Biotechnology, research and intellectual property law andrew j allen



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XII. Scope of the Patent Claim


In Biogen, the patent was held invalid because the claims were wide enough to include the same products made by methods not disclosed in the specification. It was accepted that the invention would work, but the claims were drafted too broadly, or at too high a level of abstraction, to be commensurate with the inventive step that was achieved. The patent application lay claim to 'any recombinant method of making the [HBV] antigens' .139 This type of broad claim, where the claimed monopoly exceeds the 'technical contribution to the art embodied in the invention',140can inhibit subsequent innovation by making that which may be in the public domain, or is yet to be discovered, subject to a private intellectual property right. Lord Hoffmann said:

It is inevitable in a young science, like (...) recombinant DNA technology in the 1970' s, that dramatically new things will be done for the first time. The technical contribution made in such cases deserves to be recognised. But care is needed not to stifle further research and healthy competition by allowing the first person who has found a way of achieving an obviously desirable goal to monopolise every other way of doing so.141

The social contract underlying patent law limits the scope of a patentee's monopoly by reference to the technical contribution made by the invention. Broad claims to biotechnological inventions have been criticised for monopolising large tracts of ground over and above what the patentee is entitled to.142 Sometimes a patentee can justifiably claim more than what is shown in working examples. Too narrow a scope for the claim and others will be able to avoid infringement with minor changes. The scope of a claim should be that which the patentee has made available in the sense that he has advanced the art by converting uncertainty into certainty. A patentee deserves to be rewarded with a monopoly over his solution to a recognised problem, but not to all solutions to that problem.

Usually, the existence of prior art encompassing part of the claims will serve to check over-broad claims. Where the technology is new and little prior art exists, as in biotechnology, the claims must be scrutinised to ensure that the information disclosed in the patent application enables others to work the full width of the invention claimed.143 A patent will be too broad if it claims results it does not enable, or if it claims every way of achieving a result when it discloses only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.144 Product claims are vulnerable to excessively broad claims because the inventive step often lies in the process developed to get to that product. This inventiveness does not warrant a monopoly over the entire field. As Lord Hoffmann said in Biogen: '[T]he Wright Brothers showed that heavier-than-air flight was possible, but that did not entitle them to a monopoly of heavier-than-air flying machines'.145

Broad claims are likely to arise where patents are sought for many biotechnological inventions because biological materials are described in functional rather than structural terms. For this reason. claims are naturally going to consist of generalised wording. To some extent this is unavoidable where genes are concerned because 'gene' is itself a functional term. Genes consist of lengths of DNA, but not all lengths of DNA are genes. A length of DNA can be described as a gene only when it has a described function. Functions can include comprising the coding sequence for specific polypeptides used in protein synthesis, or a gene may have a regulatory function, such as a promoter gene which interacts with the cellular environment to control when a particular section of genome is transcribed into mRNA.

Biotechnological inventions will need to use broad and general descriptive terms in order to secure effective intellectual property protection. This is because of the ease with which variety can be introduced into biological material. In a case concerning a claim that included the general terms 'plasmid,' 'bacterium' and 'regulon', the European Technical Board of Appeal supported the use of terms that embrace variants of the components of an invention.146 The reason given was that variants, of components of the invention, which are equally suitable to achieve the same effect in a manner which could not have been envisaged without the invention, must also be protected if the patent protection is to be effective. On the other hand, a claim which covers any transgenic cotton plant exceeds the protection earned by an inventor who describes only one way of transferring a foreign gene into the plant.147 It is conceivable that other ways of achieving the result may be developed that owe nothing to the teaching of the patentee.

In Ancare Gault J said in relation to the question of obviousness: 'No patent should interfere with what has been done or disclosed before nor with obvious variants of what has been done or disclosed before'.148 It is suggested the scope of biotechnological patents should also be considered to include obvious variants of the patented invention. The term 'obvious variant' has the same meaning in the context of plant varieties as essential derivation. The ease with which variants of biological materials can be developed lends support to the legitimacy of broad claims. As plant varieties become increasingly the result of inventive research work, it can be expected that difficult issues about the appropriate scope of plant patents will arise.

XIII. Disclosure


Verification of research results by other researchers may require more than access to a written report of the experiments. Biological material is especially difficult to reproduce without access to the actual material used by the inventors. Traditionally, goodwill and convention facilitated the exchange of such material between research teams.149 In order to ensure that the disclosure of inventions required by the patent social contract was met in the field of microorganisms, an international agreement was formed that calls for a system of deposits of new micro-organisms. The Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure 1977 is administered by the World Intellectual Property Organisation (WIPO). In order to comply with the enabling disclosure requirement of most countries' patent laws, it is international practice to deposit a sample of a micro-organism in a public depository. The treaty ensures that samples of micro-organisms for which patents have been granted are publicly accessible. New Zealand is yet to join this treaty, even though the guarantee of access to inventions is a key aspect of the patent social contract.

