Brazil: The Scope of Claims & Their Interpretation

Originally published in July 2001 in the the Brazilian Intellectual Property Association Gazette

Many people argue that in the field of pharmaceuticals and biotechnology the development costs of new products, from basic research to market approval, are so high (millions of dollars) that there must be rigorous patent protection for the good of society. Without such protection, scientific advancement is discouraged because companies are not assured a return on their investments, and society thereby suffers from a lack of last generation drugs. (COOPER, 2000). This is the case when the patent claims are not able to impede third parties from unduly appropriating a new compound.

Because biotechnology by definition deals with biology, questions arise as to the ethics of granting patent protection to what nature has provided. Public opinion, particularly in the United States and Europe, is always sensitive to the ethics of biotechnology research and questions of bio-security.

Moreover, biotechnology is a complex field that nearly always involves teams of specialists who must overcome a welter of difficulties to arrive at a useful result. For example, development of a recombinant vaccine requires specialists in, among other areas, immunology, molecular biology and biological processes.

Questions posed by patent examiners regarding the inventive step increasingly focus on what is currently being done in the field of genetic engineering, such as "to what extent would it be obvious for an expert in the field to carry out with a reasonable expectation of success a given procedure/method?" The fact that other persons or teams are concurrently working along the same lines might suggest that it merely involves an area that is generally interesting to investigate or "obvious to attempt," but does not necessarily imply that those who are involved or contemplating getting involved will have a reasonable chance of success. A reasonable expectation of success must not be confused with the simple desire for success (EUROPEAN PATENT OFFICE, 1999).

Nevertheless, the discussion does not end after a patent application is filed or the patent granted. Indeed, after granting, the patent holder must remain vigilant to ensure maintenance of its property rights. Violation of such rights is extremely common, often involving large amounts that can even lead to the bankruptcy of the violating firm. Problems at this stage can be minimized by an experienced patent specialist, not only to oversee the maintenance of the patent privilege but also to draft the application, particularly the claims (MACEDO; MÜLLER & MOREIRA, 2001).

The options to ensure legal efficacy of patent rights range from the simple offer of a license to exploit the invention to legal action for infringement. Any decision over whether to sue a competitor must consider a series of factors, chiefly the costs versus the benefits. Hence, before bringing suit one must judge, for example, whether the patent is really valid, what its legal efficacy is and what types of losses are at stake.

Thus, careful study of the effects of the interpretation and scope of patent claims is increasingly necessary to ensure the temporary monopoly and competitive advantage granted the patent holder.

The claims are the specific factors of the invention for which protection is sought, or better, the particular aspects that the inventors consider novel in relation to the current state of the art. In this fashion, the claims demarcate and establish the rights of the patent holder over the object of the protection. In short, the claims are the invention itself.

Preparation of the claims requires a clear and concise description of the invention in a highly stylized format. The first rule is that a claim must be elaborated in a single sentence.

Most countries require structuring the claims, principally the independent ones, in a form known as the "Jepson" type. They are formulated in the following order: (1) a preamble enumerating all the elements or steps of a combination claimed that are conventional or known, (2) an expression of connection, for example, "characterized by" or "the improvement includes" and (3) a body containing all the elements, steps and/or relationships that constitute that part of the combination claimed and which the inventor considers new.

This is more than just the recommended form, it is required by patent regulations in the majority of countries, including Brazil. However, while this is permitted by the United States Patent and Trademark Office – USPTO, such a structure is not often used in the United States.

The choice of expressions linking the characteristic elements of an invention and those known as part of the state of the art, or between a general defining term and its alternatives, is an important factor in assuring adequate protection. These linking expressions tell the reader of a patent if the claim is "open" or "closed" to additional elements. They determine whether a claim is limited to structures with only those elements (closed terminology) or open to structures containing at least those elements (open or hybrid terminology). Terms such as "including", "containing" or "having" are "open" definitions, i.e., that permit the addition of further elements as long as they have been foreseen in the basic description of the invention. The "closed" type of definition can be described by the term "consisting of". Regarding the transition expression "characterized by," this is obligatory in Brazil, often used in Germany and Japan, but rarely in the United States. It is still not clear if a claim containing "characterized by" as a linking expression constitutes an open or closed claim, although it is generally accepted as being open (TAKENAKA, 1995).

It is important to point out that the claims must be based on the description, otherwise they will not meet the requirement for sufficiency of disclosure, which can lead to a restriction on the scope of protection or even denial of the patent application.

