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Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713 Amitkumar Patel, IJPRBS, 2018; Volume 7(4): 8-36 IJPRBS

Available Online at www.ijprbs.com 8

ANALYZING PATENT TREND RELATED TO MEDICAL DEVICE INNOVATIONS

AMITKUMAR PATEL1, KINJALBEN PATEL2, JIGNESH PATEL3

1. Gujarat Technological University, Chandkheda, Ahmedabad, India

2. Registered Indian Patent Agent (IN/PA/2873), Ahmedabad, India

3. CEO, Cureill Pharma, Ahmedabad, India

Accepted Date: 19/06/2018; Published Date: 27/08/2018

Abstract: Medical devices play an important role not only in diagnosing, screening and treating patients but also in restoring patients to normal lives and in regularly monitoring important health indicators to prevent diseases. Medical devices have emerged as an important clinical route to diagnose and treat certain serious diseases for which there are no equally effective surgical or pharmaceutical alternatives are available. Development and diffusion of novel innovative medical devices have been slower than for many consumer goods due to the obstacles to innovation, but the industry is keep innovating for development of cutting edge product to solve various problems. And such latest technologies are been protected by effective means of Intellectual Property Rights (IPRs). Patent data from 1999 to May 2018, related to medical devices were analyses on following parameters Priority Country, Current Legal Status, Patenting Trends, Major Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group Data, and Technology Topics.

Keywords: Medical Device, Patent, Patent Analysis, Patent Trend, Medical Device Innovation

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Amitkumar Patel, IJPRBS, 2018; Volume 7(4): 8-36



INTRODUCTION

The global economy is now becoming more connected, although vast differences persist

between the developed and the developing countries. This is observed in all facets of life,

maybe nowhere advanced than in medical care, where malnutrition, communicable diseases,

perinatal mortality and other public health issues dominate in poor and diseases in the

wealthier countries issues of noncommunicable diseases.1

A gap between the medical and technological societies is common, making translation of

scientific conclusions into practical medical devices and procedures slower than essential.

Issues related to intellectual property rights (IPRs) are another challenges. The widespread

testing required by the health regulating agencies signifies huge and risky financial

commitments. Even afterwards fruitful clinical testing, the definitive financial outcome of

investments may be disputed, since expenses for products and services through compensation

means are not guaranteed. 1-2

Implanted medical devices denote relatively new clinical tools for the treatment of disease.

Although quarantined examples can be found in historical accounts (e.g., dental implants in

Mayan civilization and hip implants dating back to 100 years), it was in the 1950s and early

1960s that grafts gained cautious acceptance as therapeutic options for certain disorders.

Implanted cardiac pacemakers, intraocular lenses, prosthetic heart valves and aortic grafts

were introduced as breakthrough inventions. Each device addressed a previously unmet clinical

necessity. The types of therapeutic devices have expanded distinctly and today serve patients

with ophthalmic, cardiovascular, endocrine, orthopedic, renal, gastrointestinal, auditory, and

neurological disorders.3

Medical devices play an important role not only in diagnosing, screening and treating patients

but also in restoring patients to their normal lives and in regularly monitoring important health

indicators to prevent infections and diseases. With technological developments, the role of

medical devices is now expanding to advance quality of care across each phase of the

healthcare continuum.4

Medical devices have emerged as a significant clinical option to treat certain serious diseases

for which there are no equivalently effective surgical or pharmaceutical alternatives are

available. Although all clinical activities impose increased level of ethical standards of

comportment to protect patients, medical device research and development, and product

application have a number of relatively distinctive aspects that differentiate them from other

technologies such as pharmaceuticals. These include the following: R&D project selection;

regulatory necessities, and their intended and unintended properties; when is a new product

design sufficiently safe and effective for routine usage in patients; and, physician–industry



relations in the innovation development in the context of real or perceived conflict of interest.

Each of these factors has implications for the delivery of care, patient well-being, and health

care leadership.2, 5-6

The past decade has brought extraordinary change to the medical device sector, and the pace

seems to be accelerating. New regulatory requirements, severe competition, and rapidly

developing technologies are creating new complications and challenges for those operating in

the sector.1, 7

Medical device innovation has raised huge benefits to patients, especially in the developed

countries, while the population in developing countries and poor countries have experienced

much lesser benefits in comparison. Development and diffusion of novel medical devices has

been slower than for many consumer goods of household due to the barriers to novelty and

innovation. Although some of the challenges are necessary and must remain for ultimate

patient welfare and for of device efficacy, other hurdles could be removed or made lower by

better policies and closer association between various stakeholders. Combination of medical

and technological know-how may lead to faster and intensive development, thereby improved

accessibility of investment. Early R&D may happen through linkages including academia,

