Patent System in the Pharmaceutical Industry

O.A.Thusleem

The pharmaceutical sector is a major user of the patent system.

While only a small - and declining - number of new chemical entities are approved annually, thousands of patents are applied for to protect variants of existing products, processes of manufacture or, where admitted, second indications of known pharmaceutical products. Since patents confer exclusive rights regarding the production, sale and use of the patented subject matter, they can be used to restrain competition and set prices higher than those that would have existed if competitive products were available. This is the very purpose of the patent system, which is generally justified as necessary to encourage investments to develop new products and processes.¹

Given the substantial effects that patents can have on competition and, hence, prices of medicines, the criteria that are applied to examine and grant pharmaceutical patents are extremely relevant for public health policies, and not only a matter of concern for patent and industrial policy. Policy makers in the health area, as well as patent examiners should be aware that decisions relating to the grant of a patent (which is generally presumed valid until proven to the contrary) can directly affect the health and lives of the people of the country where the patent is granted and enforced.

Defining Patentability

What is a Patent?

A patent is a property right granted by a sovereign state to the inventor of a novel, nonobvious and useful invention. Because the invention must be novel (meaning that it has not been previously disclosed anywhere in the world) and because it cannot be obvious to one ordinarily skilled in the art, the grant of the property right cannot interfere with the public’s access to what already exists.²

The owner of a patent has the right to exclude others from making, using, offering for sale, or selling his or her invention for a period of 20 years from the filing of the patent application . An invention is any new or useful process, machine, article of manufacture, or composition of matter. An improvement on any of these items also can be an invention. Patent rights are territorial in nature and exist only in the national jurisdictions in which the patentee has applied for and received recognition of his property rights.

Although most countries in the world apply an absolute novelty requirement (that is, disclosure in any form anywhere in the world before the filing date will prevent the granting of a patent) some countries maintain a double standard of novelty depending on whether the disclosure of the invention has taken place within or outside their territory. In practice, the concept of novelty is narrowly construed by some patent offices, requiring an almost ‘photographic’ disclosure of the invention in a single prior document in order to consider that novelty does not exist. For experienced patent applicants, overcoming novelty barriers may be just a matter of clever design of patent applications.

Whether a claimed invention meets the tests of novelty and non-obviousness is determined by comparing it to the body of previously disclosed information in the same field. This information is usually called “prior art.” The most commonly used prior art consists of published patents that have already been issued or published by the world’s patent offices.

Defining ‘non-obviousness/inventive step’ is one of the most critical aspects of a patent regime, as it determines the level of technical contribution required to obtain a patent and the corresponding limitation on competition. Patent examiners need to consider not only what is disclosed in the prior art but also what a person skilled in the art (such as a person trained and experienced in pharmaceutical formulation) could consider obvious in the light of such prior art.

The best policy from the perspective of public health would seem to be the application of a strict standard of inventiveness so as to promote genuine innovations and prevent unwarranted limitations to competition and access to existing drugs.³ This implies that the ‘person skilled in the art’ should be deemed to have some specialized knowledge and not simply somebody with very general or ordinary knowledge in the relevant technical field. A person skilled in the art is not just an expert in his technical field but a person who should have some degree of imagination and intuition. He should not only rely on the documents found in the novelty search, but apply his experience and his knowledge. Such an examiner should be particularly strict when examining the inventive step. Finally, inventions must be susceptible of industrial applicability, since the aim of patent law is to protect technical solutions to a given problem, not abstract knowledge. Patent claims should contain, as a minimum, a technically viable solution and not merely an unresolved problem or a speculative or intended result.⁴

Another important element in the assessment of patent applications or grants is the disclosure of the invention. In accordance with Article 29.1 of the TRIPS Agreement,⁵ members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

Lack of sufficient disclosure may be a reason for refusal of an application or invalidation of a patent.⁶ This requirement has particular importance in the chemical and pharmaceutical fields to enable the reproduction of the invention during the patent term (for instance, in the case of a compulsory license) or after patent’s expiry. A special consideration should be given to cases in which a large number (sometimes millions) of compounds belonging to a group characterized by common elements is claimed.

The benefit of granting an inventor the exclusive property right of a patent for the limited period of 20 years is that he or she is given a powerful incentive to create. The inventor is assured that investors will be given the incentive to commit the financial resources necessary to support the inventor’s research and to develop it to the point where it can be manufactured and made available to the market.

Patents are exclusive property rights in intangible creations of the human mind. They exist only as provided in the laws of sovereign states, and can be enforced only to the extent that application has been made and a patent granted covering the territory of an individual state. Patent rights are limited in duration, with the global standard being 20 years from the date of application. The new product, article of manufacture or process described in the patent application must be something that has never been previously disclosed anywhere in the world and something that would not be obvious to a person ordinarily skilled in the field involved. Determinations of whether these requirements have been met are made by comparing the claims of the patent applicant against the body of published literature in the field, including previously issued patents. This process is called examination, and it assures that no one is able to claim patent rights on anything that already is into existence.⁷

Patents work differently in different industries. However, in the pharmaceutical, chemical and biotechnology industries the patent normally equals the product, and protects the extensive investment in research and clinical testing required before placing it on the market.⁶ Patent protection for chemical and pharmaceutical products is especially important compared with other industries because the actual manufacturing process is often easy to replicate and can be copied with a fraction of the investment of that required for the research and clinical testing.

The extensive cost required to produce a new pharmaceutical product has meant that private sector investment in pharmaceutical innovation has been disproportionately directed to products meeting the needs of patients in developed countries, particularly in the United States, which combines strong patent protection with a market free of price controls.

Until the TRIPS Agreement in 1994 many developing countries provided no patent protection for pharmaceutical products. And, while countries that have joined the WTO have obligated themselves to provide such protection, least developed countries are not required to meet this obligation until 2016. The continuing lack of patent protection for pharmaceutical products makes it very difficult to establish research-based industries in most developing countries. Most medical research in these countries takes place in the public sector. The lack of any means of patenting these inventions and the related lack of experience in licensing them to the private sector, suppresses the development of commercial enterprises focused on alleviating the disease burdens common to developing countries.

Whatever patent strategy is employed by the inventor, the aim is always the same – to maximize the profit accruing to the inventor and those who have supplied him or her with the capital necessary to develop and commercialize the invention. For a patent to have any commercial value there must be a market for the invention embodied in the patent, which will support the cost of development of the invention and return a profit.

The market exclusivity and higher prices are made possible by the patent rights function as a reward for the risk undertaken by those who financed the research and development leading to the new technologies.

The Global Institutions Responsible for Administering the Patent System⁸

National Patent Offices

Every country with a patent system has a national patent office where claims of inventors may be made a matter of public record. As mentioned above, in many countries there is an examination before an inventor is given any substantive rights. In other countries patent claims are registered but detailed examination is delayed until a dispute over infringement arises. However, even in these countries a search of the prior art is often conducted as a part of the registration process, and the search results are published so that members of the public can assess the claims made by the registrant.

