Articles

Bio-Science Law Review

ZHANG XIAO DU

Graduate School, Chinese Academy of Social Sciences

Patentable Subject-matter of Biotechnological Inventions

The United States

In 1873, Louis Pasteur received US Patent 141,072, claiming ‘yeast, free from organic germs of disease, as an article of manufacture’. It is considered to be the first patent concerning a micro-organism.

In 1930, the Congress of United States adopted the Plant Patent Act. It is the first law to grant patents to the breeders of plants in the world.

In 1980, the decision of the Supreme Court in Diamond v Chakrabarty, ¹ held that micro-organisms produced by genetic engineering are not excluded from patent protection by 35 USC §101. It is clear from the Supreme Court decision and opinion that the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability. The test set down by the court for patentable subject-matter in this area is whether the living matter is the result of human intervention.

In 1985, in Ex parte Hibberd, ² the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office (USPTO) held that the scope of patentable subject-matter under 35 USC §101 has not been narrowed or restricted by the passage of the Plant Patent Act and Plant Variety Protection Act, nor do these plant-specific acts represent exclusive forms of protection for plant life covered therein.

In 1987, in Ex parte Allen, ³ the Board of Patent Appeals and Interferences held that subject-matter patentable under 35 USC §101 clearly includes man-made life forms. One year later, the USPTO issued the famous ‘Harvard mouse’ patent.

In addition, DNA sequences are considered to be large chemical compounds, and may be patented as compositions of matter. Although patent claims to naturally occurring DNA sequences might be expected to trigger the ‘products of nature’ rule, courts have upheld patent claims covering ‘purified and isolated’ DNA sequences as new compositions of matter resulting from human intervention.

In its ‘Utility Examination Guidelines’, ⁴ the USPTO explains that an isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent:

• (1) An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature; or

• (2) Synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.

A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. Thus, the concern that a person whose body ‘includes’ a patented gene could infringe the patent is misfounded. The body does not contain the patented, isolated and purified gene because genes in the body are not in the patented, isolated and purified form.

European Patent Office (EPO)

Article 53(b) of the European Patent Convention (EPC) provides that European patents shall not be granted in respect of ‘plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof’.

In its decision of 16 June 1999 the Administrative Council inserted a new Chapter VI entitled ‘Biotechnological inventions’ in Part II of the EPC Implementing Regulations. The new provisions entered into force on 1 September 1999 and implemented the requirements of the EU Biotechnology Directive in European patent law. ⁵. The EPO has introduced four new rules, Rules 23b to 23e. Rule 23b sets out general matters and defines the meaning of biotechnological inventions, biological material, plant variety, and microbiological process. Rule 23c states patentable biotechnological inventions, including:

• (a) Biological material isolated from their environment, even if known in nature. This particularly applies to genes that are isolated from their natural environment by means of technical processes and made available for industrial production.

• (b) Plants or animals if the invention is not confined to a single variety

The provision clarifies the scope of Article 53(b) of EPC. It indicates that a plant grouping characterised only by a particular gene, but not by its whole genome, is not covered by the protection of new varieties and therefore is in principle patentable. This also applies if such plant grouping comprises plant varieties.

Rule 23d sets out what is not patentable. This includes processes for cloning human beings, processes for modifying the genetic identity of human beings, using human embryos for commercial purposes and modifying the genetic identity of animals such as may cause them suffering without substantial medical benefit. The list is to be seen as giving concrete form to the concepts of ‘ordre public’ and ‘morality’.

Rule 23e indicates what is and is not patentable with respect to the human body. The human body and its elements cannot be patented. However, elements of the body, when isolated from the body, may be patented.

Japan

In 1997, the Japanese Patent Office (JPO) published its ‘Implementing Guidelines for Inventions in Specific Fields’. ⁶ Chapter 2 of the Guidelines is entitled ‘Biological Inventions’. Inventions in the biotechnology field in the Guidelines are divided into four types: genetic engineering, micro-organisms, plants and animals.

Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein, and a monoclonal antibody. Inventions relating to micro-organisms include micro-organisms per se as well as those relating to the use of micro-organisms. Inventions relating to plants include plants per se, those relating to parts of plants, those of a process for creating plants, and those relating to use of plants. Inventions relating to animals include animals per se, those relating to parts of animals, those of a process for creating animals, and those relating to use of animals.

In addition, there also is the Seedling Law in Japan to protect new plant varieties. Both the Patent Law and Seedling Law can protect the same new plant variety.

China

In China, DNA fragments, genes, and proteins are also considered to be chemical substances. Because it has been possible to protect chemical substance under Chinese patent law since 1993, DNA fragments, genes, and proteins can be protected under the Chinese Patent Law.

The Chinese Patent Law provides that no patent right shall be granted for animal and plant varieties. According to the interpretation of the Examination Guidelines of Chinese Patent Office (CPO), plant variety means plant and animal variety means animal. So it seems that it is impossible to protect plant and animal under patent law by interpreting the meanings of plant variety and animal variety in the same way as EPO.

Inventions of transgenic plants and animals are an important part of biotechnological inventions and more and more products relating to genes will be produced through transgenic plants and animals. Biotechnology industry is playing an increasingly important role in the new century. If China wants to progress in the field of biotechnology, technology innovation in the field must be encouraged. It is crucial to protect biotechnology inventions, including transgenic plants and animals, under patent law. So, this article suggests deleting the provisions set out in patent law and providing patent protection for plants and animals.

As in Japan and the United States, the regulation to protect new plant varieties in China was drawn up mainly according to UPOV Convention and China has already joined the UPOVC. Following the experiences of Japan and the United States, this article suggests that both the patent law and plant variety law can protect the same new plant variety in China.

Although animal and plant varieties cannot be protected under Chinese patent law at present, the processes used in creating animal and plant varieties can be protected under Chinese patent law. So the processes to be used to create animals and plants including genetic engineering processes can be protected under Chinese patent law, if the processes are not essentially biological.

In 1992, the first time the patent law was amended, protection of a process patent was extended to the product directly obtained by the patented process. Does the protection scope of a patented process for producing animal or plant extend to the animal or plant per se directly obtained by the patented process?

In China, there is no relevant court decision to interpret the issue. The purpose of extending the protection of the process patent is to protect the process invention sufficiently. The process invention in every technical field must be treated equally. Before deleting the provision that prohibits protecting animal and plant varieties in Chinese patent law, it is important to protect animals and plants indirectly through the processes that directly produce the animals and plants.

In China, at the beginning of patent law implementation, the processes relating to use of micro-organisms could be protected under patent law. From 1993, micro-organisms per se could also be protected under patent law.

Regarding the patent application of gene invention in China, up to the end of 1999, the Chinese Patent Office had received 1,754 patent applications, of which 475 were Chinese applications, and 1,279 applications were foreign applications, coming mainly from the United States, Japan, Germany and Great Britain.

The Utility of Biotechnological Inventions

The Utility Examination Guidelines of the USPTO

According to the 1995 version of the Utility Examination Guidelines, ⁷ the USPTO used a two-prong test to determine utility of invention:

• (1) Is the described utility specific to a particular purpose?

• (2) Is it credible? ⁸

In 1997, the Clinton Administration announced that the PTO would begin allowing patents on ESTs (Expressed Sequenced Tags) based on their utility as probes. The first ‘EST patent’ apparently issued by the PTO is US Patent No. 5,817,479 which was issued to Incyte Pharmaceuticals, Inc. ⁹

This leads to a dispute. Many commentators have stated that sufficient patentable utility has not been shown when the sole disclosed use of an EST is to identify other nucleic acids whose utility was not known, and the function of the corresponding gene is not known. Some commentators suggested that PTO examination procedures would result in granting patents based on non-specific and nonsubstantial utilities, contrary to established case law

On 21 December 1999, USPTO published ‘The Revised Interim Utility Examination Guidelines’¹⁰ requesting comments from the public. At the very beginning of the new century, USPTO published its new ‘Utility Examination Guidelines’. ¹¹ The Utility Guidelines are applicable to all areas of technology. However, they are particularly relevant in areas of gene-related technologies. Under the new utility guidelines, the USPTO moves to a three-prong test for utility:

• (1) Does an invention have a specific utility?