industry, and government agency, thereby lowering investor risk aversion. Rationalizing clinical

testing, including a more standardized process to the health technology assessment

mechanism, may speed up launch and penetration of cost-effective devices. Amendments and

changes in to patent laws and the system for such laws to be practiced may lower cost and raise

competition. Although condensed prices may encounter the current business model for medical

device companies, improved sales could recompense them financially by the formation of a

true global marketplace. Numerous lifesaving significant medical devices have the prospective

to become sensibly priced mass-produced products. For the medical occupation, such progress

would make it simpler to its simple ethical values when functioning with cutting edge medical

know-how and technology.1, 3, 8

A medical device is any apparatus, material, appliance, software or other article—whether used

alone or in combination with others, including the software proposed by its manufacturer to be

used specifically for diagnostic and/or therapeutic uses and necessary for its proper

application—intended by the manufacturer to be used for human beings or animals for the

purpose of:4, 9

Diagnosis, monitoring, treatment, prevention, or alleviation of disease;

Diagnosis, monitoring, alleviation, treatment or compensation for an injury or handicap;

Replacement, Investigation or modification of the anatomy or of a physiological method;



Control of conception; and which does not accomplish its principal intended action in or on

the human body by pharmacological, immunological, or metabolic means, but which may

be supported in its function by such means

Medical devices differ according to their intended use and indications. Examples range from

simple devices such as medical thermometers, tongue depressors, and disposable gloves to

advanced devices such as computers which assist in the conduct of medical testing, prostheses

and implants. Items as complex as housings for cochlear implants are manufactured through

the deep drawn and shallow drawn manufacturing methods. The design of medical devices

includes a major segment of the field of biomedical engineering.10

Products which may be considered to be medical devices in some jurisdictions but not in others

include: aids for persons with disabilities, disinfection substances, devices for in-vitro

fertilization or assisted reproduction technologies, devices incorporating animal and/or human

tissues.11

World health organization has defined ‘Medical device’ as, any instrument, apparatus, machine,

implement, implant, appliance, reagent for in vitro use, software, material or other similar or

related article, intended by the manufacturer to be used, alone or in combination, for human

beings, for one or more of the specific medical purpose(s) of:4, 8

1. diagnosis, prevention, monitoring, treatment or alleviation of disease,

2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

3. investigation, replacement, modification, or support of the anatomy or of a physiological

process,

4. supporting or sustaining life,

5. control of conception,

6. disinfection of medical devices

7. providing information by means of in vitro examination of specimens derived from the

human body;

And does not achieve its primary intended action by pharmacological, immunological or

metabolic means, in or on the human body, but which may be assisted in its intended function

by such means.

According to US Food and Drug administration, Medical devices range from simple tongue

depressors and bedpans to complex programmable pacemakers with micro-chip technology



and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such

as general purpose lab equipment, reagents, and test kits, which may include monoclonal

antibody technology. Certain electronic radiation emitting products with medical application

and claims meet the definition of medical device. Examples include diagnostic ultrasound

products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a

manner that meets the following definition in section 201(h) of the Federal Food Drug &

Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a

medical device and is subject to premarketing and post marketing regulatory controls. A

Medical device is:4, 11-12

"An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or

other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any

supplement to them,

2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,

treatment, or prevention of disease, in man or other animals, or

3. intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on

the body of man or other animals and

Which does not achieve its primary intended purposes through chemical action within or on the

body of man or other animals and which is not dependent upon being metabolized for the

achievement of its primary intended purposes. The term "device" does not include software

functions excluded pursuant to section 520(o).

This definition provides a clear distinction between a medical device and other FDA regulated

products such as drugs. If the primary intended use of the product is achieved through chemical

action or by being metabolized by the body, the product is usually a drug. Human drugs are

regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which

include blood and blood products, and blood banking equipment are regulated by FDA's Center

for Biologics Evaluation and Research (CBER). FDA's Center for Veterinary Medicine (CVM)

regulates products used with animals. If your product is not a medical device but regulated by

another Center in the FDA, each component of the FDA has an office to assist with questions

about the products they regulate. 12

The USFDA allows for two regulatory pathways that allow the marketing of medical devices.

