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COVID, VENTILATORS & PATENTS

April 2, 2020

By: Vikrant Rana, Isheta Srivastava & Harshita Mall

With a pandemic raging, now is not the time to test the highest prices the market will bear’ – Stijn Deborggraeve, Diagnostics Advisor at MSF’s Access Campaign’[1]

INTRODUCTION

It was March 11, 2020 that world got one of the biggest jolt of the century when World Health Organization’s Director-General Tedros Adhanom announced that the COVID-19 outbreak, that started in December 2019 in Wuhan city of China, to be a pandemic, cautioning that the WHO has “rung the alarm bell loud and clear.”  Its almost one month since then and as per the health offices the virus is here to stay with us for a while.

Currently, apart from the threat posed by the pandemic, another challenge that the government must deal with is to ensure critical availability of medical infrastructure like ventilators, drugs etc. to handle the patients, so that the mortality rate remains low.

VENTILATORS BOTTLE NECK & COVID-19

As per medical professionals, the most common and severe complication in patients with COVID-19 is acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS), requiring oxygen and ventilation therapies. [2] This is where ventilators become a vital medical gear in treatment of COVID-19 patients.

Ventilators are the in shortage in India. John Hopkins, Center for Disease Dynamics, Economics and Policy, and Princeton University, have estimated that the demand for ventilator demand can be as high as 1 million in the country. Current availability in India is estimated to have between 30,000 and 50,000 ventilators. It says the US has about 160,000 and is running short in most places.[3]

In usual course, the medical system lies exclusively on specialized, proprietary, mass-manufactured ventilators from a small selection of suppliers.[4] The vast majority of medical equipment is heavily patented by a few specialty medical firms that sell small volumes because during ‘normal’ times, a medium-sized hospital only needs a handful. These firms have historically aggressively protected their intellectual monopolies.[5] One of the example can be seen from Italy wherein a patent owner of a special respirator valve used in respiratory machines allegedly threatened a patent infringement lawsuit against two engineers who volunteered to use their 3-D printing technology to manufacture the patented valves for a hospital in Brescia, Italy without obtaining permission or a license from the patent holder.

However, the need of the hour is industries come together and fight the pandemic like one and save millions of lives at stake.

INDUSTRIES & INNOVATORS FIGHTING THE BATTLE TOGETHER

Amidst the crisis, there are some companies which are coming ahead and sharing their IP rights with the world or are helping in manufacture of ventilator to curb the shortage and becoming one of the strongest soldiers in the battle against the COVID 19. These companies are listed below:

  • Medtronic, a medical device company headquartered in Ireland has publicly shared the design specifications of its Puritan Bennett 560 (PB 560) ventilator amid a global shortage of the devices.[6] The company now has PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics available at com/openventilator. The company says software code and other information will follow shortly.
  • Nocca Robotics an Indian startup which makes water-less robots that clean solar plants is racing against the time to develop an invasive ventilator that will cost INR 50,000 ($662).  By 7 April, they plan to be ready with machines that can be tested on patients after approvals.[7]
  • AgVa Healthcare, a Noida-based startup which builts cost-effective portable ventilator, is lending a hand to overcome the shortage of ventilators by ramping up the production and supply. In an interview to a daily, Diwakar Vaish, co-founder, AgVa Healthcare stated that “We are working to manufacture 20,000 units in the next 30 days”.[8]
  • Pankaj Gupta, founder of EthAum Venture Partners, working with more than 200 volunteers (including several IIT, NIT, BITS alumni) towards solving the problem of shortage of ventilators. He started the initiative titled ‘COVID India Initiative’ has been testing a tiny device that can fit into the human palm to optimise the use of ventilators, in times of emergency.[9]
  • Maruti Suzuki, a carmaker giant based in India, announced that it will help scale up the production of ventilators in the country. Maruti Suzuki said it will manufacture 10,000 ventilators in collaboration with AgVA Healthcare, an approved manufacturer of ventilators.[10]
  • UK engineering company Smiths Group is making the IP covering one of its ventilators available to other manufacturers, as part of an industry attempt to tackle the shortage of life-saving equipment.[11]
  • Mahindra Group Chairman, Anand Mahindra, has also announced that Mahindra & Mahindra is working with an indigenous maker of ICU ventilators.[12]
  • Some leading Indian industrialists, including a major medical device-making company, have offered their factories to manufacture the machines. The plan is to make 30,000 ventilators, at around 150-200 a day, by the middle of May.[13]