The World Intellectual Property Organization (WIPO)

Headquartered in Geneva WIPO is the specialized United Nations Agency that serves as the secretariat for administration of most of the global intellectual property treaties. It is the principal forum for negotiation of new patent treaties and the leading provider of technical assistance to developing countries in the field of intellectual property rights. WIPO was created in 1967 as the successor organization to the International Bureau for the Protection of Intellectual Property, which had been in existence since the 19^th Century. WIPO Currently has 179 member states.

The World Trade Organization (WTO)

The World Trade Organization was established in 1994 in Marrakech following the successful conclusion of the Uruguay Round of Trade Negotiations. The predecessor to the WTO was the General Agreement on Tariffs and Trade (GATT). A key reform of the Uruguay Round was the Agreement on Trade Related Aspects of Intellectual Property Rights, known as TRIPS, codified as an annex to the treaty establishing the WTO. It is important to recognize that the TRIPS Agreement was intended to create a more equitable system of international trade. Wealthy countries agreed to reduce barriers to imports of price competitive imports from abroad while developing countries agreed to open their markets to the high value added exports of the developed nations. These high value added exports disproportionately consist of technology in which much of the value is intangible and must be protected by strong intellectual property regimes to be effectively exploited. Pharmaceutical products constitute one of the most important categories of high technology products.

Among the major requirements of the TRIPS agreement are the following:

•WTO Member States must provide a level of rights equal to those provided in the major global intellectual property treaties administered by WIPO, including the Paris Convention on Industrial Property.

•WTO member states may not discriminate among technologies in providing patent protection, meaning that exceptions to patent protection in many countries for pharmaceutical products must be eliminated.

•WTO member states must provide patent protection for at least 20 years from the date of filing a patent application

•WTO Member States must provide effective judicial enforcement of intellectual property rights.

•A TRIPS Council was created to coordinate WTO policy in the area of intellectual property rights and to manage the resolution of disputes among states on implementation of TRIPS obligations.

Special Problems of Pharmaceutical Patents ⁹

The pharmaceutical industry is one of three technology-based industries in which the patent virtually equals the product. The others are the chemical industry (including agricultural chemicals) and the biotechnology industry, whose innovations span the spectrum from engineered plant varieties to human pharmaceutical therapies. These three industries are much different than other patenting industries. Most importantly, unlike industries which produce products requiring expensive and complex manufacturing infrastructures, the patented products of pharmaceutical companies can be easily and cheaply replicated by copiers with little capital investment. Since capital investment in the pharmaceutical industry disproportionately is directed to laboratory research and clinical trials rather than the manufacture of the final product, patent exclusivity is the only effective way to protect and receive a return on that investment.

The pharmaceutical industry has an important characteristic that sets it apart from other industries that rely on patent protection. In many technology-based industries it is possible to keep inventions a secret until the moment they are marketed. This enables inventors to delay patent filings until the last possible moment and, therefore, to maximize the effect of the 20 year patent term which runs from filing of the patent application. The culture of medical research, however, emphasizes very early disclosure of inventions, usually long before a resulting product can be placed on the market. This is because scientists working in the field of human pathology have an obligation to share their findings as soon as possible with their peers so that those peers will be able to benefit from the new knowledge in their own research. And, unlike industries such as computers and software, the pharmaceutical industry is heavily regulated by government agencies to assure the safety and efficacy of products which will be sold to consumers. In the United States, the Food and Drug Administration performs this function. Much of the investment in new drugs is in the clinical trials which are necessary to satisfy safety and efficacy regulators. The tolerance for a “buyer beware” philosophy in the pharmaceutical industry is extremely low compared to other industries.

The lengthy time period between patent filing and placing a product on the market means that pharmaceutical manufacturers receive far shorter periods of patent exclusivity than is the case for other patent dependent industries. This problem has been addressed in legislation in the United States and elsewhere which permits a patent applicant to apply for extensions of patent term to compensate for the inability to market inventions due to safety and efficacy regulation. However, the time periods permitted for such extensions do not equal the time lost in ability to market. In the United States patents can be extended only for half the time period consumed by the regulatory approval process, and for a maximum effective patent term of fourteen years.² Further, the legislation restricts the exclusive right of use which normally accompanies the patent grant by permitting generic competitors to use the product for testing and developing the generic alternative while the patent is still in effect. This permits a generic product to be marketed virtually the moment the patent expires.

While the contribution of the patent-based pharmaceutical business to job creation and the economy is impressive, the inventions of pharmaceutical researchers have a dimension difficult to quantify in economic terms – their impact in extending life and alleviating human suffering. In 2001 the pharmaceutical industry pipeline contained 402 new cancer medicines, 123 new treatments for heart disease and stroke, 83 new AIDS treatments and 176 new medicines for neurological diseases. These statistics are particularly sobering in light of the current debate over whether patents covering HIV drugs should be respected. None of the new drugs in the pipeline, much less the 74 medicines that already have caused deaths from AIDS to plummet in the United States, would have come into existence without the patent incentive and the prospect of a return on investment provided by that incentive.

This is not to dismiss the fact that many patients in the world cannot pay for these drugs and do not have access to them. However, this is not the result of the patent system. It is the result of lack of a source of funding for the purchase of drugs for those currently too poor to buy them themselves.

Effective use of the patent system in the 20th Century gave rise to commercial enterprises that advanced the progress of medical science beyond anything known in prior history. While public funding of the training of scientists and basic research vastly expanded the understanding of human pathology as the century progressed, it was the profit incentive operating through pharmaceutical companies accountable to investor shareholders, which provided desperately needed new therapies to patients. By the decade of the 1980s patent dependent pharmaceutical companies developed more than 92% of all new drugs.

Patent claims relating to Pharmaceutical inventions

A patent claim relating to a pharmaceutical product may relate to an active ingredient as such independently of or jointly with formulations, salts, prodrugs, isomers, etc., or cover any of these subject matters separately. It may also solely cover a manufacturing process or include both a process and a product. In some countries, as noted below, use-related claims are admissible. The following sections include some considerations for the evaluation of different types of claims that are typical in this area.

In undertaking such evaluation it will be important to bear in mind that while the development of new molecules of pharmaceutical use may encompass various levels of inventive steps, pharmaceutical techniques for the preparation of medicines in different forms and dosages are generally well known and part of the pool of knowledge in possession of a ‘person skilled in the art’. Hence, there is a narrow range of developments that could be considered genuinely inventive in this field in view of the state of the art.

