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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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

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In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public.The Court of Justice of the European Union (“CJEU”) ruled in its decision of June 28, 2019 (<a href="http://curia.europa.eu/juris/document/document.jsf?docid=215581&text=&doclang=EN&part=1&occ=first&mode=LST&pageIndex=0&cid=1772522">Case T-377/18</a>), that a pharmaceutical company cannot invoke the exceptions of <a target="_blank" href="http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf">Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents</a> (the “Regulation”) to prohibit public access to a periodic benefit-risk evaluation report submitted in the context of a marketing authorization of a medicinal product.  The exceptions to the Regulation for protection of court proceedings or commercial interests must be interpreted and applied strictly, as such exceptions derogate from the Regulation’s objective of ensuring the widest possible access to documents.Background to the DisputeIn the context of a communication of the Food and Drug Administration (FDA, United States) concerning the safety of a medicinal product and a drop in the share price followed by a lawsuit filed by shareholders in the U.S. against the pharmaceutical company manufacturing the medicinal product (the “DeSmet lawsuit,” a so-called stock drop lawsuit), a law firm requested access to several documents from the European Medicines Agency (“EMA”) relating to the marketing authorization of the medicinal product in question.  Despite the fact that the pharmaceutical company proposed redactions of specific sections of the report relating to the safety of the medicinal product with regard to the disclosure request, EMA decided to disclose the report without the proposed redactions.  The pharmaceutical company challenged EMA’s decision.Decision of the CJEUThe CJEU approved EMA’s decision to grant access to documents submitted in the context of a marketing authorization of the medicinal product, and found that the exceptions of the Regulation did not apply in this case. Exception to publication applies to documents relating to court proceedings (second indent of Art. 4(2) of the Regulation)The CJEU ruled that this exception only applies to documents drawn up in the context of specific pending court proceedings (e.g., pleadings in pending court proceedings) or, exceptionally, documents that contain legal positions that subsequently become the subject of such proceedings and whose disclosure would be likely to compromise the defense of the documents’ author in the context of such proceedings.  However, the contested report is a scientific document that was submitted to EMA in the context of an administrative procedure (in order to establish whether the risk-benefit balance remained unchanged), and not a document that met the conditions set forth by the CJEU. (N.B.: The term “court proceedings” also covers non-European court proceedings.)The exception to publication for protection of court proceedings is necessary to ensure observance of the principles of equality of arms.  Contrary to the claimant’s opinion, disclosure of the report would not lead to circumvention of the protections conferred by U.S. legislation in proceedings relating to preliminary investigation.  The main purpose of that legislation is characterized by the intention to limit abusive class actions, given that such actions have a negative impact on the U.S. capital markets.  Accordingly, that legislation is not concerned with the protection of court proceedings as interpreted by the EU courts and, consequently, does not affect the principle of equality of arms.Exception to publication applies to documents where disclosure undermines the protection of commercial interests (first indent of Art. 4(2) of the Regulation)The CJEU ruled that pharmaceutical companies have to show that the requested documents contain commercially sensitive information, e.g., with regard to commercial strategies of the undertakings involved or to their customer relations or where that document contains information particular to that undertaking that reveals its expertise.  Arguments such as a greater financial investment in the context of the court proceedings pending in the U.S. or the scientific nature of the complex, detailed, or specialized report are not sufficient to constitute a ground for non-disclosure.Key TakeawaysTo invoke the exception of “court proceedings,” the document must be drawn up in the context of specific court proceedings or contain internal positions of a legal nature. To invoke the exception of “commercial interest” successfully, pharmaceutical companies have to show that the requested documents contain sensitive commercial information.  The mere fact that a document concerns an interest protected by an exception is not sufficient to justify the application of that exception.  Furthermore, the risk of such interest being undermined by disclosure of the document must be reasonably foreseeable and must not be purely hypothetical. Otherwise, these exceptions do not apply and disclosure of the documents cannot be prohibited.Note that other EU Regulations, such as the Trade Secrets Directive, in particular its rules for preservation of confidentiality of trade secrets in the course of legal proceedings, do not affect the rules on public access to documents or on the transparency obligations set forth in the Regulation (<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016L0943&from=EN">recital 11 of the Trade Secrets Directive</a>).