The first, and by far the most common is the 510(k) process (named after the Food, Drug, and

Cosmetic Act section that defines the process). A new medical device that can be established to



be "substantially equivalent" to a previously legally marketed device can be "cleared" by the

FDA for marketing as long as the general and special controls, are met. The vast majority of new

medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely

requires clinical trials. The second regulatory path for new medical devices is the Premarket

Approval procedure, which is similar to the path for a new drug approval. Typically, clinical trials

are compulsory for this premarket approval pathway.12

The FDA created a three tier risk-based regulatory process to accommodate the respective

potential harms posed by medical devices. Class I products pose the lowest risk; Class II

moderate risk; and Class III the greatest risk. These are based on the level of regulation

necessary to assure safety and effectiveness. The classification procedures are described in the

Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). 12

Class I: General controls

Class I devices are subject to the minimum regulatory control. Class I devices are subject to

"General Controls" as are Class II and Class III devices. General controls include requirements

that relate to adulteration; device registration and listing; misbranding; premarket notification;

notification, including repair, replacement, or refund; banned devices; restricted devices;

records and reports; and good manufacturing practices. Class I devices are not projected to

help support or sustain life or be significantly important in preventing damage to human health,

and may not extant an unreasonable risk of illness or injury. Most Class I devices are exempted

from the premarket notification and a few are also exempt from most good manufacturing

practices regulation. Examples of Class I devices include examination gloves, elastic bandages,

and hand-held surgical instruments.

Class II: General controls with special controls

Class II devices are those for which general controls alone cannot guarantee safety and

effectiveness, and existing methods are available that provide such guarantees. In addition to

complying with general controls, Class II devices are also subject to distinct controls. A few Class

II devices are exempted from the premarket notification. Special controls may contain

mandatory performance standards, special labeling requirements and postmarket surveillance.

Devices in Class II are believed to a higher level of assurance than Class I devices, and are

designed to accomplish as indicated without causing injury or harm to patient or consumer.

Examples of Class II devices include powered wheelchairs, acupuncture needles, air purifiers,

infusion pumps, and surgical drapes.

Class III: General controls, Special Controls and premarket approval



A Class III device is one for which inadequate information exists to assure safety and

effectiveness merely through the general or special controls adequate for Class I or Class II

devices. Such a device needs premarket approval, a scientific evaluation to ensure the device's

safety and effectiveness, in addition to the general controls of Class I. Class III devices are

typically those that support or sustain human life, are of significant importance in preventing

damage of human health, or present a potential, unreasonable threat of illness or injury.

Examples of Class III devices that require a premarket notification include pulse generators,

implantable pacemaker, automated external defibrillators, HIV diagnostic tests, and

endosseous implants.

Advances in patient care often develop from keen clinical insights and a needs-based method to

innovation. Although there is a vital role for incremental improvements to present solutions,

transformational innovation is what actually drives real shifts in clinical outcomes and

subsequently patient satisfaction, market access, and economic value. Innovation programs are

focused on unmet needs reasonably than solutions, call for a careful articulation of the specific

problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research

and development funding into areas where the greatest impact can be expected.13-15

Best practice in the modern medical device industry has shifted to more closely align with

greatest practice from the consumer sector, and a third iteration of the typical model is being

adopted by leading companies. Now the procedure begins with Voice of the Customer, ie, what

do people actually need? This is followed by invention, to meet those needs, and then

implementation, secure in the knowledge that the underlying demand is real. 16

This approach moves all risk to the front of the process and all costs to the back end. This is a

far more prudent method when budgets are limited and cost to execute is at an all-time high

due to numerous factors, including cost of resources to regulatory load. It also enables a team

to iterate between invention and Voice of the Customer as essential in order to build

confidence in an implementation strategy and required investment.16

The US is the predominant player in the $350 billion global medical device business. But

emerging economies—in particular, China, India, and Brazil—are catching a growing market

share. Under the current model in the developed world, once a new product is presented,

companies crowd the market with “add-on” innovations to the product that often rise costs

with only marginal benefits to patients. 5, 17

China’s and India’s huge populations alone represent large new consumer bases. While the

growth rate of medical technology in the US stalls, a study on innovation forecasts that the

Chinese medical device market will expand 15 percent annually during the next five years.

India’s market is predicted to expand 23 percent each year. China and India also show the



highest rapid rates of growth in triadic patent families (A series of corresponding patents filed

in the US, Europe, and Japan for the same invention.), with China growing 34 percent per year,

and India 10 percent per year. 17-18

Although the US invests more in R&D than any other country, US investment in R&D as a

percentage of GDP is decreasing. China’s R&D budget, on the other hand, is growing both

absolutely and relatively. By 2020, China’s R&D expenditure as a percentage of its GDP will

reach US 2010 levels. China has also eclipsed all nations except the US in terms of its number of

research publications, and the quality of China’s research institutions is improving. As a result,

the US expects China to become a global competitor for talent, resources, and output.17-18

Faced with aggressive competition and pressure to decrease costs across the healthcare

spectrum, medical device manufacturers are banking on growth through breakthrough

innovations and engineering in the field.13

Sustained success needs a more expansive, forward-thinking development approach. Product

development is no longer purely within the dominance of science — technology and marketing

deliberations, consumer preferences and data innovation are also driving developments. With

most medical device companies having 3–5 year development life cycles, new products have to

be forward-thinking and designed to suite technologies that will be in place 5 years from now.7