Disclosure of the invention at the beginning of the patent term places the new addition to the stock of knowledge into the hands of researchers who can build upon it. The extension of knowledge is in the public interest and fulfils the obligation of the patentee under the patent social contract. The specification submitted by the applicant must contain a description of the invention. This must be sufficiently detailed so that a person skilled in the art can understand and work the invention. In New Zealand, an invention must be fairly and sufficiently described in order to fulfil the requirements for the grant of a patent.150 A function of the claims is to define the limit of monopoly. This will enable others to know the metes and bounds of the patent in order to avoid unintentional infringement.151


XIV. Conclusion


Biotechnology is important for New Zealand's future economic prosperity. This country has a strong tradition of biotechnological research which has helped to maintain its primary producers' market competitiveness. As changes in the way that biotechnological research is undertaken, particularly the increase in private funding, it will be very important to maintain incentives for technological progress. This paper has shown that the plant variety rights and patent systems can provide these incentives.

An understanding of the social contract that underpins patent law can assist in the application of this industrial age system to the biotechnological inventions of today. One key challenge for the intellectual property community is to ensure the scope of an intellectual property right, awarded to an inventor, is commensurate with the actual contribution to the relevant art made by the inventor. This will require developing language skills to correctly describe biological inventions in functional terms but at an appropriate level of specificity.

Plant variety rights should be extended to include essentially derived varieties. It is also noted that plant research is greatly assisted by the current breeder's exemption. Patent applicants face the challenge of stating their inventions at a level of generality that reflects their true achievements, and is sufficiently wide to ensure adequate protection. An inventive step, however small, deserves to be recognised and rewarded but does not warrant a monopoly protection of excessive scope.

Intellectual property systems and scientific research share the goals of promoting the advancement of knowledge. An initial perception may suggest that granting private property rights in research outcomes conflicts with the scientific tradition of free dissemination of knowledge and new discoveries. This paper has shown that with an appropriately carved research exclusion from patent infringement that perception is not accurate. The patent system is designed to allow the information developed through research to flow freely into the public domain. DNA lies at the centre of the biotechnology industries because of the value of the information encoded in nucleotide sequences. The key balance to be struck by the patent system is to promote biotechnological research while facilitating the dissemination of that genetic information to researchers who can use it to enhance many aspects of human life.


Endnotes

* Andrew Allen has an MSc in Plant Biotechnology. This paper was written as part of the undergraduate LLB Honours programme.



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  2. L C Thurow, 'Needed: A New System Of Intellectual Property Rights' [1997] Harvard Business Review 95.

  1. Petersen, above n 1, 8.

  2. Thurow, above n 3, 98.

  1. J Pilkington, An Adventure on the Old Silk Road (1989) 8.

  2. J Robertson and D Calhoun, 'Treaty on Biological Diversity: Ownership Issues and Access to Genetic Materials in New Zealand' [1995] European Intellectual Property Review 218.

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  4. From the French: Union pour la Protection des Obtentions Vegetales.

  5. [1997] RPC 1.

  1. GM Commission Report, above n 2, 108.

  2. Ibid, 420.

  3. R Teitelman, Profits of Science (1994) 179-202.

  1. Thurow above n 3, 97.

  2. GM Commission Report, above n 2, 278.

  3. M A Heller and R S Eisenberg, 'Can Patents Deter Innovation? The Anticommons in Biomedical Research' (1998) 280 Science 698.

  4. See Part VIII.

  5. Heller and Eisenberg, above n 16, 698.

  6. Discussed in Part X.

  7. R K Merton, On the shoulders of giants: a Shandean postscript (1965) 1.

  8. R S Eisenberg, 'Patents and the Progress of Science: Exclusive Rights and Experimental Use' (1989) 56 University of Chicago Law Review 1017.

  9. L Jardine, Ingenious Pursuits (1999) 317.

  1. Petersen, above n 1, 12.

  2. D Vaver, 'Intellectual Property Today: Of Myths and Paradoxes' (1990) 69 Canadian Bar Review 98, 116.

  3. J D Watson and F H C Crick, 'A Structure for Deoxyribose Nucleic Acid' (1953) 171 Nature 737.

  4. R S Eisenberg, 'Proprietary Rights and the Norms of Science in Biotechnological Research' (1987) 97 Yale Law Journal 177.