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing a

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature. The claims on review recited a method of diagnosing disorders related to muscle specific tyrosine kinase (MuSK) by detecting autoantibodies to an epitope of MuSK. The majority of the panel generally felt confined by the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories setting forth a two-step framework for determining whether claims are patent eligible. [Summarized here [<a target="_blank" href="https://lifesciences.mofo.com/topics/securing-and-protecting-diagnostic-based-claims.html">5/30 Blog Post</a>]] Although the Federal Circuit will not re-hear the matter, the en banc decision uniquely lays out eight separate opinions acknowledging the problems of the current patent eligibility jurisprudence, and requests that the Supreme Court or Congress take action. The separate opinions include the following notable dicta:Judge Lourie (concurring, joined by Judge Reyna and Judge Chen)“If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle’s Law, Maxwell’s Equations, etc. I would not exclude uses or detection of natural laws. The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.”Judge Hughes (concurring, joined by Judge Prost and Judge Taranto)“I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents. Such standards could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications.”Judge Dyk (concurring, joined by Judge Hughes and Judge Chen)“Thus, it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility. In the life sciences, development of new diagnostic methods is often based on researching complex biological systems. The inventive concepts in this area may lie primarily in the application of a natural law.”Judge Chen (concurring)“New methods for diagnosing medical conditions, as a general matter, intuitively seem to be the kind of subject matter the patent system is designed for: to encourage the risky, expensive, unpredictable technical research and development that people would not otherwise pursue in the hope that if they discover something of great medical value, then they will be protected and rewarded for that successful effort with a patent.”Judge Moore (dissenting, joined by Judge O’Malley, Judge Wallach, and Judge Stoll)“This is not a case in which the judges of this court disagree over whether diagnostic claims, like those at issue in Athena, should be eligible for patent protection. They should. None of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible.”Judge Newman (dissenting, joined by Wallach)“Athena’s diagnostic method is not a law of nature; it is a novel man-made method of diagnosis of a neurological disorder. The Athena diagnostic method, a multi-step method performed by a combination of specific chemical and biological steps, was unknown in the prior art. The Court in Mayo did not exclude such methods from eligibility for patenting.”Judge Stoll (dissenting, joined by Wallach)“Interpreting Mayo, our prior opinions seem to take for granted that the Supreme Court has foreclosed all avenues of patent protection for diagnostic claims…Our inflexible following of Mayo has created flawed decisions that are inconsistent with the precepts of Mayo and our patent system as a whole.”Judge O’Malley (dissenting)“I believe that confusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress’s direction to the courts to apply 35 U.S.C. sections 101, et seq. (“Patent Act”) as written. Specifically, the Supreme Court has instructed federal courts to read into Section 101 an “inventive concept” requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.”This dicta is promising and may signify the real possibility of change (and certainty) to patent eligibility standards in the diagnostics field.  Although it remains to be seen if Athena will file a petition for certiorari review with the Supreme Court, either the Supreme Court or Congress has been given a call to action.The en banc decision can be viewed <a target="_blank" href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2508.Order.7-3-2019.1.pdf">here</a>. [1] Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).

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

Karen G Potter Ph.D.

Karen Potter

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Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

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On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services,[1] fin

Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

On May 9, the United States Patent and Trademark Office (“PTO”) published a <a target="_blank" href="https://federalregister.gov/d/2019-09600">notice</a> in the Federal Register that it is modifying its patent term adjustment (“PTA”) procedures in view of the Federal Circuit’s decision in Supernus Pharmaceuticals v. Iancu.[1] Under the PTO Duty of Disclosure requirements, patent applicants are required to disclose any information that may be material to the patentability of an application, which can include documents cited by a foreign patent authority in a counterpart application. A failure to disclose such information in a timely manner can result in a reduction of PTA, which is a mechanism to add patent term for delays caused by the PTO, subject to reduction if the patentee fails to engage in reasonable efforts to conclude prosecution. The PTO currently uses a system designated Patent Application Locating and Monitoring (“PALM”) to track information relevant to PTA calculations. However, PALM is only equipped to register internal PTO events. Thus, the provision of information received from a foreign patent authority may not be recognized by PALM as a relevant prosecution event and can result in inaccurate PTA calculations, as demonstrated by the Supernus case. There, the PTO incorrectly reduced the PTA of a patent by 546 days, during which time the patentee had not yet received notice of the information from the foreign patent authority and was therefore incapable of disclosing the information to the PTO.  Responding to the Supernus decision, the Federal Register Notice asserts that the PTO will continue to use PALM to calculate PTA based solely on internal events, but announces a procedure to allow a patentee to request reconsideration of PTA calculation under 37 CFR 1.705(b) if “there was no identifiable effort the patentee could have under taken to conclude prosecution.” The request must include the relevant information not recorded in the PALM system and the required fee, and must be filed within two months of patent grant. An extension of up to five months may be obtained by paying additional fees. Patentees are encouraged to work with counsel to review PTA of a granted patent to ensure all PTA to which a patent is entitled has been awarded. [1] Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019).

Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office

On May 9, the United States Patent and Trademark Office (“PTO”) published a notice in the Federal Register that it is modifying its patent term adjustment (“PTA

Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision in Mayo Collaborative Services v. Prometheus Laboratories.[1]  This decision, along with subsequent court decisions, has rendered certain subject matter patent ineligible under 35 U.S.C. §101 if it exploits laws of nature or natural phenomena, cornerstones of the diagnostic industry.  Although novel diagnostic agents should be patent eligible, uncertainty remains about certain diagnostic-based method claims that rely on a correlation between a diagnostic biomarker and a disease or indication. A recent draft bill released by bipartisan members of Congress offers promise of legislative action that may restore broad patent eligibility to diagnostics.<a href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html" target="_blank">[5/24 Blog Post]</a>  Until then, recent decisions by the Federal Circuit, including Vanda Pharmaceuticals Inc. vs. West-Ward Pharmaceuticals International [3] and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA,[4] have provided some clarity on the reach of patent eligible subject matter to diagnostic method claims.  Although these decisions may open the door to issuance and validity of a patent to diagnostic methods, the Court’s decision in Cleveland Clinic Foundation v. True Health Diagnostics[5] underscores the reality that certain diagnostic-type claims may not provide adequate protection against potential infringers.  For this reason, companies should work with patent counsel to ensure that they secure patent-eligible claims to diagnostic methods and related treatments that are of defendable commercial value.Subject Matter Eligibility of Diagnostic Claims Under 35 § USC 101As part of its landmark Alice Corp. v. CLS Bank International decision, the Supreme Court articulated a two-step framework for determining whether claims are patent eligible.[6]  In the first step, it must be determined whether a claim is directed to a judicial exception (a law of nature, a natural phenomenon, or an abstract idea).  If so, it must then be determined whether the elements of the claim, individually or as a whole, “transform the nature of the claim into a patent-eligible application.”[7]  As Mayo explained, adding “conventional steps, specified at a high level of generality” to a law of nature does not make a claim patentable.  However, subject matter that includes “additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations” may be patent eligible.[8]After a long line of decisions finding many diagnostic-based claims to be patent ineligible under Section 101, the Federal Circuit has recently found certain types of diagnostic method claims to be patent eligible.  In Vanda Pharmaceuticals, the claim at issue was directed to the identification of a genetic variant that renders individuals poor metabolizers of a compound used to treat schizophrenia, and administering specific and different amounts of the compound to individuals, depending on whether they harbored the genetic variant.  Similarly, in Endo Pharmaceuticals, the claims were directed to treating pain in a renally impaired patient with a compound, wherein the creatinine clearance rate of the patient was measured, and a lower dosage of the compound was administered to the patient, depending on the patient’s rate of creatinine clearance.  The Court found the claims at issue in these two cases to be patent eligible, as being directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.”[9]This is contrast to the recent Federal Circuit decision in Athena Diagnostics vs. Mayo Collaborative Services.[10]  There, a claim reciting a method of diagnosing disorders related to muscle specific tyrosine kinase (MuSK) that only included a step of detecting autoantibodies to an epitope of MuSK was deemed to be patent ineligible because it did not sufficiently transform a law of nature into a patent-eligible application of the law, as required by the original Mayo decision.In response to the Federal Circuit’s evolving jurisprudence, the PTO published revised subject matter eligibility guidelines in January 2019.[11]  The new guidelines explain that a “claim that recites a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.”  To this end, the PTO guidelines explain that a claim reciting a practical application of a judicial exception is patent eligible at step one of the Alice/Mayo test.  In this way, both the revised PTO guidelines and the Federal Circuit decisions have provided some clarity that is in line with the initial guidance provided by Mayo.While the courts have clarified how patent applicants may overcome the subject matter eligibility hurdle to secure patents to diagnostic-type claims, integrating a “practical application” into a diagnostic method claim may require reciting a series of steps to apply a natural correlation involving a biomarker, such as detecting the biomarker in a sample, diagnosing a patient as having a disease or condition related to the biomarker, and treating the patient with an appropriate therapeutic.  