Patent Infringement and Freedom to Operate Analysis

Mandar Manolikar GNA Patent Gurukul.

ACKNOWLEDGEMENT

Acknowledgement

I would like to take this opportunity to express my sincere thanks to Dr. Gopakuamr. Nair, for his enthusiasm in tesching and without the urge generated by him to strive for that extra bit this project would not have reached this shape. I would also like to thank my family, Mama and Mami, without their love and support this project would not have completed. Last but not the least; I would like to thank Ashish and Shweta who were very helpful throughout this coursework.

Date: 27th Feb. 2011

Mandar Manolikar

ABSTRACT

Abstract
The object of Patent law is to provide protection for inventions, in-turn creating an environment conducive to research and development (R&D). The R&D requires heavy investment; therefore it is inevitable that due safeguard for the IPR against infringement must be provided, as such infringements can cause heavy losses. At the same time one must be vigilent of not infringing third-party IPRs. This dissertation takes a brief overview of Patent Regime in India; goes on to take an overview of patent infringement and litigation procedures in India, and also a preview of FTO analyses.

ABBREVIATIONS

Abbreviations
GATT - General Agreement on Trade & Tariff TRIPS Trade Related aspects of Intellectual Property Rights IPR Intellectual Property Right R & D Research Development WTO World Trade Organisation MNCs Multinati National Companies GDP Gross Domestic Product IP Intellectual Property IT Information Technology IPAB Intellectual Property Appellate Board FTO Freedom To Operate U.S. PTO United States Patent and Trademark Office

Table of Contents

Acknowledgements ................................................................................................................. 3 Abstract ...................................................................................................................................5 List of Abbreviations ................................................................................................................7 Table of Contents ............................................................................................................... 9-10

Table of Contents
1.0 Introduction............................................................................................................................11 1.1 Object of Patent Law..............................................................................................................12 1.2 Value of Patent System...........................................................................................................12 1.3 International Character...........................................................................................................12 1.4 Main Provisions Associated With Trips Agreement ................................................................13 1.5 History of Patent Law in India.................................................................................................13 1.6 New Patent Regime in India....................................................................................................14 1.7 Post TRIPS effects of Patent Regime in India on Economy......................................................14 1.8 Effect of New Patent Regime on Research Based Industries ii................................................17 1.8.1 The Pharmaceutical Industry......................................................................................17 1.8.2 The Information Technology Industry.........................................................................17 2.0 Patent Infringement and Litigation in India.............................................................................18 2.1 What Constitutes A Patent Infringement?..............................................................................19 2.1.1 Direct patent infringement.........................................................................................20 2.1.2 Indirect patent infringement......................................................................................20 2.1.3 Contributory patent infringement..............................................................................20 2.2 Detecting patent infringement................................................................................................20 2.3 Steps to establish infringement...............................................................................................21 2.4 Indian Patent Legal System......................................................................................................22 2.5 Patent infringement disputes in India......................................................................................23 2.6 Patent claim infringement.......................................................................................................24 2.7 Injunction................................................................................................................................24

2.8 Procedure followed by judges in patent infringement cases in India xxii................................25 2.8.1 Methods on judicial procedure..................................................................................25 2.8.2 Facts finding and application of substantive lawxxii...................................................26 2.9 Case Study: Bajaj Auto ltd. Vs. TVS Motor Company Ltd.........................................................27 2.9.1 The case......................................................................................................................27 2.9.2 The technology...........................................................................................................27 2.9.3 The arguments...........................................................................................................27 2.9.4 The verdict..................................................................................................................28 3.0 Freedom to Operate................................................................................................................29 3.1 What Is Freedom to Operate?................................................................................................31 3.2 Freedom to Operate Analyses, ..............................................................................................31 3.2.1 Infringement Analyses................................................................................................31 3.2.2 Invalidity Analyses......................................................................................................31 3.2.3 Invalidity Based on Novelty: Anticipation...................................................................31 3.2.4 Invalidity Based on Obviousness................................................................................32 3.3 Why Are FTO Analyses Conducted?, .......................................................................................32 3.4 FTO Analysis Preparations: Overview.....................................................................................33 3.5 Due Diligence..........................................................................................................................34 3.6 An Explainatory Case Study....................................................................................................34 3.6.1 The Case ....................................................................................................................34 3.6.2 FTO Preparations........................................................................................................35 3.6.3 FTO Analysis...............................................................................................................35 3.6.4 Formal FTO Opinion....................................................................................................35 3.7 Conclusions.............................................................................................................................35 4.0 Endnotes.................................................................................................................................37

Chapter 1.0 Introduction

1.1 Object of Patent Law The object of granting a patent is to encourage and develop a new technology and industry. An inventor may disclose the new invention only if he is rewarded, otherwise he may work on it secretly. Thus the theory which the patent system is based upon is that the opportunity of acquiring exclusive rights in an invention stimulates technical progress in four waysi: It encourages research and invention It induces an inventor to disclose his discoveries instead of keeping them as trade secret It offers the reward for the expenses in developing the invention till the stage at which it is commercially practicable and It provides an incentive to invest capital in the yet-to-prove new lines of production, which might not prove profitable if it were to face competition in the initial stage.

1.2 Value of Patent Systemii There exists some controversy as to the precise extent of the contributions made by the patent system to the economic development of a country. But the adoption of some kind of patent protection for inventions is in place in almost all countries. The ever increasing number of applications for patents received by the patent offices in all industrially advanced countries is an indication of the universal recognition of the importance of the patent system. Most of the inventions and discoveries made in all fields of technology are published in the patents specifications filed in the patent offices of different countries. A world- wide exchange of technical information has been made possible only by publications of such patent specifications.

1.3 International Characteriii In a sense patents have assumed an international character. The increasing numbers of applications for patents from foreigners received in almost all countries is an indicator of the fact. Attempts are being made from time to time by international associations for the protection of individual property and to introduce more and more uniformity and harmonization among national Patents systems. The International convention for the Protection of Industrial property (Paris Convention) and GATT and TRIPS agreement are examples of attempts at harmonization of the law of patents & other forms intellectual property.