• (2) Does an invention have a substantial utility?

• (3) Does an invention have a credible utility?

In addition, a well-established utility of invention is always acceptable and easily recognised.

Specific utility

‘Specific utility’ means a utility that is specific to the subject-matter claimed. This contrasts with a general utility that would be applicable to the broad class of the invention. For example, a claim to a polynucleotide whose use is disclosed simply as a ‘gene probe’ or ‘chromosome marker’ would not be considered to be specific in the absence of a disclosure of a specific DNA target. The use of a protein as an antigen is not a specific utility as essentially all proteins are antigens.

Substantial utility

‘Substantial utility’ means a utility that defines a ‘real world’ use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a ‘real world’ context of use are not substantial utilities. Both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a ‘substantial utility’ define a ‘real world’ context of use. Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved, a method of treating an unspecified disease or condition, a method of assaying for or identifying a material that itself has no specific, substantial and credible utility, a method of making a material that itself has no specific, substantial and credible utility, and a claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility do not define ‘substantial utilities’.

Note that ‘throw away’ utilities do not meet the tests for a specific or substantial utility. For example, using transgenic mice as snake food is a utility that is neither specific (all mice could function as snake food) nor substantial (using a mouse costing tens of thousands of dollars to produce as snake food is not a ‘real world’ context of use). ¹²

The substantial utility did not exist in the 1995 version of the Utility Examination Guidelines. The purpose of adding the substantial utility in the new Guidelines is to eliminate ‘throw away’ utility.

Credible utility

An assertion is credible unless

• (a) the logic underlying the assertion is seriously flawed, or

• (b) the facts on which the assertion is based are inconsistent with the logic underlying the assertion.

Credibility of a utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use according to the disclosure of the application and any other evidence of record claimed by the applicant. For example, a perpetual motion machine has no credible utility because no perpetual motion machines would be considered to be currently available.

Well-established utility

An invention has a well-established utility if a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention and whether the utility is specific, substantial, and credible. ‘Well-established utility’ does not encompass any ‘throw away’ utility that one can dream up for an invention or a non-specific utility that would apply to virtually every member of a general class of materials.

The Utility of DNA Fragment Inventions

According to the new ‘Utility Examination Guidelines’ of the USPTO, if an isolated DNA fragment has a specific, substantial, and credible utility, the DNA fragment invention satisfies the requirement of utility and a patent can be granted for the DNA fragment. Where a new use is discovered for the patented DNA fragment, that new use may qualify for its own process patent. Of course, the later patent is a dependent patent of the DNA fragment patent.

In the inventions of DNA fragments, the utility of ESTs is a highly contentious issue. Some people think that the requirement of industrial application according to Article 57 EPC is met if the subject-matter of the invention as claimed can be made or used in any kind of industry. There is no doubt that an EST can be used to obtain the corresponding full-length cDNA and the genomic sequence. Furthermore, an EST can be used as a marker to map the chromosomal region of the gene. ¹³ The British Group of AIPPI thinks it is going too far to hold that the utility merely ‘as a probe’ will not suffice as an ‘industrial application’ for the purpose of patenting an EST. ¹⁴. But a potential use or a use for the purpose of experiment research is not a specific or substantial utility.

According to the new ‘Utility Examination Guidelines’, the view of USPTO now is that an EST whose use is disclosed simply as a ‘gene probe’ or ‘chromosome marker’ would not be considered to have a specific utility. EST is a kind of DNA fragment. It satisfies the requirement of utility if a credible, specific and substantial utility of the EST, for example use as a probe to diagnose a specific disease, is disclosed.