Such multi-step processes may be carried out by multiple entities.  It’s easy to imagine that the first step would be carried out by a diagnostic company, while the latter two steps would be carried out by a physician.Thus, even if the patent eligibility hurdle is overcome, these same applicants may face an additional obstacle when they seek to enforce their patents against multiple potential infringers.  Specifically, patent owners may be required to prove induced infringement, which has additional evidentiary burdens beyond those required to prove direct infringement by a single actor.Proving Infringement by Multiple ActorsWhere multiple actors are alleged to infringe different steps of a patent claim, plaintiffs commonly must assert a theory of induced infringement.  That is, a plaintiff alleges that a defendant infringed some steps of a claim and induced another actor to infringe the other steps of the claim, or the defendant induced another actor to infringe all steps of the claim.  To prevail on a claim of induced infringement, however, a plaintiff must prove that the defendant had the specific intent to induce another party to infringe.  Additionally, induced infringement must be predicated on direct infringement.[12]  When multiple parties carry out different steps of a method, direct infringement is shown by a single defendant controlling or directing the actions of the other defendant(s), such that all actions are attributable to a single defendant.[13]  Directing or controlling another’s actions is demonstrated by (1) conditioning participation in an activity or receipt of a benefit upon performance of a step or steps of a claimed method and (2) establishing the manner or timing of that performance.[14]  Recent Federal Circuit cases highlight the potential difficulty of proving induced infringement of a multi-step method claim.  In Cleveland Clinic, the Cleveland Clinic Foundation (“CCF”) owned a method of treatment patent reciting multiple steps that were alleged to be separately carried out by True Health, a diagnostic company, and physicians. CCF sued True Health on an induced infringement theory, but lost as a result of not being able to provide factual support showing that True Health specifically intended to induce the physicians to infringe the patent at issue by diagnosing and treating patients.[15] In contrast, in the Eli Lilly and Co. v. Teva Parenteral Medicines case, the method claim included a step of administering a pretreatment and another step of administering a treatment. There, the plaintiff was able to show that the defendant induced infringement, as its product labeling instructed physicians to condition a patient’s receipt of treatment on the patient self-administering the pretreatment at specific doses and times.[16]  Vanda was also able to prove induced infringement of its multi-step method claim against the generic manufacturer West-Ward based on general language on West-Ward’s product label that the dose of the drug should be reduced in half if the patient is a poor metabolizer.[17]  A difference between Cleveland Clinic and cases in which induced infringement was found is the development of the factual record supporting the inducing activity, particularly as highlighted by language on a product label. ConclusionClients seeking patents related to personalized medicine should pursue claims that both comply with patent eligibility requirements and mitigate evidentiary burdens for finding induced infringement.  Drafting claims that capture a practical application of a natural correlation, but in a form that would be infringed by a single actor, may reduce the factual inquiries necessary to prove infringement, as compared to claims requiring multiple actors.  Further, a patent strategy should coordinate the language of patent claims to what may be on a product label, particularly because many potential infringers, including generic manufacturers, may practically implement similar instructions on their product label.[1] Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).[<a target="_blank" href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html">5/24 Blog Post</a>] <a href="https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html" target="_blank">https://lifesciences.mofo.com/topics/congress-bipartisan-bill-on-patent-eligibility.html</a>[3] Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018).[4] Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals Inc., 919 F.3d 1347 (Fed. Cir. 2019).[5] Cleveland Clinic Foundation v. True Health Diagnostics LLC,  859 F.3d 1352 (Fed. Cir. 2017)[6] Alice Corp. Ptd. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 217-18 (2014).[7] Id. at 217.[8] Mayo at 82.[9] Endo at 1354.[10] Athena Diagnostics, Inc. v Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).[11] https://federalregister.gov/d/2018-28282[12] Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 920-21 (2014).[13] Id.[14] Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357, 1364-79 (Fed. Cir. 2017).[15] Cleveland Clinic at 1364.[16] Eli Lilly at 1369.[17] Vanda at 1130-31.

