Patents, Vaccines, and VirusesA conversation about the role of IP in the age of COVID-19

Thursday, April 16, 2020

Please note that the views and opinions expressed in this presentation are those of the presenters, not that of their employers, or of Derwent. This presentation is for informational purposes only and should not be used as a substitute for legal advice.

Head Product ManagerBiopharma Intellectual PropertyClarivate

Sandeep Thakur

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DirectorBiotech & Chemical Practice GroupSterne, Kessler, Goldstein & Fox

Gaby Longsworth, Ph.D.

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Senior DirectorProduct Strategy & Commercial PlanningTheravance Biopharma, Inc.

Doreen Alberts

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Founder,Bodkin IP

Andrea Davis

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Managing DirectorPatinformatics, LLC

Tony Trippe

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Patents, Vaccines, and VirusesA conversation about the role of IP in the age of COVID-19

THE SCIENCE Understanding and treating COVID-19

THE PATENT ECOSYSTEM IMPACTPreparation and prosecution during a pandemic

INNOVATION IN THE LABIn search of effective COVID-19 vaccines

INNOVATION IN ENGINEERING New approaches to ventilator technology

CONTINUING THE DISCUSSIONExpert panel Q&A

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Understanding and treating COVID-19

THE SCIENCE

What is the Coronavirus?FAMILY CoronaviridaeSUBFAMILY Betacoronavirus

– Severe Acute Respiratory Syndrome (SARS-CoV-2, COVID-19)

– Related betacoronaviruses: • Rhinovirus (Common Cold)

• Middle East Respiratory Syndrome (MERS)

• Severe Acute Respiratory Syndrome coronavirus (SARS)

– Major proteins: • Spike glycoprotein

• COVID-19 virus proteaseCOVID-19. CDC Illustration. https://www.cdc.gov/coronavirus/2019-ncov

This makes searching for patents on specific viruses a little challengingCoronavirus is a generic name for a large number of viruses

• To date there are almost no patent documents on COVID-19 specifically

• Patenting of coronaviruses research has been going on for decades – mostly for animal vaccines

• SARS caused an enormous spike in patenting activity which overlapped with coronavirus

• Coronavirus research continued as interest in SARS waned

• MERS never became a pandemic so patenting never exceeded 50 families per year

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Count of Coronavirus Patent Families by Earliest Publication Year and Virus Name

MERS SARS COV

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• All of the potential drug structures contain a heterocyclic ring system usually a 6,6 or 6,5

• The substructure search generated 2,054 substances in the DRUGU file

• A full substructure search would generate more than 30,000 similar substances

• Running the last 4 years generated 6,657 substances in 848 patents

Where can we find potential COVID-19 drugs? Let’s look at some

similar structures

Sources: STN and FIZ Karlsruhe

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• The highlighted patent is one of two for Remdesivir, the lead Gilead compound

• It’s located in the Virus Infection area of the map

• These are next to the Respiratory area

• With the patents generated from the structure search clustered by activity a researcher can prioritize what documents to look through

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What are these substances used for? Derwent Innovation ThemeScape map clustering on mechanism of action and activity

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Preparation and prosecution during a pandemic

THE PATENT ECOSYSTEM IMPACT

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In search of effective COVID-19 vaccines

INNOVATION IN THE LAB

Let’s search one on SequenceBase, powered by GENESEQSequences of some essential proteins have been identified

COVID-19 Virus Protease, Chain A• Other anti-viral efforts have identified the protease as a key

target for drug and vaccine development

• SGFRKMAFPS GKVEGCMVQV TCGTTTLNGL WLDDVVYCPR HVICTSEDMLNPNYEDLLIR KSNHNFLVQA GNVQLRVIGH SMQNCVLKLK VDTANPKTPKYKFVRIQPGQ TFSVLACYNG SPSGVYQCAM RPNFTIKGSF LNGSCGSVGFNIDYDCVSFC YMHHMELPTG VHAGTDLEGN FYGPFVDRQT AQAAGTDTTITVNVLAWLYA AVINGDRWFL NRFTTTLNDF NLVAMKYNYE PLTQDHVDILGPLSAQTGIAVLDMCASLKE LLQNGMNGRT ILGSALLEDE FTPFDVVRQCSGVTFQ

• University of Hong Kong has 18 families overall on Coronaviruses

– These five also show up in the Bat Spike Glycoprotein search and specifically cover research on SARS vaccines

– Other families cover small molecules and additional immunization agents for respiratory viruses

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Count of COVID-19 Virus Protease Sequence Search Patent Families by Top Assignees