New medical devices are commonly a result of cooperation between academia and commercial

interests. This may cause clashes between the wish to publish and the concern in patenting and

acquiring IPRs. Previously, the IPRs of hospital employees and academicians may have been

inadequately protected, leaving the scientist with the option to keep an innovation secret or

bring it out in public domain, risking loss of protection by the later. Medical device companies

forecast partnerships, rather than in-house struggles, which will drive the future of innovation

and speed up to market. Ongoing cooperation and innovation through partnerships in an

extremely competitive and specialized industry needs new business models for joint projects,

new ways of making strategic fundings, and new approaches to R&D that encompass a broader

spectrum of partners and a more capacious mindset.1, 19

The speed of innovation will continue to rise as new innovations and players revolutionize

product development, manufacturing processes, and business models. Technology transfer

organizations are helping cooperation between corporations and universities, thereby reducing

this barrier. Small companies, developing pioneering devices, may be in an unfavorable

situation to protect their IPR against business organizations with vast legal and financial

resources. Big corporations often cover their products by wide and general patents, inhibiting

new innovation. Physicians are important contributors to device innovation and insufficient IPR



regulations may present additional barrier to innovative progress unless technology transfer

organizations vigorously assist in protecting IPRs.13-15

Obtaining a patent may boost innovation by giving patented product exclusivity for the time of

the patent protection. On the other hand, patents expressively increase the price of devices

and may decrease innovative efforts in the similar field. 1, 14

Most medical device and diagnostics invention is based largely on some understanding of the

vital laws of nature with respect to biology. However, while most medical device patents define

tangible products or diagnostic methods, natural phenomena, laws of nature, and abstract

ideas are not patentable. Whomsoever invents or discovers any new and useful machine,

process, manufacture, composition of matter, or any new and useful development thereof, may

obtain a patent therefor, subject to the conditions and requirements of this title.6, 20-21

The aim of the present paper is to review the patent filing trends and analyze the patent data

on following parameters: Priority Country, Current Legal Status, Patenting Trends, Major

Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group

Data, and Technology Topics related to medical device related innovations.

Methods

In present work, we applied patent analysis to identify the innovation trends in medical device

domain Comparing and analyzing the basic data set on different parameters. The results are

showing the patent trends in medical device innovations. Present study provides data and

analysis based on the following parameters: Priority Country, Current Legal Status, Patenting

Trends, Major Current Owner of Technologies, Assignee Type, International Patent

Classification (IPC) Group Data, and Technology Topics.

In order to get a quantitative estimation of such patent data, we have analyzed the patent data

available on Patent research and collaboration platform PatSeer. PatSeer is a one-stop analysis

and collaboration platform for Patent and Non-patent Literature search. PatSeer offers various

search, analysis and visualization tools for effectively looking in to large volume of data. We

found that most patents filed, published or granted are captured in to the database with very

short period of time after their original release by various publishing authorities. PatSeer

includes full text patent data from 51 countries, it also includes searchable English translations

and bibliographic data from 104+ countries as part of INPADOC data. It includes approximately

74 million full-text records in a database of 115 million+ records. This ensures coverage of

required patent data for trend analysis of related technologies on various parameters.10

To analyze the patent data and trends related to medical device innovations, records till a

period of 15th May 2018 was analyzed on PatSeer, the method for selection of relevant patent



data and documents was made based on Medical Device as key word in Title, Abstract, Claims

and Description (TACD) of all patent records available on PatSeer database. Further the

available dataset was analyzed based on the selection of most appropriate International Patent

Classification (IPC) Code of most relevant patent documents in the area of medical devices.6, 21

With the Search Terms TACD: (Medical Device), initially we found 586561 total records from the

database, further these records were deduplicated based on simple family members

parameter, so as to eliminate repetitive multiple records from same patent family and only one

record per patent family will come out. We had received total 190292 records from the whole

dataset, based on de duplication of records on the basis of simple family members. Further

from all available results, they were analyzed based on most prevailing International Patent

Classification (IPC) Codes of each patent document, and most relevant IPC classes were been

identified related to medical device domain. This has led to finalizing of following major IPC

Main Groups as: A61F2/00, A61B17/00, A61B5/00, A61N1/00, A61M25/00 and A61M5/00.

RESULT AND DISCUSSION

To analyses the patent trends in the area of medical device via PatSeer database, we had

carried out search using following IPC Main Groups: A61F2/00, A61B17/00, A61B5/00,

A61N1/00, A61M25/00 and A61M5/00 and data collected as on 15th May 2018.