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allow

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

On May 22, 2019, members of Congress made available for public comment a one-page draft of a bill that aims to rewrite the patent eligibility provisions of the Patent Act to address the muddled jurisprudence spawned by the Supreme Court cases of Mayo Collaborative Services v. Prometheus Laboratories and Alice Corp. v. CLS Bank International.  Notably, the draft legislation eliminates per se judicial exceptions to patent eligibility, and it also proposes removing the word “new” in Section 101 to restore analysis of patent eligibility to a threshold inquiry separate from other patent requirements, such as novelty and nonobviousness.  Although the draft bill is designed to solicit feedback rather than serve as a final bill for voting on, the lawmakers hope that it will ultimately culminate in a bill that would shift the pendulum back in favor of patent eligibility.  “We believe this framework represents a true balance that will restore integrity, predictability and stability to our nation’s patent system, while also preventing the issuance of overly broad patents,” said Senator Thom Tillis, who is one of the members of Congress leading the effort.The draft bill can be viewed <a target="_blank" href="https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4876-8F51-A03CF4A63E26">here</a>.A more thorough discussion of the draft bill can be viewed <a target="_blank" href="https://www.law360.com/technology/articles/1162395/draft-patent-eligibility-bill-would-undo-alice-mayo">here</a>.

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Associate

Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

Congress releases bipartisan draft bill to repair the law on patent eligibility

On May 22, 2019, members of Congress made available for public comment a one-page draft of a bill that aims to rewrite the patent eligibility provisions of the 

Congress releases bipartisan draft bill to repair the law on patent eligibility

On May 14, 2019, the Council of the European Union adopted the <a href="http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect" target="_blank">amending Regulation (EC) No. 469/2009</a>, effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will be binding in all Member States of the EU without any further act of national implementation.BackgroundA Supplementary Protection Certificate (“SPC”) enables a patent holder to extend the market exclusivity of an approved medicinal product for a maximum of five years after the patent covering such product expires. The SPC is intended to compensate the patent holder for the revenue lost as a result of not being able to market the product during the lengthy regulatory approval process, and to amortize the patented product’s high research and development costs. Hence, the EU, by offering strong and extended patent protection, intends for SPCs to promote the research and innovation necessary to develop medicinal products and prevent pharmaceutical companies’ relocation to countries outside the Union market.The generic’s industry, however, also deserves a certain level of protection. Ensuring access to competitively priced pharmaceuticals, the timely availability of generics and biosimilars is tremendously important in healthcare systems in Europe and around the world.Yet, the current regime on SPC protection in Europe has resulted in a double standard. Generics companies located outside the EU are allowed to (1) produce generics and biosimilars that will be exported to countries outside the EU, or (2) stockpile such products in order to launch them in the EU on the day after an SPC has expired. Manufacturers of generics or biosimilars based in the EU, however, are prohibited from taking similar actions while the respective SPC is in force, even if they intend to export the product outside the EU. This major competitive disadvantage has the potential to delocalize manufacturing and discourage investment in Europe.The New SPC Regulation aims to correct this imbalance and level the playing field between manufacturers of generics and biosimilars based inside and outside the EU.What will change?The New SPC Regulation allows companies to manufacture generics or biosimilars in the EU for the purpose of (1) exporting them to countries outside the EU where protection does not exist or has expired and (2) stockpiling the product for six months or less in order to launch those products in the EU on the day after the corresponding SPCs have expired, in each case contingent on their fulfillment of the following obligations, which are laid out in the New SPC Regulation.Manufacturers of generics or biosimilars are obliged to:<ul><li style="margin-bottom: 10px;">inform (1) the competent authority in the Member State where the manufacturing is to take place or where the first related act prior to the manufacturing is to take place, and (2) the SPC holder with a standard form for notification that is attached to the New SPC Regulation; and</li><li style="margin-bottom: 10px;">inform the competent authority and the SPC holder no later than three months before (1) the start date of the manufacturing in the relevant Member State, or (2) the first related act prior to manufacture, whichever is earlier; and</li><li style="margin-bottom: 10px;">notify the competent authority as well as the SPC holder about any changes before those changes take effect; and</li><li style="margin-bottom: 10px;">in cases of manufacturing for the purpose of export, affix the black and white logo on the outer packaging of products in a size as to be sufficiently visible:</li></ul><img height="102" width="150" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blteaa65c9134a88000/6273176f0d4d8e1d7f10f2e6/eu-spc-logo.jpg?format=auto&quality=60" type="asset" sys-style-type="download"> Source: <a href="http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect" target="_blank">http://www.europarl.europa.eu/doceo/document/TA-8-2019-0401_EN.html?redirect</a>;<ul><li style="margin-bottom: 10px;">pay fees that a Member State may require for notifications to be made to the competent authorities which should be set out at a level which does not exceed the costs considering the expenditures for the administration; and</li><li style="margin-bottom: 10px;">ensure that all of the relevant contractual parties are fully informed and aware that (1) manufacturing is taking place under the manufacturing waiver regime and (2) any act outside the scope of the manufacturing waiver infringes the SPC as long as the SPC applies.</li></ul>Does the manufacturing waiver apply to all SPCs?The regime of the manufacturing waiver applies to SPCs with applications that were filed on or after the date the New SPC Regulation enters into force (“Effective Date”). The manufacturing waiver will not apply to SPCs that have been granted before the Effective Date. Beginning on July 1, 2022, the manufacturing waiver will apply to SPCs with applications that were filed before the Effective Date and that take effect on or after the Effective Date.What will not change?During the term of the SPC, a diversion in the EU of a product made under the exception remains prohibited (e.g., a product that was manufactured for export purposes cannot be placed or re-imported into the EU; a product manufactured for storing purposes to be placed on the market in the EU one day after the SPC expires cannot not be commercialized in the EU as long as the SPC is in force). Furthermore, the manufacturing waiver does not apply to any act carried out to import products into the EU market merely for the purpose of repackaging, re-exporting or storing (i.e., any act outside the scope of the New SPC Regulation remains prohibited).OutlookThe manufacturing waiver’s effect on the research, development, and production of innovative medicines in the EU remains to be seen. Whether the New SPC Regulation’s objectives will be achieved is also uncertain. Of particular interest is whether the waiver will sufficiently balance patent holders’ and generics and biosimilars manufacturers’ different interests. So too is the waiver’s ability to correct the imbalance between manufacturers of generics and biosimilars inside and outside the EU, and whether six months is a sufficient period of stockpiling to achieve the day-one launch. Finally, one hopes the manufacturing waiver will have a positive effect on public health expenditures, and result in better and more affordable access to medicines.