1.4 Main Provisions Associated With Trips Agreement patent of products:

iv

The TRIPS consistent Indian patent law addressed three important issues relating to Adoption of definition of pharmaceutical substance Exclusion of mere discovery of a new form of known substance and new use for a known substance as patentable subject matter and Protecting the interests of those who are already producing the products which may be granted patent protection in the new regime. The patent regime adopted in TRIPS by the developed countries is somewhat capitalist in nature as it prioritizes the profit motive over the social responsibilities. In addition to these discrepancies TRIPS also rule out any discrimination between the technological sectors, and advocates the uniform extent of protection for all the technological inventions fulfilling the criteria. Even after the acceptance of the TRIPS agreement, the following five major areas still continue to be controversial for both the parties to the TRIPS: IPRs and access to medicines, IPRs, community property rights and indigenous knowledge, IPRs and biodiversity, IPRs, biotechnology and agriculture, IPR policy and trade. There is no doubt that product patent regime has encouraged the R&D for diseases, notably those with the lucrative potential market in the industrialized world. However, TRIPS has failed and will continue to fail to stimulate sufficient R&D for diseases that primarily affect poor countries. TRIPS had forced all the developing countries to switch over to product patent regime from process patent regime and hence, restrict the access of the cost effective essential medicines to their people. 1.5 History of Patent Law in India Patent Act in India is more than 150 years old. The Patent Act was first enacted in the year 1856 under the rule of British and subsequently amended several times. India had inherited The Patents and Designs Act 1911 from the colonial times that provided for protection of all inventions except those relating to atomic energy; and a patent term of 16 years from the date of applicationv . After Independence of India there was a need to revise The Patents and Designs Act 1911 to facilitate the local industry and in accordance with the stage of development of the country. The Patents Act in India was framed after years of consideration and on the basis of the recommendations made by the Justice Rajagopal Ayyangar Committee (1958)vi . The Patent Act 1970, provided for process patents for pharmaceuticals and agro-chemical products and for a shorter period i.e. 7 years for pharmaceutical, agro chemical and food products; as against 16

years for other categories. This enabled the growth of a strong local generic drug industry, which produced the same drugs as the MNCs at relatively low prices. India, since 1970, had a Patent law that was proclaimed by many as a model for other developing countries. The Indian Law stressed on the obligations of the Patent holder and had strong provisions that prevented the abuse of the Patent holder's monopoly rights. One of the important factors that contributed to the growth of Indian pharma industry was the fact that The Patent Act 1970 did not provide for monopoly rights in the area of drugs and agro-chemicalsvii,viii as only process patents, and not product patents, were recognized. Thus, by allowing only process patents India today witnesses a thriving generic pharmaceutical industry that is capable of exporting generic drugs to certain developed countries. 1.6 New Patent Regime in India India became a member country of WTO in 1994, and thus with the accession at WTO India was compelled to honour TRIPS agreement, which was a part of WTO agreement. India being a developing country was given a grace period of ten years - January 01, 1995 to December 31, 2004 - to fully comply with TRIPS requirements. India amended the Patents Act 1970 twice, in the year 1999 ix and in 2002x again to comply with the WTO requirements of TRIPS agreement. These amendments in 1999 and 2002 did not completely comply with the WTO requirements and so there was a need to frame an Act that was more compatible with the requirements of TRIPS. After a lot of debates and deliberations, Indian Parliament on March 23, 2005 passed the Patents (Amendments) Bill 2005. This in turn paved the way for a radical shift in India from a weak process patent system to a strong TRIPS compliant Product Patent System xixii. The bill was passed in compliance with India's commitment to the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property Rights, or TRIPS xiii. With the third amendment of The Patents Act 1970 in March 2005 by the Indian government, Indian pharmaceutical companies were prohibited to market a generic drug - a drug patented elsewhere by using a different process. But amended Indian Patents Act has provided measures and safeguards that will not be detrimental to Research and Development activities in the country, specifically in the field of pharmaceutical products. Safeguards are built in to prevent ever greening of patents xiv.( Ever greening refers to extending patent life of a product beyond its stipulated term of 20 years.)

1.7 Post TRIPS effects of Patent Regime in India on Economy After signing TRIPS in 1995, Indian patent law has been revised three times in compliance with its provisions. The first revision in 1999 introduced Exclusive Marketing Rights for the patent holders of drugs or medicines xv. The number of patent applications has greatly increased in India since then: it stood at 4,924 in 1999-2000 and 8,503 in 2000-2001.

Fig. 1: Annual Pattern of Patent Filing in India*

* - Source: Impact of the Intellectual Property System on Economic Growth, WIPO Report ii.

The second revision of Indian patent law in compliance with TRIPS was in 2002 and this extended the term of a patent. R&D expenditures and GDP have increased more sharply since 2003, which reflects the impact of the IP system on the economy.

Fig 2: GDP growth%*

* - Source: Impact of the Intellectual Property System on Economic Growth, WIPO Report ii.

The number of patents granted has greatly increased since 2003, and the number of domestic patents granted outstripped the number of patents granted to foreign applicants for the first time in 2004-2005. It suggests that TRIPS is also effective in domestic IP creation.

Fig: 3 Patents Granted to Indian and Foreign Companies*

* - Source: Impact of the Intellectual Property System on Economic Growth, WIPO Report ii.

The third revision of Indian patent law in compliance with TRIPS was in 2005 and this introduced a patent system for substances xvi. The number of patent applications has greatly increased in India since 2005 (Fig. 1). This suggests that the introduction of the patent system for substances has had an effect on IP creation. The trend in patent applications has been very similar to that for R&D expenditures since 1999, which suggests that R&D is closely related to IP protection.

Fig 4: Relationship between Patents Filed and R&D Expenditure*

* - Source: Impact of the Intellectual Property System on Economic Growth, WIPO Report ii.

1.8 Effect of New Patent Regime on Research Based Industries

ii

1.8.1 The Pharmaceutical Industry The pharmaceutical industry today is the top-ranked science-based industry in India with wide-ranging capabilities in the complex field of drug manufacture and technology. The patent system is expected to be very important for the industry. Ranbaxy and Dr. Reddys Laboratories are representative of the pharmaceutical field. These two companies have applied for many patents; (259 & 205 patent applications were filed respectively by Ranbaxy and Dr. Reddys Laboratories between 1995 and 2005.) Intellectual property has been one of the most important factors for the current success of these two companies. Since 1995, Ranbaxy and Dr. Reddys Laboratories have spent heavily on R&D and received high revenues as well as making numerous patent applications. This suggests that TRIPS has had an effect on economic growth as well as on the creation of intellectual property in these companies. 1.8.2 The Information Technology Industry The IT industry in India is recognized globally, and it is a leading technology-based industry. Every effort is being made by the industry and the government to safeguard this situation in a manner conducive to respecting the IPRs of others and exploiting their own intellectual property. Wipro is representative of the IT field. It is active in the areas of patent application and R&D. The company has achieved significant global sales and high revenues as well as making multiple patent applications since 1995. This suggests that TRIPS has had an effect on economic growth as well as the creation of IP in Wipro.