The search for said IPC Main Groups were conducted on PatSeer database with two strategies,

direct search with IPC Main Group without any deduplication of results, and search with IPC

Main Group with deduplication of results based on simple family members to narrow down the

results as well to remove the duplicate values. The results of such search, along with the

detailed technical definition for each of these most relevant IPC main groups related to medical

device related patents is mentioned in below Table 1.



Table 1: IPC Main Group based patent search for medical device patents on PatSeer database.

IPC Main

Group

IPC Main Group Definition With no

deduplication

of result

records

With

Deduplication

of results

based on

simple family

of records

A61F2/00 HUMAN NECESSITIES;

MEDICAL OR VETERINARY SCIENCE; HYGIENE;

FILTERS IMPLANTABLE INTO BLOOD VESSELS;

PROSTHESES; DEVICES PROVIDING PATENCY TO,

OR PREVENTING COLLAPSING OF, TUBULAR

STRUCTURES OF THE BODY, E.G. STENTS;

ORTHOPAEDIC, NURSING OR CONTRACEPTIVE

DEVICES; FOMENTATION; TREATMENT OR

PROTECTION OF EYES OR EARS; BANDAGES,

DRESSINGS OR ABSORBENT PADS; FIRST-AID

KITS;

Filters implantable into blood vessels;

Prostheses, i.e. artificial substitutes or

replacements for parts of the body; Appliances

for connecting them with the body; Devices

providing patency to, or preventing collapsing

of, tubular structures of the body, e.g. stents

94427 25169

A61B17/00 HUMAN NECESSITIES;


DIAGNOSIS; SURGERY; IDENTIFICATION;

Surgical instruments, devices or methods, e.g.

tourniquets

158272 67226



A61B5/00 HUMAN NECESSITIES;


DIAGNOSIS; SURGERY; IDENTIFICATION;

Measuring for diagnostic purposes

200426 98991

A61N1/00 HUMAN NECESSITIES;


ELECTROTHERAPY; MAGNETOTHERAPY;

RADIATION THERAPY; ULTRASOUND THERAPY;

Electrotherapy; Circuits therefor

18304 11645

A61M25/00 HUMAN NECESSITIES;


DEVICES FOR INTRODUCING MEDIA INTO, OR

ONTO, THE BODY;

Catheters; Hollow probes

87859 32952

A61M5/00 HUMAN NECESSITIES;


DEVICES FOR INTRODUCING MEDIA INTO, OR

ONTO, THE BODY;

Devices for bringing media into the body in a

subcutaneous, intra-vascular or intramuscular

way; Accessories therefor, e.g. filling or cleaning

devices, arm rests

49572 23674

The information collected is based on most relevant IPC Main Group data, which was further

analyzed on various parameters: Priority Country, Current Legal Status, Patenting Trends, Major

Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group



Data, Technology Topics related to medical device innovation patents and results were found as

following:

Priority Country

To analyze the countries, where in the major innovations were been developed in these areas,

in present study we had analyzed the top countries from where the innovations are first

generated, the priority country. This represent the key countries where in maximum R&D was

involved for development of new technology in said domain of medical device. Data was

analyzed to sort top fifteen innovator countries jointly for the listed IPC Main Groups.

In Table 2 data for top fifteen priority country is provided for medical device related patents in

descending order of filled patent applications. In Figure 1 represents a Graph for top fifteen

priority countries for Medical Device Innovations. Figure 2 represents a density of medical

device related patents filled by various countries of the world.

Table 2: Data for top fifteen priority country

Sr. No. Priority Country Priority Country Code Total Applications

1 USA US 101655

2 Japan JP 31611

3 China CN 28281

4 Germany DE 14225

5 Russia RU 10006

6 Ukraine UA 7501

7 Korea KR 6270

8 Soviet Union SU 6129

9 Europe EP 5153

10 France FR 4997

11 U.K. GB 4306

12 Australia AU 1839



13 Taiwan TW 1707

14 Sweden SE 1304

15 Italy IT 1173

Figure 1: Graph for Top 15 Priority Countries for Medical Device Innovations

Figure 2 Density of medical device related patents filled by various countries of the world.



Current Legal Status

To analyze the current legal status of available large number of patent documents, which were

filled across the world by various applicants. They were further analyzed to check how many

patents were in force, how many were expired, and expired for what reasons, How many were

withdrawn etc.

The available patent data set was further analyzed to obtain details related to current legal

status of said patent documents in all jurisdictions where ever they had filled patent

application. All patents were grouped based on their status of applied, active, inactive, expired,

withdrawn, surrendered, granted, revoked, refused, SPC etc. Here SPC is to be considered as

patent term extension. Table 3 below represent the statistics for Current Legal Status of all

relevant patents data set. Figure 3 below represent the graphical representation for Current

Legal Status of all relevant patents data set.