Manufacturing Waiver Weakens SPC Protection in Europe

On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009, effectively exempting certain manufacturing activities in 

Manufacturing Waiver Weakens SPC Protection in Europe

The Federal Circuit ruled on January 23, 2019, that the United States Patent and Trademark Office (“PTO”) erred in reducing the term of a patent owned by Supernus Pharmaceuticals by 546 days, during which time the company could not have furthered prosecution of the application. The Patent Term Adjustment (“PTA”) statute explains that the length of a patent term may be reduced by the number of days that an applicant fails to engage in reasonable efforts to conclude prosecution of an application. Thus, the PTO cannot subtract from a patent term any time during which an applicant is incapable of making reasonable efforts to conclude prosecution. The Court’s decision highlights the importance of recognizing whether a patent applicant is capable of making efforts to further the patenting process.

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Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

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The Federal Circuit ruled on January 23, 2019, that the United States Patent and Trademark Office (“PTO”) erred in reducing the term of a patent owned by Supern

In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years.Once a patent has been filed, a corresponding pharmaceutical product often has to undergo time consuming regulatory approval before it can be marketed. Sometimes there are only a few years left on the patent by the time the product is first launched. As a result, the net sales time under the exclusivity conferred by the patent is often not long enough to ensure sufficient research incentives and the possibility of compensation. In the EU, Regulation (EC) No 469/2009 (“SPC Regulation”)addresses this issue by providing the possibility to obtain SPCs for an authorized medicinal product, granting essentially the same rights as the original patent (the “basic patent”) for an additional maximum term of five years. Yet another six months can be added if the requirements of the Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006 (“Pediatric Extension Regulation”) are met.

A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe

In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions nec

A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe

The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision.The Court confirmed the Commission’s finding that most of Servier’s practices (patent settlement agreements including connected side deals) violated the European cartel ban (Article 101 TFEU) since they hindered the market entry of cheaper generic drugs. The Court, however, rejected the Commission’s decision on the abuse of market power by Servier (Article 102 TFEU) since the Commission did not correctly define the relevant market.