Chief APJ Linda Horner—and three attorneys from Morrison Foerster—Stacy Cline Amin, Mehran Arjomand, and Jean Nguyen. Together the panelists discussed how both federal agencies are working together to improve the patent system in an effort to address drug pricing in the United States. The possible changes to the patent system have potentially far-reaching implications, not only in the life sciences, but also in other industries. But companies still have the opportunity to steer these possible changes by submitting written comments related to the USPTO-FDA collaboration by February 6, 2023, or by submitting written comments related to the USPTO examination and continuation practice by February 1, 2023. Key themes and takeaways from the webinar are detailed below.USPTO-FDA CollaborationOn July 9, 2021, President Biden issued an <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/">Executive Order on Promoting Competition in the American Economy</a> that called for action to ensure that the patent system does not unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law. The Order stirred up a series of letters, including a <a href="https://www.uspto.gov/sites/default/files/documents/EO14036-FDALettertoPTO.pdf">September 2021 letter</a> from Acting FDA Commissioner Woodcock to the USPTO. Commissioner Woodcock stated that addressing drug competition and access to more affordable medicine was a top priority of the administration, the Department of Health and Human Services, and the FDA. To that end, Commissioner Woodcock raised several concerns about how the patent system is being misused through what she referred to as “patent thickets,” “evergreening,” and “product-hopping.” She invited the USPTO to collaborate with the FDA to address drug pricing issues. USPTO Director Vidal responded positively in a <a href="https://www.uspto.gov/sites/default/files/documents/PTO-FDA-nextsteps-7-6-2022.pdf">July 2022 letter</a> by providing potential USPTO initiatives to incentivize innovation in the pharmaceutical space without unnecessarily delaying access to low-cost medicines.That exchange has led to the first steps in the agencies’ collaboration. For example, Judge Horner noted the USPTO and the FDA are currently working together to assess and analyze patent exclusivity and drug approval data from approximately 10–15 drugs. Further, Judge Horner stated that the “first steps are to collaborate through information sharing and cross training.” Notably, the USPTO hosted the FDA for a <a href="https://www.uspto.gov/initiatives/uspto-fda-collaboration/engagements#:~:text=The%20United%20States%20Patent%20and%20Trademark%20Office%20%28USPTO%29,documents%20in%20Patent%20Trial%20and%20Appeal%20Board%20proceedings.">training event</a> where the USPTO showcased how prior art determinations are made. The FDA, in turn, is now preparing training for the USPTO on locating publicly accessible FDA material for prior art determinations.The collaboration also led to the USPTO publishing a <a href="https://www.federalregister.gov/documents/2022/11/07/2022-24107/joint-uspto-fda-collaboration-initiatives-notice-of-public-listening-session-and-request-for">Notice of Public Listening Session and Request for Comments on Joint USPTO-FDA Collaboration Initiatives</a> on November 7, 2022.This upcoming listening session is an opportunity for public input from a broad group of public stakeholders on areas for USPTO-FDA collaboration and engagement. Areas for comment include:<ul><li>Publicly available FDA resources for USPTO patent examiner training;</li><li>Tools for the USPTO and the FDA to identify inconsistent statements submitted to the two agencies;</li><li>How America Invents Act (AIA) proceedings intersect with Hatch-Waxman Paragraph IV and BPCIA “patent dance” litigation;</li><li>How the USPTO and the FDA can further collaborate with respect to patent term extension (PTE) determinations;</li><li>Policy considerations or concerns regarding method of use patents, FDA use codes, and “skinny labeling”;</li><li>Policy considerations or concerns regarding risk evaluation and mitigation strategies (REMS) associated with certain FDA-approved products;</li><li>“[C]oncerns about the potential misuse of patents to improperly delay competition or to promote greater availability of generic versions of scarce drugs that are no longer covered by patents”; and</li><li>Any other comments related to the USPTO-FDA collaboration.