1. What are intellectual property rights? How are they relevant to SMEs in the pharmaceutical sector?

Intellectual property refers to the exclusive rights granted by the State over creations of the human mind, in particular, inventions, literary and artistic works, distinctive signs and designs used in commerce. Intellectual property is divided into two main categories: industrial property rights, which includes patents, utility models, trademarks, industrial designs, trade secrets, new varieties of plants and geographical indications; and copyright and related rights, which relate to literary and artistic works.
Industrial property (IP) rights are extremely important for the pharmaceutical industry. The use of the IP system by SMEs in the pharmaceutical industry depends largely on the business strategy of a company, its size, resources, innovative capacity, competitive context and field of expertise. Research-based, innovation-led companies that seek to develop new drugs, improve or adapt existing drugs or develop new pharmaceutical/medical equipment or processes, tend to rely heavily on the patent system to ensure they recover the investments incurred in research and development. Companies that rely on licensing in or licensing out of pharmaceutical products will need to be knowledgeable about the patent system to so that they are able to negotiate fair and balanced licensing contracts. SMEs in the pharmaceutical industry may use the wealth of information contained in patent documents as a crucial input to their R&D work, to get ideas for further innovation, to ensure their "freedom to operate" or to find out when a patent is due to expire opening the door for the introduction of generics.
Confidential information, protected as trade secrets, is also important for many companies, as is the valuable know-how or undisclosed test data relating to new or improved drugs. Understanding the trademark system is important for companies selling branded products. Industrial designs, plant variety protection and copyright and related rights are generally less relevant to most SMEs in the pharmaceutical sector but this could vary depending on the product line and strategy of each company. Follows a brief summary of key points on each intellectual property right.

Patents

A patent is an exclusive right granted by the State for an invention that is new, involves an inventive step (or is non-obvious) and is capable of industrial application (or useful). It provides its owner the exclusive right to prevent others from making, using, offering for sale, selling or importing the patented invention without the owner's permission. A patent is a powerful business tool for companies to gain exclusivity in the market over a new product or process and develop a strong market position and/or earn additional profits through licensing.
A patent is granted by the national or regional patent office. It is valid for a limited period of time, generally for 20 years from the filing date (or priority date) of the patent application, provided the renewal (or maintenance) fees are paid to keep the patent in force. In some countries, a longer period of protection may be obtained for pharmaceutical products to compensate for the loss of effective period of protection due to delays in obtaining marketing approval from the relevant public health regulatory bodies.
In return for the exclusive rights granted by a patent, the inventor is required to disclose his invention to the public in the patent application with sufficient detail to enable a person skilled in the relevant technology to practice the claimed invention. Patents, and in many countries patent applications, are disclosed to the public through publication in an official journal or gazette.

Trademarks

A trademark is a sign capable of distinguishing the goods or services produced or provided by one enterprise from those of other enterprises. Any distinctive words, letters, numerals, drawings, pictures, shapes, colors, logotypes, labels or combinations that distinguish the origin of goods or services may be considered a trademark. In some countries, advertising slogans are also considered trademarks and may be registered as such at national trademark offices. An increasing number of countries also allow for the registration of less traditional forms of trademarks such as single colors, three-dimensional signs (shapes of products or packaging), audible signs (sounds) or olfactory signs (smells). Aside from the protection of logos and brand names, in some countries, companies in the pharmaceutical industry rely on trademark protection for the distinctive shape or color of pharmaceutical products (such as capsules or tablets) and product packaging.
Trademark protection can be obtained through registration or, in some countries, also through use. Even where trademark rights can be acquired through use, companies are well advised to register a trademark by filing the appropriate application form with the national or regional trademark office. While the term of protection may vary, in a large number of countries registered trademarks are protected for 10 years. Registration may be renewed indefinitely (usually, for consecutive periods of 10 years) provided renewal fees are paid in time.

Trade Secrets

Broadly speaking, confidential business information which provides an enterprise a competitive edge may be considered a trade secret. The misappropriation, disclosure or unauthorized use of such information is regarded as an unfair practice and a violation of the trade secret. Depending on the legal system, the protection of trade secrets forms part of the general concept of protection against unfair competition or is based on specific provisions or case law on the protection of confidential information.
Confidential business information may benefit from protection as a trade secret as long as:

• it is not generally known, or readily accessible, to circles dealing with that type of information;
• it has commercial value because it is secret; and
• it has been subject to reasonable steps by the rightful holder of the information to keep it secret (e.g. through physical and electronic control mechanisms or by entering into non-disclosure or confidentiality agreements)

In the field of pharmaceuticals, great importance is attached to the protection of undisclosed test data, which is required to be submitted for obtaining marketing approval of new drugs. Authorities in charge of marketing approval for new drugs are thus required to protect such data against unfair commercial use by competitors. Further, authorities should protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure the protection of such data against unfair commercial use. The duration of data exclusivity varies from country to country but is often of 10 years.

Plant Variety Protection

Plant variety protection, also called a "plant breeder's right" (PBR), is a form of intellectual property right granted to the breeder of a new plant variety. According to such rights, certain acts concerning the exploitation of the protected variety require the prior authorization of the breeder. Plant variety protection is an independent sui generis form of protection, tailored to protect new plant varieties and has certain features in common with other intellectual property rights. To be granted a PBR, it is necessary to file an application for examination by the designated authority. For a variety to be protected, it must be new, distinct, uniform and stable, and must have a suitable denomination. In some countries, novel plants may be protected by patents, provided the requirements of patentability are met. In the pharmaceutical industry, plant variety protection is relevant in relation to new plant varieties used for medicinal purposes.