Table 3: Current Legal Status of all relevant patents data set

Sr. No. Current legal status Total

1 Inactive - Expired 87043

2 Active - Granted 76286

3 Active - Applied 72193

4 Inactive - Nonpayment 47169

5 Inactive - Withdrawn / Surrendered 39113

6 Inactive - Rejected / Refused / Suspended 13775

7 Inactive - Opposition / Revoked 366

8 SPC Inactive - Expired / Rejected 4

9 SPC Active - Granted / Applied 1



Figure 3: Graphical representation for Current Legal Status of all relevant patents data set

Patenting Trends

Further analysis was made to check for the patent filing trend in these domains for data

available on PatSeer from time period of 1st January 1999 till 15th May 2018. To this we have

analyzed the data for how many patent applications were filed and how many patents were

granted in total, on yearly basis during said time period. Cumulative data for filing and grant of

patents from all countries across the world, available on PatSeer database was analyzed.

Further the data set is analyzed to check for the total number of patent applications were filed

in all jurisdictions in a defined period of time, and total number of relevant patents granted by

all jurisdiction in to same amount of time period. The data were been analyzed on yearly basis

starting from January 1999 to 15th May 2018. Table 4 below represents the patenting trend,

data for total number of patent applications filed and total patents granted on yearly basis by

all jurisdictions in cumulative manner. Figure 4 represents the graphical representation of

patenting trend, data for total number of patent applications filed and total patents granted for

same data.

Table 4: Patenting Trend

Year Applications Filed Grant Published

1999 14517 9671

2000 21301 10084

2001 20357 11974



2002 22221 13191

2003 22206 13186

2004 17280 13990

2005 12783 13431

2006 12921 6279

2007 11206 6550

2008 11057 6374

2009 10923 6471

2010 10311 6744

2011 11080 6717

2012 12881 6977

2013 14968 7011

2014 14529 6865

2015 13647 4586

2016 10218 3020

2017 2468 2024

Till 15th May 2018 42 462



Figure 4: Graphical Representation for Patenting Trend for Medical Device Patents

Current owner (Assignee):

From initial screening of records related to top priority countries, current legal status of filed

patent applications, patent filing trend now further analysis was made to identify the major

current owner of technologies. It was analyzed to identify who holds the maximum number of

patents in said area of medical device innovations.

Patent data set was analyzed further to check for the top assignee/current owner of maximum

patents in these areas. The top assignees had been find out based on the maximum number of

patent applications filed and granted, holds by any assignees from all relevant patents data set.

From the whole patents data set attempt was made to identify top fifty assignees in key

technology areas related to medical devices. Table 5 below represents the patenting trend,

data for top fifty assignees worldwide who holds maximum number of patents in these

domains. Figure 5 is a graphical representation to show the top fifty current owners of patents

with number of patents hold by each owner in medical device domain.

