Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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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In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

Josephine Garban, Patent Agent in New York and San Diego, contributed to this article.Stacy Cline Amin, Kristen Mathews, and Rachel Park co-authored an article for Law360 that discusses the FBI’s private industry notification reminding medical device companies that cybersecurity has to be front of mind.They wrote, "The FBI specifically highlighted the vulnerability of underlying software life cycles, which are often specified by the manufacturer and aid in providing cyber threat actors time to discover and exploit weaknesses. The FBI warned that outdated software which is not compatible with security patches and updates are prone to cyberattacks."Read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt4b41f875e4041f8f/635aae091012fd7700084d64/221025-cybersecurity-expectations-medical-device.pdf" target="_blank">full article</a>.

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Cybersecurity Expectations Intensify for Medical Device Cos.

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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Stacy Cline Amin, Kristen Mathews, and Rachel Park co-authored an article for Law360 that discusses the FBI’s private industry notification reminding medical device companies that cybersecurity has to be front of mind.

Cybersecurity Expectations Intensify for Medical Device Cos.

Having a clear picture of financing options is key for early-stage companies and will be relevant to players in the alternative protein industry generally, given the significant amounts of investment that the industry has seen in recent years (a record US $5bn was invested in 2021) and the rapid growth we are seeing in companies in this sector.Read the <a href="https://www.mofo.com/resources/insights/221020-financing-options-for-an-early-stage-company?utm_source=publication&utm_medium=email" target="_self">full client alert</a>.

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

Simon Arlington

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

Michelle Si-Ting Luo

Michelle Luo

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Financing Options for an Early Stage Company in the Alternative Protein Industry

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Having a clear picture of financing options is key for early-stage companies and will be relevant to players in the alternative protein industry generally, given the significant amounts of investment that the industry has seen in recent years (a record US $5bn was invested in 2021) and the rapid growth we are seeing in companies in this sector.

Financing Options for an Early Stage Company in the Alternative Protein Industry

Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends. The rise of telehealth services during the COVID-19 pandemic resulted in new and adapted forms of fraud, and Kate offers predictions for where law enforcement will focus attention in the future and how to mitigate exposure. <a href="https://www.americanbar.org/groups/health_law/voices-in-health-law/telehealth-fraud-enforcement/" target="_blank">Listen to the podcast</a>.

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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices

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Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends.

Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices

Patent Term Adjustment (PTA) is additional patent term for U.S. patents to compensate for delay in issuance. The statute (35 U.S.C. § 154(b)) provides three bases for PTA: delayed response by the USPTO (“A delay”), failure to issue a patent within three years (“B delay”), and delay due to appeal (“C delay”). For C delay, patent term is extended for “appellate review by the Patent Trial and Appeal Board or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability.”In Sawstop v. Vidal, the Federal Circuit read the italicized statutory language for C delay narrowly, thereby limiting the likelihood of an appeal conferring additional PTA. First, the Court read “reversing an adverse determination of patentability” to require that a claim after appeal be “substantively allowable, not just free of a particular rejection.”[1] Second, the Court read “the patent was issued under a decision in the review” to require that the claim not “differ[] substantively” from appeal to issuance. [2] While the Court addressed two different patents, its analysis of U.S. Patent No. 9,522,476 (“’476 patent”) exemplifies its narrow reading of the statutory language.During the prosecution of the ’476 patent, claim 11 was finally rejected as obvious based on a combination of references. On appeal, the Patent Trial and Appeal Board (PTAB) found that the Examiner had not made the requisite findings of fact regarding combining certain figures of a reference in the combination, but found claim 11 nonetheless obvious over the same combination. The PTAB thus reversed the Examiner’s rejection, but issued a new ground of rejection. On remand, Sawstop reopened prosecution to address the new ground of rejection. After several amendments, claim 11 was allowed and issued as claim 1 in the ’476 patent. The USPTO did not grant any PTA for the time spent on the appeal. Sawstop appealed this PTA determination to a district court, which granted summary judgment to the USPTO. Sawstop then appealed to the Federal Circuit.On appeal, Sawstop argued that the overturning of the Examiner’s rejection at the PTAB was “reversing an adverse determination of patentability,” thereby triggering C delay adjustment. The Court disagreed. It read “patentability” as requiring the claim to be “substantively allowable.”[3] Because claim 11 remained rejected before and after the PTAB appeal, the appeal resulted “in no substantive change in the patentability of claim 11.”[4] The reversal of a “mere ‘rejection’” in this scenario did not mandate PTA, according to the Court.[5]The Court found that Sawstop was not entitled to PTA for an additional reason. To address the new ground of rejection, Sawstop reopened prosecution and amended claim 11 to obtain issuance. Sawstop argued that claim 11 would not have issued but for the successful appeal and its accompanying delay. Once again, the Court disagreed that this was enough to warrant a C delay adjustment. It noted that the statutory language provides that the “patent was issued under a decision in the review.” To the Court, this language required that “at least one claim that ‘issued’ must have been analyzed by the Board or District Court that issued the ‘decision in review.’”[6] Because issued claim 11 differed substantively from claim 11 on appeal, no PTA was warranted.The Sawstop decision narrows the reading of the statutory language for C delay adjustments. Arguably a rejection is an “adverse determination of patentability,” such that overcoming a rejection on appeal is reversing such a determination. To require an allowable claim removes entire classes of appeal outcomes—e.g., where there is a new ground of rejection—from PTA. Furthermore, the Court’s gloss on “issued under a decision in a review” precludes substantive amendment post-appeal on a surviving claim. But the Court emphasized that C delay was not “intended to categorically compensate applicants for all appellate delays that were the applicant’s fault.”[7] Given this policy determination, practitioners should carefully consider how to structure their appeals for both success on appeal and maximum potential for PTA. For example, it may be worthwhile to curate a claim set ahead of appeal with several layers of narrower claims. Such narrow claims may be found allowable on appeal. And layering increases the chances that at least one claim after appeal survives through issuance without being substantively changed. Otherwise applicants may find themselves in Sawstop’s position—successfully navigating years of appeal without any patent term adjustment to show for those efforts.[1] Sawstop slip opinion at 8.[2]Id. at 11.[3] Id. at 11.[4] Id. at 8.[5] Id. at 8.[6] Id. at 9.[7] Id. at 12.

Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop

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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.

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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Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop

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Patent Term Adjustment (PTA) is additional patent term for U.S. patents to compensate for delay in issuance.

For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims against food manufacturers based on allegations that consumers were misled by a product’s marketing into believing that the product was more “healthy” than it really is.Read the <a href="https://classdismissed.mofo.com/topics/241022-water-is-in-white-bread-is-out-healthy-gets-a-new-look-in-2023" target="_blank">full blog post</a>.

Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023