Industrial Designs

An industrial design is the ornamental or aesthetic aspect of a product. The design may consist of three-dimensional features, such as the shape or surface of a product, or of two-dimensional features, such as patterns, lines or color. In most countries, an industrial design must be registered in order to be protected under industrial design law. As a general rule, to be registrable, the design must be "new" or "original", and sometimes both. Once a design is registered, a registration certificate is issued. The duration of protection varies significantly from country to country, but is generally of at least 10 years, as requested by the TRIPS Agreement (though renewals may be required to benefit from the full length of protection). In the pharmaceutical industry, industrial design protection may be used, for example, to obtain exclusivity over the design of medical equipment.

Copyright and Related Rights

Copyright grants authors, artists and other creators (e.g. software companies, multimedia producers, website designers) legal protection for their literary and artistic creations. "Related rights" are the rights granted to people who often play a creative role in communicating some types of works to the public, such as performers, producers of sound recordings and broadcasting organizations. Copyright protection in the pharmaceutical industry may arise, for example, in relation to advertising campaigns or other creative output.
The remaining questions in this chapter will deal primarily with industrial property rights and, in particular, patents and trademarks.
Resources:

1.  "Secrets of Intellectual Property: A Guide for Small and Medium-sized Enterprises", ITC/WIPO publication on with questions and answers on intellectual property of relevance to SME exporters.
    
2. WIPO's SME website at: www.wipo.int/sme. Includes articles, case studies, FAQs and guides on intellectual property for small and medium-sized enterprises.
    
3.  "Inventing the Future: An Introduction to Patents for Small and Medium-sized Enterprises" WIPO publication 917 at: http://www.wipo.int/freepublications/en/sme/917/wipo_pub_917.pdf

2. Where can I find information on industrial property protection and related procedures in different countries?

Industrial property (IP) rights, such as patents, trademarks and industrial designs, are "territorial rights" that are protected through a registration or grant procedure. This means that they can only be enforced in countries (e.g. France) or regions (e.g. Member States of the African Intellectual Property Organization [OAPI]) where protection has been established and is in force. Thus, a company in the pharmaceutical industry that has duly filed an application to protect its inventions, trademarks or designs in its domestic market, and was granted patents, trademarks or industrial design protection, has no protection in export markets, unless the same rights were applied for and granted by the national (or regional) IP office of the export market in question. This is why it is important for companies operating in export markets to have a good knowledge of the IP laws, regulations, fees and procedures in those markets and ensure that their rights are adequately protected there as well. For patents, trademarks and industrial designs, the systems for international filing and registration administered by the World Intellectual Property Organization (WIPO) offer mechanisms for applying for protection in various countries through a single application for each type of IP. More information on these systems is available under Qu. 7.
Almost every country in the world has legislation protecting industrial property. Over the years, there has been significant harmonization of IP laws. Nevertheless, there still remain significant differences in terms of how the IP system operates in different countries or regions. Differences relate not only to procedure but in some cases also to what can be protected by means of which IP rights.
The best place to start looking for information on the laws, regulations and procedures for the protection of IP rights in your country or in another country is at the national and/or regional office(s) in charge of IP protection in that country (or region). IP offices are public sector bodies that generally come under the supervision of one of the government ministries (e.g. the Ministry for Trade and Industry). The primary function of these offices is the grant or registration of IP rights based on duly filled applications. While in many countries there is a single IP office covering all industrial property rights (copyright is often administered by a different office), in some countries the granting of patents and the registration of trademarks is the responsibility of different offices. The contact details of all IP offices may be found at the following web site: http://www.wipo.int/directory/en/urls.jsp.
IP agents and IP lawyers may also be a useful source of information and advice on intellectual property issues. IP agents and lawyers are private sector service providers who are qualified to either represent clients during the application and prosecution of IP rights and/or to defend clients in the courts in case of an intellectual property dispute. Many countries require companies from overseas to hire a national IP agent domiciled in the country in question in order to file a patent or trademark application.
Finally, you may consult the national legislation of a given country to obtain details on IP protection in that country. The WIPO web site includes a collection of national IP laws that may be consulted free of charge online at: http://www.wipo.int/clea/en/
Resources:

1. Collection of Laws for Electronic Access (CLEA): the web site includes a collection of national IP laws that may be consulted free of charge online at: http://www.wipo.int/clea/en/
2. A directory of national and regional IP offices with contact details and websites is available from the WIPO website at: http://www.wipo.int/directory/en/urls.jsp

3. What can be patented?

In most countries, patents may be obtained for product and process in any field of technology, including pharmaceuticals, provided that they comply with certain requirements.¹ In patent law, an invention is generally defined as a solution to a technical problem. An invention may relate to the creation of an entirely new product or process, or may simply be a functional improvement to a product or process that provides a unique solution to a technical problem. To be eligible for patent protection, an invention must meet several criteria, which may differ slightly from country to country. On the whole, however, most countries worldwide use the same (or similar) criteria for patentability, namely that:

• the invention consists of patentable subject matter;
• it is new (novelty requirement);
• it involves an inventive step or be non-obvious (inventive step or non-obviousness requirement);
• it is capable of industrial application or useful (industrial applicability or utility requirement); and
• it is disclosed in the patent application in a clear and complete manner (disclosure requirement).

Patentable subject matter

Under many national laws, patentable subject matter is defined negatively, i.e. by providing a list of what cannot be patented. However, there are important differences between countries in terms of what may represent unpatentable subject matter. For example, patent legislation in some countries includes some of the following as unpatentable subject matter:

• Discoveries and scientific theories;
• Aesthetic creations (which may be protected by industrial designs);
• Schemes, rules and methods for performing mental acts;
• Newly discovered substances as they naturally occur in the world;
• Inventions the exploitation of which is contrary to "public order" or morality;
• Diagnostic, therapeutic and surgical methods of treatment for humans or animals (but not products for use in such methods);
• Plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

In the pharmaceutical industry, types of inventions that are patentable in many countries (as long as the other criteria are met) include new pharmaceutical compounds, new or improved products for diagnostics, new dosage forms of known therapeutics, microorganisms, novel combinations of known compounds, processes and methods used for manufacturing a particular product, new and/or improved manufacturing equipment and new and/or improved drug delivery mechanisms or technologies. The list is by no means exhaustive and not all of the above are patentable in all countries.