Having chosen an adequate form of protection, the next question that must be addressed concerns exactly what is to be patented. Many inventions are related, for example, to methodologies on how to produce medications or clone genes more than the physical result or final product. The decision on what to patent must be based on the commercial prospects of the object or process to be protected. According to John White, partner of the Cooper & Durham office in New York, "obtaining a patent is easy, the question is: what is its scope of protection and what is your patent worth?" (NURTON, 1997). Besides this, one must consider the importance of a balance between the scope of a patent and its validity, i.e., one must seek the distinctions among the invention itself, which must provide something novel - with inventive step and industrial application and, lastly, the state of the art.

Having presented the form and terminology employed in the claims, it is important to clarify the differences between: (i) product claims and (ii) process claims. Product claims include references to the product in the preamble and the narration of the structural characteristics and functional properties of same in the body of the claim. Traditionally, claims of the product-by-process type are also treated as product claims which, however, have process limitations in the body of the claim. A process claim includes the definition of the process in the preamble and recital of the steps carried out in same in the body of the claim.

This distinction between product and process claims is important insofar as the effect of the protection granted by the patent differs with the category of the claim. A patent related to a product claim will cover all acts to produce, use, market, sell or import a product that has the structural characteristics described in the claim. Regarding a patent whose claim is destined to a process, current national laws and international treaties recognize the holder’s right to at least the product obtained directly therefrom.

The Brazilian Industrial Property Law (Law 9.279/96), in its Article 42, Item II, grants the owner of a process patent the right to impede third parties from using the patented process and from using, marketing, selling or importing with these purposes the product obtained directly from the patented process.

Understanding the rules of the industrial property system (particularly those pertaining to violation of patent rights) is important even for companies that do not customarily patent their products and/or processes. Development of a new product can turn into a nightmare if just before launch it is discovered that it cannot be marketed due to an existing patent. The disaster is even greater when a company inadvertently places a product on the market and/or uses a process having patent rights belonging to others. For this reason, it is wise to conduct a thorough patent search anytime a new product or process is planned.

On the other hand, at the time of filing a patent application the applicant should have a good idea about the protection he wishes to receive and what this protection means, so as to insure the respect of his property by third parties and, lastly, guarantee the appropriate financial return from exploiting the patent. Such knowledge enables the evaluation of the impact of the original claim structure and the posterior modifications arising from the examiner request, on the capacity to give profits from the patent eventually granted.

Nevertheless, the commercial value of a patent depends not only on the potential of the innovating firm to exploit the technology itself, or seek partners interested in participating, but also on the scope of the claims.

Biotechnology is a particularly volatile sector considering the high number of legal disputes in relation to products. The majority of inventions in this field are related to improvements, and therefore it is not easy to obtain highly lucrative products. Furthermore, there is often a high degree of dependence and even interdependence among patents.

According to Robert Blackburn, vice president and head of the patent committee of Chiron Corporation, not all countries are like the United States, Japan and many European countries in having clearly established rules concerning the scope of protection and legal efficacy of patents (NURTON, 1997).

The worldwide practice is that the scope of protection provided by a patent is defined by its claims, that is, the wording of the claims determines the limits of the rights assured by the patent. As a result, although the scope of protection is not limited to a literal interpretation of the claims, a patent does not grant unlimited protection to the basic or general inventive concept.

As a general rule in determining infringement, the accused product or process must have all the characteristics of at least one of the independent claims of a patent. A frequent interpretation is that the simple addition of characteristics to a claimed invention does not rule out infringement, regardless of whether these added characteristics are themselves known or new, even if inventive.

Interpretation of a claim is based on determination of the legal meaning of the terms of the claim, through interpretation of the specification. This can also be achieved based on other information regarding the state of the art, the file history, and of its general meaning in the technical field in question. It is often helpful to consult specialized dictionaries for the precise meanings of words used in the claim or the opinions of respected technical experts or legal scholars.

The starting point in determining the extent of a claim is the fact that infringement can occur in two basic forms: (i) a literal infringement and (ii) an infringement by equivalence.

A literal infringement occurs when each element of the infringing product coincides with the definition contained in the claim. To prove a literal infringement can involve interpreting the meaning or scope of a determined expression in the claim. Once this is established, the correspondence with the respective element of the infringing product is immediate.

An infringement by equivalence (a type of non-literal infringement) occurs when the element of the infringing product does not mesh exactly with the definition of the element in the claim, but functionally constitutes the technical equivalent of this element. The admission of this type of infringement is important to prevent unfair loss of protection due to inadequate wording of patent claims, and also to avoid that unlicensed third parties benefit unduly from such a patent.

Another type of non-literal infringement, which was common in the past particularly in Germany, is a partial infringement or sub-combination. This is deemed to exist when a third party’s product does not have all the elements of the patent claim, but in the final analysis involves unfair exploitation of the patented invention. Since the all-element rule does not apply, the omission of one or more claim elements from the accused product does not rule out the occurrence of infringement. (TAKENAKA, 1995). Currently, however, there are cases in which patent experts suggest that the scope of protection as per Article 69 of the European Patent Convention should extend to sub-combinations, at least in cases where the omitted element does not affect the result of the invention or the way it functions. Nevertheless, it is important to point out that few share this view.