Chapter 2.0 Patent Infringement and Litigation in India

Companies around the globe thrive on technology and innovation for their success. Patents provide protection to these innovations and grant exclusive rights to the innovator to practice his/her invention. In terms of money, it is simply amazing how much an invention can generate. U.S Patents 4,681,893 and 5,273,995 protect Atorvastatin, better known as Lipitor, invented by Bruce D. Roth. Presently Lipitor is the largest selling drug in the world accounting for sales of $12.7 billion in 2007 xvii. In another example, University of California generated more than $500 million in last five years in patent royaltiesxviii. Significant revenues may be generated by out-licensing the patents and through sales of products protected by patents. If the patent holder is vigilant enough, any infringement may be a source of income by way of damages/ settlement if the patent is knowingly or unknowingly infringed by an individual or a company. In one such example, in India, Matrix Labboratories Ltd, Hyderabad, received lump sum of Rs. 95 crore towards settlement of a potential patent infringement suit with a multinationalxix. On the other hand, patent litigations have also cost millions of dollars to companies in legal expenses and awarded damages due. For example, on Oct 12, 1990, Eastman Kodak had to pay U.S $909,457,567 to Polaroid in a patent infringement case and almost went bankruptxx. By way of another example, on April 22, 2005 Medtronic, the worlds largest medical technology company, paid U.S $1.35 billion to settle a patent lawsuitxxi. Thus, it is not only important to protect innovations through patents, it is extremely important for companies to check, potential patent infringement by them or their competitors. 2.1 What Constitutes A Patent Infringement?xxii A patent granted to a person bestows exclusive right to the person to make, distribute, mortgage, or sell the invention. Patents are jurisdictional rights, and are therefore restricted to a country that grants the patent. Patents are analogous to Real-estate properties. Both grant exclusive rights to the owner. Violation of the exclusive rights of a Real-estate property by someone who unlawfully uses an area of the real-estate property is called encroachment. Similarly, an encroachment upon the invention patented by the owner is called "infringement". Patent infringement is the unauthorized making, using, offering for sale, selling of any patented invention within a jurisdiction, or importing into the jurisdiction of any patented invention during the term of a patent. In India, Sections from 104 to 114 of the Indian Patents Act 1970 provide guidelines relating to patent infringement. Patent infringement occurs when a product infringes one or more patentsxxiii. To determine patent infringement, firstly a product or a process is analysed and compared with all relevant patents that may claim an invention similar to the product. Secondly, the product or the process is scrutinized to see if the product or the process

reads on one or more patents and is substantially described by the claims of the one or more patents. There are three basic types of patent infringements. 2.1.1 Direct patent infringement Direct patent infringement is the most obvious and the most common form of patent infringement. In the most basic definition, direct patent infringement occurs when a product that is substantially close to a patented product or invention is marketed, sold, or used commercially without permission from the owner of the patented product or invention. 2.1.2 Indirect patent infringement Indirect patent infringement suggests that there was some amount of deceit or accidental patent infringement in the incident, for e.g. a person A holds a patent for a device and a person B manufactures a device which is substantially similar to the person As device. The person B is supplied with a product from a Person C to facilitate manufacturing of the person Bs device. If the device so manufactured by the person B infringes on the Person As patent, then the person C indirectly infringes the Person As patent. 2.1.3 Contributory patent infringement Further, if such a product is knowingly sold or supplied, it may lead to contributory patent infringement. For example, in the above example if the person C knowingly supplies the product to the Person B then the infringement is construed as contributory patent infringement. 2.2 Detecting patent infringement Determining patent infringement is very crucial for a company. A company may hold patents and may have products and/or processes in the market which may be protected by these patents. However, patenting an invention or a product is not the last stop. To reap complete benefits of patent system, these patents should be enforced by the company. Thus, the company should make sure that competitors products and/or processes are not infringing on their patents and are not damaging the companys revenues, market share, and market position. The company should also make sure that none of its products and/or processes is infringing patents granted to others. This is important because, in such a scenario the company may have a product and/or a process in the market which has breakthrough invention at its core and generates a significant amount of revenues for the company. However, if that product infringes on some patents, then the company may end up incurring significant financial losses in the litigation process due to the infringement. A direct way to determine patent infringement is to keep a market watch for all patents and related products released in the market in a particular technology domain,

especially for competitors. All these products can then be closely examined to determine what features of these products read onto the inventions patented by a company. To facilitate this, the company can avail some patent analytic services to create a patent portfolio for the company, especially, if the company has a huge number of patents across various technological domains. Secondly, the company should keep an eye on all the published patent applications of its potential competitors. This can be done by doing a patent-watch in the technology area and by analysing the patenting activity of competetors in last couple of years. The portfolios generated using patent-watch help in anticipating the product that a competitor may be launching. A comparison with the companys patent portfolio may establish that some of these anticipated products may infringe on one or more of its patents. This gives an early idea about competitors moves and helps the company prepare in advance to take further appropriate action. For example, to save litigation costs, the company may try to invalidate / oppose the patent/patent publication beforehand, so that the competitor never launches the product in question. 2.3 Steps to establish infringement Having detected that one of the patents of the company might be infringed by a competitors product or process, a detailed analysis should be performed to establish patent infringement. The product or the process need not infringe all claims of a granted patent; in fact it is merely enough even if the product or process in question is found to infringe even a single claim of the granted patent. To perform this analysis, a complete description of all products or processes of a competitor, which will include all product brochures or promotional materials, web site pages, instructions or directions for use, advertisements, and product packaging, should be compared with patents that are being infringed. The infringement analysis may be depicted in the form of a claim chart, which highlights the features, of a competitors product or process that read onto one or more claims of the patents granted to the company. The usual strategy of a defendant will be to try to invalidate the patent in question and if the defendant succeeds in invalidating the patent, then the litigation suit will have to be withdrawn. Therefore, before filing a patent infringement suit, it is very essential to get an invalidation search conducted for the patents to evaluate the strength of the patents. It is advisable to establish validity of the patents before filing a patent infringement suit against a competitor, because, if a competitor succeeds in invalidating the patents in question, the company may incur significant legal costs and also market prestige, position, and its market share will be at stake.