The novelty requirement

An invention is new (or novel) if it does not form part of the prior art. The prior art is, in general, all the knowledge that has been made available to the public prior to the filing date (or priority date) of the relevant patent application or (in the United States) prior to when the invention was "made". The definition of "prior art" differs from country to country. In many countries, any invention made available to the public anywhere in the world in written form, by oral communication, by display or through use constitutes the prior art. Thus, in principle, the publication of the invention in a scientific journal, its presentation in a conference, its use in commerce or its display in a company's catalogue before the filing date (or priority date) of the application claiming that invention would constitute acts that could destroy the novelty of such invention and render it not patentable.
It is important to note, however, that in some countries, there is a grace period (usually of 6 or 12 months from the public disclosure of the claimed invention by the inventor) during which an applicant may file an application without the novelty being destroyed by such disclosure.

The inventive step/non-obviousness requirement

An invention is considered to involve an inventive step (or to be non-obvious) when, having regard to the prior art, the invention would not have been obvious to a person skilled in the particular field of technology. The non-obviousness requirement is meant to ensure that patents are not granted on developments that a person skilled in the relevant art could easily deduce from what already exists.

Industrial applicability/utility requirement

To be patentable, an invention must be capable of being used in industry (or meet the utility requirement). This means that the invention cannot be a mere theoretical phenomenon, but it must be useful and provide some practical benefit. The term "industry" is used in the broad sense, meaning anything distinct from purely intellectual or aesthetic activity, and includes, for example, agriculture. In biotechnology, the utility requirement has become particularly important in the context of the patenting of genetic sequences over which possible industrial applications are unclear. Some countries require that the utility be well established and asserted for the claimed invention in a specific, substantial and credible manner.

The disclosure requirement

According to the applicable national or regional legislation of most countries a patent application must disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the specific technical field (enabling disclosure requirement). For example, a patent application for a new pharmaceutical product, must include enough practical information so that anyone familiar with the relevant technical field is able to follow the indicated steps and replicate and produce an effective copy of it. In some countries, patent legislation requires the applicant to disclose the "best mode" for practicing the invention. For inventions involving microorganisms, many countries require that, if the microorganism is not accessible to the public and the claimed invention cannot be described in such a way to comply with the enabling disclosure requirement without having access to that microorganism, such microorganism be deposited at a recognized depositary institution, which is capable of maintaining the microorganism in a live culture for a prescribed period of time.

Patents in the life sciences

To comply with requirements under the TRIPS Agreement of the World Trade Organization, most countries allow for the patenting of microorganisms and, as explained above, often require the deposit of a sample of the microorganism at a recognized depositary institution when necessary to comply with the enabling disclosure requirement. Some countries exclude plants and animals (other than microorganisms) from patentability. Biological materials that have been purified and isolated from their natural environment or produced by means of a technical process are patentable in many jurisdictions. National patent law in many countries may also list some specific types of inventions that are excluded from patentable subject matter, such as processes for cloning human beings or processes for modifying the germ line genetic identity of human beings.
Depending on the country, plant varieties are protected either by the patent system, by a sui generis protection system for new varieties of plants (see http://www.upov.int/ for further information) or by a combination of the two.

Patents on improved variations and new uses

In many countries, improvements made to existing products are patentable, as are also new uses of a patented product, provided all the patentability requirements are met. In the pharmaceutical industry, it is not uncommon for companies to file patent applications for new therapeutic indications of a known drug. But such protection is not available in all jurisdictions. In addition, companies often file applications on new formulations or delivery methods of a drug, new and improved manufacturing processes, reduced dosage regimens, new versions of the active compound or other variations that meet the patentability requirements.
Resources

1. "Inventing the Future: An Introduction to Patents for Small and Medium-sized Enterprises" WIPO publication 917.  http://www.wipo.int/freepublications/en/sme/917/wipo_pub_917.pdf
2. Intellectual Property and Biotechnology: A Training Handbook, APEC 2001. http://www.apecipeg.org/library/resources/biotech.asp
3. "Biotechnology Intellectual Property Manual" published in 2001 by Biotechnology Australia, available on-line
4. "Primer: Genome and Genetic Research, Patent Protection and 21st Century Medicine" http://www.bio.org/ip/primer/main.asp
5. When is Something Prior Art Against a Patent. Web page at: http://www.iusmentis.com/patents/priorart/ provides an easy to understand explanation of what constitutes prior art.

4. What rights are granted by patent protection?

A patent grants its owner the right to exclude others not having his consent from commercially exploiting the invention. This includes the right to prevent or stop others from making, using, selling, offering for sale or importing the patented invention without the owner's prior permission.
It is important to note that a patent does not grant the "freedom to use" the technology covered by the patent, but the right to exclude others from the use of the technology. While this may seem a subtle distinction, it is essential in understanding the patent system, its relationship to product regulatory regimes and how multiple patents can interact. In fact, there may be patents that build on previous patents or the commercialization of which require regulatory approvals or the use of other patented inventions. In some cases, a company may need to obtain a license over other people's patents in order to commercialize its own patented invention.
In the pharmaceutical industry, the right to exclude others from use of the invention does not provide the right to market a given new drug, as the drug will still have to undergo certain tests (e.g. clinical trials) and obtain marketing approval prior to commercialization, regardless of whether it has been patented or not. In short, getting a patent on a pharmaceutical product does not grant the right to put it on the market.
The rights granted under a patent may be licensed, through a contract in which the patent owner agrees with a third party to allow certain specified uses of the patented invention generally in exchange for a payment of lump-sum payments and/or recurring royalties. A license may be limited according to purpose, field of use, territorial coverage and other conditions for which the authorization to use the patented invention is provided. Companies in the pharmaceutical industry may cross-license their technologies with other companies to permit both to use and benefit from their respective patented technologies. There are also situations in which a "patent pool" (or clearing house) could be created by a number of companies, in order to facilitate extensive licensing of a number of patents relating to a given technological field.