VENTILATOR PATENT FILINGS AMIDST COVID-19

With a lot of other developments, one area that is currently functioning strongly are the innovation minds that are coming up with weapons to fight the battle against the COVID-19.

With the innovation on rise the obvious result is these innovators filing for patents. As per the official records of the IP India, available on its website, the details of the patents applications that have been filed in 2020 are given below.

S.No. Invention Title Application Number Filing Date Field of Invention Applicant Inventor/Inventors
1.        Vanes for the impeller of a ventilator, impeller, and axial ventilator, diagonal ventilator, or radial

Ventilator”

202017004359 31/01/2020 Mechanical Engineering Ziehl-Abegg SE Tobias Gauss, Daniel Seifried, Thomas Bitz, Frieder Loercher, Georg Hofmann And Loenne
2.        System and method for mounting ventilator on wheelchair 202047010176 09/03/2020 Bio-Medical Engineering Koninklijke Philips N.V. David Hoysan And Matthew Answine

COMPULSORY LICENSING & COVID-19

Another important but forgotten chapter of Patent law that we can look into here is Compulsory Licensing.

Generally, Patents are granted to encourage inventions and to secure that it is worked on a commercial scale. But at the same time the Indian Patents Act, 1970 provides measures by way of compulsory licensing (CL) to ensure that the patents do not impede the protection of public health and nutrition and the Patent Rights are not abused by the Patentee.

In India, Compulsory Licenses are granted in order to:

  • Prevent the abuse of patent as a monopoly;
  • Make a way for commercial exploitation of the patented invention by an interested person; and
  • Address the public health concern in India.

Generally, Compulsory License is an intervention mechanism that enables the government to balance between two disparate objectives- rewarding patentees for their invention and making the patented products available to third party in times of need just like now.

It is the right time for the government to resort to the much-needed compulsory licensing provision as the lockdown can help prevent further spread of virus, however we also need to take concrete steps to fight the virus.

Countries most affected by the COVID-19 pandemic are taking emergency legal measures. For example Canada responding to the pandemic passed COVID-19 Emergency Response Act on March 25, 2020. As part of the government’s response to COVID-19, the Act amends numerous statutes including the Patent Act and the Food and Drugs Act. The amendments to the Patent Act effectively introduce compulsory licensing during the COVID-19 public health emergency. The COVID-19 Emergency Response Act added a new section 19.4. Under the new section 19.4, upon Application by the Minister of Health, the Commissioner of Patents shall authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.[14] Further, countries like USA, Chile, Ecuador & Germany have also resorted to the ‘Compulsory Licenses’ for COVID-19 medicines, vaccines and other medical tools. The government of Israel has also issued a compulsory licence for patents on a medicine they were investigating for use for COVID-19.[15]

Further, for the perusal of readers below is a table containing the details of published patents for last five years in India as per the official records of the IP India available on its website.

S.No. Invention Title Application Number Filing Date Field of Invention Applicant Inventor/Inventors
2019 – Search Field: Title/Ventilator
Thermal Ventilator 201941050745 09/12/2019 Mechanical Engineering Dr. K. VISAGAVEL Dr. K. Visagavel & Dr. Pss. Srinivasan
Air-Guiding Tube Component, Liquid-Storage Device, Humidifier, And Ventilator 201947012508 29/03/2019 Mechanical Engineering BMC Medical Co., Ltd. Zhi Zhuang
2018 – Search Field: Title/Ventilator
Portable Light-Weight Ventilator System 201827033958 10/09/2018 Bio-Medical Engineering Inovytec Medical Solutions Ltd Mark Shahar And Nir Barkai