Formulations and compositions

The same active ingredient may be presented in different dosage forms, for instance, as tablets, capsules, ointment or aqueous solutions for parenteral administration, which in turn can be formulated using different pharmaceutically acceptable excipients.⁷

A large number of patents claim formulations of new or existing drugs, often including specifications of dose or concentration, either as the principal claim or in subordination to claims over the active ingredients or their uses. ‘Composition claims’ cover active ingredients and pharmaceutically acceptable carriers or excipients, such as fillers, binders, disintegrants and lubricants.

Patents granted solely on the basis of formulation or composition claims do not protect the active ingredients as such, and different formulations or compositions comprising the same ingredients may - if they are in the public domain - be commercialized by competing companies. However, such patents may be used to discourage competition through ‘strategic’litigation, that is, by alleging infringement and requesting provisional injunctions that block commercialization until a final decision is made.

Formulation or composition claims are deemed acceptable by some patent offices, under certain conditions. This is, for instance, the case of the United Kingdom. Known substances may be protected by product claims to pharmaceutical compositions containing them, if the composition is in a form which is novel and inventive over any known products. In particular, a claim may be made to a medicament having a form of administration which is novel and distinct from the previous use. For example, an anti-eczema ointment containing X would be regarded as clearly distinct from a tablet containing X for controlling blood pressure. The ointment is new because X has never been formulated in this form before, and it would be inventive if the previous use of X would not suggest its use in topical form.

In some cases, a particular claimed formulation is associated with certain effects, such as controlled release in blood of a drug. Achieving such effects is generally part of the ordinary skill of a person knowledgeable in the formulation of pharmaceuticals, unless there are exceptional circumstances, such as the use in a product of a new excipient that produces a truly unexpected or surprising effect, for instance, a noticeable reduction in side effects or an extraordinary improvement in drug release, such as a sub-dermal device that will release insulin for a long period.

In India, the patent office has considered that the Patent Act denies claims to compositions obtained by mere admixture resulting in the aggregation of the properties of the components therefrom. Thus, a novel pharmaceutical composition with a single active ingredient (known or novel) with an inert carrier is not patentable in India as there is no synergy between the components viz. the active compound and the inert carrier. The existence of synergy, however, should not be considered per se as demonstrating inventive step, if the composition is obvious to a person skilled in the art.

As a general rule, formulation techniques and the range of compounds that may be used for developing pharmaceutically viable products in different forms are well known to a person skilled in the art. For instance, it is not inventive to use particular stabilizing agents (such as pH regulators) or some compounds to improve bio-availability, as these are well known. In some cases, certain salts are preferred for the preparation of particular formulations, such as tablets, while other salts may be preferred for the formulation of liquid pharmaceutical preparations. In most cases, it is likely that the claimed inventions in this field lack inventive step.

Similarly, claims relating to pharmacokinetic parameters, micronisation of a known product or particles distribution within a given diameter or weight should not generally be deemed admissible. As mentioned above, the existence or not of inventive step is not to be determined exclusively on the basis of documentation in the prior art, but taking into account the average knowledge of a person trained and experienced in pharmaceutical formulation.

Finally, it should be noted that processes to prepare formulations or compositions are generally well known and routinely applied. Hence, claims over such processes would rarely be inventive. Likewise, simple experiments/trials are not sufficient to support patentability.

Recommendation: New formulations and compositions, as well as processes for their preparation, should generally be deemed obvious in the light of the prior art, particularly when a single active ingredient is claimed in association with known or unspecified carriers or excipients. Exceptionally, claims of this type could be patentable if a truly unexpected or surprising effect is obtained, for instance, when a really difficult problem or a long standing need, such as a noticeable reduction in side effects, is solved in a non-obvious way, or when the solution found leads to a tremendous advantage compared to the state of the art.

Combinations

Claims are sometimes directed to combinations of previously known active ingredients. In some cases, the specific covered compounds and quantities are indicated, while in others they generally refer to a category of therapeutic compounds, such as antacids. If claims on combinations are accepted subsequent to a patent on the relevant active ingredient/s, the patent owner may be able to indirectly extend the term of protection granted under the basic patent.

In some countries, combinations claims are rejected unless the combination generates a new and non-obvious synergy or distinct effect. If a synergistic effect is to be relied on to allow patentability, it must be possessed by everything covered by the claims, appropriately described and proven in the patent specification (for instance, on the basis of biological tests) and be the manifestation of an inventive step. A new synergy need not be considered, as such, as inventive, since it may be obvious for a person skilled in the art. Moreover, the synergy between two or more drugs may be deemed a ‘discovery’ rather than an ‘invention’, since the synergy takes place in the body and is found through clinical trials. It is also to be noted that, in some cases, combination claims may in practical terms be equivalent to claims over medical treatments (the patentability of which is excluded in most countries), to the extent that they only provide a method of administering a combination of existing drugs. Also, combining drugs to avoid resistance is normal practice in pharmaceutical development and should generally be seen as evident to a person with average skills in the field.

Recommendation: Combinations of known active ingredients should be deemed non inventive. If, however, a new and non-obvious synergistic effect is considered a basis for patentability, it should be properly demonstrated by biological tests and appropriately disclosed in the patent specifications.

Dosage/dose

Some patent applications claim inventions consisting of the dosage for administration to patients of an existing product, including pediatric dosages. Although drafted as product claims, these claims have the same effect as claims over methods for medical treatment, as the subject matter is not a product or process but the way in which a product is therapeutically used.

Some countries admit patents on dosages under certain circumstances. For instance, the UK Guidelines allows for the patenting of a dosage where there is a new medical indication and the dosage is substantially different from that for the known use. The UK approach is only valid, however, where second indication patents are permitted. When the only contribution made by the applicant is a new dosage for the same use of a drug, the subject matter would not be patentable. The same would apply if the dosage refers to a new use, to the extent that a new use is not patentable. Moreover, changes in dosages would rarely be of an inventive nature and may be considered as not meeting the industrial applicability standard, since the invention would only have effects on the body and not technical effects.

Recommendation: New doses of known products for the same or a different indication do not constitute inventions, particularly (but not only) in countries where methods of medical treatment are not patentable as such.

It may be possible in cases where the required dosage for a new medical use is markedly different from that for the known use, to allow a claim to a unit dosage form containing the known active ingredient in such an amount that the unit dosage form is novel and not obvious to have been made up in that amount for the prior art use. Thus if the new medical use requires a dose of, for example, ten times (or one tenth) that for the prior art use, then a claim to a unit dosage form might be judged to be novel and inventive and allowable. In assessing the inventiveness of such claims it should be remembered that dosages required are usually related to body weight so that children's doses are smaller than those for adults.