Limitations and exceptions to patent rights

Some of the basic limitations of a patent include:

• territorial limitation (as described above, a patent is a territorial right that only has effect in the jurisdiction for which it has been granted);
• time limitation (up to 20 years from the date of filing of the application, with possible extension in some countries for products that undergo regulatory approval such as certain types of pharmaceutical products);
• limitation in scope (a patent only provides exclusive rights over the claimed invention as described in the patent claims).

In addition, in many countries, there are exceptions to patent rights that allow third parties to use the invention without the consent of the patent owner, for example, to conduct research for non commercial purposes using the patented invention (often referred to as "experimental use" exception) or to prepare and apply for regulatory approval of a pharmaceutical product before the date of expiry of the relevant patent(s) (also referred to as "safe harbor" or "Bolar" provisions"), so as to speed up the commercialization of a generic products after that date. Given vast differences between countries in these matters, it is generally advisable for companies to be well informed on the specific practice in each country prior to engaging in any such activities.

Compulsory licenses

Compulsory licenses are licenses granted without the consent of the patent holder. Typically, they are granted either to remedy anti-competitive practices or in situations of national emergency.² They limit the exercise of the patent rights, but they do not work in the same way as exceptions. A compulsory license limits the enforcement of a patent vis-à-vis the person(s) being granted such a compulsory license. It does not revoke or invalidate the patent concerned. Compulsory licenses are granted by a national authority provided that all the necessary conditions specified in the national patent law are met. Compulsory licenses are generally subject to time and geographical restrictions. In addition, the patent holder is also entitled to compensation taking into account the economic value of the compulsory license.

Parallel imports

Parallel imports occur when goods produced in one country by an owner of IP rights, or with his consent, are imported by a third party into another country, in which the same IP rights exist, without the consent of the owner of the IP rights. Parallel imports are also often referred to as "gray market goods" as they are legitimately produced items, which are offered for sale outside the approved territory or channels of distribution established by the IP owner. Different countries or regions have different policies on parallel importation and international agreements provide national governments flexibility. Each country's law needs to be consulted.

Anti-trust or Competition law

As a general rule, governments may also invoke competition law to mitigate anticompetitive use of the exclusive rights conferred by patents, wherever it considers that a patent holder is abusing the market power provided by the patent. This sometimes occurs when a patent holder seeks to impose what are considered to be anti-competitive obligations on a licensee (such as price-fixing). There are situations in which compulsory licensing may be used as a remedy for redressing the abuse resulting from anti-competitive practices.
Resources

1. Website of the World Trade Organization. Information on the TRIPS Agreement of the WTO and its specific implications for the pharmaceutical sector, in particular issues relating to compulsory licensing and parallel importing available at: "TRIPS and Pharmaceutical Patents: Fact Sheet": http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm and TRIPS and public health: http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm
2. Studies of the Commission on Intellectual Property Rights, Innovation and Public Health. The studies look into various issues relating to innovation, research and development, intellectual property and public health. Useful to understand some of the current debates about IP protection in the health sector, particularly in developing countries. http://www.who.int/intellectualproperty/studies/en/

5. How do I obtain patent protection in my own country?

In order to get a patent application for your invention, it is absolutely critical to keep it confidential prior to filing the patent application. In most circumstances, public disclosure or use of your invention, including clinical testing of a drug, prior to filing a patent application destroys the novelty of the invention, rendering it unpatentable in many countries, unless the applicable patent law provides for a "grace period" (generally of 6 months or one year) that allows the applicant to disclose the invention and file the application later within the grace period.

Prior art search

Generally the first step for any company considering patent protection for an invention is to perform a prior art search. With over 40 million patents granted worldwide, and millions of printed publications, which are all potential prior art against your application, there is a good chance that some reference, or combination of references, may render an invention, or part of it, non-novel or obvious, and therefore unpatentable. A prior art search can prevent a company from wasting money on filing and prosecuting a patent application if the search reveals prior references that are likely to preclude the patenting of a given invention (more on prior art searches and the use of patent databases in Qu. 8).

Filing a patent application

Once a company has performed a prior art search and decided to seek patent protection for its invention, it will need to prepare a patent application and submit it in the prescribed manner to the national or regional patent office. Some patent offices make it possible for applicants to submit their application on-line and may even provide discounts to those who do so. The patent application has a range of functions:

• It defines the scope of the invention claimed, and thus determines the legal scope of the patent right;
• It describes the nature of the invention, including detailed instructions on how to carry out the invention; and
• It gives details of the inventor, the patent owner and other business and legal information.

Patent applications are similarly structured worldwide and consist of a request, a description, claims, drawings (if necessary) and an abstract. A patent application may be anywhere between a few pages to hundreds of pages long depending on the nature of the specific invention and the technical field.
The claims are generally considered the most important part of a patent application as they define the scope of the patent. They are crucial to the effective protection of an invention, for if they are badly drafted, the patent may be worthless regardless of how valuable the invention is. In enforcement actions, interpreting the claims is the first step in determining whether the patent is valid and in determining whether the patent has been infringed. It is strongly advisable to seek advice of an expert to draft patent applications, particularly the claims.
The steps taken by the patent office to grant a patent vary from country to country but, broadly speaking, follow a similar pattern:

• Formal examination: The patent office examines the application to ensure that it complies with the administrative requirements or formalities (i.e. that all relevant documentation is included, the patent application is complete and the application fee has been paid).
• Search: In many countries, the patent office conducts a search to determine the prior art in the specific field to which the invention relates. The search report is used during the substantive examination to compare the claimed invention with the prior art.
• Substantive examination: The aim of the substantive examination is to ensure that the application satisfies the conditions of patentability. Not all patent offices check applications against all the conditions of patentability. The applicant is given the opportunity to remove any objections that may be raised during the examination and if the applicant fails to do so in the specified time, the patent office will refuse the grant of the patent.
• Publication: In many countries, the patent application is published 18 months after the filing date (or priority date) irrespective of whether it has been granted or not. In general, all patent offices also publish the patent once it is granted.
• Grant: If the examination process has reached a conclusion favorable to the applicant, the patent office will grant a patent on the application and issue a certificate of grant. The time taken for a patent to be granted may vary significantly depending, among other things, on whether the patent office makes a full substantive examination on the application and/or on whether there are any pre-grant oppositions to the application and on the field of technology. In general, patent offices take between 2 and 6 years to grant a patent.
• Opposition: Many countries provide a period during which third parties may oppose to the grant of a patent, for example, on the basis that it is not new. Opposition proceedings may be pre-grant or post-grant procedures.

First to file vs. first to invent

In most countries, if more than one person independently made the same invention, a patent is granted to the first person to file a patent application claiming that invention. An exception is the United States of America where a first-to-invent system applies, by which, where more than one application with respect to the same claimed invention are filed, the patent will be granted to the first inventor who conceived and reduced the invention to practice. In order to prove inventorship within a first-to-invent system, it is crucial to have well-kept, duly signed and dated laboratory notebooks that may be used as evidence in case of a dispute with another company or inventor.
Resources

1. A Guide to Filing a Utility Patent Application. United States Patent and Trademark Office. Web page at: http://www.uspto.gov/web/offices/pac/utility/utility.htm . Basic information on filing a patent application in the United States.
    
2. Guidelines for Examination in the European Patent Office: Website at: http://www.european-patent-office.org/legal/gui_lines/e/c_iv.htm provide the guidelines followed by EPO used for examination of patents.
    
3. Manual of Patent Practice. United Kingdom Patents Office Website at: http://www.patent.gov.uk/patent/reference/mpp/ provides detailed information on the manner, form and content of making a patent application in UK.
    
4. Keeping a Laboratory Notebook. British Technology Group. Useful for companies interested in filing patents in the United States. http://www.btgplc.com/btguploads/BTG_LabNotebook_Jul02.pdf

6. How do I protect my IP rights in export markets?

As mentioned under Qu 2, IP rights are territorial rights, and in order to obtain protection in foreign markets, it is necessary to apply for protection with effect in those countries.
An applicant who has applied for IP protection in one country and applies for protection for the same IP right in other countries within a set period of time (referred to as the priority period under the Paris Convention) will benefit from the date of filing of the first application (priority date). This means that the subsequent applications will be regarded as if they had been filed on the priority date and your application will have priority over other applications for the same invention, trademark or industrial design filed after the priority date. The priority period is 12 months for patents and six months for trademarks and industrial designs.
In the case of patents, after the expiration of 12 months from your first filing date and until the patent is first published by the patent office (generally 18 months after the priority date) you may still have the possibility to apply for protection for the same invention in other countries (assuming it has not been disclosed), but you can no longer claim priority of your earlier application. Once the invention has been disclosed or published, you may be unable to obtain patent protection in foreign countries altogether, due to loss of novelty. Therefore, as a general rule, it is highly advisable, and often indispensable, to file your foreign patent applications within the priority period.

Filing applications abroad

For IP rights that require registration (such as patents, trademarks and industrial designs) there are essentially three alternative procedures for applying for IP protection in other countries.

The national route

One option is to seek protection in individual countries separately by applying directly to national industrial property offices. Each application may have to be translated into a prescribed language. You will be required to pay the national application fees and some countries will also require that you hire a national IP agent to submit the application. If you are still in the phase of assessing the commercial viability of an invention or are still exploring potential export markets or licensing partners, the national route may be particularly expensive and cumbersome, especially where protection is being sought in a large number of countries. In such cases, the facilities offered by the WIPO-administered international filing and registration systems for inventions, marks and industrial designs (see "The international route" below) offer a simpler and generally less expensive alternative.

The regional route

Some countries have established regional agreements for obtaining IP protection for an entire region with a single application. The regional IP offices include:

• African Intellectual Property Organization: http://oapi.wipo.net/
• African Regional Intellectual Property Organization: http://www.aripo.org/
• Benelux Trademark Office & Benelux Designs Office: http://www.bmb-bbm.org/ & http://www.bbtm-bbdm.org/
• Eurasian Patent Office: http://www.eapo.org/
• European Patent Office: http://www.epo.org/
• Office for Harmonization in the Internal Market (European Union Community Trademark and Community Design): http://oami.eu.int/
• Patent Office of the Cooperation Council for the Arab States of the Gulf: http://www.gulf-patent-office.org.sa/