2.4 Indian Patent Legal System The courts in India receive (a) Patent Administrative Cases and (b) Patent Infringement Cases. In patent administrative cases, the Indian Patent Office is the defendant. These types of cases include dispute on grant of a patent, patent invalidation and upholding, and compulsory licensing. In patent infringement cases, patentee or patent assignees pursue damages against wilful infringement conducted by the alleged infringer. These cases include infringement of patent, disputes relating to ownership of patent, disputes regarding patent rights or right for application, patent contractual disputes, contractual disputes of assignment of patent right, patent licensing, and dispute relating to the revocation of patents. Fig. 1 below shows the hierarchy of courts in patent administrative cases. As regards to the administrative cases the appeal is made to the Appellate Board under Sec. 117-A of the Patents Act, 1970.

Source Patent Infringement and Litigation System in India xxii

Fig. 2 below shows the hierarchy of courts in patent infringement cases. Regarding the disputes pertaining to infringement, Section 104 of The Indian Patents Act 1970 states that the patent infringement suit shall not be instituted in a court lower than District Court in India. Further, if the defendant files a counterclaim against revocation of the patent, then the suit, along with the counter-claim, shall be transferred to the High Court for decision.

Source Patent Infringement and Litigation System in India xxii

2.5 Patent infringement disputes in India Patent infringement disputes in India starts with a suit that a plaintiff files in the District Court, which is followed by a reply to the suit by the defendant. Subsequently, a hearing is held as per the Patent Rules 2003 in the District Court, taking into consideration evidences, scientific experts testimony, statements of the witness etc. After considering the defences put forth by defendants the District Court decides the dispute and award the damages or prescribe the penalties, provided the infringement is established xxiv. If either the plaintiff or the defendant are not satisfied, they can approach the High Court under Article 226/227 and further to the Supreme Court under Article 32,133,136,or 142, as shown in fig. 2. In India only High Courts have the power to deal with matter of both infringement and invalidity simultaneously. A specialized forum, i.e., Intellectual Property Appellate Board (IPAB) has now been established. Provisions related to IPAB were introduced into the Act in 2002 and are enforced now. Also, all pending appeals from Indian High Courts under the Patents Act were to be transferred to the IPAB from April 2, 2007. The IPAB has its headquarters at Chennai and has sittings at Chennai, Mumbai, Delhi, Kolkata and Ahmedabad. The IPAB is the sole authority to exercise the powers and adjudicate proceedings arising from an appeal against an order or decision. Also, all the cases pertaining to revocation of patent other than a counter-claim in a suit for infringement and rectification of register pending before the Indian High Court shall be transferred to the IPAB. In case of a counter-claim in a suit for infringement, the Indian High Court continues to be the competent authority to adjudicate on the matter. The IPAB also has exclusive jurisdiction on matters related to revocation of patent and rectification of register. The IPAB in its sole discretion may either proceed with the appeals afresh or from the stage where the proceedings were transferred to itxxv.

2.6 Patent claim infringement As described above, patent infringement may occur where the defendant has made, used, sold, or imported in India any invention that has been patented in India. In India, no infringement action may be started until a patent has been granted. In India, a right to obtain provisional damages requires a patent holder to show the following xxvi: The infringing activities occurred after the patent application was published; The patented claims are substantially identical to features of the process or the product infringing the patent; and The infringer had actual notice of the published patent application. The Supreme Court of India has laid down the following guidelines to determine infringement of a patent, based on Biswanath Prasad Radhey Shyam v. Hindustan Metal Industriesxxvii: Read the description and then the claims; Find out what is the prior art; What is the improvement over the prior art; List the broad features of the improvement; Compare the said broad features with the defendants process or apparatus; and If the defendants process or apparatus is either identical or comes within the scope of the plaintiffs process or apparatus, there is an infringement. 2.7 Injunction Injunction is as an equitable remedy in the form of a court order, whereby a party is required to do, or to refrain from doing, certain acts. An injunction may be preliminary or permanent. A preliminary injunction is a provisional remedy granted to restrain activity of a defendant on a temporary basis until the Court can make a final decision after trial and a permanent injunction is one which is granted after the trial xxviii. Preliminary (temporary or interim) injunction and permanent injunction are provided under Order 39, Rule 1-2 of Code of Civil Procedure, 1908. For the court to order an injunction, the plaintiff has to fulfil the following criteria xxix: Establish his case only at a prima facie level, i.e., the plaintiff has to show that he has some possibility of success and that his claim is not vexatious; Demonstrate irreparable injury if a temporary injunction is not granted; and Demonstrate that the balance of convenience is in favour of the plaintiff (i.e. the plaintiff will be more disadvantaged because of the non-grant of the injunction or that the defendant will be disadvantaged because of the grant of one). Permanent injunction is granted only after the trial when the Court concludes that the defendants product infringes the plaintiffs patent. In Dhanpat Seth & Others (plaintiffs/ patentee) Vs. Nil Kamal Plastic Crates Ltd (Defendants) xxx; the plaintiffs solicited grant of permanent injunction restraining the defendant from infringing Indian Patent No.