Implementing Guidelines for Biological Inventions of the JPO

A discovery that is not a creation does not meet the requirement of utility. A newly discovered micro-organism existing in nature, a newly discovered plant per se and a newly discovered bird per se are discoveries because they do not involve creativity. Inventions that are incapable of industrial application do not meet the requirement of utility. Inventions of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein and a monoclonal antibody whose utility is not described in a specification or cannot be inferred, do not meet the requirement of utility. An invention of a micro-organism per se, a plant per se or an animal per se whose utility is not described or cannot be inferred does not meet the requirement of utility.

China

At present, there is no re-examination board decision or court decision relating to the utility of gene-related inventions. There is no related provision in the Examination Guidelines of the CPO. Now the CPO is instituting relevant Guidelines. This article suggests that the CPO should use the experiences of the USPTO for reference to institute utility examination guidelines for gene-related inventions.

The Novelty of Biotechnological Inventions

Particularity of Novelty in the Field of Biotechnological Invention

In the field of biotechnological inventions, the issue of novelty often is combined with the issue of subject-matter. The ‘Product of Nature’ doctrine creates an important restriction in biotechnology, because biotechnology products and processes may be derived from duplication of compounds found in living organisms or produced by naturally occurring animals or plants. ¹⁵ If it is accepted that transgenic plants and animals, modified micro-organisms and isolated and purified DNA sequences are the results of human intervention and they are patentable subject-matter, naturally, they are ‘new’ in the sense of having no previous existence in the state of the art.

The Novelty Issues of DNA Fragment

ESTs, SNPs and partial gene sequences, once isolated and characterised and made available to the public form a part of the state of the art, in the same way as any other chemical. ESTs, SNPs, partial gene sequences and full-length gene sequences are different chemicals. One chemical is not novelty destroying to a different chemical; in the same way, ESTs, SNPs, or partial gene sequences forming a part of the state of the art are not novelty destroying to full-length gene sequences. Similarly a full-length gene sequence forming a part of the state of the art is not novelty destroying to a section of it. ¹⁶

In ‘Biotechnology Comparative Study on Biotechnology Patent Practices Comparative Study Report’¹⁷ by the USPTO, EPO and JPO, there is a posited case. The prior art (Y) is a structural gene encoding a functional polypeptide, the whole sequence of which is disclosed. The claimed invention (Y') is a partial DNA fragment of Y. Does the claimed invention (Y') has novelty over the prior art (Y)?

The three Offices present a generally similar result, that is, such an invention that relates to this partial sequence is regarded as being novel when an invention relating to a partial sequence has not been disclosed in concrete terms in publicly known literature. It looks like a selection invention. It seems that the DNA fragment is new based on the reason of selection invention. But the invention selecting a DNA fragment from a full-length gene sequence is not a selection invention. The DNA fragment is an isolated compound that is different from the full-length gene compound. Because the DNA fragment and the full-length gene are different compounds, the full-length gene sequence forming part of the state of the art is not novelty destroying to the DNA fragment. If it is considered that an invention of a DNA fragment isolated from a full-length gene sequence is a selection invention, the DNA fragment invention will become a dependent invention of the full-length gene invention. The DNA fragment invention is not a dependent invention of the full-length gene invention. The two inventions are independent.

China

At present, there is no re-examination board decision or court decision relating to the novelty of gene-related inventions. There is no related provision in the Examination Guidelines of the CPO. But then, as in other countries, if the subject-matter issue of a DNA fragment, gene, transgenic plant or animal, and so on is solved subsequently, the novelty issue related is solved.

As in Japan, in the Examination Guidelines of the CPO where there is a difference between two inventions, they are deemed identical (substantially identical) if the difference is considered to be a very minor difference in the embodied means to solve a problem. Thus the CPO may use the provisions set out in the ‘Implementing Guidelines for Inventions in Specific Fields’ of the JPO for reference in instituting its own novelty examination guidelines for gene-related inventions.