</li></ul>With such significant topics up for comment and both agencies at the table, those interested in the outcome should attend the upcoming January 19, 2023 <a href="https://www.uspto.gov/about-us/events/joint-uspto-fda-public-listening-session-collaboration-initiatives">Public Listening Session</a> and submit comments. Those who wish to speak must <a href="https://www.uspto.gov/about-us/events/joint-uspto-fda-public-listening-session-collaboration-initiatives">register</a> by January 5, while those who wish to attend but not speak must register by January 17. Further, the period for submitting <a href="https://www.regulations.gov/document/PTO-P-2022-0037-0001">written comments</a> closes on February 6, 2023.Duty of Disclosure and Duty of Reasonable InquiryA September 2021 letter from Senator Leahy and Senator Tillis to the USPTO arguably prompted the USPTO to publish another notice, a <a href="https://www.federalregister.gov/documents/2022/07/29/2022-16299/duties-of-disclosure-and-reasonable-inquiry-during-examination-reexamination-and-reissue-and-for">Notice on the Duties of Disclosure and Reasonable Inquiry</a>, on July 29, 2022. The Notice clarified the duty of disclosure and duty of reasonable inquiry, namely (i) who has the duty to disclose material information, (ii) what material information must be disclosed, (iii) what is the duty of reasonably inquiry, and (iv) that deliberate schemes not in accordance with candor and good faith are prohibited. A <a href="https://lifesciences.mofo.com/topics/recent-biden-administration-efforts-on-drug-pricing-uspto-notice-focuses-on-eliminating-inconsistencies-in-uspto-fda-statements">MoFo blog post</a> previously discussed this Notice.The panel had the benefit of obtaining Deputy Commissioner Bahr’s insight on two key aspects of the Notice. First, the Notice “has no real independent force in effect.” Instead of changing the USPTO’s position, “it simply informs the public of how the PTO sees these two [duties] as interplaying together in this particular area.” Second, the duty of reasonable inquiry applies even when a patent practitioner has no actual knowledge of an FDA submission. As Deputy Commissioner Bahr explained, “the attorney should really know what is being said by a company to different agencies concerning the same invention.” While there are no “per se rules” because “reasonable” depends on the exact circumstances, “if you have an invention and it’s something that you know you’re going to get FDA approval for, or need FDA approval for, there should be some check into what is being said to the different agencies.”The panelists also discussed potential enforcement mechanisms to ensure the duty of disclosure has teeth. Would inconsistent statements be considered false or misleading statements by the Department of Justice (DOJ), thereby allowing DOJ to employ traditional criminal tools, or tools under the Federal Food, Drug, and Cosmetic Act, to address the issue? While such DOJ enforcement would be unprecedented, Stacy Cline Amin noted that many actions the agencies have already taken would have been considered third rails in the past. And such scrutiny aligns with the DOJ’s increased focus on enforcement in the life sciences industry.USPTO Examination and Continuation PracticeThe above-discussed letters, along with a June 2022 letter from a group of Senators identifying the patent thickets issue, arguably led to yet another Notice. On October 4, 2022, the USPTO published a <a href="https://www.federalregister.gov/documents/2022/10/04/2022-21481/request-for-comments-on-uspto-initiatives-to-ensure-the-robustness-and-reliability-of-patent-rights">Notice for Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights</a>. This Request for Comments (RFC) included questions from the Senators’ letter and the USPTO initiatives proposed in Director Vidal’s <a href="https://www.uspto.gov/sites/default/files/documents/PTO-FDA-nextsteps-7-6-2022.pdf">July 2022 letter</a> related to:<ul><li>Specific sources of prior art not currently available through the Patents End-to-End Search system;</li><li>Changes, if at all, to claim support and/or continuation practice;</li><li>Changes, if at all, to request for continued examination (RCE) practice;</li><li>Changes, if at all, to restriction, divisional, rejoinder, and/or non-statutory double patenting practice;</li><li>How eliminating terminal disclaimers would affect patent prosecution strategies and patent quality;</li><li>Whether filing a terminal disclaimer should be an admission of obviousness;</li><li>Whether the USPTO should require a second look before issuing a continuation patent on a first office action;</li><li>Whether there should be heightened examination requirements for continuation patents;</li><li>Setting a time limit for filing continuation applications relative to the original application;</li><li>Increasing up-front fees to reflect the actual cost of obtaining a patent; and</li><li>Any other comments related to ensuring robustness and reliability of patent rights.