195917, granted in their favour on July 11, 2005. As the case progressed the defendants successfully proved to the Court that the Kilta (patented article of the plaintiffs) is a mere imitation of traditional Kilta made by bamboos and has been in use since times immemorial. As a result, the Court not only rejected the plaintiffs request for permanent injunction but also revoked the Indian Patent No. 195917. Thus, the plaintiff was not able to establish the case (at a prima facie level, as) and the patent in question was revoked. 2.8 Procedure followed by judges in patent infringement cases in India
xxii

In India judges of District Courts, High Courts and Supreme Court deal with patent infringement cases. Described below are general methods used by Indian judges in deciding such type of cases: 2.8.1 Methods on judicial procedure Concerned parties, plaintiff and defendant, are notified in advance of the judicial rights and the judicial obligations they shall comply with during lawsuits. The parties are required to exchange the evidence before the trial begins. When the plaintiff accuses the defendant of infringement, the plaintiff is responsible for providing the proof. During trial, parties concerned are required to verify and cross-examine disputed facts and evidences. If the defendant is accused of infringing a process patent, then reversal of burden of proof is implemented. In other words, the party who is accused of infringement is responsible for providing evidences for the manufacture process of such product. Either the plaintiff or the defendant may appeal to the Appellate board against the decision of the Controller and other matters within three months from the date of the decision. The plaintiff should bring the suit in the court within three years from the date of infringement (which is called the limitation period). The limitation period for the suit starts from the date of infringing act and not from the date of the grant of the patent. The limitation period is defined by the Section 40 of the Indian Limitations Act. Section 77 of the Patents Act, 1970 confers powers of a Civil Court on the Controller in following matters: The Controller can summon and enforce the attendance of any person and examine him on oath; Every party is entitled to know the nature of his opponents case. The Controller can direct and obtain the documents from plaintiff for handing it to defendant or vice versa; The Controller can receive evidence on affidavits from the plaintiff or defendant;

 During the proceeding of suit some people are exempted from appearing in person. In such circumstances, the Controller is empowered to issue Commissions for the examination of witnesses or documents; The Controller can award costs which are reasonable with regard to all the circumstances of the case; The Controller can be requested to review his decision. This can be done by filing form 24 along with prescribed fee within one month from the date of decision; The Controller can set aside an order passed in absence of any party at the hearing. However, the affected party should make a request to set aside an order. This can be done by filing form 24 along with the prescribed fee within one month from the date of communication; and The Controller also has the power of taking oral evidence. He may also allow any party to be cross-examined on the contents of his affidavit. The Controller may also accept documentary evidence unaccompanied by an affidavit. 2.8.2 Facts finding and application of substantive law xxii To make conclusions for infringement actions against patents, the courts generally adopt the following steps: a. The protection scope of patent right are determined; b. Relevant technical characteristics of products which are accused of infringing the patent is determined; and c. The essential technical characteristics of the claims of the patent and that of the products accused of infringement are compared. The Courts may apply the Estoppel Principle in patent litigation. In other words, during prosecution, the contents abandoned by the patentee can no longer be used against the party accused of infringement. To calculate the amount of compensation for losses due to patent infringement, the court uses following methods: a. The actual economic loss incurred to the patentee due to infringement is considered as the amount of compensation against such a loss; b. The total profit obtained by the infringer through infringement is regarded as the amount of compensation against such a loss. The arithmetic formula could be expressed as: profit obtained from each piece of infringed product X total number of infringed products sold = infringement profit; and c. A reasonable amount not less than the royalty of patent licensing is regarded as the amount of compensation against such a loss.

2.9 Case Study: Bajaj Auto ltd. Vs. TVS Motor Company Ltdxxxi. 2.9.1 The case In 2007 Bajaj Auto Ltd. (hereafter referred to as Bajaj) filed a patent litigation suit against TVS Motor Company Ltd. (hereafter referred to as TVS) in court. Bajaj alleged that CCVTi technology used by TVS in manufacturing, marketing, selling, offering for sale or exporting 2/3 wheelers, including the proposed 125-CC FLAME infringes on one of Bajajs granted Indian Patent No. 195904. 2.9.2 The technology Bajaj was granted Indian Patent No. 195904 in respect of a patent application titled "An Improved Internal combustion engine working on four stroke principle" with a priority date of 16th July 2002. According to Bajaj, they invented a unique technology of using two spark plugs for efficient burning of lean air fuel mixture in a small bore engine in the size between 45 mm and 70 mm. The use of two spark plugs in large bore engines or in high performance/racing bikes was known in the Automobile industry. However, the above invention of the Bajaj was not known. The Bajajs invention which is called "DTS-i Technology" is a step of providing a second spark plug in a small bore engine running lean, was never thought of or implemented in the automobile industry. Further, according to Bajaj, it results in better combustion in a comparatively shorter duration of time leading to reduction in emission and improved fuel consumption while maintaining the predetermined level of performance. According to Bajaj the essential features of its invention are: Small displacement engine as reflected by a cylinder bore diameter between 45 mm and 70 mm; Combustion of lean air fuel mixtures; Using a pair of spark plugs to ignite the air fuel mixture at a predetermined instant. 2.9.3 The arguments Bajaj argued that they applied for the grant of the patent on 16.07.2002 and the patent was granted on 07.07.2005, which was published in Issue No. 28/2005 dated 29.07.2005. According to Bajaj, there was no opposition filed by anyone including TVS either before or after the grant of patent. However, TVS questioned the validity of Bajajs patent just 7 days before the launch of its proposed 125-CC motorcycle by filing an application for revocation of Bajajs patent No. 195904 before Indian Patents Appellate Board (IPAB). Bajaj argued that the TVS.s 4 stroke combustion engine in small bore lean burn engine of size 54.5mm x 53.5mm and combusting lean air fuel mixture infringes its patent. Bajaj stated that TVS using 3 valves in the engine does not dilute the infringement as the number of valves is not an essential feature of its invention. In counter-attack, TVS argued that the use of two spark plugs in an IC engine with three

valves was well known in the art and that Bajaj cannot seek patent for the use of two spark plugs in an IC engine. TVS further argued that in order to avoid the said situation, Bajaj misled by introducing a limitation of bore size to the US Honda patent. TVS also argued that Bajaj had full knowledge that US Honda patent did not have any such limitation. Along with US Honda Patent No. 4534322, TVS cited number of prior arts against Bajajs "DTS-i Technology" in an attempt to revoke Bajas patent. TVS also added that Bajajs claim is two spark plugs with two valves, whereas its technology is about having two spark plugs with three valves. 2.9.4 The verdict In this case Madras High Court denied injunction against TVS. However, the court ordered that TVS shall not receive any further booking for TVS Flame containing the disputed engine technology patent. The court also allowed TVS the liberty to deliver the already booked TVS Flame motor-cycles provided they maintained accounts for the motorcycles so delivered.