Salts, ethers and esters

Frequently, pharmaceutical patents protect new salts of known active ingredients. Salts are normally formed to increase stability or solubility of the drug. It is common knowledge in the pharmaceutical field that salts result in different solubility and, therefore, in different bioavailability. If an active ingredient is an acid or base, then any chemistry student knows how to make a salt, and can make predictions about its likely physicochemical properties.

There may be exceptional cases in which new salts present unexpected advantages in properties as compared to what is in the prior art. Such advantages should be supported by information about the results of appropriate tests incorporated into the patent specifications. The processes for forming salts are also normally obvious to a person trained in the field. There may be very exceptional cases where forming a salt (for instance, with optimal crystalline characteristics) of complex molecules require special skills and may be eventually patentable as a process. However, the complexity of a process does not provide sufficient ground for claiming inventive step. Similarly, ethers as well as esters of known alcohols, although fundamentally different to salts, are generally subject to the same objection of obviousness.

Recommendation: New salts, ethers, esters and other forms of existing pharmaceutical products can generally be obtained with ordinary skills and are not inventive. This may not apply, exceptionally, when tests, appropriately conducted and described in the specifications, demonstrate unexpected advantages in properties as compared to what was in the prior art.

Polymorphs

Some therapeutically active ingredients present polymorphic forms, that is, they may exist in different physical forms (as amorphous solid and/or in different crystalline forms), which may have different properties more or less pharmaceutically significant (such as solubility and therefore bioavailability). Polymorphism is a natural property: polymorphs are not created’ or ‘invented’; they are discovered normally as part of routine experimentation related to drug formulation. They result from the conditions under which a compound is obtained. Any compound that presents polymorphism will naturally tend to its more stable form, even without any human intervention.¹⁰

The significance of different polymorphs is almost entirely in their relative rate of dissolution (in theory the extent of dissolution can be affected too but this is rarely of practical significance). Occasionally there is an effect on long-term stability if the most stable polymorph had not been selected for development in the first place. The practical effect of changing the polymorph is, consequently, on the dissolution rate of the finished product and, potentially, an effect on bioavailability, or a change in the long term stability profile. There could also be in some cases manufacturing advantages in choosing a particular polymorph. However, there is no question of an effect on safety or efficacy, since the active ingredient is the same.

Independent patent applications on polymorphs have become increasingly frequent and controversial, as patents thereon can be used to obstruct or delay the entry of generic competition. Polymorphs can be deemed within the prior art - and therefore nonpatentable - if they are inevitably obtainable following the process of the basic patent on the active ingredient. Moreover, the possibility of discovering different crystals is obvious when polymorphism is found.

Solvates, including hydrates, were originally considered as "pseudo-polymorphs". Nevertheless, according to the International Conference of Harmonization (ICH) of 1999, they are to be deemed ‘polymorphs’. Hydrates/solvates will rarely be inventive, as they are obvious to produce in most situations. Hence, claims relating to changes in the content of water in known molecules (deriving in mono-hydrates, bi-hydrates, etc.) should generally be considered non-inventive and not patentable. It should also be noted that for most solvates and polymorphs, like for new salt forms, only data on quality and, where required, bioequivalence are needed, that is, no more data than for the approval of a generic product. This is the reason why in many jurisdictions these variants of a substance are deemed to be the ‘same’ substance for health regulatory purposes.

Recommendation: Polymorphism is an intrinsic property of matter in its solid state. Polymorphs are not created, but found. Patent offices should be aware of the possible unjustified extension of the term of protection arising from the successive patenting of the active ingredient and its polymorphs, including hydrates/solvates. Processes to obtain polymorphs may be patentable in some cases if they are novel and meet the inventive step standard.

Selection patents

A “selection patent” is a patent under which a single element or a small segment within a large known group is “selected” and independently claimed based on a particular feature not mentioned in the large group. A “selection invention” may be applied for, for instance, when a range of products characterized as having n-carbon atoms has been patented, and later on a patent on a specific range (e.g. C1-C4) is claimed.

If a large group of elements is patented, the patent owner may use the selection patent to extend the term of protection for the selected subset beyond the expiration of the original

patent. While accepted in some jurisdictions when the selected elements possess a surprising advantage, selection patents have been denied when the supposed advantage is a property shared by all or nearly all the large group.

Recommendation: As a general rule, selection patents should not be granted if the selected components have already been disclosed or claimed and, hence, lack novelty. If unexpected advantages of existing products were deemed patentable under the applicable law, the patentability of a selection could be considered when an inventive step is present.

Analogy processes

Products and processes are two distinct categories of eligible subject matter for the purposes of patent protection. The patentability of each of them must be evaluated according to their own properties and characteristics. However, manufacturing processes (often called ‘analogy processes’) that are not by themselves novel or inventive but which are used for the preparation of new or inventive but unpatented compounds are deemed patentable in some jurisdictions under a legal fiction. The doctrine of analogy processes expands the possibility of appropriation of knowledge in the public domain.

In the United States , the patent office has held “analogy process” claims to be unpatentable unless they were inventive in themselves, but legislation carved out an exception for biotechnology. An statutory amendment to the U.S. law in 1993 determined that a biotechnological process claim would be nonobvious if it involved new and non-obvious starting materials or produced a new and nonobvious result. While this solution was only targeted to biotechnology, it has been extended by case law to other fields of technology.

An example of a patent probably granted on the basis of an implicit application of the concept of analogy process is patent AR 242.562 on the process for obtaining amlodipine besylate. The claimed and described process is a simple chemical reaction: the production of a salt from an acid with a base. This reaction is described by the simple formula: acid + base = salt + water, which can be found in elementary chemistry textbooks.

The application of the doctrine of analogy processes may lead to the protection of nonpatentable pharmaceuticals, as the TRIPS Agreement (Article 28.1(b)) requires the extension of patent protection to the products directly obtained with a patented process.

Recommendation: Non-novel or obvious pharmaceutical processes, regardless of whether the starting materials, intermediaries or the end product are novel or inventive, should be considered not patentable as such.

Enantiomers

Enantiomers (or optical isomers) behave in relation to one another as an image does to its mirror image. In organic chemistry, enantiomers spontaneously occur, for example, in compounds that comprise a carbon atom with four different substituents. This property has been exploited in the patent field by often claiming, first, the “racemic” mixture of both enantiomers, and later claiming rights over the most active enantiomer, thus evergreening the originally obtained protection. It is routine to test whether one or the other enantiomer in isolation is more active than theracemic mixture of both, as it is expected that one optical isomer will typically have much higher activity than the other, so that superior activity for at least one of the isomers as compared to the racemate is to be expected. When the chemical formula of a compound with enantiomers is disclosed, the novelty of the latter is also lost as the formula necessarily reveals the existence of the enantiomers.