</li></ul>Deputy Commissioner Bahr named a number of ideas floating around at the USPTO: (i) “increas[ing] the sampling rate for continuation applications . . . we could possibly do a better job of making sure that the claims are fully supported by the original disclosure”; (ii) “increas[ing] the amount of examining time”; or (iii) “assigning cases after a certain number of continuations to a different examiner than examined the parent to ensure that those cases get a completely fresh look.” Deputy Commissioner Bahr further discussed the USPTO’s initiatives with comparing the USPTO examination and issuance practice for pharmaceutical patents to the practices by patent offices in other countries. Although this initiative is in its nascency and is a long-term project, he emphasized that the USPTO Office of International Legislative Affairs is familiar with patenting practices in other countries and coordinates with the USPTO’s counterparts around the world. The duty of disclosure may extend beyond other U.S. government agencies like the FDA, so companies should ensure they make consistent statements both domestically and internationally.Changes made in response to the RFC will likely have a significant impact on patent rights and procedures. As Judge Horner noted, any future rulemaking is not specific to just pharmaceutical patents but would also apply to all technologies. Interested parties should be sure to submit <a href="https://www.regulations.gov/document/PTO-P-2022-0025-0001">written comments</a> before the comment period closes on February 1, 2023. Notably, the comment period for the USPTO examination and continuation practice Notice ends before the comment period for the USPTO-FDA collaboration Notice.PTAB and the USPTO/FDADirector Vidal’s <a href="https://www.uspto.gov/sites/default/files/documents/PTO-FDA-nextsteps-7-6-2022.pdf">July 2022 letter</a>responsive to the FDA also mentioned improving the process for challenging issued patents before the Patent Trial and Appeal Board (PTAB). Director Vidal indicated that the USPTO will work with the FDA to study filings of AIA proceedings on Orange Book-listed patents and biologic patents.Judge Horner noted that the “USPTO conducted internal studies . . . [that] showed that only 4% of all AIA petitions challenge orange book listed patents [and] only 2% of all AIA petitions challenged biologic patents . . . .” The “study also revealed [that] challenges to both Orange Book and biologic patents have decreased over time.” Judge Horner noted that this is a unique area, with potential timing and estoppel implications due to Hatch-Waxman and the BPCIA. Nonetheless, the USPTO, according to Judge Horner, is exploring whether anything can be done “to facilitate” the use of these proceedings when it makes sense to do so.The <a href="https://www.federalregister.gov/documents/2022/11/07/2022-24107/joint-uspto-fda-collaboration-initiatives-notice-of-public-listening-session-and-request-for">Notice of Public Listening Session and Request for Comments on Joint USPTO-FDA Collaboration Initiatives</a> notes the intersection of AIA proceedings with Hatch-Waxman paragraph IV disputes and the BPCIA patent dance framework as being a discussion topic during the January 19, 2023 <a href="https://www.uspto.gov/about-us/events/joint-uspto-fda-public-listening-session-collaboration-initiatives">Public Listening Session</a>. Some panelists noted that perhaps the Hatch-Waxman statutory framework makes PTAB challenges unattractive. This is an area that the USPTO and the FDA are hoping for comments on and even discussion of at the Public Listening Session. This area is important for companies in the life sciences industry to focus on, as it could be ripe for potential policy reform by the agencies and/or Congress.ConclusionMorrison Foerster panelists noted that there was not enough time to discuss other hot topics such as skinny labels, REMS patents, the Orange Book, and patent term extensions/adjustments, just to name a few. These topics as well as the ones discussed in the webinar are going to be on the agenda for the joint USPTO-FDA Public Listening Session on January 19, 2023, and potentially the subject of future webinars.At Morrison Foerster, our FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Patent Practice Group to ensure that life sciences companies remain compliant with all federal and state requirements. The USPTO and the FDA are working together in an unprecedented collaboration to reduce the cost of drugs, and the agencies are specifically calling on industry to inform the trajectory of the outlined initiatives. If your company is potentially affected by these ongoing changes, please contact MoFo’s life sciences team so that we can ensure you have a chance to influence USPTO and FDA activity before it is too late.Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this post.