Bat Spike Glycoprotein• 98% structural similarity to COVID-19 Virus S protein• MFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSSTRGVYYPDKVFRSSVLHLTQDLFLPFFSNVTWFHAIHVSGTNGIKRFDNPVLPFNDGVYFAS

TEKSNIIRGWIFGTTLDSKTQSLLIVNNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLEGKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPPGFSALEPLVDLPIGINITRFQTLLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETKCTLKSFTVEKGIYQTSNFRVQPTDSIVRFPNITNLCPFGEVFNATTFASVYAWNRKRISNCVADYSVLYNSTSFSTFKCYGVSPTKLNDLCFTNVYADSFVITGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNSKHIDAKEGGNFNYLYRLFRKANLKPFERDISTEIYQAGSKPCNGQTGLNCYYPLYRYGFYPTDGVGHQPYRVVVLSFELLNAPATVCGPKKSTNLVKNKCVNFNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVITPGTNASNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNSYECDIPIGAGICASYQTQTNSRSVASQSIIAYTMSLGAENSVAYSNNSIAIPTNFTISVTTEILPVSMTKTSVDCTMYICGDSTECSNLLLQYGSFCTQLNRALTGIAVEQDKNTQEVFAQVKQIYKTPPIKDFGGFNFSQILPDPSKPSKRSFIEDLLFNKVTLADAGFIKQYGDCLGDIAARDLICAQKFNGLTVLPPLLTDEMIAQYTSALLAGTITSGWTFGAGAALQIPFAMQMAYRFNGIGVTQNVLYENQKLIANQFNSAIGKIQDSLSSTASALGKLQDVVNQNAQALNTLVKQLSSNFGAISSVLNDILSRLDKVEAEVQIDRLITGRLQSLQTYVTQQLIRAAEIRASANLAATKMSECVLGQSKRVDFCGKGYHLMSFPQSAPHGVVFLHVTYVPAQEKNFTTAPAICHDGKAHFPREGVFVSNGTHWFVTQRNFYEPQIITTDNTFVSGSCDVVIGIVNNTVYDPLQPELDSFKEELDKYFKNHTSPDVDLGDISGINASVVNIQKEIDRLNEVAKNLNESLIDLQELGKYEQYIKWPWYIWLGFIAGLIAIIMVTIMLCCMTSCCSCLKGCCSCGSCCKFDEDDSEPVLKGVKLHYT

• GSK recently announced that they were partnering with Sanofi on COVID-19 vaccine development

• Diagnostic Hybrids had the second highest number of patent families in the COVID-19 virus protease search as well and were acquired by Quidel

• There is concern that some of the diagnostic tests available in the US are not precise enough, but the Quidel real-time RT-PCR assay has been approved for the US, Europe and Canada and looks to be based on some of these assets

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Count of Bat S Protein Sequence Search Patent Families by Top Assignees

Let’s search another on SequenceBase, powered by GENESEQSequences of some essential proteins have been identified

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New approaches to ventilator technology

INNOVATION IN ENGINEERING

Patenting trends over the past 50 years

VentilatorsA look at patent trends over the last 50 years

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1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Publication Year

Total CN US

Source: Derwent Innovation

VentilatorsA look at key players by patent ownership

Source: Derwent Innovation

0 200 400 600 800 1000 1200 1400

KONINKLIJKE PHILIPS N.V.

RESMED INC.

MEDTRONIC INC

DRAEGERWERK AG

FISHER & PAYKEL HEALTHCARE CORP LTD

AEONMEDCO LTD

GENERAL ELECTRIC COMPANY

TEIJIN LTD.

BECTON DICKINSON & CO

SMITHS GROUP PLC

ACAD OF MILITARY MED SCI

L'AIR LIQUIDE S.A.

CHINESE ACADEMY OF SCIENCE

TERUMO CORP.

BMC MEDICAL CO LTD

Current Owner

No. of Families

New ventilator innovators resulting from the pandemic

0 20 40 60 80 100

Resmed

Chiesi Farmaceutici

Neurovision Medical Products

Hamilton Medical

Mallinckrodt Hospital Products Ip

Air Liquide

Advanced Inhalation Research

Apex Medical

Beijing BMC Medical

Medtronic

3rd Party Validity Challenges

Patent Owner Petitioner

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2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Evolution of Infringement Cases

Collected Cases # of Decisions

VentilatorsA look at validity and infringement

Sources: Darts-IP

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Expert panel Q&AAsk your question by typing it into the Q&A box on your screen

CONTINUING THE DISCUSSION

Thank you

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