The international route

The WIPO-administered systems of international filing and registration simplify greatly the process for simultaneously seeking IP protection in a large number of countries. WIPO-administered systems of international protection include three different mechanisms of protection for specific industrial property rights.
A system for filing international patent applications is provided under the Patent Cooperation Treaty (or PCT) system. An important advantage of the PCT is that it provides up to 18 additional months on top of the 12-month priority period, during which applicants can explore the commercial potential of their product in various countries and decide where to seek patent protection. Payment of the fees and translation costs associated with national applications are thus delayed. The PCT is widely used by applicants to keep their options open for as long as possible. PCT applicants also receive valuable information about the potential patentability of their invention in the form of the PCT International Search Report and the Written Opinion of the International Searching Authority. This enables the applicant to make an informed decision on whether and where to pursue patent protection.
In addition, filing an applications using the PCT route significantly reduces the initial transaction costs of submitting separate applications to each patent office. The PCT may also be used to file applications in some of the regional systems. Guidance on how to submit an international application under the PCT can be obtained from your national patent office and/or from WIPO at www.wipo.int/pct.
International protection of trademarks is facilitated by the Madrid system for the international registration of marks. The principal advantages of using the Madrid system are that the trademark owner can register its trademark in all the countries party to the system (over 70) by filing a single international application, in one language, subject to one set of fees and deadlines. Thereafter, the international registration can be maintained and renewed through a single procedure. More information on the international registration of marks can be obtained either from national trademark offices or on the WIPO website: www.wipo.int/madrid/.
International protection of industrial designs is provided by the Hague Agreement Concerning the International Deposit of Industrial Designs. An applicant from a Member country to the Hague Agreement can file a single international application with WIPO; the design will then be protected in as many Member countries of the treaty (currently 38) as the applicant wishes. The agreement provides applicants with a simpler and cheaper mechanism for applying for industrial design registration in various countries. Full information on the Hague Agreement, including the application form, can be obtained from the WIPO website at: www.wipo.int/hague/
Resources

1. Secrets of Intellectual Property: A Guide for Small and Medium-sized Enterprises. ITC/WIPO publication on with questions and answers on intellectual property of relevance to SME exporters.
    
2. Basic Facts about the PCT. http://www.wipo.int/pct/en/basic_facts/basic_facts.pdf The publication provides basic information on the Patent Cooperation Treaty . For more in-depth information, see website of the PCT.
    
3. Tool box for applicants of the European Patent Office. http://www.european-patent-office.org/_new_tb_applic/index.en.php

7. What is patent information? How can I use it for the benefit of my company?

"Patent information" is the technical and legal information contained in patent documents published periodically by patent offices. A patent document contains the full description of how a patented invention works and the claims that determine the scope of protection. It also contains details of who patented the invention and when it was applied for and granted, and provides references to relevant literature. It is estimated that approximately two-thirds of the technical information revealed in patent documents is never published elsewhere and the entire set of patent documents worldwide contains over 40 million items. This makes patent information the single most comprehensive collection of classified technological data.
Patent information (as contained in patent databases) can be useful to pharmaceutical companies for a number of reasons. One of the most important is as a source of technical information, which companies may find of great value in their research and development and strategic business planning. Most inventions are disclosed to the public for the first time when the patent (or, depending on the national law, when the patent application) is published by the patent office. Thus, patents are a valuable source of information about current research and innovations, often long before the innovative products appear on the market. Patent databases may also be used to find out about the legal status of a patent and in particular to find out whether a specific patent has expired. This may be particularly relevant for companies considering the introduction of a generic drug once the relevant patent has expired. Some of the most important reasons for using patent databases include:

• To avoid unnecessary expenses in researching what is already known
• To identify and evaluate technology for licensing and technology transfer
• To keep abreast of the latest technologies in a specific field of expertise
• To find solutions to technical problems
• To locate potential business partners
• To monitor activities of real and potential competitors
• To identify niche markets
• To find out about the legal status of a patent
• To avoid possible infringement problems
• To assess the patentability of an invention
• To oppose the granting of patents where they conflict with a company's own patent(s)

Freedom to operate

Using patent information is particularly important in the pharmaceutical industry when a company wishes to launch a new product or introduce an existing product into a new market. Prior to launching a new product, and often even prior to initiating a new line of research that may lead to the development of a new product, it is important that companies in the pharmaceutical industry seek to minimize the risk of infringement by securing their "freedom to operate" (FTO), i.e. ensuring that the commercial production, marketing and/or exporting of their new product, process or service does not infringe the intellectual property rights of others. An FTO analysis invariably begins by a search of patent literature for issued or pending patents and in order to obtain a legal opinion on whether a product, process or service may infringe existing patent(s) (or patent applications) owned by others.
An FTO analysis based on the search of patent literature is in many ways just the first step. If the patent search reveals that there are one or more patents that limit your freedom to operate, your company will have to decide how to proceed. Assuming that the blocking patent(s) is/are valid, some of the most common strategies are the following:

• Licensing in (i.e. obtaining authorization from the patent owner to use the technology through a licensing contract in exchange for a lump-sum payment and/or royalties).
• Cross-licensing (i.e. obtaining authorization from the patent owner to use the invention in exchange for your granting to the other party the right to use one or more of your own patented inventions).
• Inventing around (i.e. steering research or making changes to the product or process in order to avoid infringing the patent(s) owned by others).
• Not entering a given market where the invention is protected.

Where to search for patent information

Most intellectual property offices worldwide offer facilities for the general public to consult patent databases. Some national and regional patent offices have also made their patent databases available online, generally free-of-charge. In addition, a number of private service providers offer sophisticated databases for a commercial fee. Some of the latter may be particularly important for searching chemical compounds and genetic sequences, which cannot easily be searched using the free on-line databases.
While the Internet has significantly simplified access to patent information, it is not always easy to perform a high-quality patent search, as patent jargon may sometimes appear complex and obscure and professional searching requires training. While preliminary searches may be performed through the free on-line databases, most companies requiring patent information for taking key business decisions (e.g. whether to apply for a patent or not) will generally rely on the services of skilled patent professionals who have access to some of the more sophisticated databases.
A list of on-line patent databases of national and regional IP offices is available from the following website: http://www.wipo.int/ipdl/en/resources/links.jsp In addition, there are a number of patent databases offered by commercial providers.

