Cardiovascular Medical device sector: a Patent landscape Report

Medical devices are now a pervasive part of modern medical care. The medical device industry includes a wide range of products for various kinds of therapeutic area and diseases. It is comprised of the companies that are involved in developing, manufacture, and market medical apparatuses, instruments, equipment, devices and supplies. The medical device sector comprises of different types of products ranging from simple bandages to life sustaining implantable devices. Owing to the increased prominence of cardiac diseases in the country, exploring the cardiovascular device sector would show the trend, pitfall and the growth of innovation in this area.

This report encompasses patents filed in cardiovascular device sector in the Indian Patent office and also includes Patents that have entered though PCT. This analysis involves several types of cardiovascular devices that include commonly known devices such as Pacemaker, Angiographs, ECG and also latest sophistications such as Coronary Stents, Artificial Heart Valve, Cardiac Assist device etc. Coronary stent is a small tube that is inserted into the coronary arteries to widen its wall thereby treating blockages. Artificial heart valve is of two types: biological and mechanical heart valve; they are replaced when the natural heart valve malfunctions and it obstructs the blood flow between the chambers of the heart. Cardiac assist device is a broad term which refers to the devices that support or substitute the function of the heart during cardiac arrest or a cardiac surgery.

1)      No. of Patents Granted/published in different sectors of Cardiovascular devices

The category cardiac medical device is a generic category of devices that could not be classified into any of the mentioned categories. This category involves devices useful during the cardiac surgery, cardiac defibrillator, angioplasty device etc. Largest number of patents is filed in the Heart valve sector, with a significantly large pool of under-served patients; represent the biggest opportunity for the leading medical equipment and devices manufacturers. This is followed by Stents that contributes to the major part of the total minimally invasive vascular interventional devices market used in coronary and peripheral procedures. No much research activity is taking place in the area of angiographs and heart implant sector in India, which means that such older techniques are replaced by the advanced sophistications in recent years.

2)      Patent filings by Geography                                                                              

The graph 2 represents the number of granted patents and published applications those of Indian origin and which have entered Indian national phase through PCT application. It shows that cardiovascular market is dominated by the international players and very meagre contribution by the Indian companies. The expanded view shows the geographical distribution of PCT applications. United States of America generates overwhelming majority of the PCT applications filling in this field, followed by Germany, Australia, Canada, France and UK. Israel has granted patents in India territory; indicates the interest of applicant to enter Indian market. Further Japan also shows to arise with PCT applications in Indian National phase.

3)      Key players in the industry

The report summarizes that foreign companies like Koninklijke Philips Electronics and Sunshine Heart Company Pvt. Ltd are the top key players in cardiovascular medical device in India.

These companies have involved in intellectual gains of their devices through patents.  Cardiovascular medical devices by Koninklijke Philips Electronics includes Stents (2 granted patents), Monitoring device (4 published applications), Magnetic resonance imaging involved in cardiac disease diagnosis (1 in granted patents and 1 published application) and Computed topography (2 granted patents). This data reveals that Philips is actively involved in Patenting their cardiovascular device innovation and marketing in India. Sunshine Heart Company Pvt. Ltd., a US-Australia based medical device company is engaged in the design and development of C-Pulse heart assist devices. The Company has only one operating segment, which is the research and development of heart assist devices and keenly involved in innovation of cardiac assist devices. All India institute of medical science is the only Indian player in this field. Medtronic Inc. (U.S.) is the world’s leading medical technology company specializing in implantable and invasive therapies. Medtronics in India have 2 granted patents in Heart valve sector and 2 granted patents in other Cardiac medical device. 

Conclusion

Cardiovascular medical devices in Indian market have made enormous growth in last five years and the growth rate of technological convergence in medical device will become deeper over time. There is considerable work being done at the interface between mechanical and electronic engineering, with bioscience, in developing sophisticated cardiovascular devices such as life sustaining stents, prosthetic heart valves, sophisticated operational tools, Imaging technologies and ultra modern diagnostic kits, and many more on the list. The number of granted patents and applications are increasing every year in way giving enough space for the innovators to apply their technical skills by innovating new equipments in the field of cardiovascular medical devices. Indian market for medical supplies and disposables is dominated by the domestic manufacturers, whereas importers dominate the costly and high end medical equipments. Thus, the report emphasises that India is emerging as a biggest market for the medical giant to invest their intellectuals in the Indian patent pool.

