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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Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole.

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Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action | MoFo Life Sciences

Mark D. McBriar Ph.D.

Bu Yin Ph.D.

Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole.<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> The Supreme Court emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art”<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> and discussed circumstances in which a patent might be determined to be obvious. An objective analysis for determining obviousness includes considering: (1) the scope and content of the prior art, (2) the differences between the prior art and the claims at issue, (3) the level of ordinary skill in the field of art, (4) and any objective indicia of non-obviousness.<a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> Objective evidence of non-obviousness, or “secondary considerations,” includes evidence of commercial success, long-felt but unsolved needs, failure of others, and unexpected results.<a href="#_ftn4" target="_self" id="_ftnref4">[4]</a>Pharmaceutical composition claims and method of treatment claims may often face obviousness rejections and validity challenges involving arguments that a claim feature (e.g., pharmacokinetic parameters or an effect of a therapeutic combination) is inherent. To establish inherency in an obviousness analysis, “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.”<a href="#_ftn5" target="_self" id="_ftnref5">[5]</a> In general, the burden to establish inherency in the obviousness context is high.A prima facie case of obviousness for methods using a combination of known chemical compounds can be overcome if the combination yields unexpected results, such as a synergistic effect.<a href="#_ftn6" target="_self" id="_ftnref6">[6]</a> The precedential decision of In re Couvaras<a href="#_ftn7" target="_self" id="_ftnref7">[7]</a> contains cautions on the importance of distinguishing between unexpected results obtained with a combination of two known pharmaceuticals as opposed to an unexpected mechanism of action – if a claim merely recites a mechanism of action in a known use of a known compound (or a combination of compounds), the claim limitation is likely inherent and cannot be used to overcome a prima facie case of obviousness, even if the mechanism of action is previously unappreciated or surprising.BackgroundInventor John Couvaras filed a patent application for combatting hypertension, with claims directed to methods of increasing the release of prostacyclin in blood vessels by co-administering two antihypertensive agents: (1) a gamma-aminobutyric acid-a (GABA-a) agonist and (2) an angiotensin II receptor blocker (ARB).<a href="#_ftn8" target="_self" id="_ftnref8">[8]</a> During prosecution of the application, Couvaras conceded that GABA-a agonists and ARBs “have been known as essential hypertension treatments for many, many decades.”<a href="#_ftn9" target="_self" id="_ftnref9">[9]</a> The examiner not only agreed, but also found that the results of the compounds’ administration (i.e., increasing prostacyclin release, activating uninhibited GABA-a receptors, and smooth muscle relaxation) were not patentable because they naturally flowed from the administration of known antihypertensive agents.<a href="#_ftn10" target="_self" id="_ftnref10">[10]</a>Patent Trial and Appeal Board (“Board”)Couvaras appealed to the Board, arguing that the mechanism of action recited in the claims, e.g., increasing prostacyclin release, was an unexpected result sufficient to overcome the prima facie case, and thus patentable. Unpersuaded, the Board affirmed the rejection, holding that the claimed result of increasing prostacyclin release was inherent in the obvious administration of the two known antihypertension agents.<a href="#_ftn11" target="_self" id="_ftnref11">[11]</a> In particular, the Board found that the increase in prostacyclin release was “simply a recitation of an inherent, but unknown, property of an otherwise obvious formulation” and that “identifying an inherent result of the combination of GABA and ARB compounds does not constitute a patentable invention unless there is also a showing that the newly discovered inherent result also provides an unexpected benefit.”<a href="#_ftn12" target="_self" id="_ftnref12">[12]</a>Federal CircuitCouvaras appealed to the Federal Circuit, in part arguing that because the increased prostacyclin release was unexpected it cannot be dismissed as having no patentable weight due to inherency, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017).<a href="#_ftn13" target="_self" id="_ftnref13">[13]</a> In rejecting Couvaras’ argument, the Federal Circuit noted that Honeywell “held that ‘unexpected properties may cause what may appear to be an obvious composition to be nonobvious,’ not that the unexpected mechanisms of action must be found to make the known use of known compounds nonobvious.”<a href="#_ftn14" target="_self" id="_ftnref14">[14]</a>After addressing representative independent claim 11, the Federal Circuit noted that the dependent claims included limitations “drawn to dosing amounts and time-release formulations”<a href="#_ftn15" target="_self" id="_ftnref15">[15]</a> and that all of the claims stand or fall based on the analysis provided.<a href="#_ftn16" target="_self" id="_ftnref16">[16]</a>The court further found that Couvaras attempted to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents – “the two antihypertension agents exert the same ultimate result as the two separate compounds were known to effect: a decrease in blood pressure.”