Some patent offices, such as EPO, have considered that enantiomers of known racemates may be deemed novel, but that its patentability is a matter of inventive step. A single enantiomer (of an active ingredient that was previously registered with the health authority as a racemate) may be registered in its own right if it is of adequate quality, safety and efficacy. But this does not equate to a patentable invention, since the enantiomers were present in the racemate and the latter’s pharmacological/therapeutic activity was based almost entirely (if not entirely) on the active enantiomer.

Recommendation: Single enantiomers should generally not be deemed patentable when the racemic mixture was known. However, processes for the obtention of enantiomers, if novel and inventive, may be patentable.

Active metabolites and prodrugs

In some cases, pharmaceutical compounds generate an active metabolite, which is the product of the compound’s metabolism in the body. Metabolites are derivatives from the active ingredients that are produced in the body, and cannot be deemed as ‘created’ or ‘invented’. However, active metabolites can have different safety and efficacy profiles to those of the parent molecule. On the other hand, when metabolized in the body, inactive compounds (called “prodrugs”) can produce a therapeutically active ingredient. In some cases, patent claims cover a drug and its prodrug/s. In situations where the active ingredient is not patented, a patent over a prodrug as such may extend control by the patentee over the market of the active ingredient that is metabolized. A prodrug may be regarded as the original drug ‘in disguise’.

In the case of terfenadine, which had been sold for many years in the United Kingdom as an antihistamine drug, the patent holder obtained a further patent on the active metabolite fexofenadine and attempted to block competition in the market of terfenadine, after the patent for the latter had expired. This was deemed to be an unacceptable attempt to extend patent protection.

One possible way of dealing with patents over prodrugs - which may be novel and inventive in some cases - is to allow them when the patentability standards are met, provided that the active ingredient is properly disclaimed (that is, excluded from the patent claims).

Recommendation:a) Active metabolites of drugs should generally not be deemed patentable separately from the active ingredient from which they are derived.

b) Patents over prodrugs, if granted, should disclaim the active ingredient as such, if previously disclosed or otherwise non-patentable. Like other subject matter claimed in a patent, a prodrug should be sufficiently supported by the information provided in the specifications. In addition, evidence may be required that the prodrug is inactive or less active than the compound to be released, that the generation of the active compound ensures an effective level of the drug and that it minimizes the direct metabolism of the prodrug as well as the gradual inactivity of the drug.

Method of treatment

Some patents claim methods of treatment, including prophylaxis, cure, relief of pain, diagnosis or surgical methods. These claims do not cover a product per se, but the way in which it is used in order to obtain certain effects.

In many cases, a method of treatment claim is not apparent at first sight since reference may be made, for instance, to compositions which are not characterized by their chemical structure or intrinsic characteristics but by their dosage or form of administration. It is important, hence, to carefully examine the claims in order to identify and appropriately deal with cases in which under the appearance of product claims it is a method of treatment that is actually disclosed.

The TRIPS Agreement (Article 27.2) explicitly allows members to exclude therapeutic, diagnostic and surgical methods from patent protection, and many countries do follow this approach. If such exclusion has been provided for, claims describing such methods or claims that are equivalent thereto should be refused. Even in the absence of a specific exclusion from patentability, such methods should be deemed not patentable in countries where the standard of industrial applicability applies, since they only produce effects on the body and have no industrial application. The same would apply to the case of cosmetic methods.

Recommendation: Methods of treatment, including for prevention, diagnosis or prophylaxis should be deemed non patentable where industrial applicability is required as a condition for patentability (including in cases where the patentability of such methods is not expressly excluded).

Use claims, including second indications

Patenting of the medical use of a product, including first and second indications of a known medicinal product has become common practice in the pharmaceutical field. According to a literal interpretation of the TRIPS Agreement, which only obliges to grant patents over products and processes, Members should be under no obligation to grant use claims, including second indications.

The European Patent Convention and the law of some countries allow for the patenting of the first pharmaceutical indication of a known product. Second indications are accepted under European jurisprudence and in other countries However, the patenting of a new use of a known product including, in particular, second indications, expands the scope of protection inconsistently with the novelty requirement.

In addition to the lack of novelty, there are other possible objections to the patentability of second indications:

-there is no industrial applicability, since what is new is an identified effect on the body, not the product as such or its method of manufacture;

-a patent covering the second medical indication of a known product is substantially equivalent to a patent over a method of therapeutic treatment.

Admitting the patentability of second indications extends the protection of pharmaceuticals to cases where no new product has been developed. Many countries reject claims over such indications.

Recommendation: Claims relating to the use, including the second indication, of a known pharmaceutical product can be refused, inter alia, on grounds of lack of novelty and industrial applicability.

Mechanisms to enhance the examination of Pharmaceutical patents

There are several measures that countries can implement in order to incorporate a public health perspective into patent examination

Pre- and post-grant opposition

Patents are granted, even in countries where substantive examination takes place, without the State’s guarantee about the utility of the invention or the validity of the patent. However, challenging the validity of a granted patent before judicial courts is costly, and obtaining a decision may take years. This gives a major advantage to title holders, since third parties - especially small and medium enterprises in developing countries or the public that may be affected by a wrongly granted patent - will be reluctant or unable to bear the cost and take the risk of litigation. Wrongly granted patents that unduly block competition and prejudice consumers may, hence, remain in force for the full period of the grant. To address this problem and enhance the examination of patents, many patent laws provide for the possibility of filing observations or an opposition to the granting of a patent application. Such a presentation can be made after the publication of the application (or a summary thereof) within a specified term or, if allowed by the applicable law, at any time before the approval of the application. Of course, the longer the period, the greater the opportunities for the patent office to receive observations from third parties, as the existence or relevance of some patent applications may not be immediately recognized. The admissible observations generally relate to non-compliance with any of the patentability requirements, but may also include insufficiency of disclosure and other reasons.

Pre-grant opposition mechanisms help examiners to improve the analysis they undertake, as third parties can bring to their attention precedents that may not have been identified, and lead to the granting of more solid patents while avoiding the creation of rights over developments that are not really inventive.

Filing a pre-grant opposition or observations requires capacity to monitor published patent applications and the skills necessary to make the search and analysis of precedents that may be opposed. This requires enhancing the technical knowledge of domestic pharmaceutical companies, ministries of health and civil society to deal with the intricacies of patent law and claims’ drafting and interpretation.

A key issue is also the extent to which the information contained in the publication about a patent application is sufficient for interested parties to identify those situations in which an opposition should be submitted. In many cases, the published abstracts and other data about a patent application do not properly characterize a claimed pharmaceutical invention. For instance, the majority of abstracts relating to pharmaceutical inventions does not include the International Nonproprietary Name (INN) that identifies the relevant compounds, but rather report the chemical formula, chemical names or other names that do not allow an easy identification of the patent as related to the compound.