 

Ventilator 201827002554 22/01/2018 Mechanical Engineering Kim Tae Joong Kim Tae Joong
2017 – Search Field: Title/Ventilator
“NATURAL AIR DRIVEN TURBO VENTILATOR WITH NOVEL WING DESIGN, LOCKED TYPE BASE, ITS ARRANGEMENT AND WORKING THEREOF” 201741044077 08/12/2017 Mechanical Engineering Shivanand Balehosur Shivanand Balehosur
A PORTABLE VENTILATOR SYSTEM 201711043364 04/12/2017 Mechanical Engineering Deepak Agrawal And

Diwakr Vaish

 

Deepak Agrawal And

Diwakr Vaish

 

A PORTABLE VENTILATOR SYSTEM 201711041445 20/11/2017 Mechanical Engineering Diwakr Vaish

 

Diwakr Vaish

 

MEDICAL VENTILATOR SYSTEM AND METHOD FOR PROVIDING RESPIRATORY SUPPORT TO A PATIENT 201741039744 08/11/2017 Bio-Medical Engineering General Electric Company Gunaranjan Chaudhry, Sanjay Vijayaraghavan, Arun Girimaji And Prakash Sr.
SYSTEMS AND METHODS FOR DETECTION OF VENTILATOR AND PATIENT DISCONNECTIONS USING PATIENT LUNG COMPLIANCE ESTIMATED ON BOTH INHALATION AND EXHALATION PHASES OF A BREATH 201747026093 21/07/2017 Bio-Medical Engineering Koninklijke Philips N.V. Fernando Jose Isaza
ROOM VENTILATOR AND AIR PURIFIER 201724009893 21/03/2017 Mechanical Engineering Karl Wagner And Laura Wagner Karl Wagner And Laura Wagner
METHOD FOR CONTROLLING AN ELECTRIC VENTILATOR 201727000378 04/01/2017 Mechanical Engineering Spal Automotive S.R.L. De Filippis Pietro
2016 – Search Field: Title/Ventilator
Ventilator Resuscitator Device And Method Of Ventilation 201617043392 20/12/2016 Mechanical Engineering Evgeny PECHERER

 

Evgeny Pecherer

 

Patient-Ventilator Asynchrony Detection 201647024461 18/07/2016 Biotechnology Koninklijke Philips N.V.,  Carl Tams, Neil Euliano,

Michael Banner,

Gabrielli, Andrea

Decision Support System For Lung Ventilator Settings 201617019564 07/06/2016 Mermaid Care A/S Dan Stieper Karbing And Stephen Edward Rees
A Ventilator 201647001070 12/01/2016 Mechanical Engineering
2015 – Search Field: Title/Ventilator
Ventilator System 4209/KOLNP/2015

 

23/12/2015 Mechanical Engineering Carefusion 303, Inc. Adrian D. Desilva, Huy Thanh Vu, Richard Le, Jeffrey Harold Miller, Hector Gonzalez, Raul Valdez, Chiun Wang, Malcolm R. Williams and Steven Duquette

 

Critical Care Ventilator With Mouth Piece Ventilation 6797/CHENP/2015 30/10/2015 Mechanical Engineering
Ventilator Aerosol Delivery System 1200/DELNP/2015 13/02/2015 Bio-Medical Engineering Philip Morris Products S.A. James Leamon, Timothy Gregory, Jan Mazela And  Christopher Henderson
  Remark 02 Patents Filed By The Applicant : Spacelabs Healthcare, Llc

Application Nos:

2977/Delnp/2009 – Abandoned

6909/Delnp/2011 – Abandoned

 

The Specification Discloses A Ventilator System That Can Be Manufactured Quickly With Minimal Skill Requirements And Rapidly Deployed In Response To Epidemic Respiratory Disease Conditions. In One Embodiment, The Ventilator, Having A Minimal Number Of Controls, Is Used To Give Ventilation Or Mechanical Breathing To A Patient Suffering Ards. The Mechanical Ventilation Is Based On Pressure Control And Has Variable Pressure, Breathing Rate, And Oxygenation. Preferably, The Ventilator Is Rapidly Deployable, Easy And Intuitive To Operate, And Capable Of Sustaining At Least 75% Of Epidemic Respiratory Distress Victims Who Require Assisted Ventilation Until Resuming Normal Breathing.