Table 5: Top Fifty Current Owners for Medical Device Related Patents

Sr. No. Current Owner Total

1 JOHNSON & JOHNSON 5944

2 BOSTON SCIENTIFIC CORP 5313



3 MEDTRONIC INC 4640

4 ABBOTT LAB 3694

5 COVIDIEN PLC 3446

6 KONINKLIJKE PHILIPS NV 2976

7 TERUMO CORP 2634

8 NIPPON LIFE 2609

9 TOSHIBA CORP 1596

10 PANASONIC CORP 1397

11 BECTON DICKINSON & CO 1293

12 SIEMENS AG 1287

13 STRYKER CORP 1247

14 GENERAL ELECTRIC CO 1199

15 SCIMED LIFE SYSTEM INC 1096

16 BOSTON SCIENT LTD 1093

17 ZIMMER BIOMET 1063

18 BARD INC 1033

19 B BRAUN MELSUNGEN AG 1026

20 HITACHI LTD 997

21 SAMSUNG GROUP 991

22 COOK MEDICAL TECHNOLOGY LLC 789

23 CANON INC 778

24 FUJIFILM HOLDING CORP 760

25 SIEMENS AKTIENGESELLSCHAFT Ã–STERREICH 734



26 BAXTER INTERNATIONAL INC 673

27 G OBRAZOVATEL NOE UCHREZHDENIE 673

28 TYCO HEALTHCARE GROUP LLP 668

29 SMITH & NEPHEW PLC 611

30 SEIKO GROUP 610

31 SANOFI SA 590

32 UNIV CALIFORNIA 574

33 COOK GROUP INC 565

34 ROCHE HOLDING AG 555

35 KONICA MINOLTA HOLDING INC 547

36 OMRON TATEISI ELECTRONIC CO LTD 520

37 NOVARTIS AG 502

38 EDWARDS LIFESCIENCES CORP 500

39 BAYER AG 473

40 SUMITOMO GROUP 428

41 ROCHE DIABETES CARE INC 408

42 FUJIFILM HOLDINGS CORP 389

43 BECTON DICKINSON & COMPANY NEW JERSEY 381

44 NIPRO CORP 374

45 GEN HOSPITAL CORP 373

46 SUMITOMO BAKELITE CO LTD 359

47 STORZ KARL GMBH & CO KG 341

48 FUJITSU LTD 338



49 LIVANOVA PLC 326

50 SONY CORP 323

Figure 5: Top Fifty Current Owners for Medical Device Related Patents



Assignee Type

After analyzing the patent data set for top current owners of patents, to check the share of

patents holding by various broad categories of assignees, a further analysis of patent data set

was made based on the basis of assignee type. The patents were been grouped in to following

groups of assignees: Firm, Individual, University, Government, Hospital, Institutes and Others.

Table 6 below represents a total number of patents hold by each type of the assignee. Figure 6

below represents a graphical representation to show the total number of patents hold by each

type of the assignee.

Table 6: Assignee Type

Sr. No. Assignee Type Number of Patent Applications

1 Firm 131012

2 Individual 60292

3 University 19250

4 Hospital 4877

5 Government 1477

6 Institutes 79

7 Other 42508

Figure 6: Total patents hold by each type of assignee

51%

23%

7%2%

1%

0%

16%

Assignee Type - Number of Patent Applications

Firm

Individual

University

Hospital

Government

Institutes



Key IPC Classes

Further to analyze the micro areas of innovations in these broad fields of innovation, the patent

data were been analyzed based on the International Patent Classification (IPC) system. IPC

analysis of the data set was performed on the IPC Sub Group Data to define micro technical

domains of each innovations protected by patents. And attempt was made to identify the total

number of patent applications filed in particular technology domains.

All patents are systematically classified according to their specific technical field. Though

various existing national classification systems, the International Patent Classification (IPC)

system is a common system shared by all patent offices. Further information on the IPC,

including how to use keywords to find the right classification, is available at,

http://www.wipo.int/classifications/ipc. To present research study further attempt was made

to analyze the micro areas of technologies, based on the IPC sub group code assigned to each

patent by respective authorities. A definition for each of those IPC sub group codes are

provided in below mentioned Table 7. Attempt was made to identify top fifty such IPC sub

groups which have maximum number of patents classified with said such IPC codes. Based on

the aspect and scope of each patent application, respective authorities may assign one or more

IPC sub group codes to each of these patents. This will reflect the core major domains in the

field of medical device, where in maximum research is been carried out and innovations were

developed.

Table 7: Top IPC Sub Group with Definition.

Sr.

No.