Chapter 3.0 Freedom to Operate

As life sciences companies develop their patent portfolios, they come to realize that being able to patent their inventions is only the beginning. They must also be able to use their inventions to make and sell products. A patent grants an inventor the right to exclude others from making, using, or selling a claimed invention, however, it does not give the inventor the right to make, use, or sell the claimed inventionin other words, having a patent does not guarantee that the patentee can exploit it, as third parties may have patent coverage that dominates the patentees position. It is important to note that the claims of a patent determine what can or cannot be made, used, or sold. Within the life sciences industry, a particularly common mistake in evaluating a competitors IP portfolio is to focus on what the patentee did (e.g., what actual science was performed). This can lead to a number of problems because it is not what the patentee does that counts but what it claims in its patent. A few simplistic analogies are appropriate. A chemical example is depicted below.

Fig. 1: Example elustrating Freedom to Operate

In the above example, because the proposed product includes H at the R1 location and a substituted aryl at the R2 location, the proposed product falls within the scope of claim 1. Accordingly, the proposed product would infringe the 567 patent without a license. An additional example worth noting is in the area of combination patents. Company C has a patent to Drug X, useful as a chemotherapeutic. Company D wants to sell Drug X in combination with its own Drug Y, useful for the treatment of hair loss. Company D needs a license from Company C in order to do so. Thus, the patentability of an invention is different from the ability to practice it, the latter of which is generally referred to as freedom to operate.

3.1 What Is Freedom to Operate?xxxii Freedom to operate (FTO) is the ability of patentee to develop, make, and market products without legal liabilities to third parties (e.g., other patent holders). A truly determinative FTO finding only comes under two circumstances. In one instance, a company licenses the patent, in which case such company knows it will not be sued for infringement. In the other, final FTO status comes after adjudication, in which a court finds either no infringement of the third-party patent or that the third-party patent is invalid. In some cases, a company will rely on both reasons (e.g., the company may rely on non-infringement of some claims of a patent and invalidity of other claims). Examples of infringement and invalidity analyses are provided later in this chapter. 3.2 Freedom to Operate Analysesxxxiii, xxxiv 3.2.1 Infringement Analyses As seen before the Infringement can take place in several ways. Direct Patent Infringement Indirect Patent Infringement Contributory Patent Infringement The first step in such an analysis is to determine whether the proposed product(s) or method(s) infringe the third-party patents. A few visual examples are presented to explain the general conceptsin each case, the infringing compound must have a claimed feature of the patented compound. Each example that follows underscores the importance of understanding the claim terms. Again, if we take the example (Fig. 1), the proposed product does not literally infringe the 567 patent due to the difference in the methyl and propyl groups. In this example, does the term aryl include the fused heteroaryl at R2? This requires an analysis of the term aryl, taking into account the description and/or definition in the specification of the patent, the file history of the patent, dictionary definitions, and the like. If the term aryl is distinct from the term heteroaryl, then infringement is unlikely. 3.2.2 Invalidity Analyses Invalidity of a claim requires that the claim does not meet at least one of the statutory requirements of a patentnamely, that the invention is patentable, novel, and nonobviousand that the specification meets the requirements of Section 3 and 10 (including definiteness, written descriptions, enablement, and best mode). The examples below are relatively straight forward, and thus not necessarily exemplary. 3.2.3 Invalidity Based on Novelty: Anticipation An invalidity analysis begins with a structured search for one or more references that were publicly available prior to the priority date of the patent. For example, a paper,

authored by Early et al., appeared in the Golden State Journal of Chemistry on January 1, 1988.

Fig. 1: Example elustrating Invalidity Based on Novelty: Anticipation

The priority date for the application that matured into U.S. Patent No. 1,234,567 is March 15, 1989. Since Early et al. disclosed a compound that is within the scope of the claims of the 567- patent, the 567 patent is invalid as anticipated by the disclosure of Early et al. 3.2.4 Invalidity Based on Obviousness In this example, Earlys compound differs by only a single carbon atom. Thus, it does not anticipate the claimed compound, but under the Hass-Henze doctrine, a homolog of a known compound, differing by only a single carbon atom, is obvious over the known compound. Note, however, that there can be exceptions to this rule; for example, if the homolog has unexpected properties (e.g., better half-life, lower toxicity, and so forth), the claimed compound may not be obvious over the known compound. 3.3 Why Are FTO Analyses Conducted?xxxv, xxxvi FTO analyses are conducted for a variety of reasons and by different parties. FTO analyses often occur prior to start of a project. It is also important to perform an FTO analysis prior to the acquisition of patent assets, such as an in-license or acquisition of a company or division. Particularly in the case of life sciences companies, the value of the patent assets is determined in large part by the ability to practice the claimed technology. FTO analyses can also be used in research tree decisions, in which several potential research paths are technologically feasible. Generally, picking the path with the least third-party IP is desirable so as to avoid potential litigation or licensing royalties. Following table gives a preview as to how a well worked out FTO analysis can help.

Table 1. Strategic FTO options

Source: Cha. 14.1 Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options, by Antole Krattiger, in Handbook of Best Practices xxxiv

3.4 FTO Analysis Preparations: Overview xxxvii The FTO analysis must be organized, logical, methodical, meticulous, and carefully documented. An important initial step in a thorough FTO analysis is the completion of the following preparations: Assembling the FTO team

 Analysing, understanding, and dissecting the technology Assessing plant pedigrees Recognizing technical considerations Interviewing the researchers Locating notebooks, lab records, and computer files Formulating the series of FTO questions Selecting scientific databases Selecting patent databases Understanding U.S. Patent and Trademark Office (PTO) information (file wrappers and disclosures) Remaining aware of the 18-month period of silence Maintaining due diligence throughout the FTO analysis Though the materials, methods, and tools used may be dissimilar from technology to technology, the fundamental FTO principles and procedures remain unwavering for each of these. Hence, by following this FTO analysis blueprint, a series of sound FTO questions can be formulated, so as to lay a solid foundation from which a reliable FTO analysis can be developed. Patent counsel can then draw upon this analysis to formulate either one or a series of FTO opinions.

3.5 Due Diligencexxxviii During the preparation, set-up, data accumulation, and FTO question-formulation stages of an FTO analysis, due diligence is required. Due diligence, broadly defined, is Such a measure of prudence, activity, or assiduity, as is properly to be expected from, and ordinarily exercised by, a reasonable and prudent person under the particular circumstances; [Due diligence is] not measured by any absolute standard, but depends on the relative facts of the special case. From a practical standpoint, due diligence necessitates a methodical approach, such that all forms of IP and TP rights are garnered, organized, and assembled into a coherent document, for example, a Microsoft Excel spreadsheet. The question often arises, as to how much diligence is enough. The answer? When one finds oneself treading the same ground, then the requirements of due diligence are satisfied.