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Mehran Arjomand is chair of the firm's Patent Trial and Appeal Board Practice and heads the firm's technology patent practice. Mr. Arjomand began his legal career as a litigator. After five years, he 

Mehran Arjomand

Mehran Arjomand is chair of the firm's Patent Trial and Appeal Board Practice and heads the firm's technology patent practice. Mr. Arjomand began his legal career as a litigator. After five years, he joined Morrison & Foerster, where he developed a strong foundation in USPTO prosecution and procedure. With his combined litigation and prosecution experience, he is able to counsel clients on end-to-end strategies—from patent creation to patent challenges.

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Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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The USPTO and the FDA Join Hands to Promote Competition

Is 2021 the Value-Based and Shared Savings Revolution?

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On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA).

The USPTO and the FDA Join Hands to Promote Competition

On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes a wide range of payment policies that can have significant and widespread effects on various aspects of the healthcare provider community. This article highlights how provisions in the 2023 Fee Schedule could affect telehealth companies in the upcoming year.Medicare Telehealth Services NarrowedEvery year, CMS reviews requests by the public to add or delete certain services on the Medicare Telehealth Services List for reimbursement. Under the CMS process for review, the proposed services are assessed to determine whether they qualify under one of three categories of services: (a) Category 1 Services, which are permanently added to the Telehealth Services List because they are similar to professional consultations, office visits, and office psychiatry services that are currently on the Telehealth Services List; (b) Category 2 Services, which are permanently added to the Telehealth Services List because, although they are not similar to current telehealth services, use of telecommunications systems to furnish the services produces demonstrated clinical benefits to the patients; and (c) Category 3 Services, which are temporarily added to the Telehealth Services List because there are likely to be clinical benefits when the services are furnished via telehealth systems, but there is not yet sufficient evidence available to consider the services for permanent addition under the Category 1 or Category 2 criteria. During the pandemic’s Public Health Emergency (PHE), CMS added many services to the Telehealth Services List under Category 3. In this rulemaking, CMS reassessed the services that were made temporarily available via telehealth systems for the PHE.In calendar year 2020, CMS added more than 135 new Medicare telehealth services to its Medicare Telehealth Services List. In contrast, under the 2023 Fee Schedule, CMS added very few new telehealth codes, while maintaining a group as Category 3 temporary codes, and will also be eliminating many telehealth services after the expiration of the PHE. <ul><li>Permanent New Telehealth Services Added. CMS permanently added five codes to its Category 1 Telehealth Services List –G0316, G0317, G0318, G30002, and G3003 ‒ which provide for reimbursement of prolonged services (e.g., nursing facilities) and chronic pain management. Generally, CMS determined that these services provided via telehealth consultations were similar to services already on the Telehealth Services List.</li><li>Temporary Telehealth Services. Another 15 services that were added because of the PHE are being moved to Category 3 codes. The codes will be included on the Telehealth Services List through 2023 to allow time to evaluate data that may support their permanent addition to the list on a Category 1 or Category 2 basis. The codes cover a wide array of services. See Table 12 at 87 Fed. Reg. 69458 (Nov. 18, 2022). </li><li>Telehealth Services Eliminated. Most notably, CMS announced that 54 of the 263 codes that had been temporarily available due to the PHE, will remain on the Telehealth Services List for the later of 151 days after the expiration of the PHE, or December 31, 2023. After such date, the announced services will not be included in the services payable by CMS. See 87 Fed. Reg. 70,186‒70,187. In short, CMS determined that those services would not be furnished using the full scope of required service elements via two-way video communication, as though the services were provided in person. </li></ul>Telehealth Flexibilities for Originating Site, Types of Telehealth Practitioners, and Audio-Only ServicesMajor Temporary Flexibilities Will EndDuring the course of the PHE, CMS has exercised its authority granted under various legislation to waive or modify certain Medicare telehealth payment requirements. In this final rulemaking, CMS again restated that the following modifications would expire:<ul><li>Removal of the geographic and site of service originating site restrictions;  </li></ul><ul><li>Removal of restrictions on types of practitioners who can provide telehealth services; and</li><li>Allowing certain services to be provided via audio-only methods.</li></ul>As a result, on the date that is 151 days after the end of the PHE or December 31, 2023, whichever is applicable, the following restrictions will again apply to Medicare telehealth services (see generally 42 C.F.R. 410.78):<ul><li>Medicare reimbursement will not be allowed for telehealth visits furnished to patients who are at home, except for certain services. Patients will again be required to be physically present in an office, clinic, or medical facility within a rural area, for most services.</li></ul><ul><li>Medicare reimbursement for telehealth visits furnished by physical therapists, occupational therapists, speech language pathologists, and audiologists will no longer be allowed.</li><li>Medicare will no longer cover audio-only visits for physical health encounters.</li></ul>Permanent Changes for Substance Use Disorders and Mental Health DisordersCertain changes for telehealth services related to substance abuse disorders and mental health disorders, however, were made permanent through statute:<ul><li>For treatment of (a) a substance use disorder (SUD) or (b) a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with an SUD diagnosis, there are no geographic restrictions and telehealth services may be provided to the patient at their home as a permissible originating site.