Pre-grant procedures should be implemented in a manner that does not obstruct bona fide patent applications. In some countries, the person who files a pre-grant opposition or observations can participate in some way in the ensuing procedures (inter-partes procedures). In others, they must be considered by the examiner, but the person who submitted them does not become party (ex-parte procedures).

The availability of post-grant administrative procedures is also important to enhance the quality of patents granted, as these procedures may generally be completed at a lower cost and in a shorter time than court procedures. In sum, it is advisable that national laws provide for mechanisms of pre- and/or post grant opposition. The effectiveness of such mechanisms may be significantly enhanced if the published patent applications or their summaries include all relevant data for the identification of the subject matter of the application. In particular, patent offices should require that all patent applications (and their summaries) related to pharmaceuticals include the INN , where available.

Patent protection for Pharmaceutical products

Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity afforded by patents in order to sustain drug prices, recoup research and development (R&D) expenditures and finance the development of new products.¹¹

Like other inventions, medicines are entitled to patent protection if they meet certain requirements. Unlike other products, however, medicines are required to undergo a strict regimen of tests and evaluations to determine their safety and efficacy before they can be sold commercially. The testing process is rigorous and time-consuming, involving animal and clinical trials of each prospective new drug. Much of the testing takes place after a patent for a drug has been applied for and results in significant lag between the invention of the drug and its sale to the public. Meeting government-imposed regulatory requirements consumes part of the period of patent protection, so that this is shorter for the pharmaceutical sector than for other industries.

Innovative companies have responded to this disadvantage by lobbying vigorously for measures to strengthen the patent system and for changes to the regulatory process that would decrease the time involved in obtaining marketing approval for a drug.

Conclusion

Whether subject to the TRIPS Agreement or not, countries can determine their own criteria to assess patent applications consistently with their public health policies. Patent regimes are generally part of national technological and industrial strategies, but is also crucial to design them consistently with public health strategies. It is important, in particular, that the scope of patentability be congruent with public health policies, and that governments be aware that unduly expanding what can be patented may distort competition and reduce access to medicines. Patents over minor developments may be effectively used to discourage or block competition, as generic producers, purchasing agencies and consumers, especially in developing countries, generally lack the substantial technical and financial resources needed to challenge wrongly granted patents or defend against infringement claims.

The analysis and criteria presented in this document intend to provide general guidance to patent offices and other bodies that participate in the examination of pharmaceutical patents, in a way that is consistent with patent law and, at the same time, congruent with public health objectives, in particular with the right of access to medicines by all. They should be further refined and adjusted to national legislation, as appropriate.

In order to be able to implement these guidelines, or otherwise preserve the capacity to determine the criteria for the examination of pharmaceutical patents, countries should not adhere to international instruments that may erode the flexibilities currently allowed by the TRIPS Agreement for that purpose, such as the capacity to define the concept of invention and the criteria to apply the standards of patentability, notably with regard to the level of inventive step.

An indispensable requirement for dealing with patent applications with a public health perspective, is obviously to adequately train and retain qualified examiners. Training provided by patent offices of developed countries may increase examiners’ technical skills, but also induce standards of evaluation that may lead to an undue expansion in the scope of patentability of pharmaceuticals.

Finally, patent examiners should be aware that the decisions they take, although apparently technical in nature, may have very practical implications for the health and life of people, as wrongly granted patents can be used to unduly restrict competition and limit access to needed medicines.

Glossary of Patent terminology ^12-17

Applicant

The person or company that applies for the patent and intends to “work” the invention (i.e. to manufacture or licence the technology). In most countries the inventor(s) does not necessarily have to be the applicant. In the United States , applicants must be the inventor(s), except in a few exceptional circumstances (e.g. legal representatives of a deceased inventor may make a patent application).

Applicant country

The applicant is the patentee at the date of the application. When counting patents by geographical area, they can be attributed to the country of residence of the applicant. Patent counts by applicant concentrate on patent “ownership” (i.e. the number of patents owned by residents of each country). For example, a patent application filed by IBM Belgium is allocated to Belgium , even though the ultimate ownership of IBM Belgium might be in another country.

Application for a patent

To obtain a patent, an application must be filed with the authorised body (Patent Office) with all the necessary documents and fees. The patent office will conduct an examination to decide whether to grant or reject the application.

Application date

The patent application date is the date on which the patent office received the patent application.

Citations

Citations may be made by the examiner or the applicant/inventor. They comprise a list of references that are believed to be relevant prior art and which may have contributed to the "narrowing" of the original application. The examiner can also cite references from technical journals, textbooks, handbooks and sources. The citations practices of the EPO differ substantially from the USPTO. Applicants to USPTO are legally required to include a full list of prior art known or believed to be relevant (“duty of candor”). At EPO, no such requirement exists for applicants.

Claim(s)

These define the invention that the applicant wishes to protect. A main claim will define the invention in its broadest form, by including its essential technical features. Further "dependant" claims can then relate to additional features of the invention.

Continuation

This is mainly relevant to the USPTO. Continuations are second or subsequent applications for the same invention claimed in a prior application and filed before the first application becomes abandoned or granted. Continuations must claim an invention which is part of or directly derived from the original application to gain the benefit of the parent filing date.

Designated countries

Countries in which patent applicants wish to protect their invention. This concept is specific to European patent applications and international patent applications filed under the Patent Cooperation Treaty (PCT). Since January 2004, all international applications filed designate by default all PCT contracting countries bound by the PCT treaty as of the filing date. For EPO patent applications, the applicant has to designate specific countries. However, if the applicant pays designation fees for seven countries, then it is considered that the designation fees for all the EPC member states have been paid and all the EPC countries will be automatically selected. However, designation of a country does not automatically provide patent rights in that country. A patent has to be validated in the designation country for it to be effective.

Disclosure

The first public disclosure of details of an invention. This may be deliberately revealed outside the patent system to make the invention unpatentable, or what is described in a patent application. In return for a patent (monopoly rights for a limited time period), the applicant must make a full disclosure of the invention for which protection is sought.

Equivalent

A patent that relates to the same invention and shares the same priority application as a patent from a different issuing authority.

European Patent Convention (EPC)

The Convention on the Grant of European Patents (European Patent Convention, EPC) was signed in Munich 1973 and entered into force in 1977. As a result of the EPC, the European Patent Office (EPO) was created to grant European patents. Currently, there are 31 EPC member countries (as at December 2005). In addition, extension agreements exist with five countries, which allow the possibility of extending European patents to those countries upon request. EPC member countries are Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, the Netherlands, Poland, Portugal, Romania, the Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EPC extension countries are Albania, Bosnia and Herzegovina, Croatia, the Former Yugoslav Republic of Macedonia, and Serbia and Montenegro.

European Patent Office (EPO)

The European Patent Office (a regional patents office) was created by the EPC to grant European patents, based on a centralised examination procedure. By filing a single European patent application in one of the three official languages (English, French and German), it is possible to obtain patent rights in all the EPC member and extension countries by designating the countries in the EPO application. The EPO is not an institution of the European Union.