IPC Sub Group/Full Class Total

Patents

1 A61B5/00 - Measuring for diagnostic purposes 92364

2 A61B17/00 - Surgical instruments; devices or methods 63075

3 A61M25/00 - Catheters ; Hollow probes 29397

4 A61F2/00 - Filters implantable into blood vessels ; Prostheses 23314

5 A61M5/00 - Devices for bringing media into the body in a subcutaneous;

intra-vascular or intramuscular way ; Accessories therefor

16808

6 A61B19/00 - Instruments; implements or accessories for surgery or diagnosis 10832

7 A61N1/00 - Electrotherapy ; Circuits therefor 9723



8 A61F2/30 - Joints 7745

9 G06F19/00 - Digital computing or data processing equipment or methods;

specially adapted for specific applications

7676

10 A61B5/11 - Measuring movement of the entire body or parts thereof 7439

11 A61B17/34 - Trocars ; Puncturing needles 6285

12 A61B5/145 - Measuring characteristics of blood 6141

13 A61M25/01 - Introducing; guiding; advancing; emplacing or holding catheters 6122

14 A61B17/32 - Surgical cutting instruments 5817

15 A61B1/00 - Instruments for performing medical examinations of the interior

of cavities or tubes of the body by visual or photographical inspection

5528

16 A61M1/00 - Suction or pumping devices for medical purposes ; Devices for

carrying-off; for treatment of; or for carrying-over; body-liquids ; Drainage

systems

5282

17 A61B5/0205 - Simultaneously evaluating both cardiovascular conditions and

different types of body conditions

5260

18 A61B10/00 - Other methods or instruments for diagnosis 5184

19 A61B5/01 - Measuring temperature of body parts 5004

20 A61B17/22 - Implements for squeezing-off ulcers or the like on inner organs

of the body ; Implements for scraping-out cavities of body organs

4986

21 A61B5/024 - Measuring pulse rate or heart rate 4810

22 A61B6/00 - Apparatus for radiation diagnosis 4807

23 A61B5/04 - Measuring bioelectric signals of the body or parts thereof 4695

24 G06Q50/22 - Health care 4685

25 A61B18/14 - Probes or electrodes therefor 4643

26 A61B18/00 - Surgical instruments; devices or methods for transferring non-

mechanical forms of energy to or from the body

4499



27 A61B17/12 - For ligaturing or otherwise compressing tubular parts of the

body

4384

28 A61F2/46 - Special tools for implanting artificial joints 4361

29 A61B5/02 - Measuring pulse; heart rate; blood pressure or blood flow ;

Combined pulse/heart-rate/blood pressure determination ; Evaluating a

cardiovascular condition not otherwise provided for

4340

30 A61B17/04 - For suturing wounds ; Holders or packages for needles or suture

materials

4331

31 A61F2/02 - Prostheses implantable into the body 4139

32 A61M5/32 - Needles ; Details of needles pertaining to their connection with

syringe or hub

4102

33 A61B5/055 - Involving electronic magnetic resonance 4074

34 A61B5/1455 - Using optical sensors 3971

35 A61M31/00 - Devices for introducing or retaining media 3613

36 A61F2/06 - Blood vessels 3602

37 A61B5/08 - Measuring devices for evaluating the respiratory organs 3597

38 A61B5/05 - Measuring for diagnosis by means of electric currents or magnetic

fields

3489

39 A61B17/28 - Surgical forceps 3400

40 A61B8/00 - Diagnosis using ultrasonic; sonic or infrasonic waves 3380

41 A61B17/56 - Surgical instruments or methods for treatment of bones or joints

; Devices specially adapted therefor

3241

42 A61F2/958 - Inflatable balloons for placing stents or stent-grafts 3042

43 A61N1/05 - For implantation or insertion into the body 3001

44 A61B90/00 - Instruments; implements or accessories specially adapted for

surgery or diagnosis and

2991



45 A61F2/28 - Bones 2989

46 A61M37/00 - Other apparatus for introducing media into the body 2959

47 A61B5/0402 - Electrocardiography 2916

48 A61N1/36 - For stimulation 2900

49 A61B5/107 - Measuring physical dimensions 2892

50 A61B5/103 - Measuring devices for testing the shape; pattern; size or

movement of the body or parts thereof; for diagnostic purposes

2834

Technology Topics:

After analyzing the full patent data set to find out top fifty IPC groups to identify the micro

areas of research, further attempt was made to define a macro level areas of all these patent

documents. To see the macro areas of research, the patent documents data set was further

been grouped into various groups of Technology Topics, the total area of records related to

particular technology topics were been shown based on the total number of patent documents

pertaining to said domain in present study dataset, which is shown in below Figure 7.

Figure 7: Technology Topics Related to Medical Device



CONCLUSION

The present analysis of patent documents between January 1999 and 15th May 2018 in the

area of medical device was carried out by means of patent information analysis so as to get

some insights. The analysis was carried out using most relevant IPC Main Groups: A61F2/00,

A61B17/00, A61B5/00, A61N1/00, A61M25/00 and A61M5/00, which represent maximum

innovations protected by means of patents in the varied domains of medical devices. From the

initial screening of records it was found that in medical device industry maximum innovations

were generated in the areas of prostheses, surgical instruments, measuring instruments for

diagnostic purposes, electrotherapy and circuits thereof, catheters like hollow probes, devices

for bringing media into the body etc. From the priority country analysis of all patent documents

it was evident that maximum patents were been filed by USA, Japan, China, Germany, Russia in

order, followed by other countries. Each of these countries holds more than ten thousand

patents in said domain. It was also concluded that apart from patent applications and granted

patents in this domain, large number of patents are in inactive phase due to the reason either

of withdrawal, surrender, expired, nonpayment of fees, rejected, refused or suspended. From

patenting trend it can be observed that, patent filings related to medical device innovations are

not showing continuous rise or fall, it was observed that during a period of 1999 to 2005 large

number of applications were filed and granted compared to 2005 onwards time period as

under study. Further analysis was made to identify major current owners of technologies in this

domain, and top 50 assignees had been identified with total number of patents they are

holding in this area. Johnson & Johnson, Boston Scientific Corp, Medtronic Inc, Abbott Lab and

Covidien Plc are the top five assignees who holds the maximum patents in the areas of medical

devices. Further analysis was made to categorize the patent applications and patents, based on

the type of assignee. From this it was evident that, majority of patents were hold by firms,

followed by individual and university as assignees. Further the innovations were grouped and

analyzed based on micro level in various technical fields, based on various IPC sub group codes,

to which areas maximum patent applications were been filed. Patent data was also grouped in

various broad technology topics, to identify area of research topics on macro level.



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