Labeling product as “Patent Pending”

Bindu Sharma (bindu@origiin.com)

From the date of filing of patent application to the grant is a long procedure and often disappoints the inventor for the reason that grant of patent is going to take long time and securing patent of his interest becomes a great worry till then. However, when a patent application is filed (provisional or complete specification), patent office issues a receipt on which date of filing or priority date is stated. It is worth noting that from that date, the product for which patent has been applied for  or product made by a process for which patent has been applied for can be marked as “patent pending” or "patent applied for" as a warning or a notice, meaning that patent has been applied for but not yet granted. The marking as an express notice serves to notify potential infringers, that they may be liable for damages, seizure, and injunction once a patent is issued.  The patent law gives applicant all rights and privileges of a patent holder except that law suit cannot be initiated till patent is granted.

 Prime advantages of marking products as “patent pending” are that it not only helps to avoid innocent infringement but also encourages patentees to give notice to the public that the article is patented and also aids the public to identify that the article is patented. Indian patent law (Section 111, Indian Patent Act of 1970) limits the award of damages in patent infringement cases when an infringer or the defendant is able to prove that he was unaware of the patent-in-suit. However, the Patent Act effectively reverses this allocation of the burden of proof in cases where an article is marked with the word “patent” and a patent number. In a suit for infringement of a patent, damages or an account of profits shall not be granted against the defendant who proves that at the date of the infringement he was not aware and had no reasonable grounds for believing that the patent existed. Therefore, marking the products as “Patent pending” serves an important public notice that patent has been applied for and leaves little space for innocent infringement.

Patent pending marking is not restricted to the patent application but also for granted patents in which case the products need to be marked as “patented”. However, a person shall not be deemed to have been aware or to have had reasonable grounds for believing that a patent exists by reason only of the application to an article of the word “patent”, “patented” or any word or words expressing or implying that a patent has been obtained for the article, unless the number of the patent accompanies the word or words in question. That means that mention of patent number is also important to be mentioned if the product in question is patented. For example, in Australia, the preferred marking is "Aust. Pat. App. No. yyyynnnnnn" where "yyyy" is the four-digit year of the application and "nnnnnn" is the six-digit number allocated by the Australian Patent Office.

According to Section 120 of Indian Patents Act, 1970, use of marking, such as “Patent pending” or “patent applied for”, where no patent has been actually applied for is an offense and if any person falsely represents that any article sold by him is patented in India or is the subject of an application for a patent in India, he shall be punishable with fine which may extend to one lakh rupees. The use of words “patent”, “patented”, “patent applied for”, “patent pending” or other words expressing or implying that an article is patented or that a patent has been applied for shall be deemed to refer to a patent in force in India, or to a pending application for a patent in India, unless there is an accompanying indication that the patent has been obtained or applied for in any country outside India".

Even though marking products for which patent has been applied for, care should be taken while using the word "Patented” as it should be used only after grant of the patent. Hence, before grant is accorded, it is advisable to mark products as "Patent Pending" or “Patent applied for”, to indicate that patent application has been filed but patent is not granted yet.

What is a Compulsory License?

By Santhoshi Basuthkar (santhoshi.b.s@gmail.com)

In developing countries like India, where AIDS is spreading widely, access to lifesaving medicines is a dire need. The Indian Pharmaceutical industry is mainly involved in producing generic drugs and there are very few R&D centers in the country that invent new drugs. Thus we mainly depend upon importing those valuable medicines from the developed nations. Several multinational pharmaceuticals use this opportunity to hike up the prices of their drugs when it is being sold to the markets of the developing nations. This prevents the easy access of medicines to the needy patients. Compulsory licensing is one such tool to prevent such dominance of monopoly exhibited by the multinational industries. A compulsory license (CL) to a patented product is granted when the government allows someone to produce the patented product without the consent of the patent owner. It is an involuntary act between a willing buyer and an unwilling seller, enforced by the state.

Patents are granted to encourage the inventors to disclose their inventions and also to grant them monopolistic right to exploit the invention. The objective of patent grant in india is to ensure that the inventions are worked in India on a commercial scale and to the fullest extent without any undue delay. If the patentee is not commercializing the invention and as a result, the reasonable requirements of the public are not met or the patented product is not available to public at reasonable price, the compulsory license is available as a remedy against abuse of patent right.

Many patent law systems provide for the granting of compulsory licenses in various situations. The Paris Convention of 1883 provides that each contracting state may

take legislative measures for the grant of compulsory licenses. The Article 5A (2) of the Paris Convention reads:

"Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work."