European patent

A European patent can be obtained for all the EPC countries by filing a single application at the EPO in one of the three official languages (English, French or German). European patents granted by the EPO have the same legal rights and are subject to the same conditions as national patents (granted by the national patent office). It is important to note that a granted European patent is a “bundle” of national patents, which must be validated at the national patent office for it to be effective in member countries. The validation process could include submission of a translation of the specification, payment of fees and other formalities at the national patent office. This is because once a European patent is granted, competence is transferred to the national patent offices.

Expiry date

The date when a patent has run its full term in a country and is no longer valid.

First to file

A patent system in which the first inventor to file a patent application for a specific invention is entitled to the patent. This law is increasingly becoming the standard for countries adhering to the so-called Trade-Related aspects of Intellectual Property (TRIPs) guidelines. At the EPO and JPO, patents are awarded on the first to file basis, whereas at the USPTO, patents are awarded on the first to invent basis.

First to invent

In the first to invent system a patent is awarded to the first person who made the invention, even if another person filed for a patent before the person who invented first.

Grant

A temporary right given by the authorised body for a limited time period (normally 20 years) to prevent unauthorised use of the technology outlined in the patent. A patent application does not automatically give the applicant a temporary right against infringement. A patent has to be granted for it to be effective and enforceable against infringement.

Grant date

The date when the patent office issues a patent to the applicant. On average it takes three years for a patent to be granted at the USPTO and five years at the EPO.

GERD

Gross domestic expenditure on research and development.

Infringement

Unauthorised use of a patented invention.

Intellectual property rights (IPR)

IPR allows people to assert ownership rights on the outcomes of their creativity and innovative activity in the same way that they can own physical property. The four main types of intellectual property rights are: patents, trademarks, design and copyrights.

International patent application

Patent applications filed under the Patent Cooperation Treaty (PCT) are commonly referred to as international patent applications. However, an international patent (PCT) application does not result in the issuance of “international patents”, i.e. at present, there is no global patent system that is responsible for granting international patents. The decision of whether to grant or reject a patent application filed under the PCT rests with the national or regional (e.g. EPO) patent offices.

International Patent Classification (IPC)

The International Patent Classification, which is commonly referred to as the IPC, is based on an international multilateral treaty administered by WIPO. The IPC is an internationally recognised patent classification system, which provides a common classification for patents according to technology groups. The IPC is a hierarchical system in which the whole area of technology is divided into a range of sections, classes, subclasses and groups. There are eight sections that are broken down into classes and subclasses. IPC is periodically revised in order to improve the system and to take account of technical development. The current (eighth) edition of the IPC entered into force on 1 January 2006 .

Inventive step

An invention is considered to include an inventive step if it is not obvious to a skilled person in the light of the state of the art. At the EPO, the inventive step is one of the most important criteria (along with novelty and industrial application) that need to be fulfilled in order to obtain a patent. The USPTO employs the concept of “non-obviousness”, which is equivalent to the inventive step criterion of the EPO in a legal context.

Inventor country

Country of the residence of the inventor, which is frequently used to count patents in order to measure inventive performance.

Japan Patent Office (JPO)

The JPO administers the examination and granting of patent rights in Japan . The JPO is an agency of the Ministry of Economy, Trade and Industry (METI).

Lapse

The date when a patent is no longer valid in a country or system due to failure to pay renewal (maintenance) fees. Often the patent can be reinstated within a limited period.

Licence

The means by which the owner of a patent gives permission to another person to carry out an action which, without such permission, would infringe on the patent. A licence can thus allow another person to legitimately manufacture, use or sell an invention protected by a patent. In return, the patent owner will usually receive royalty payments. A license, which can be exclusive or non-exclusive, does not transfer the ownership of the invention to the licensee. In certain countries, patent law contains rules on compulsory licenses. The law empowers the courts to decide if a compulsory license should be issued and what should be the terms and conditions.

Licence of right

In some countries it is possible for anyone to get access to the use of patents under licence of right in return for payment of a licence fee. For example, in the United Kingdom, licence of right has been in existence for a number of years. Patent owners are able to get a discount on the renewal fee by offering licence of right for their patents.

Maintenance fees See renewal fees.

Non-obviousness See inventive step.

Novelty

If an application for a patent is to be successful, the invention must be novel (new). The invention must never have been made public in any way, anywhere, before the date on which the application for a patent is filed (or before the priority date).

OECD triadic patent families

The triadic patent families are defined at the OECD as a set of patents taken at the European Patent Office (EPO), the Japan Patent Office (JPO) and the US Patent & Trademark Office (USPTO) that share one or more priorities. Triadic patent families data are consolidated to eliminate double counting of patents filed at different offices (i.e. regrouping all the interrelated priorities in EPO, JPO and USPTO patent documents).

Opposition to the grant of a patent

Anyone can file an opposition to the grant of a European patent, within nine months of the mention of the grant of a European patent in the European Patent Bulletin. Opposition to a European patent can be filed on the grounds that: the patent’s subject matter is not patentable, the patent does not disclose the invention clearly and completely, and the patent’s subject matter extends beyond the content of the application filed. The opposition system does not exist in Japan (abolished in 2003) or the United States .

Paris Convention

The Paris Convention for the Protection of Industrial Property was established in 1883 and is generally referred to the Paris Convention. The Paris Convention established the system of priority rights. Under the priority rights, applicants have up to 12 months from first filing their patent application (usually in their own country) in which to make further applications in member countries and claim the original priority date. It was originally signed by eleven countries; currently 169 countries are party to the treaty (January 2005).

Patent

A patent is an intellectual property right issued by authorized bodies to inventors to make use of, and exploit their inventions for a limited period of time (generally 20 years). The patent holder has the legal authority to exclude others from commercially exploiting the invention (for a limited time period). In return for the ownership rights, the applicant must disclose the invention for which protection is sought. The trade-off between the granting of monopoly rights for a limited period and full disclosure of information is an important aspect of the patenting system.

Patentability

Patentability is the ability of an invention to satisfy the legal requirements for obtaining a patent. The basic conditions of patentability, which an application must meet before a patent is granted, are that the invention must be novel, contain an inventive step (or be non-obvious), be capable of industrial application and not be in certain excluded fields (e.g. scientific theories and mathematical methods are not regarded as inventions and cannot be patented at the EPO).

Patent Cooperation Treaty (PCT)

As of July 2005, there were 128 countries party to this treaty, which was signed in 1970 and entered into force in 1978. The PCT provides the possibility to seek patent rights in a large number of countries by filing a single international application (PCT application) with a single patent office (receiving office). The PCT procedure consists of two main phases: (a) an “international phase”; and (b) a PCT “national/regional phase”. PCT applications are administered by the World Intellectual Property Organisation (WIPO).