<a href="#_ftn17" target="_self" id="_ftnref17">[17]</a> In quoting another Federal Circuit case, the court explained that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”<a href="#_ftn18" target="_self" id="_ftnref18">[18]</a> Thus, even if the mechanisms of action are unexpected, they are still results that naturally flow from the administration of a mixture of compounds, and therefore, are inherent. Unfortunately, Couvaras did not show any benefit of the combination or that the ultimate result from administering the combination is different from that of individually administering the antihypertension agents. In the absence of such an unexpected benefit or result, the mere recitation of a mechanism of action is insufficient to overcome a prima facie case of obviousness.In re Couvaras is informative in that it emphasizes the importance of secondary considerations (e.g., unexpected results) in overcoming prima facie cases of obviousness, particularly in combination therapy cases where individual pharmaceutical active ingredients have known effects that can be related to the claimed effect.Practical Tips for ProsecutionWhen addressing a prima facie case of obviousness, the arguments should be focused on actual unexpected therapeutic results.<a href="#_ftn19" target="_self" id="_ftnref19">[19]</a> Practitioners should consider adding claim limitations that recite the therapeutic result, as the Court noted that Couvaras’ success in establishing unexpected results relied on the demonstration that “the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages.”<a href="#_ftn20" target="_self" id="_ftnref20">[20]</a> This would be consistent with case law where the result of a combination of known compounds is sufficiently surprising, such as when the combination results in an unexpected synergy.<a href="#_ftn21" target="_self" id="_ftnref21">[21]</a>Further, practitioners should keep in mind that “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art”<a href="#_ftn22" target="_self" id="_ftnref22">[22]</a> and a direct or indirect comparison is permissible.<a href="#_ftn23" target="_self" id="_ftnref23">[23]</a> Further, in order to establish unexpected results for an invention, the unexpected results must be commensurate in scope with the claims.<a href="#_ftn24" target="_self" id="_ftnref24">[24]</a>  Arguments associated with an unappreciated mechanism of action may be useful if they are tied to an unexpected ultimate effect (which may, but does not need to be, recited in a claim), otherwise the mere recitation of the mechanism of action in the claim may be discounted as inherent. The additional limitation of the mechanism of action may also make it more difficult to prove infringement. As a result, practitioners should consider avoiding mechanism of action limitations in at least the independent claims and instead focus on establishing the benefits of the claimed subject matter.References<a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> See MPEP §§ 2111-2116.01.<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007).<a href="#_ftnref3" target="_self" id="_ftn3">[3] </a>Graham v. John Deere, 383 U.S. 1, 17-18 (1966).<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> See MPEP § 2141(II).<a href="#_ftnref5" target="_self" id="_ftn5">[5]</a> PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195-96 (Fed. Cir. 2014).<a href="#_ftnref6" target="_self" id="_ftn6">[6]</a> Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014).<a href="#_ftnref7" target="_self" id="_ftn7">[7]</a> In re Couvaras, No. 2022-1489, 2023 WL 3984753 (Fed. Cir. June 14, 2023).<a href="#_ftnref8" target="_self" id="_ftn8">[8]</a> See In re Couvaras, 2023 WL 3984753, at *1.<a href="#_ftnref9" target="_self" id="_ftn9">[9]</a> See id., at *3 (quoting J.A. at 998).<a href="#_ftnref10" target="_self" id="_ftn10">[10]</a> See id. (quoting J.A. at 1011-18).<a href="#_ftnref11" target="_self" id="_ftn11">[11]</a> In re: John L. Couvaras, No. 2022-001037, 2021 WL 6124743, at *3-4 and *7 (P.T.A.B. Dec. 24, 2021) (“Decision”).<a href="#_ftnref12" target="_self" id="_ftn12">[12]</a> See Decision, at *14.<a href="#_ftnref13" target="_self" id="_ftn13">[13]</a> See In re Couvaras, 2023 WL 3984753, at *8 (citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017).<a href="#_ftnref14" target="_self" id="_ftn14">[14]</a> See id. (citing Honeywell International Inc., 865 F.3d at 1355).<a href="#_ftnref15" target="_self" id="_ftn15">[15]</a> See In re Couvaras, 2023 WL 3984753, at *3 (quoting J.A. at 982-87).<a href="#_ftnref16" target="_self" id="_ftn16">[16]</a> See id.<a href="#_ftnref17" target="_self" id="_ftn17">[17]</a> See id., at *8.<a href="#_ftnref18" target="_self" id="_ftn18">[18]</a> See id. (quoting In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012)). See also In re Huai-Hung Kao, 639 F.3d 1057, 1070-71 (Fed. Cir. 2011).<a href="#_ftnref19" target="_self" id="_ftn19">[19]</a> Application of Gershon, 372 F.2d 535, 537 (C.C.P.A. 1967) (explaining that “[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected beneficial results are evidence of unobviousness thereof”).<a href="#_ftnref20" target="_self" id="_ftn20">[20]</a> See In re Couvaras, 2023 WL 3984753, at *9.<a href="#_ftnref21" target="_self" id="_ftn21">[21]</a> See Sanofi-Aventis Deutschland GmbH, 748 F.3d at 1354.<a href="#_ftnref22" target="_self" id="_ftn22">[22] </a>In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).<a href="#_ftnref23" target="_self" id="_ftn23">[23] </a>In re Payne, 606 F.2d 303, 316 (C.C.P.A. 1979). See also In re Merchant, 575 F.2d 865, 869 (C.C.P.A. 1978) and In re Blondel, 499 F.2d 1311, 1317 (C.C.P.A. 1974).<a href="#_ftnref24" target="_self" id="_ftn24">[24] </a>In re Clemens, 622 F.2d 1029, 1035 (C.C.P.A. 1980).

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