Compulsory licensing is one of the flexibilities on patent protection included in the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. Article 31 of TRIPS lists a number of conditions for issuing a CL.  India joined the TRIPS agreement in 2005 thereby providing stronger provisions for CL. Today, many countries such as Canada, France, UK, USA, Australia, Zimbabwe, Ghana, Brazil, Equador, Malaysia, and Thailand have provisions for granting CL. Section 84 of Indian Patents (Amended) Act, 1970 states the provisions for granting CL. It mainly deals with three major conditions for granting a CL: a) Reasonable requirements of the public with respect to the patented invention have not been satisfied, b) The patented invention is not available to the public at a reasonably affordable price and c) The patented invention is not worked in the territory of India.

The first Compulsory License in India was granted recently on 9^th Mar 2012, to Natco Pharma for the manufacture of its patented anti-cancerous drug, Nexaver. Natco would sell the drug at 97% lesser rate of its original cost. The grant of the first CL in India has been welcomed with mixed reviews. Undoubtedly, the CL would ease the suffering of the needy patients by getting cheaper access to valuable medicines. However, the pharma giants had to swallow a bitter pill. It takes around 2 billion dollars to innovate a single drug and launch it in the market, grant of such compulsory licenses would shake their product pipeline as the ROI (Return of Investment) for such expensive drugs would not be met. Experts say that such events will also reduce the innovations happening in the pharma sector.  Nevertheless, the main notion of  inventing new drugs is to meet the needs of the patients, hence it would be wise for pharmaceutical companies to come up with new price slabs while launching their product to respective countries.

Copyright notice: Proper format is important

      By Anita Kalia (anita@origiin.com)

Copyright is a right given by the law to creators of works such as literary, dramatic, musical, and artistic as well as producers of cinematographic films. It is important to know that copyright gives protection for the expression of an idea and not for the idea itself. India is a member of the Berne Convention, an international treaty on copyright, under which, registration of copyright is not an essential requirement for protecting the right. It would, therefore, mean that the copyright on a work created in India would be automatic [inherent] and would simultaneously be protected through copyright in all the member countries of the Berne Convention. The moment, an original work is created, the creator starts enjoying the copyright. However, an undisputable record of the date on which a work was created must be kept.

Appropriate notice of copyright in a proper format is important to be included in the work even though there is no statutory requirement to put it. Having copyright notice serves as an identifier placed on copies of the work to inform the world or the third party (ies) of the copyright ownership. While use of a copyright notice was once required as a condition of copyright protection, it is now optional, though it is highly recommended to include it for various reasons. Use of the copyright notice is the sole responsibility of the copyright owner and does not require formal or advance permission from the Copyright Registry. It is interesting to note that copyright notice can be legitimately included in the work such as website, software CD, books etc even without formal registration of the work with Copyright Registry.

The copyright notice should be clear enough to an ordinary user of the work under normal conditions of use and should not be concealed from view upon reasonable examination. Advantages of putting copyright notice are that it:

 ü  informs the public that the work is protected by copyright;

ü  indicates name of the copyright owner;

ü  shows the year of first publication of the work; and

ü  has added advantages in case of copyright infringement.

In the event that a work is infringed by third party, if a proper notice of copyright appears on the published copy or copies to which a defendant in a copyright infringement suit had access, then no weight shall be given to such a defendant's defense based on innocent infringement for the reason that innocent infringement occurs only when the infringer did not realize that the work was protected. With a proper copyright notice, infringer cannot take defense of innocent infringement.

Commonly used format to put copyright notice comprises of following elements:

ü  The copyright symbol © (the letter C in a circle), or the word "Copyright" can be used;

ü  The year of first publication of the work shall be added; and

ü  Further to this, the line such as “All rights reserved” can also be used.

Some of the examples of copyright notice are as below:

Copyright © 2012 Origiin IP Solutions LLP, All right reserved

In case of DVD or CD, usually you may see following format:

Copyright © 2012 XYD entertainment. All right of the produced and owner of the CD content reserved. Unauthorized copying, public performance and broadcasting of this content/recording is prohibited and punishable under Copyright Act, 1957.

Copyright notice on the work is a express notice that work is protected by copyright law. Therefore, even if there is no statutory requirement to have copyright notice on the work, it is wise to include it on the work for various reasons.

Copyright Infringement & Substantial similarity

By Rajitha TR

 Copyright law comprises legal principles and rules envisaging the protection of those who produced intellectual works in the field of literature, music and fine arts including photographs, films and performance of artists. The principle objective of Copyright law is to protect the author’s original work from being reproduced in an un-lawful manner.

Copyright infringement is violation of exclusive rights of the copyright holder, the unauthorized or prohibited use of works under copyright such as the right to reproduce or perform the copyrighted work, or to make derivative works. To establish copyright infringement in court of law, a copyright owner must establish proof of copyright ownership and proof of copying by direct evidence of copying or by indirect evidence showing access to the original work; and "substantial similarity" between the original and allegedly infringing work.