  5. Ibid 178.

  6. GM Commission Report, above n 2, 278.

  1. See Part X.

  2. R Teitelman, Profits of Science (1994) 183-90.

  1. Ibid.

  2. Katz v Horni Signal Mfg. Corp 145 F 2d 961, (2 d Cir, 1944).

33 Hampton and Baker, above n 8, 269.

  1. D I Bainbridge, Intellectual Property (1999) 321-3.

  1. Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529, 533 (Gault J).

  1. Pope Appliance v Spanish River (1929) 46 RPC 23, 55 (Viscount Dunedin).

  2. GM Commission Report, above n 2, 277.

  3. Patents Act 1953 (NZ) s 30(3).

  1. R S Eisenberg, 'Re-examining The Role Of Patents In Appropriating The Value Of DNA Sequences' (2000) 49 EMORY Law Journal 783, 798.

  2. D Vaver, 'Intellectual Property Today: Of Myths and Paradoxes' (1990) 69 CanadianBar Review 98, 121.

  1. Diamond v Chakrabarty 447 US 303 (1980).

  2. Chiron Corporation v Organon TeknikaLtd (No. 10) [1995] FSR 325, 332 (Aldous J).

  3. Thurow, above n 3, 95.

  1. M Enserink, 'Patent Office May Raise The Bar on Gene Claims' (2000) 287 Science 1196.

  2. GM Commission Report, above n 2, 280.

  3. Patents Act 1953 (NZ) s 2.

  4. Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529, 534.

  5. [2000] 2 NZLR 529.

  6. National Research Development Corp v Commissioner of Patents (1959) 102 CLR 252.

  7. Ibid 269.

  8. Ibid 271.

  1. T Reichhardt, 'Patent on gene fragment sends researchers a mixed message' (1998) 396 Nature 499.

  2. M Enserink, 'Patent Office May Raise The Bar on Gene Claims' (2000) 287 Science 1196.

  3. See Part X.

  4. The Agreement on Trade Related Aspects of Intellectual Property Rights, Article 27(1).

  5. GM Commission Report, above n 2, 283.

  6. Patents Act 1953 (NZ) s 10(7).

  7. Patents Act 1953 (NZ) ss 13, 14.

  8. Patents Act 1953 (NZ) s21(b).

  1. Patents Act 1953 (NZ) s 60.

  2. Ancare New Zealand Ltdv Cyanamid ofNZ Ltd [2000] 3 NZLR 299, 315.

  3. Biogen Inc v Medeva plc [ 1997] RPC 1,34.

  4. Harwood v Great Northern Railway Company [1865] 11 HLC 654, 682.

  5. Patents Act 1953 (NZ) s 21(1)(e).

  6. Patents Act 1953 (NZ) s 41(1)(f).

  7. Ancare New Zealand Ltdv Cyanamid ofNZ Ltd [2000] 3 NZLR 299, 309 (Gault J).

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  2. Smale v North Sails [1991] 3 NZLR 19, 44.

  3. Ancare New Zealand Ltd v Cyanamid ofNZLtd [2000] 3 NZLR 299, 309.

  4. British Westinghouse v Braulik (1910) 27 RPC 209, 230 (Moulton LJ).

  5. Molnlycke A B v Procter & Gamble Ltd [1994] RPC 49.

  6. Wildey and White 'sMfg Co. Ltd v Freeman andLetrikLtd (1931) 48 RPC 405, 414 (Maugham J).

  7. Molnlycke A B v Procter & Gamble Ltd [1994] RPC 49, 112 (Nicholls VC).

  1. Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529, 530 (Gault J).

  1. Monsanto Company v Stauffer Chemical Company (NZ) [1984] FSR 559.

  2. Ibid 565.

  3. Ibid 564 ( Eichelbaum J).

  4. Ibid 567 ( Eichelbaum J).

  5. Ibid 566.

  1. Patents Act 1977 (UK) s 60(5).

  2. Monsanto Co v Stauffer Chemical Co [1985] RPC 515, 542 (Dillon LJ).

  3. GM Commission Report, above n 2, 278.

  1. [1985] RPC 515.

  1. A Baker, 'GATT, TRIPS, the revision of New Zealand's patent legislation and pharmaceuticals' [1997] New Zealand Intellectual Property Journal 245.

  1. Patents Act 1953 (NZ) s 46.

  2. Baker, above n 85, 245.

  3. Glaxo Group Ltd v Commissioner of Patents [ 1991 ] 3 NZLR 179.

  1. M Perry and P Krishna, 'Making Sense of Mouse Tales: Canada Life Forms Patents Topsy- Turvy' [2001] European Intellectual Property Review 196, 203.

  1. GM Commission Report, above n 2, 278.

  2. Ibid 279.

  3. Ibid.

  1. L Jardine, Ingenious Pursuits (1999) 316.

  2. R S Eisenberg, 'Patents and the Progress of Science: Exclusive Rights and Experimental Use' (1989)56 University of Chicago Law Review 1017, 1036.