The case law of the Boards of Appeal of the EPO is based on a narrow concept of novelty, that is, the disclosure of a prior document does not include equivalents of the features which are explicitly or implicitly disclosed; equivalents can only be taken into account when it comes to considering inventive step. This narrow concept of novelty, which excludes equivalents, is of particular importance for the application of Article 54(3). In a 1987 decision (T 167/84), ¹⁸ the board commented that conflicting applications within the meaning of Article 54(3) were included in the state of the art solely from the point of view of novelty, but were considered in the light of their ‘whole contents’. In order to mitigate the harsh effects of the ‘whole contents approach’, its application was confined to novelty. Further, in order to reduce the risk of ‘self-collision’, it had always been considered justified to adopt a strict approach to novelty.

In China and Japan, a conflicting application does not include an application that has been filed with the Patent Office by the same applicant. So, at least, there is no risk of ‘self-collision’.

In China, the exception to lack of novelty can be applied to inventions which are exhibited at an international exhibition sponsored or recognised by the Chinese Government, made public at a prescribed academic or technological meeting, and disclosed by any person without the consent of the applicant before the date of filing.

Compared with the exception to lack of novelty in Japanese patent law, the scope of the exception to lack of novelty in Chinese patent law is very narrow. So it is more important to take equivalence into account to determine novelty of invention. Then, in order to reduce the possibility that the technical information disclosed by the applicant himself forms a part of the state of the art in favour of the inventive step in assessing the corresponding patent application, not only identical invention but also a substantially identical invention can be applied to the exception to lack of novelty. In the field of biotechnology, the exception to lack of novelty also is very important.

The Inventive Step of Biotechnological Inventions

United States

In Re Bell¹⁹

Early DNA patent cases focused on the obviousness of the method used to isolate the sequence rather than the obviousness of the sequence itself. In Re Bell, the Court of Appeals for the Federal Circuit (CAFC) focused on the structure of a DNA sequence rather than on the method used to obtain the sequence.

In Re Bell, the PTO reasoned that once a portion of the amino acid sequence is known, the method for isolating DNA sequences encoding a given protein is obvious: simply prepare and utilise nucleotide probes based on the amino acid sequence to isolate the full-length DNA. Thus, the entire nucleotide sequence of the gene would be prima facie obvious when the amino acid sequence for that gene could be found in the prior art. The CAFC disagreed. The court commented:

It may be true that, knowing the structure of the protein, one can use the genetic code to hypothesize possible structures for the corresponding gene and that one thus has the potential for obtaining that gene. However, because of the degeneracy (redundancy) of the genetic code, there is a vast number of nucleotide sequences that might code for a specific protein.

The court cautioned that its view was ‘not to say that a gene is never rendered obvious when the amino acid sequence of its coded protein is known’ but that was not the situation in the present case. The art in question suggested use of only a short probe and the applicants apparently had to choose a longer probe in order to obtain the gene in question and thus had taken a step contrary to the prior art teaching. Thus, what the applicants had done was not obvious. ²⁰

In Re Deuel²¹

In this case, the CAFC stated that the existence of art disclosing a protein and a technique that can be used to determine the DNA sequence coding for that protein does not make obvious the specific claimed DNA sequence coding for that protein. Due to the redundancy of the genetic code, the disclosure of a partial protein sequence does not suggest a particular DNA sequence coding for the protein. The fact that one can conceive a general process in advance for preparing an undefined compound does not mean that a claimed specific compound was precisely envisioned and therefore obvious.

The CAFC did state that a different result might occur if the prior art disclosed a small and simple protein so that all DNA coding for that protein would be obvious. ²²

Japan

In Japan, the basic principle to assess the inventive step of a gene-related invention is that as follows: a gene-related invention does not have an inventive step, provided that a person skilled in the art could make the invention easily at the time of filing. However, when it is considered that the invention has advantageous effects that a person skilled in the art cannot foresee, said invention has an inventive step.