 In case of any copyright infringement, the plaintiff (party who initiates the law suit) must prove that the defendant’s (a person or party against whom an action or claim is brought in a court) work is “substantially similar” to the plaintiff’s work. Hence, the infringement test involves two important components. First, did the defendant actually copy the plaintiff’s work? And secondly whether the copied elements would protect the expression and is sufficiently important to be actionable. In simple words, the aim of the test is to determine if the copying constitute any infringement.

 To prove copyright infringement, infringer shall have access to the plaintiff’s work. In this context, access means whether the infringer had a suitable opportunity to witness the original work or not. Therefore, while determining infringement, the courts often compare all possible elements of both the works created by the plaintiff and the defendant & exclude all public domain elements from work and look only to the key elements that are protectable. Hence, in establishing the protectable elements, the court would distinguish between the idea underlying in the work created and its expression. For that reason the term “substantial similarity” causes confusion in the copyright infringement analysis because the same term has different meanings at two different points in the infringement analysis.

The traditional approach to identify substantial similarity is the “Total concept and feel” test which relies on the visceral response of the ordinary observer or the audience or more appropriately the ‘lay observers’ test. The basis of the test is to determine whether an average lay observer would recognize the alleged copy as having been appropriated from the copyrighted work. The ordinary observer is then taken as a bench mark against the determination of presence or absence of substantial similarity.

The other approach is the “Extrinsic-intrinsic test” which is applicable to most literary works, such as books and scripts, musical compositions and artwork. This test comprises two separate tests firstly the extrinsic test measures whether there was substantial similarity in general ideas of the infringed and the original work and secondly, the intrinsic test which measures the substantial similarity in the protectable expression of both the works.

Yet another approach is the “Abstraction-Filtration-Comparison” or AFC test. AFC test involves three steps in order to determine the substantial similarity of the non-literal elements of a computer program.

Landmark case R.G. Anand v. Delux Films delivered by Indian Supreme court helps in understanding the concept of the substantial similarity.  In this case, the author of the play Hum Hindustani R.G. Anand sued a production company Delux films for making a movie that was allegedly an exact copy of his play. The Supreme Court of India held that despite some similarities, the movie did not infringe the play’s copyright as there some substantial dissimilarities between the two. The dissimilarities were differences in story, theme, characterization and climaxes. Apart from this the Court also held that the copyright cannot be sought for an idea, it’s applicable only for an expression of an idea and not idea itself, as the allegation by Anand was that the defendants violated his copyright by copying his idea which was held invalid.

Therefore, the issue of substantial similarity is a critical element in infringement claims. Even where the fact of copying is conceded, no legal consequences will follow from the fact unless the copying is substantial. Furthermore, the term “substantial similarity” is not defined in the Copyright Act and it is a fact determined by the judge or the jury. Thus the decision rests on the shoulders of the Court to decide which test needs to be applied for which case and give a good justice.

Patent search: What is the right time to do it?

The word “patent search” or “prior-art search” in patent law means any information that relates to the knowledge existing prior to the date of invention, which has been made available in the public domain. This knowledge (or “prior art” or “state of art”) may be in any form such as patent, scientific literature, publications (such as journal articles, proceedings of conferences, data books and display information from technical exhibitions), public discussions or news from anywhere in the world. The prior-art search is often performed by a patent attorney or a patent agent or a patent searcher and it is conducted through various patent and non-patent databases and other relevant technological websites to identify relevant prior-arts. 

Novelty of an invention is always determined before inventive step because the creative contribution of the inventor can be assessed only by knowing the novel elements of the invention. The invention is supposed to be lacking in novelty, if information about the invention has already been disclosed. Thus, for example, if a claim specifies alternatives or defines the invention by reference to a range of values (e.g. of composition, temperature, etc), then the invention is not new if one of these alternatives, or if a single example falling within this range, is already known. Thus, a specific example is sufficient to destroy the novelty of a claim to the same thing defined generically.

Purpose of patent search

Patent search is done for various reasons such as:
1.         Patent search gives clear idea on the work claimed or published by others and helps inventor to assess chances of getting patent for his invention.
2.         Even if the invention that the inventor intends to claim is already claimed by third party (ies), results of patent search give him direction on how further research shall be done.

3.         Patent search shall also be done before planning research and development to make sure that the companies don’t waste time in re-inventing the Wheel/duplication of work and focus purely on innovation.

4.         Patent search also helped to assess strength of the competitions by revealing their names and gives picture of the inventions for which they have filed for patents.

When to do patent search?