Pending application

In this case, an application is with the patent office. No decision has been made on whether to grant or reject the patent application (e.g. application is still waiting for search and examination). In 2004, the total number of pending applications at JPO and USPTO amounted to around 610 000 and 756 000, respectively. The number of total pending applications is expected to increase in the coming years.

Prior art

Previously used or published technology that may be referred to in a patent application or examination report, i.e. (a) in a broad sense, technology that is relevant to an invention and was publicly available (e.g. described in a publication or offered for sale) at the time an invention was made; or (b) in a narrow sense, any such technology which would invalidate a patent or limit its scope. The process of prosecuting a patent or interpreting its claims largely consists of identifying relevant prior art and distinguishing the claimed invention from that prior art. The objective of the search process is to identify patent and non-patent documents constituting the relevant prior art in order to determine whether the invention is novel and includes an inventive step.

Priority country

Country where the patent is first filed before being (possibly) extended to other countries.

Priority date

The priority date is the first date of filing of a patent application, anywhere in the world (normally in the applicant’s domestic patent office), to protect an invention. The priority date is used to determine the novelty of the invention, which implies that it is an important concept in patent procedures. For statistical purposes, the priority date is the closest date to the date of invention.

Publication

In most countries, a patent application is published 18 months after the priority date. For example, all pending EPO and JPO patent applications are published 18 months after the priority date. Prior to a change in rules under the American Inventors Protection Act of 1999, USPTO patent applications were held in confidence until a patent was granted. Patent applications filed at the USPTO on or after 29 November 2000 are required to be published 18 months after the priority date. However, there are certain exceptions for the publication of pending patents. For example, an applicant can ask (upon filing) for the patent not to be published by certifying that the invention disclosed in the application has not and will not be the subject of an application filed in another country.

Publication date

The date on which the patent application is published (i.e. the information is available to public). This normally occurs 18 months after the priority date.

R&D

Research and experimental development (R&D) comprises creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of knowledge to devise new applications.

R&D expenditures

The basic measure of R&D expenditures is “intramural expenditures”; i.e. all expenditures for R&D performed within a statistical unit or sector of the economy.

Renewal fees

Once a patent is granted, annual renewal fees are payable to patent offices to keep the patent in force. In the USPTO these payments are referred to as maintenance fees. For example, all USPTO granted (utility) patents are subjected to maintenance fees which are due after three and half years, seven and half years, and eleven and half years following the date of the original patent grant.

Request for examination

Patent applications filed at the USPTO are automatically examined by a patent examiner to decide whether to grant (or reject) a patent. Patent applications filed at the EPO and JPO do not automatically enter the examination process. The applicant has to submit a request for examination within six months of the application at the EPO and three years at the JPO.

Search report

The search report is a list of citations of all published prior art documents which are relevant to the patent application. The search process, conducted by a patent examiner, seeks to identify patent and non-patent documents constituting the relevant prior art to be taken into account in determining whether the invention is novel and includes an inventive step.

Substantive examination

A full examination conducted by a patent examiner to determine whether to grant or reject the patent application.

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Agreement on trade-related aspects of intellectual property rights requires members to comply with certain minimum standards for the protection of IPR. But members may choose to implement laws which provide more extensive protection than is required in the agreement, so long as the additional protection does not contravene the provisions of the agreement. The WTO’s TRIPS agreement, negotiated in the 1986-94 Uruguay round, introduced intellectual property rules into the multilateral trading system for the first time.

United States Patent and Trademark Office (USPTO)

The USPTO administers the examination and granting of patent rights in the United States. It falls under the jurisdiction of the U.S. Department of Commerce.

Utility model

Also known as “petty patent”, these are available in some countries (e.g. Japan). This type of patent involves a simpler inventive step than that in a traditional patent and it is valid for a shorter time period.

World Intellectual Property Organization (WIPO)

An intergovernmental organisation responsible for the negotiation and administration of various multilateral treaties dealing with the legal and administrative aspects of intellectual property. In the patent area, the WIPO is notably in charge of administering the Patent Cooperation Treaty (PCT) and the International Patent Classification system (IPC).

References

1. On the functions of the patent system, see Commission on Intellectual Property Rights, Innovation and Public Health , Public Health, Innovation and Intellectual Property Rights, World Health Organization (available at www.who.int) 2006 (hereinafter ‘CIPIH’).
2. Cook, Trevor (2002), A User's Guide to Patents, Butterworths, London.
3. Correa , Carlos (2001a), Trends in drug patenting. Case studies, Corregidor, Buenos Aires.
4. Bently L. and Sherman B. (2001), Intellectual property law, Oxford University Press.
5. Straus, Joseph (1996), Implications of the TRIPs Agreement in the field of patent law, in F-K Beier and G Schricker, From GATT to TRIPs-The Agreement on Trade- Related Aspects of Intellectual Property Rights, Max Planck Institute for Foreign and International Patent, Copyright and Competition Law, Munich.
6. Wegner, Harold (1994), Patent law in biotechnology, chemicals & pharmaceuticals, Stockton, Chippenham.
7. Grubb, Philip (1999,. Patents for chemicals, pharmaceuticals and biotechnology. Fundamentals of global law, practice and strategy, Clarendon Press, Oxford.
8. Bruce Lehman, President, International Intellectual Property Institute, The

Pharmaceutical Industry and the Patent System.

9. Thomas, Daniel (2003), Patentability problems in medical technology, IIC, vol. 34.No. 8 p. 847-994.
10. Bernstein J. (1999), ‘Concomitant polymorphs’, Angew. Chem. Int. Ed 38, p. 3440- 3461.
11. Bale Jr., Harvey E., “Patent Protection and Pharmaceutical Innovation,” 29 New York University Journal of International Law and Politics (1996-97), 95.
12. European Patent Office (www.european-patent-office.org)
13. Japan Patent Office (www.jpo.go.jp)
14. Thomson Scientific terminology (scientific.thomson.com/support/patents/patinf/terms/)
15. UK Patent Office (www.patent.gov.uk)
16. US Patent and Trademark Office (www.uspto.gov)
17. World Intellectual Property Organization (www.wipo.int)

About Authors:

O.A.Thusleem, R&D department, Jamjoom pharmaceuticals, Jeddah-21442, Saudi Arabia.
e-mail – thus162@hotmail.com
Phone – 00966-2- 6081111 Ext. 121
Fax – 00966-2- 6081222

Saleem Z. Shaikh, R&D department, Jamjoom pharmaceuticals, Jeddah-21442, Saudi Arabia.

M.S. Muneera, R&D department, Jamjoom pharmaceuticals, Jeddah-21442, Saudi Arabia