 Patent Pool & Covid[16]

The heads of the World Health Organization and Unitaid, a UN-backed group funding global health innovation, have welcomed a proposal devised by Costa Rica for companies voluntarily to pool their intellectual property for all medical interventions — including treatment, vaccines and diagnostics. Doing so would enable governments or generic drugmakers to manufacture and sell the products at much lower prices than are currently available in the world market.

Pharmaceutical companies have joined intellectual property pools in the past that have enabled treatments for HIV/Aids, tuberculosis and Hepatitis C to be extended to low-income countries at affordable prices. The proposed coronavirus pool, however, would be available to countries worldwide. In a statement, the WHO said it was committed to equitable access, including for interventions related to Covid-19, the disease caused by the novel coronavirus. “We are exploring all avenues to ensure people who need it have access to effective and safe products for Covid-19,” it said.

Switzerland’s Roche, which makes testing kits for the virus, agreed to share the recipe for its testing liquid with the Dutch government after lawmakers there accused it of rationing supply and significantly decreasing national testing capabilities.

 

The COVID-19 outbreak, which has been declared a Pandemic has severely hit nations worldwide and subsequently the Government of India has also taken several precautionary measures to curb and lower the impact of the deadly virus.

Keep watching this space for more updates on Corona Virus.

[1] https://www.msfindia.in/covid-19-msf-calls-for-no-patents-or-profiteering-on-covid-19-drugs-tests-and-vaccines/

[2] https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2763453

[3] https://economictimes.indiatimes.com/small-biz/sme-sector/covid-19-ventilators-hospitals-agva-healthcare-coronavirus/articleshow/74840459.cms)

[4] https://f1000research.com/articles/9-218#ref-13

[5] Boldrin M, Levine DK: Against intellectual monopoly. Cambridge: Cambridge University Press. 2008;  Pagano U: The crisis of intellectual monopoly capitalism. Cambridge J Econ. 2014

[6] https://www.massdevice.com/breaking-medtronic-shares-ventilator-ip-to-combat-shortages-against-coronavirus/

[7] https://www.bbc.com/news/world-asia-india-52106565

[8] https://economictimes.indiatimes.com/small-biz/sme-sector/covid-19-ventilators-hospitals-agva-healthcare-coronavirus/articleshow/74840459.cms

[9] https://yourstory.com/2020/03/coronavirus-crisis-life-saver-ventilator-splitter

[10] https://yourstory.com/2020/03/coronavirus-crisis-life-saver-ventilator-splitter

[11] https://www.lifesciencesipreview.com/news/ventilator-maker-offers-up-ip-to-tackle-shortage-3962

[12] https://yourstory.com/2020/03/coronavirus-crisis-life-saver-ventilator-splitter

[13] https://www.bbc.com/news/world-asia-india-52106565

[14] https://www.lexology.com/library/detail.aspx?g=7c0446cb-c431-4725-94c5-c48c9041c54c

[15] https://www.msfindia.in/covid-19-msf-calls-for-no-patents-or-profiteering-on-covid-19-drugs-tests-and-vaccines/

[16] https://www.ft.com/content/b69afd98-a8af-40d9-b520-4231d9cac68f

 

Read more about law and Corona Virus in our articles below: 

The Gamut between Rise of Cyber Crime and Coronavirus

Coronavirus and Force Majeure Clause in Contracts

India: The Functioning of the Indian Judiciary amidst Novel Coronavirus (COVID-19) Outbreak

Indian Supreme Court’s response to COVID – 19: extends period of limitation for all!

Novel Coronavirus (Covid -19) Outbreak: Delhi High Court takes its battle a Notch Higher

 

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