The International Patent Classification

The international patent classification (IPC) is a hierarchical classification system used to classify and search patent documents. The seventh edition of the IPC consists of eight sections, 120 classes, 628 subclasses and approximately 69,000 groups. The eight sections are:
A. Human Necessities;
B. Performing Operations; Transporting;
C. Chemistry; Metallurgy;
D. Textiles; Paper;
E. Fixed Constructions;
F. Mechanical Engineering; Lighting; Heating; Weapons; Blasting;
G. Physics;
H. Electricity.
Currently, over 100 countries use the IPC to classify their patents: www.wipo.int/classifications/en/ipc/index.html
Resources:

1. On-line patent databases. A list of on-line patent databases of national and regional IP offices is available from the following website: http://www.wipo.int/ipdl/en/resources/links.jsp
2. The European Patent Office Guide to Patent Information on the Internet, Available at web site: http://www.european-patent-office.org/espacenet/info/manual.htm explains how to use the internet for patent-related activities and to find scientific and technical information relating to patents. It contains information about the internet itself, and suggests a number of tips and tricks for searching the net. It also includes lists of internet addresses of scientific and technical interest, as well as sources relating to patent information.
    
3. WIPO Patent Information Services (WPIS) for http://www.wipo.int/innovation/en/wpis/pdf/wpis.pdf the document provides information on different types of searches, information on WPIS, its services, and guidelines of submission of requests.

8. Why are trademarks important for pharmaceutical products? How do I register my trademark?

While most businesses realize the importance of using trademarks to differentiate their products from those of their competitors, not all realize the importance of protecting them by registration. Given the importance that a trademark may have in determining the success of a product in the marketplace and enhancing product recognition and the development of a loyal clientele, it is essential to ensure that the company using a given trademark has obtained exclusive rights over it.
Registering a trademark gives a company the exclusive right to prevent others from marketing identical or similar products under the same mark or under a confusingly similar mark. Protected trademarks may also be licensed to other companies, thus providing an additional source of revenue for the company.
In some countries (particularly countries that follow a "common law" system, such as the US, Canada, the UK, Australia or India) trademark rights may also be acquired through use. The main advantages of registration in such cases are:

• Registration provides proof of rights, which is particularly important in case of disputes with third parties;
• An application can be filed prior to using the mark;
• Registration makes it easier and cheaper to enforce;
• The trademark is included on the official trademark register; and
• The ® sign can be used next to the trademark.

When choosing a trademark it is important to bear in mind the categories of signs that are usually not accepted for registration. Applications for trademark registration are usually rejected on what are commonly referred to as "absolute grounds" when the trademark is not considered sufficiently distinctive (e.g. it is the generic name of the product or chemical compound, it is too descriptive of the product in question or is considered deceptive).
Applications may also be rejected on "relative grounds" when the trademark is in conflict with prior trademark rights. Having two identical (or very similar) trademarks for the same type of product could cause confusion among consumers. Some trademark offices check for conflict with existing marks (including unregistered well-known marks) as a regular part of the registration process, while others only do so when the trademark is challenged by a third party after publication of the trademark. In either case, if the office considers a trademark to be identical or confusingly similar to one that already exists for identical or similar products, it will be rejected or cancelled as the case may be.

Trademark registration

Before submitting an application for trademark registration, companies should ensure that a proper trademark search has been carried out. This is to make sure that the trademark you intend to use, or a confusingly similar one, is not already registered by another company for identical or similar products. It is advisable to conduct a trademark search not only in your own country but also, as far as possible, in potential export markets, in order to avoid problems of infringement at a later stage.
A trademark search may be conducted directly by your company or you may hire the services of a trademark agent. Whatever the manner that is chosen, it is important to bear in mind that any such trademark search is only preliminary. While it is relatively simple to ensure that a trademark is not identical to an existing validly registered trademark, it may be difficult to ensure that the trademark of choice is not "confusingly similar" to another trademark. This is why the guidance of an experienced trademark agent, who is familiar with the practice of the trademark office and court decisions, may be extremely helpful. A list of trademark databases is available from the following webpages: http://arbiter.wipo.int/trademark/output.html.
In order to register a trademark, applicants are required to send or hand in a duly completed trademark application form, which will include:

• the contact details of the company,
• a graphic illustration of the mark (a specific format may be required)
• a description of the goods and services and/or class(es) for which the company wishes to obtain trademark protection,
• and payment of the required fees.

Use requirement

A company may apply for trademark registration prior to using it in the market to commercialize its products or services, but some countries will not officially register the trademark until the applicant has shown proof of use (e.g. the United States). Additionally, in most cases, the registration of a trademark that has not been used for a given period of time (usually 3 to 5 years following registration) may be cancelled. This is to try to guarantee that the registration is done with the intention of actually using the trademark in the marketplace, rather than simply for the purpose of obstructing its use by others.

Trademark symbols

Many companies use signs such as ®, TM, SM, MD (French for marque deposeé) or MR (Spanish for marca registrada) or equivalent symbols next to their trademark in order to inform consumers and competitors that the word, logo or other sign is a trademark. While such symbols are not a requirement and generally provide no further legal protection for the trademark, it may be a convenient way of informing others that a given sign is a trademark, thus warning possible infringers and counterfeiters and inhibits marks from losing their distinctiveness. The ® symbol, MD and MR are used once the trademark has been registered. TM denotes that a given sign is a trademark and SM is sometimes used for service marks.

Use in advertising

If your mark is registered as a logo with a specific design or font, make sure that, wherever it appears, it is represented in exactly the form in which it is registered. Monitor and supervise its use closely, as it is critical to the image of your company's products. It is also important to avoid using the trademark as a verb or noun so that it does not come to be perceived by consumers as a generic term.