3.6 An Explainatory Case Studyxxxix 3.6.1 The Case A Chinese producer of medical supplies (the client) has asked BDC - The Business Development Company GmbH (BDC), Switzerland, through its German distributor to perform a due diligence evaluation to clarify whether the client will be free to sell four medical product lines in view of any existing third party patent rights in the European market. In order to identify relevant third party patent rights for the clients products in

Europe, patent documents with valid claims protecting features that are likely to be implemented in the clients medical products have been evaluated in three steps. 3.6.2 FTO Preparations In a first step, related patents in the business field were identified. Based on the documents and product information provided by the client, a search strategy was mapped out and conducted in patent databases. More than 1000 patent documents in the field were screened and related patent documents that claimed defined search features implemented in the clients devices were identified. Potentially critical valid patent claims were evaluated in a second step. Thereby, a legal status and patent family analysis of the related patent documents was performed in order to exclude patent documents that are not in force anymore. In addition, the legal status and the geographical coverage of the remaining patents and patent applications were determined. This step lead to 50 relevant third party patent rights. 3.6.3 FTO Analysis In the last step, a detailed freedom to operate analysis was performed by comparing the claimed features of the relevant patents and patent applications with the features of the clients medical devices of each product line. The analysis yielded 11 third party patent rights in total that might be infringed by the clients devices, if marketed in certain European countries. 3.6.4 Formal FTO Opinion However, the client seems to be free to commercialize the devices of the first product line in due time, as two critical patents will expire within the next months. Only two patent applications were found for the devices of the second product line. Consequently, the prosecution of these patent applications was analyzed to determine the potential scope of protection, if they will be granted. Finally, three patents and four patent applications were evaluated in detail by the client and BDC to determine a strategy for designing the concerned devices around these patent rights. Now the client and its distributor have a solid basis for commercializing their products in Europe without running the huge risk of being sued for patent infringement.

3.7 Conclusions The preparations for an FTO analysis will determine the quality of the final work product. Organization, thoroughness, and meticulous documentation will all combine to contribute to a successful outcome. A comprehensive checklist of what must be established during the early stages of the FTO analysis serves as a helpful tool. For example, the list should include: Possible pertinent patents, including their prosecution and/or litigation status

 Patent applications Third-party trade secrets, including whether they might have been misappropriated All third-party IP rights All research tools used to make the agri-biotech product or pharmaceutical innovation Any agreements (for example, trade secret licenses, or technology-use licenses, noting conditions and restrictions appurtenant) And finally, it is imperative that all records are properly maintained. Consistent records of all searches and search terms must be documented and organized. This should include: Spreadsheets of all FTO search results Records of search terms used Databases searched Interviews with researchers, with notes Notes and annotations by patent counsel Having spent the early phases of the FTO analysis with the disciplined rigor laid out in this chapter, the later steps in the FTO analysis should proceed with a minimum of problems. Diligence will pay off in the end with a solid and reliable FTO analysis that can be routinely updated and revised and that can also provide patent counsel with the requisite information for drafting FTO opinion letters.

Chapter 4.0 Endnotes

Indian Patent Law - Some Reflections, available at http://www.ipfrontline.com/depts/article.aspx? id=11882&deptid=6, The object of patent law is to encourage scientific research, new technology and industrial progress. The price of the grant of the monopoly is the disclosure of the invention at the Patent Office, which, after the expiry of the fixed period of the monopoly, passes into the public domain. Impact of the Intellectual Property System on Economic Growth, A report by University of United nations and World Intellectual Property Organisation, Proponents maintain that the IP system is an effective way to enhance creativity, promote technological innovation, improve trade and enhance competitive positioning. However, its efficacy as a means to achieve economic development is still to be confirmed. Some developing nations questioned whether the IP system is the most effective and appropriate way to fuel the economy. International Patent law harmonisation A search of right balance; Philipe Baechtold, Tomoko Miyamoto Journal of Intellectual Property Rights, Vol 10, May 2005, pp 177 187. Trade Related Intellectual Property Rights - 2006, A report by The Coimbatore District Small Scale Industries Association. The Gazette of India, Ministry of Law and Justice, The Patents (Amendment) Act, 2005 (15 of 2005), received assent of President on April 4, 2005 and published on April 5, 2005, entered into force on January 1, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf. WTO, Agreement on Trade-Related Aspects of Intellectual Property Rights Annex 1C (entered into force on Apr. 15, 1994), available at http://www.wto.org/english/docs_e/legal_e/27-trips.doc India harmonized its patent law with patent regimes in most of the countries in compliance with the provisions contained in TRIPS Agreement. Indian Patent Law and Pharma Industry, available at http://www.gnaipr.com/Articles/Indian%20Patent %20Law%20and%20Pharma%20Industry.pdf , Dr. Gopakumar Nair states: Provisions of the 1970 Act, which helped the National pharma industry to grow at a double digit pace have already been discussed and debated widely. Special amended provisions for pharmaceuticals, deleting product patenting (retaining process patenting), introducing Licences of Right, liberal Compulsory Licensing provisions, reduction of patent protection period from 14 years to 7 years (from date of application) and 5 years (from date of sealing) in the Patent Act, 1970, virtually kept pharma patents out of protection and open for commercialization for anyone at will. Indian Patent Act Jeopardising the Lives of Millions, available at http://phm-india.org/index.php? option=com_docman&task=cat_view&gid=59&Itemid=15, Mr. Amit Sen Gupta states: India, since 1970, had a Patent law that was seen by many as a model for other developing countries. The Indian Law stressed on the obligations of the Patent holder and had strong provisions that prevented the abuse of the Patent holders monopoly rights. Of particular importance was the fact that the Indian Patent law did not provide for monopoly rights in the area of drugs and agro-chemicals. The results were clear - the Indian drug industry developed to become the strongest and most self-reliant industry in the developing world. Gazette of India, The Patents (Amendment) Act, 1999, available at http://ipindia.nic.in/ipr/patent/patact_99.PDF, (last visited Sep. 3, 2007). published on March 26, 1999 and entered into force from Jan. 01, 1995 Gazette of India, The Patents (Amendment) Act, 2002, available at http://ipindia.nic.in/ipr/patent/patentg.pdf (last visited Sep. 3, 2007), published on June 25, 2002 and entered into force from May 20, 2002 Praveen Raj R.S., "India moving to a Strong Patent Regime -Challenges & Concerns", Scientist -IP management, Regional Research Laboratory, Trivandrum, accessed at http://www.patentmatics.org/pub2005/pub10b.pdf Gazette of India, The Patents (Amendment) Act, 2005, available at http://ipindia.nic.in/ipr/patent/patent_2005.pdf, published on April 5, 2005 and entered into force from January 1, 2005 Health Groups Criticize India's New Drug Patent Law, accessed at http://www.sci-techtoday.com/story.xhtml?story_id=31764 Biswajit Dhar, Post-2005 TRIPS scenario in patent protection in the pharmaceutical sector: The case of generic pharmaceutical industry in India, available at http://www.iprsonline.org/unctadictsd/docs/Dhar%20Indian%20Pharma%20November06.pdf