A Japanese patent attorney thinks that the JPO examines the obviousness of genes according to the Implementing Guidelines based on the obvious-to-try test. ²³

The definition of inventive step of Japanese patent law determines that the basic principle to assess the inventive step of a gene-related invention is based on the obvious-to-try test. If there is an obvious-to-try method for making an invention from the view of a person skilled in the art, generally, it is considered that the invention is prima facie obvious. In the United States, the CAFC rejects as a standard of determining obviousness the idea that something can be held unpatentable because it is merely ‘obvious to try’.

The difference from the principle of assessing inventive step also exists in related comparative studies on biotechnology patent by the USPTO, EPO and JPO. For example, there is a posited case in the ‘Biotechnology Comparative Study on Biotechnology Patent Practices Comparative Study Report’. The prior art (Y) is a structural gene encoding a functional polypeptide, the whole sequence of which is disclosed. The claimed invention (Y') is a partial DNA fragment of Y. Does the claimed invention (Y') have inventive step over the prior art (Y)?

The USPTO suggests only an assessment of the entire state of the art as well as the information contained in the specification. It does not give an answer to whether the claimed invention has inventive step or not, because the USPTO holds that patentability shall not be negatived by the manner in which the invention was made. It is crucial whether there is a suggestion or incentive to create the claimed invention in the prior art. The JPO answers usually no, since it is merely a normal and common procedure for a person skilled in the art to obtain a partial DNA sequence on the provision that the corresponding whole sequence of the structural gene has been known from the prior art. In addition, in the United States, the applicant can submit evidence including unexpected results to prohibit the prima facie conclusion of obviousness; while in Japan, if there is a specific difficulty in obtaining the claimed invention with the state of the art, or if the claimed invention has advantageous effects that a person skilled in the art cannot foresee, the said invention has an inventive step.

In the said case, the JPO holds that a DNA fragment encoding a protein having some unexpected property vis-à-vis the known protein may be acknowledged as inventive. In general, the USPTO agrees with the position.

China

As with utility and novelty, at present, there is no re-examination board decision or court decision relating to the inventive step of gene-related inventions. There is no related provision in the Examination Guidelines of the CPO.

Particularity of the Inventive Step for Biotechnology Process Inventions

In Re Durden, ²⁴ the CAFC held that a known process employing an unobvious starting material or final product is not patentable. This per se rule was regularly used to defeat the patentability of a claimed biotechnological process for making or using a patentable composition of matter. It is considered that the application of Re Durden to biotechnological processes is too broad and is inappropriate.

The adverse impact on the biotechnology industry was most severe in those instances involving first generation biotechnology products, that is, products identical or very similar to the naturally occurring product, produced by patentable transformed organisms (transformants). Competitors could practise the process ‘overseas’ using the patentable transformant and import the product produced by the patentable transformant without any fear of infringement. ²⁵ In addition, many biotechnology products are natural products and are not patentable in and of themselves. Thus, process patents are particularly important to the industry.

The Biotechnology Patent Protection Act was signed into law by President Clinton on 1 November 1995. It overthrew the application of Re Durden to biotechnological process inventions. ²⁶ The real purpose of the Act is only to ensure that those patentable biotechnological processes using or resulting in a patentable composition of matter are in fact patented.

The companion cases of Re Ochiai²⁷ and Re Brouwer²⁸ were the first time the CAFC dealt with the non-obviousness problem of biotechnological processes in light of the enactment of the Biotechnology Patent Protection Act.

The Ochiai and Brouwer approach is simple, logical, and straightforward: if the novel and non-obvious starting material is a part of the otherwise obvious process, the process is non-obvious because, without the knowledge of the starting material, one would not have been able to choose it to make the product in the process. Likewise, if the novel and non-obvious resulting material is a part of the otherwise obvious process, the process is non-obvious because, without the knowledge of the resulting material, it would not have been obvious to someone with ordinary skills in the art how to make the resulting material. ²⁹

The ‘Implementing Guidelines for Inventions in Specific Fields’ of JPO states that since the micro-organism used per se has an inventive step, a process using the micro-organism also has an inventive step. The interpretation is similar to the Biotechnology Patent Protection Act of the United States.