</li></ul><ul><li>For diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished at or after the end of the PHE for COVID-19, there are no geographic restrictions and telehealth services may be provided to the patient at their home as a permissible originating site. Significantly, the statute prohibits payment for telehealth services furnished in patients’ homes under this provision, unless the physician or practitioner furnishes an item or service in person, without the use of telehealth communication, within six months prior to the first time the physician or practitioner furnishes a telehealth service to the patient, and thereafter, once every 12 months.  CMS clarified in its comments, however, that if a beneficiary began receiving mental health telehealth services during the PHE, or during the 151-day period after the end of the PHE, then they would not be required to have an in-person visit within six months; rather, they will be considered established and will instead be required to have at least one in-person visit every 12 months (so long as any such subsequent telehealth services are furnished by the same individual physician or practitioner (or a practitioner of the same sub-specialty in the same practice) to the same beneficiary). This means that these services would be subject to the requirement that an in-person visit is furnished within 12 months of each mental health telehealth service for those services that are subject to in-person visit requirements (unless an exception is documented by the treating practitioner).</li></ul>Direct Supervision of Clinical StaffDuring the course of the PHE, CMS has changed the definition of “direct supervision” as it pertains to supervision of diagnostic tests, physicians’ services, and some hospital outpatient services, to allow the supervising professional to be immediately available through virtual presence using real-time audio/video technology, instead of requiring their physical presence. In the final rulemaking, CMS determined that this flexibility for virtual supervision, would no longer apply.After the end of the calendar year in which the PHE ends, then, Medicare telehealth services may no longer be performed by clinical staff incident to the professional services of the billing physician or practitioner who only provides virtual supervision. The rules will revert back to the original requirements where “direct supervision” will again require the immediate, in-person, physical availability of the supervising physician or other practitioner, although the professional need not be present in the same room during the service.Remote Therapeutic MonitoringRemote Therapeutic Monitoring (RTM) is the use of medical devices to monitor a patient’s health or response to treatment using non-physiological data.  RTM is used to actively monitor a patient’s musculoskeletal activity and respiratory activity, as well as medication response and adherence, and response to therapy. Generally, CMS emphasized its continuing goals of enhancing access to RTM and allowing the codes to reflect a broad range of clinical activities and use of various levels and involvement of auxiliary staff. CMS also took into consideration whether some of the complexities of coding for RTM could be eliminated. In the end, however, CMS made few changes to its payment policies for RTM. CMS declined to establish a generic RTM device code that is agnostic to the specific body system involved (e.g., musculoskeletal or respiratory) or therapy type (e.g., medication therapy response) that the device monitors, but promised to consider this in a future rulemaking. Additionally, CMS declined to adopt any new G-codes that would have reflected more flexibilities around provision of services by auxiliary clinical staff and supervision thereof. Instead, CMS chose to maintain its current policies for the existing RTM treatment management CPT codes, with two notable clarifications. First, CMS is allowing “general” supervision (as opposed to the more cumbersome “direct” supervision) for all RTM services. “General” supervision means the procedure is furnished under the billing provider’s overall direction and control, but the billing provider’s presence is not required during the procedure. This modification provides additional flexibility for the provision of services by certain clinical auxiliary personnel (e.g., lower-level licensed or unlicensed personnel). Second, CMS did adopt a new CPT code for cognitive behavioral therapy monitoring devices, indicating its continued support of RTM services.Since 2019, when CMS first adopted payment policies for remote physiological monitoring (RPM), the offerings for remote monitoring services have exploded. Just as CMS quickly but methodically developed policies for RPM, the final rulemaking indicates that steps towards a fully developed regulatory framework in this area will be incremental. Digital health companies interested in expanding into varied remote monitoring services should closely watch developments under the federally funded programs. Not only do these programs cover a large portion of patients of healthcare services in the United States, but the policies and regulations adopted by CMS strongly influence how commercial payors structure their own offerings and reimbursement strategies. Developments in this area over the next year will be key in shaping pricing models, as well as care delivery models for remote monitoring companies.Key TakeawaysTelehealth companies providing services to Medicare patients will be significantly impacted by the modifications to telehealth services that are reimbursable in 2023, as well as the major shift in the manner in which reimbursable telehealth services will be provided at the end of the PHE. Even those telehealth companies serving non-Medicare populations should consider the impact of these changes on their businesses. Many commercial and Medicare Advantage health plans use the CMS Physician Fee Schedule and associated policies for other lines of business, often in a blanket manner. Many of the shifts that will be occurring in 2023 and beyond will affect the operational, as well as financial, aspects of any business that works with health plans that adopt the Medicare payment policies.Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this post.

