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.

Round Rock Research, LLC v. [Multiple Defendants]

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

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Of Counsel

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 July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a <a href="https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf">Notice</a> in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings before the USPTO or Patent Trial and Appeal Board (PTAB). It is an outgrowth of President Biden’s 2021 <a href="https://lifesciences.mofo.com/topics/biden-administration-executive-order-on-promoting-competition-in-the-american-economy-drug-pricing-and-healthcare-industry-initiatives">Executive Order on Promoting Competition in the American Economy</a>, in which the acting U.S. Food and Drug Administration (FDA) Commissioner <a href="https://www.uspto.gov/sites/default/files/documents/EO14036-FDALettertoPTO.pdf">wrote to</a> the acting USPTO Director highlighting numerous areas in which the USPTO and FDA could work together to reduce drug costs. In particular, the Notice emphasized the duty to disclose material information and statements from communications with the FDA. Companies that make submissions to both the USPTO and the FDA, such as pharmaceutical companies and medical device manufacturers, should pay special attention to the Notice.Disclosing Information Received from the FDAAs part of an abbreviated new drug application (ANDA), generics can provide arguments that patents covering the innovator drug are invalid in a Paragraph IV certification. The Paragraph IV certifications are then communicated to the patent owners by the FDA.The duty of “reasonable inquiry” under 37 C.F.R 11.18(b)(2) requires that each party submitting a paper to the USPTO perform an inquiry that is reasonable under the circumstances to confirm the accuracy and consistency of statements made therein, but does not detail what is involved in a reasonable inquiry.The Notice now expressly clarifies that the duty of reasonable inquiry includes reviewing paragraph IV certifications received by patent owners to determine their materiality to patentability of any pending matters before the USPTO. “If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2),” the Notice states.Additionally, the Notice warns that merely submitting the FDA’s listing of paragraph IV certifications to the USPTO does not satisfy the duty of disclosure, since these lists “do not include patent numbers, relevant claims, or an explanation of the basis for the certification.”Importance of Consistency in Statements Before the USPTO and FDAThe Notice underscores the importance of consistency in statements made before the USPTO and the FDA. Specifically, the Notice states that “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”A recent Federal Circuit decision, <a href="https://cafc.uscourts.gov/opinions-orders/20-1799.opinion.9-1-2021_1828017.pdf">Belcher Pharmaceuticals v. Hospira</a> (Fed. Cir. Sept. 1, 2021), was cited as an example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market—can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.”In <a href="https://www.ipwatchdog.com/2021/09/02/federal-circuit-upholds-delaware-courts-inequitable-conduct-analysis/id=137298/">Belcher</a>, the Federal Circuit affirmed a district court’s ruling that a patent covering a formulation of the drug epinephrine is unenforceable due to inequitable conduct. In a new drug application (NDA) filed with the FDA, Belcher’s Chief Scientific Officer had submitted several prior art references disclosing an “old” pH range for the epinephrine formulation. During prosecution before the USPTO, however, Belcher failed to disclose the references submitted to the FDA, and argued that the claims were patentable because the same pH range was “was unexpectedly found to be critical by the Applicant to reduce the racemization of l-epinephrine.”Key TakeawaysBelcher illustrates the key tension between relying on existing information for regulatory approval and establishing novelty and non-obviousness for patentability purposes. Parties involved in proceedings before the USPTO or PTAB that are seeking FDA approval should take special care to ensure consistency and coordination of strategies. As part of the duty of reasonable inquiry, parties should ensure that information and statements received from or submitted to the FDA are reviewed by both FDA regulatory counsel and patent counsel for potential materiality to patentability and disclosure to the USPTO or PTAB. This duty cannot be avoided by deliberate schemes to prevent individuals with the duty of disclosure from obtaining knowledge of material information, which the Notice indicates is “inappropriate.”Finally, parties should err on the side of disclosure to avoid allegations of inequitable conduct. As stated in the Manual of Patent Examining Procedure and reiterated in the Notice, “[in] close cases where the materiality or consistency of the information is in question, the applicant should consider submitting this information to the USPTO.” Given the significant leadership attention this topic has received at both the FDA and the USPTO, and the political pressure on both agencies to assist in the Biden administration’s efforts to reduce drug costs, the FDA and USPTO are likely both considering enforcement tools that may be employed to ensure appropriate disclosures.

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

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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Patent Agent

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

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

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On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. 

Our <a href="https://federalcircuitry.mofo.com/topics/last-week-in-the-federal-circuit-august-15-august-19-the-court-rebuffs-patent-owner-s-attempt-to-read-anda-application-in-isolation">Federal Circuitry blog</a> recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf">Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc</a>., No. 21-2342.You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA saysFor our case of the week, we turn to the ANDA world. As readers know and in the simplest of terms, an ANDA is an Abbreviated New Drug Application, which a generic drug manufacturer (which we’ll off-and-on refer to as the ANDA applicant) files with the FDA to seek approval to sell a generic version of a brand name drug. Before the generic goes on the market, the brand manufacturer can file an action to enjoin the generic from reaching the market. Ordinarily, it does so under Section 271(e)(2), which makes it an (artificial) act of infringement for an ANDA applicant to file an ANDA that infringes the brand manufacturer’s patent claims. Section 271(e)(2) requires comparing the patent claims to the ANDA’s specification—as the proposed generic product must meet the ANDA’s specifications.<a href="https://federalcircuitry.mofo.com/topics/last-week-in-the-federal-circuit-august-15-august-19-the-court-rebuffs-patent-owner-s-attempt-to-read-anda-application-in-isolation">Read more</a>.

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

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Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. 

Brian R. Matsui

Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

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Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

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Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc., No. 21-2342.

Our Federal Circuitry blog recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/19-2054.OPINION.8-11-2022_1990706.pdf" target="_blank">Hologic, Inc. v. Minerva Surgical, Inc.</a>, No. 19-2054.You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post-MinervaYou have to feel a little sorry for a party that beats the incredible odds of getting Supreme Court review only to end up with the same result. That’s what happened in our case of the week. Unless you’ve been living under a rock (or the proverbial equivalent of a rock in patent-land—the MPEP maybe), you’re no doubt aware of one of the few relatively recent Supreme Court patent cases: <div><a href="https://www.supremecourt.gov/opinions/20pdf/20-440_9ol1.pdf" target="_blank">Minerva Surgical, Inc. v. Hologic, Inc. </a>(And once again, here’s where a few readers shed a tear for what could have been in American Axle.) As a recap, the Supreme Court granted cert to decide whether the doctrine of assignor estoppel found any support in patent law. Assignor estoppel precludes an assignor of a patent from later challenging that patent’s validity. At least initially, smart money was on the “no” side, as nothing in the U.S. Code expressly provides for assignor estoppel, and this is supposedly a textualist Supreme Court.</div>

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express