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Chapter IVA of The Patents (Amendment) Act, 1999 provides grant of Exclusive Marketing Rights (EMR) for a period of 5 years if the product in these applications is granted patent by any of the WTO member countries. 3(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy"

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http://en.wikipedia.org/wiki/Atorvastatin http://www.patenthawk.com/blog/2007/11/impunity.html, Peter Latmen states It receives by far more patents from the U.S. government than any school in the country. And by licensing out its intellectual property, the university has generated about $500 million in patent revenue in the past five years, [earning $193.5 million last year alone.] Patent infringement suit: Matrix Labs set to get Rs 95-cr settlement, C.R.Sukumar, Asia Africa Intelligence Wire, February 12, 2005 http://www.bustpatents.com/kodak0.htm Medtronic Settles Medical Device Patent Litigation Against Doctor For $1.35 Billion, by Walter Egbert, Intellectual Property Report, Vol 5, Isuue 48, May 2005, available at http://www.bakerbotts.com /file_upload/EgbertArticle.htm Patent Infringement and Litigation in India, Atul Dixit and Ankush Bedi, available at http://www.ipproinc.com/admin/uploads/Patent_Infringement_and_Litigtion_in_India_57.pdf Patent Infringement in India, available at http://intellectuallylegal.wordpress.com/2010/08/15/patentinfringement-in-india/ Patent Infringement in India, available at http://intellectuallylegal.wordpress.com/2010/08/15/patentinfringement-in-india/: states that Indian Limitations Act governs the period of limitation for bringing a suit for infringement of patent, which is three years from the date of infringement. A suit for patent infringement is required to be filed in a district court having jurisdiction to try the suit, the jurisdiction is governed by the Civil Procedure Code (C.P.C.) the cause of action must have arisen in a place within the jurisdiction of the court where the suit is to be filed. However, where the defendant counter claims revocation of the patent the suit along with the counter claim will be transferred to the High Court. Intellectual Property Appellate Board, available at http://www.rkdewan.com/editorials-intellectualproperty-appellate-ipab.jsp Chakraborty available at https://www.aippi.org/download/commitees/175/GR175india.pdf

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xxvi The role of equivalents and prosecution history in defining the scope of patent protection by Samaresh xxvii Biswanath Prasad Radhey Shyam Vs. Hindustan Metal Industries, available at
http://www.lawyersclubindia.com/sc/BISWANATH-PRASAD-RADHEY-SHYAM-Vs-HINDUSTANMETAL-INDUSTRIES-806.asp

xxviii India limitations on injunctions, available at http://keionline.org/content/view/200/1

xxix Chapter XVIII, Patent Act (Amended),1970, Sect 108 (1) The reliefs which a Court may grant in any suit for infringement include an injunction and, at the option of the plaintiff, either damages or an account of profits. Sect. 108(1): "Provided that, in any suit for infringement of a patent relating to a drug, where the constitutional right to health or public health concerns arise, it shall be presumed that monetary damages will be a sufficient remedy for infringement, unless the patentee can show the existence of an extraordinary circumstance where monetary damages are inadequate and where the plaintiff will suffer irreparable harm if an injunction is not granted"

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Dhanpat Seth And Ors. vs Nil Kamal Plastic Crates Ltd. on 3 August, 2006, http://www.indiankanoon.org/ doc/107067/

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A project report on: Bajaj Auto Ltd. Vs. T.V.S. Motor Company Ltd. A Case Study. Submitted byAnoop Kumar Yadav, at Dr. Ram Manohar Lohiya National Law University, Lucknow, Nov. 2009, available at http://www.scribd.com/doc/22543786/bajaj-auto-ltd-vs-tvs-motors-ltd-case-study. Cha. 7 Freedon to Operate, Intellectual Property Strategy available at http://www.morganlewis.com/documents/erh/ERH_FreedomToOperate_ELSCDeskbook.pdf Legal Advisor, p. 21 (January 2005).

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xxxiii Look Before You Leap: Investing in a Freedom to Operate Patent Review by Tamsen Valoir , Executive
xxxiv Cha. 14.2 Freedom to Operate: The Preparations, by Stanley P. Kowalski, in Handbook of Best Practices available at http://www.iphandbook.org/handbook/ch14/ xxxv Basics of Writting Patent Non-infringement and Freedom to Operate Opinions, by B.R. Nagori and Vipin Mathur, Journal of Intellectual Property Rights, Vol. 14, Jan. 2009, pp 7-13.

xxxvi Cha. 14.1 Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options, by Antole Krattiger, in Handbook of Best Practices available at http://www.iphandbook.org/handbook/ch14/ xxxvii Kryder RD, SP Kowalski and AF Krattiger. 2000. The Intellectual and Technical Property Components of Pro-Vitamin A Rice (Golden Rice): A Preliminary Freedom-to-Operate Review. Brief No. 20, ISAAA: Ithaca, NY. www.isaaa.org/kc/bin/isaaa_briefs/index.htm. xxxviii IP Due Diligence A Necessity, Not a Luxury, By Ian Cockburn available at http://www.wipo.int/sme/en/documents/ip_due_diligence.htm xxxix Case Study: Freedom to Operate Analysis in the Field of Medical Devices , by BDC- The Business Development Company GmbH, Switzerland available at www.bdc-basel.com