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes a wide range of payment policies that can have significant and widespread effects on various aspects of the healthcare provider community. This article highlights how provisions in the 2023 Fee Schedule could affect telehealth companies in the upcoming year.

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This is the first such consultation completed by the agency and, while not a formal approval process, means that FDA has no further questions about UPSIDE’s conclusions that (1) its production process is safe and (2) its cultured chicken cell products are as safe as comparable foods, like traditionally produced chicken leg meat.Human food produced using animal cell culture technology is subject to an interagency regulatory framework between FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and USDA’s Food Safety and Inspection Service (FSIS). <a href="https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell" target="_blank">Under the agencies’ formal agreement</a>, both agencies agreed to a regulatory framework in which CFSAN regulates the initial steps of cell collection, cell banking, and cell differentiation. Once the cells are removed from their sealed growth environments at the harvest stage, FSIS oversees their further processing, labeling, and packaging.To market its product, UPSIDE will still need to meet additional FDA requirements, such as food facility registration, and will need a grant of inspection from FSIS for the manufacturing establishment. The product itself also must bear a USDA mark of inspection. USDA has yet to issue any guidance or regulations addressing product labeling, so many questions remain regarding how cell-cultured foods can be marketed. If <a href="https://www.federalregister.gov/documents/2021/09/03/2021-19057/labeling-of-meat-or-poultry-products-comprised-of-or-containing-cultured-animal-cells" target="_blank">FSIS’s advance notice of proposed rulemaking</a> is any indication, the agency’s eventual rulemaking on these issues will be hotly contested by industry and other interest groups.UPSIDE submitted a <a href="https://www.fda.gov/media/163262/download" target="_blank">Premarket Notice for Integral Tissue Culture Poultry Meat</a> to FDA on October 1, 2021, and amended it multiple times in response to FDA’s requests for further information and points of clarification. FDA was particularly interested in the genetic engineering method UPSIDE uses to immortalize its cell lines, and its ability to maintain single-species lines free from microbial or chemical contamination. The consultation process spanned over a year and covered every step of the cell culture process, including (1) how the cells are isolated, (2) how the cell bank is maintained and monitored, (3) how the cells are multiplied and differentiated, and (4) how the cell material is harvested.<div class="embedded-entry redactor-component block-entry" type="entry" data-sys-entry-uid="blt55bed3bf86d934f6" data-sys-entry-locale="en-us" data-sys-content-type-uid="image_content" sys-style-type="block"><div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt42e24a20d96e86cd/637ce41176567a10a7cbb880/cultured-animal-cells-flowchart-what-fda-evaluated-in-first-pre-market-consultation.png?format=auto&amp;quality=60" alt="cultured animal cells flowchart what fda evaluated in first pre market consultation"></div></div>FDA invites additional consultations from cultured meat producers looking to enter the U.S. market. “FDA is ready to work with additional firms,” and <a href="https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development" target="_blank">intends to release new guidance</a> on its process for regulating animal cell cultured foods by the end of 2022. Cultured meat and other novel food producers should rejoice: FDA is committed to supporting innovation in the food supply. We are very much looking forward to browsing the cell cultured aisle of the local supermarket and cannot wait to be able to sample the cell cultured products of our clients!