The right time of doing patent search is at the stage of idea itself. Before investing time and money working on the idea, it is extremely important to assess whether the idea is novel or already published or claimed by anyone else. Often the inventors assume novelty of idea by looking at the products which are already in market and comparative analysis of such products with their idea makes them believe that idea is novel. The hard reality is that a small fraction of the patents are commercialized and big chunk of patents, even though are not commercialize but certainly form part of the prior art and may prevent an inventor from getting patent on his invention

Therefore it is imperative for the inventors to perform patent search at the stage of idea itself, assess chances of patentability as well as infringement of patent right of the third party (ies) before investing money and time in research. This is crucial for the inventor to make decision on patentability of the invention, it is important to get the search done in time.

Jurisdiction for patent search

Patent search is done world-wide or globally even though patent rights are territorial. A publication related to the invention in US is enough to destroy novelty and prevent an inventor patenting the same invention in India even though there is no valid patent granted in India.

Conclusion

Timely patent search is an important not only to assess chances of getting a patent but also to plan research and development in an organization and know competitors in the same area of technology. It is good idea to perform patent search at the stage of idea itself to save time, money and to have better quality of research output.

US or India: Where to file for a patent first?

United States Patent and Trademark Office (USPTO) often is one of the favorite or lucrative destination for the applicants for filing a patent application for various reasons, the prime reason being that usually the target as well as potential market of the invented product or process is US. Another major reason for interest in filing in US is that US patent laws permit broader spectrum of software patents compared to Indian Patent Law which says that software per se is not patentable till it has technical application. For all these reasons, at the time of filing for a patent, the biggest dilemma an inventor has is where to file for a patent first, in India or US?

In this article, we will explore the advantages of filing in India first and consequences of filing in US first if the inventor is a resident of India.

Filing in India first makes sense (U/S 39)

Before taking a decision on where to file first, it is essential to understand what does Indian Patent Law says about foreign filing. The issue is sensitive as well as critical and lack of expert legal advice on the same may have fatal consequences.

Accordingly to Section 39 (Residents not to apply for patents outside India without prior permission) of the Patents Act 1970, a person who is resident in India shall not make application for grant of patent outside India without:

1.             Either taking Foreign Filing Permission (FFP) from the Controller of patents. This permission is usually granted by the Controller within 21 days and is required not only for foreign filing but also for filing a PCT application; or

2.             Filing for a patent for the same invention in India and waiting for 6 weeks.

Who is “Resident of India”?

The term “Resident of India” has not been defined in the Patents Act, 1970 but according to Income Tax Act, an individual can be termed as a 'Resident of India' if he stays for the prescribed period during a fiscal year i.e. 1st April to 31st March, either for:

1. 182 days or more; or
2. Has been in India in aggregate for 365 days or more in the previous four years.     

Any person who does not satisfy these norms is termed as a 'Non-Resident'. A resident individual is considered to be 'ordinarily resident' in any fiscal year if he has been resident in India for nine out of the previous ten years and, in addition, has been in India for a total of 730 days or more in the previous seven years. Residents who do not satisfy these conditions are called individuals 'not ordinarily resident'.

Rational behind filing in India first

Main rational behind having Section 39 is to safeguard national defense and security. If the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permisson for foreign filing without the prior consent of the Central Government. Such application may be imposed Secrecy Directions and the Controller may give direction for prohibiting or restricting the publication of such application if it appears to him that the invention in question falls in one of a classes notified to him by Central Government as relevant for defence purposes or the Controller himself considers it to be so. However, this section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.

Do you lose anything by filing in India first?

It is a myth that by filing in India first and US later, one loses on the date and the date of filing in US gets delayed. The fact is that even if you file for a patent in India first, you can file the same application in US (as convention application) immediately after expiry of 6 weeks from the date of Indian filing. At the time of filing in US, you can claim priority date from your Indian filing as both India and US are convention countries. Effectively, this means that even though you file in India first and US later, the same date of priority can be maintained in USPTO as well as . Infact when priority is claimed from Indian filing, the applicant has to submit in USPTO, the priority document obtained from the Indian Patent Office.

Therfore, it actually doesnot matter where you filed first, but yes, it certainly is a better and a safe choice to either file for a patent in India first or take permission from the Controller for foreign filing.

Consequences of violating section 39

If a person makes or causes to be made an application for the grant of a patent in contravention of section 39, he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both. Hence, it is important to either file application in India first or take FFP from the Controller of Patents.

Conclusion

In the instances where the applicant is a resident of India, it is important to consider filing for a patent in India or taking permission for foreign filing from the Controller, before filing for a patent in foreighn country ot PCT the the reason that violation of this provision can lead to fatal consequences.