  3. Eisenberg, above n 26, 225.

  4. Eisenberg, above n 94, 1078.

  5. J P Karp, 'Experimental Use as Patent Infringement: The Impropriety of a Broad Exception' (1991) 100 Yale Law Journal 2169, 2180.

  1. Ibid 2183.

  2. Ibid.

  3. Ibid.

  4. Heller and Eisenberg, above n 16, 698.

  1. Eisenberg, above n 21, 1017.

  2. M Wadman, 'NIH is likely to challenge genetic 'probe' patents' (1997) 386 Nature 312.

  1. M A Holman and S R Munzer, 'Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags' (2000) 85 Iowa Law Review 735.

  2. Heller and Eisenberg, above n 16, 698.

  3. R Merges and R Nelson, 'On the Complex Economics of Patent Scope' (1990) 90 Columbia Law Review 839.

  4. R S Eisenberg, 'Genes, Patents, and Product Development (1992) 257 Science 903.

  5. Biogen Inc v Medeva plc [1997] RPC 1.

  6. Ibid 51.

  1. Ibid.

  2. Ibid 45 ( Lord Hoffmann).

  3. J Thomson, The Grey Penumbra of Interpretation Surrounding the Obviousness Test for Biotech Patents' [1996] European Intellectual Property Review 90.

  4. I G FarbindustrieAG's Patent (1930) 47 RPC 289, 323 (Maugham J).

  1. Genentech v Wellcome [1989] RPC 147, 274.

  2. In re Bell 991 F2d 781 (Fed Cir, 1993).

  3. In re Deuel34 USPQ 2d 1210 (Fed Cir, 1995).

  1. [1989] RPC 147.

  2. Ibid 273 ( Mustill LJ).

  3. Biogen Inc v Medevaplc [1997] RPC 1, 44 (Lord Hoffmann ).

  4. Ancare New Zealand Ltd v Cyanamid of NZ Ltd [2000] 3 NZLR 299, 309 (Gault J).

  5. Biogen Inc v Medeva Plc [1995] RPC 25.

  6. BIOGEN/Hepatitis B [1995] EPOR 1.

  7. B C Reid, 'Biogen in the EPO: The Advantage of Scientific Understanding' [1995] European Intellectual Property Review 98.

  8. Biogen Inc v Medeva Plc [1995] RPC 25.

  9. Samuel Parkes & Co Ltd v Cocker Brothers Ltd (1929) 46 RPC 241, 248.

  1. Ancare New Zealand Ltd v Cyanamid of NZ Ltd [2000] 3 NZLR 299, 309.

  2. B Sherman, 'Patent Law in a Time of Change: Non-Obviousness and Biotechnology' (1990) 10 Oxford Journal of Legal Studies 278, 283.

  3. Ancare New Zealand Ltd v Cyanamid of NZ Ltd [2000] 3 NZLR 299, 315 (Gault J).

  4. Biogen Inc v Medeva plc [1997] RPC 1, 34.

  5. P E Montague, 'Biotechnology Patents and the Problem of Obviousness' (1993) 4 Australian Intellectual Property Journal 3.

  6. Hampton and Baker, above n 8, 269.

  7. In re Sigco 36 USPQ 2d 1380 (Fed Cir, 1995).

  8. R H Kjeldgaard and D R Marsh 'Recent Developments in the Patent Protection of Plant-based Technology in the United States' [1997] European Intellectual Property Review 16.

  1. See Part V.

  2. Biogen Inc v Medeva plc [1997] RPC 1, 45.

  3. Biogen Inc v Medeva Plc [1995] RPC 25.

  4. Biogen Inc v Medeva plc [1997] RPC 1, 45.

  5. Ibid 52.

  1. Ibid 51 (Lord Hoffmann).

  2. Ibid.

  3. Ibid 52 (Lord Hoffmann).

  4. T Roberts, 'Broad Claims for Biotechnological Inventions' [1994] European Intellectual Property Review 371.

  1. R S Crespi, 'Biotechnology, Broad Claims and the EPC’ [1995] European Intellectual Property Review 267.

  2. Biogen Inc v Medevaplc [1997] RPC 1, 51.

  3. Ibid 52.

  4. GENENTECH/Polypeptide expression T292/85 [1989] EPOR 1.

  5. Roberts, above n 142, 371.

  6. Ancare New Zealand Ltd v Cyanamid of NZ Ltd [2000] 3 NZLR 299, 315.

  1. Eisenberg, above n 26, 177.

  2. Patents Act 1953 (NZ) s 10(3), (4).

  3. Electric & Musical Industries Ltd v Lissen Ltd (1939) 56 RPC 23.
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