FDA Clears the Path to Lab-Grown Meat

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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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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Clears the Path to Lab-Grown Meat

De Novo Classification Final Rule to Take Effect Next Year

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On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken.

On November 8, 2022, FDA issued a draft guidance document on <a href="https://www.fda.gov/media/163018/download" target="_blank">Sameness Evaluations in an ANDA — Active Ingredients</a> (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass noncovalent derivatives. Importantly, the active ingredient can take a different physical form than the active ingredient in the reference listed drug (RLD), and FDA will not consider this as relevant in determining sameness. FDA also noted that the active ingredient in a drug product “may undergo a change in chemical form during drug product manufacture such that the active ingredient is converted to a different chemical form.” In such cases, FDA considers the converted chemical form to be the active ingredient, and ANDA filers should use the converted form, as present in the final dosage of the RLD, for comparison when demonstrating sameness.Distinguishing Sameness Evaluation in Different Classes of Small Molecule DrugsThe Draft Guidance offers specific discussion on active ingredient sameness in synthetic peptides and complex mixtures. As to synthetic peptides, FDA noted that sameness can “generally be established through physicochemical characterization and biological evaluation,” and while compendial standards may be available for some peptides, FDA still recommends that ANDA applications conduct comparative testing of the generic peptide to the RLD. For complex mixtures, FDA “evaluates all relevant data in the ANDA and other relevant scientific information to determine whether an active ingredient of a complex mixture has been adequately characterized for the purposes of assessing active ingredient.” FDA noted that, while some complex mixtures may have multiple active ingredients, they will not be considered a fixed-drug combination product as they have not been intentionally combined. ANDA filers should characterize constituent components in the generic peptide in reference to the RLD by running multiple batches on both products under similar conditions, and then comparing the two. If the comparison test shows that the complex mixture contains a well-characterized component, “the [filer] should propose ranges for each molecule in common based on the comparative testing,” and provide explanation for why any differences are acceptable. As to other small molecule drugs, FDA encourages ANDA filers to review product-specific guidance documents, which may indicate how FDA will evaluate active ingredient sameness.Active Ingredient Sameness Evaluations and Engaging with FDAIn the Draft Guidance, FDA reiterated its commitment to working with industry through the controlled correspondence process and pre-ANDA meetings to ensure that ANDA filers are utilizing an appropriate method to determine sameness. Interestingly, FDA doubled down on its commitment “to reduce, refine, and replace animal use in testing when feasible,” and FDA encouraged sponsors to consult with FDA as to whether there is an appropriate alternative method to test for equivalency. FDA also committed to updating guidance documents relevant to demonstrating sameness to reflect the appropriate methodology as informed by the evolution of scientific understanding and technology. Finally, <a href="https://www.regulations.gov/docket/FDA-2022-D-0697" target="_blank">FDA is seeking comment</a> on the Draft Guidance, and with the request for comment closing on January 8, 2023, affected members of industry should consider working with counsel to file a comment sooner rather than later. Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this alert.

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

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FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

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On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). 