In other words, as mentioned by Gustavo Morais (MORAIS & BEAKLINI, 1998), if the allegedly offending product or process leaves out one of the elements of the claim, there can be no infringement by equivalence, a view upheld by the United States Supreme Court in Warner Jenkinson Co. Inc. n . Hilton Davis Chemical Co.

One of the situations where it is possible to limit the application of the Doctrine of Equivalents is related to the file-wrapper or prosecution history estoppel.

Basically, this type of estoppel in patent law bars an applicant that has acquiesced in the rejection of a broad claim in the patent application from later asserting that a deliberately more restrictive claim is equivalent to the original claim.

Not all acts during the prosecution of a patent application permit that this history can be cited as a defense. In general, competitors can use the following acts by the applicant in formulating a defense on grounds of prosecution history estoppel: (i) sustentation of a restricted interpretation of patent claims as not covering certain concrete aspects, which makes the application invalid, including amendment of terms contained in the claims, (ii) cancellation of claims, and (iii) arguments used to distinguish the invention from the state of the art. When an applicant adds an unnecessary limitation to distinguish his invention from the state of the art, even if this is done erroneously but in good faith, courts traditionally consider this limitation irreversible. However, in some recent cases, such as Warner-Jenkinson, this traditional view has not been upheld. Even though the applicant had introduced the limitation of a lower pH range (which was not necessary to distinguish the invention from the state of the art), the doctrine of equivalents was applied to establish the violation had occurred.

A particular point that must be considered in evaluating the relevance of statements made by the applicant during the technical prosecution to determine the scope of the claims rests in judging to what extent these statements influenced the decision to grant the patent. An example would be statements that were presented to justify the patentability of a more restrictive claim due to documents on the state of the art cited by the examiner. Obviously, if an argument was used by the applicant with no direct connection with the documents cited and was not entirely relevant to the granting, such argument can be considered of lesser relevance in determining the scope of the patent claims. It is common for examiners to make demands for the applicant to restrict his claims, based on the allegation that such claims are overly vague and must define the invention more objectively. In such cases, the limitation is not imposed by any document on the state of the art, in light of which the scope of the claims is overly broad, but rather by a judgment of the examiner, based on subjective criteria that can be shown to be inadequate as actual infringements arise in practice (AHLERT, to be published).

Finally, the applicant must remember that amendments made during prosecution, with the objective of overcoming a rejection based on lack of novelty, obviousness and/or insufficiency of disclosure, may completely bar the application of the doctrine of equivalents on the amended claim element.

Specifically for the United States, the Federal Circuit’s recent decision in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd. et al (Fed. Cir. Nov. 29, 2000), has made an immediate impact on all pending applications and a majority of unexpired issued patents.

According to the court, when an applicant narrows the scope of protection sought due to the technical examination, he must be able to show that such amendment occurred for reasons unrelated to patentability. Otherwise, the doctrine of equivalents cannot be applied to that amended element.

The case is now set to go to the United States Supreme Court and unless the previous ruling is overruled, it will have a great impact on how the doctrine of equivalents is applied there. In this case, the people responsible for drafting patent applications, and particularly claims, will have to pay great attention to the scope of protection that the client seeks, to a detailed enough description of the invention, and to what already exists on the cutting edge of technology, thus avoiding the need to amend the scope of the claim during the technical examination of the patent application to meet any of the patentability requirements.

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2. COOPER, I. P. Biotechnology and the Patent System. In: Biotechnology and the Law, West Group, 2000. v. 1, chapter 1, p.. 15.
3. MACEDO, M.F.G; MÜLLER, A.C.A.; MOREIRA, A.C. Patentes em Biotecnologia: Um Guia Prático para os Elaboradores de Pedidos de Patente. Brasília: EMBRAPA. 2001.
4. TAKENAKA, T. Application of Claim Interpretation: Theory and Principles. In: Interpreting Patent Claims: The United States, Germany and Japan. Munique: VCH, 1995. Chapter 3, p.69-193.
5. NURTON, J. Biotechnology’s winning formulas. Managing Intellectual Property, p. 18-32, 1997.
6. MORAIS, G.; BEAKLINI, L. O. Patentes: Abrangência da Proteção e Interpretacão de Reivindicação. In: XVIII Seminário Nacional de Propriedade Intelectual. 1998, São Paulo. Anais. p. 28-38.).
7. AHLERT, I. B. Interpretação de Reivindicações e Infração de Patentes na Lei Brasileira de Propriedade Industrial. Rio de Janeiro. At press.
8. www.findlaw.com

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances./P>