In 1993, the inventive step criteria in a re-examination board decision of the CPO (No.327) were similar to the inventive step criteria of the Biotechnology Patent Protection Act of United States in 1995.

In that decision, the board held that a new germ must be considered to assess the inventive step of a zymolysis process in which the specific germ is used. The new germ is one of the indispensable technical features of the invention. If the new germ is neglected, the process is a conventional technology in the field of micro-organism zymolysis. However, because the claimed process includes the use of the new specific germ that is screened out by the inventor and the claimed process has an advantageous effect, the claimed process has an inventive step.

This article suggests that the CPO should keep and continue to improve the principle that was established in that decision.

1. 447 US 303, 309, 206 USPQ 193, 197 (1980).

2. 227 USPQ 443, 448 (Bd. Pat. App. & Inter. 1985).

3. 2 USPQ2d 1425, 1428 (Bd. Pat. App. & Inter. 1987).

4. http://frwebgate

5. ‘Notice dated 1 July 1999 concerning the amendment of the Implementing Regulations to the European Patent Convention’, Official Journal EPO, 8 September 1999, at 545 to 587.

6. Implementing Guidelines for Inventions in Specific Fields, Chapter 2, ‘Biological Inventions’:

7. Final Utility Examination Guidelines, Federal Register, 14 July 1995 (60 FR 36263-265).

8. ‘Biotechnology Patent Practice in the New Millennium’19 Biotechnology Law Report 22(1) (February 2000), Mary Ann Liebert, Inc., Meeting Reports.

9. Michael S. Tuscan and Reid G. Adler, ‘Patenting of Expressed Sequence Tags in the United States’, [1998/1999] 5 BSLR 175 to 178.

10. Federal Register, 21 December 1999 (Vol. 64 (244)).

11. See Note 4 above.

12. Revised Interim Utility Guidelines Training Materials.

13. Dr Martin Grund and Dr Volker Vossius, ‘Patentability of ESTs under the EPC’, [1998] 3 BSLR at 106 to 109.

14. The British Group of AIPPI, ‘Patentability Requirements and Scope of Protection of Expressed Sequence Tags(ESTs), Single Nucleotide Polymorphisms (SNPs) and Entire Genomes’, [2000] 1 EIPR at 39 to 42.

15. Courtney J. Miller, ‘Patent Law and Human Genomics’, The Capital University Law Review, 1997, 26 Cap. UL Rev. 911.

16. See Note 14 above.

17. Trilateral Project 24.1 – Biotechnology Comparative Study on Biotechnology Patent Practices Comparative Study Report:

18. OJ 1987, 369.

19. 991 F.2d 781 (Fed. Cir. 1993).

20. Biotechnology and United States Patent Practice’ Revised 2 July 1996 vol. 3 © 1996 Ladas & Parry:

21. 34 USPQ 2d 1210 (1995).

22. See Note 20 above.

23. Yusuke Hiraki, Problems Regarding the Patentability of Genomics and Scope of Protection of ESTs in Japan:

24. 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985).

25. Thomas G. Wiseman, ‘New Protection for Biotechnology Patent Processes’ — Patent the Biotechnology Patent Protection Act:

26. The Biotechnology Process Patent Act of 1995, Public Law 104-4 1 November 1995, 109 STAT. 351.

27. 37 USPQ2d 1127 (Fed. Cir. 1995).

28. 37 USPQ2d 1663 (Fed. Cir. 1995).

29. Jeremy (Je) Zhe Zhang, ‘In Re Ochiai, In Re Brouwer and the Biotechnology Process Patent Act of 1995: The End of the Durden Legacy?’, 1997 PTC Research Foundation of Franklin Pierce Law Center IDEA:The Journal of Law and Technology, 1997, 37 IDEA 436.

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