Generics and brandname drugs

Dictionaries tend to define a "generic" as a product - particularly a drug - that does not have a trademark. For example, "paracetamol" is a chemical ingredient that is found in many brandname painkillers and is often sold as a (generic) medicine in its own right, without a brandname. This is "generic from a trademark point of view".
Sometimes "generic" is also used to mean copies of a patented drug, a drug whose patents have expired or a drug that is made and marketed by a company in another country in which the drug is not patented - "generic from a patent point of view". Patented drugs are almost always sold under a brandname or trademark. When a drug, protected by patent in one country, is made by another manufacturer in a country where the drug is not protected by a patent, then in such other country it may be sold under the name of the chemical ingredient (making it clearly generic), or under another trademark (which means they are still generic from a patent point of view but not from a trademark point of view).³
Resources:

1. Making a Mark: An Introduction to Trademarks for Small and Medium-sized Enterprises. World Intellectual Property Organization, The guide available at the web page: http://www.wipo.int/freepublications/en/marks/900/wipo_pub_900.pdf provides easy to follow overview of trademarks, protection, their types, use, and enforcement with illustrations and examples.
    
2. FAQs on Trademarks of the International Trademark Association (INTA). http://www.inta.org/info/faqs.html
3. Guidelines for Trademark Examination. International Trademark Association: http://www.inta.org/downloads/tap_tmexam1998.pdf provides guidelines for Trademark registration offices on the criteria for evaluation of trademarks

9. What are the most crucial considerations when managing the IP assets of a company in the pharmaceutical industry?

Managing the IP assets of a company in the pharmaceutical industry is more than just acquiring the formal IP rights through the national or regional IP office. Patent or trademark rights are not worth much unless they are adequately exploited. Moreover, some types of valuable IP (such as trade secrets) do not require formal registration but call for other practical measures for their protection (e.g. confidentiality agreements). Finally, the enforcement of IP rights might be crucial to ensure that the IP rights are respected in the marketplace.
Enterprises in the pharmaceutical industry willing to extract full value from their know-how, innovation and creativity should, therefore, take adequate steps to develop an IP strategy for their business and seek to integrate it within their overall business strategy. This implies, for example, including IP considerations when drafting business plans and marketing strategies. Understanding the relationship between the IP system and the system for obtaining marketing approval for new drugs by the relevant public health regulatory body is also important. A basic IP strategy would generally include at least the following:

A Strategy on the protection of IP rights

A single product or service may be protected by various forms of IP rights covering different aspects of that product or service. In the pharmaceutical industry, various aspects of a new drug may be patented (e.g. the chemical compound, processes, new uses for the same compound, improved variations, dosage regimens, etc.). Companies must consider the best protection package (including the reliance on trade secret protection, if considered appropriate) and make sure that all the formal rights are acquired in the relevant markets. Making an IP audit of the company may be an important first step for identifying protectable assets that may not have been adequately exploited by a company in the past.
Small and medium-sized exporters should also bear in mind that creating a comprehensive IP portfolio with protection in various markets may be a considerable investment. This is particularly the case for patents. SMEs must therefore carefully assess the costs and benefits of patenting on a case by case basis and develop a strategy/policy on the filing of patent applications that is commensurate to its budget and market opportunities.

A Strategy on IP Exploitation

IP rights may be exploited in a variety of ways. These may include the commercialization of IP-protected pharmaceutical products benefiting from the exclusive rights provided by the IP system; the entering into exclusive and/or non-exclusive licensing agreements with one or more other companies; the sale or assignment of IP assets to other firms; the creation of joint ventures or strategic alliances in order to exploit complementary IP assets of other companies; the use of IP rights to obtain access to other companies' technology through cross-licensing agreements; and/or the use of IP rights to support an application for obtaining funds to take a patented product to market.
Enterprises should decide in each case how they may best exploit their IP assets both domestically and internationally while ensuring that they have freedom to operate and do not unnecessarily run into trouble by infringing the IP rights of others.

A Strategy on IP Monitoring

Consulting patent databases regularly is important in order to find out about recent technical developments and new technologies, identify new licensing partners, suppliers or new market opportunities, ensure your freedom to operate, monitor the activities of competitors, find out about the legal status of a patent and identify possible infringers. In addition, companies will need to monitor the market to identify possible infringement by other companies (e.g. the use of your trademark by others that may be eroding or diluting a company's own trademark or the release of an infringing generic).

A Strategy on IP Enforcement

A clear strategy on IP enforcement is crucial to avoid the losses that may be incurred by the existence of infringing goods in the market and the high costs involved in some IP disputes. The main responsibility for identifying and taking action against imitators or infringers of IP rights lies with their owner (unless such responsibility has been transferred to a licensee). A patent owner, therefore, is responsible for monitoring the use of its patented invention(s) or registered trademark(s) in the marketplace, identifying any infringers and deciding whether, how and when to take action against them.
It is advisable to contact an IP lawyer to assist in taking any steps for enforcing IP rights, both domestically and/or in any export markets, which may include the sending of a "cease and desist letter" informing the alleged infringer of a possible conflict between your rights and the company's business activity, approaching a court to obtain an "interim injunction" in order to surprise the infringer at his business premises and/or initiating civil proceedings against the infringing company.
In many cases, IP disputes are settled out of court and often result in a licensing agreement thus providing the authorization to the alleged infringer to continue selling the product in question in exchange for a lump-sum payment or royalties. Arbitration and mediation are often used to avoid long and expensive litigation. It is generally advisable to include a special provision in licensing contracts for any dispute that may arise to be referred first to arbitration or mediation. More information on arbitration and mediation can be found at: http://arbiter.wipo.int/center/index.html.
Resources

1. Website of WIPO's SMEs Division. A range of articles, case studies and documents on IP strategies targeted to small and medium-sized enterprises. Available at www.wipo.int/sme
2. Medicon Valley Patent Guide.  How to Patent Biotech and Medicotech Inventions, Medicon Valley Academy 2002.  http://www.mva.org/media(3,1033)/Medicon_Valley_Patent_Guide.pdf
    
3. Intellectual Property and Biotechnology: A Training Handbook, APEC 2001. http://www.apecipeg.org/library/resources/biotech.asp
4. Biotechnology Intellectual Property Manual published in 2001 by Biotechnology Australia, available on-line.

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