However, one of the major rate limiting steps for this revolution is a legal issue prohibiting worldwide patenting of transgenic inventions. This obstacle is formidable in Europe - ironically, as born out in the cloned sheep Dolly, this an area of the world that has been extremely innovative in the developments. The European Union (EU) is now preparing to vote on the Biotechnology Patent Directive, which would remove legal prohibitions to patenting transgenics.

Sowing the Seeds of Discontent

In Europe, there are two laws that have blocked the patentability of trangenics. Under a treaty, the European Patent Convention's (EPC's) Article 53(a), inventions whose commercial use would be contrary to public policy are not patentable. Under Article 53(b), the law goes on to exclude "plant and animal varieties" from patentability (1).

The problem with Articles 53(a), and (b) - and this treaty in general - is that their interpretations vary from country to country. As a result, the European Patent Organization(EPO);Munich) and EU member states have selectively decided to issue or reject transgenic patents.

Two contradictory cases illustrate this confusion. The first case involves the "Harvard mouse." The invention introduced an activated oncogene, the myc gene, into a nonhuman mammalian genome, which resulted in a trangenic mouse that is susceptible to cancer. In the first round of patent examinations, the EPO's patent examining division rejected Harvard's patent application, excluding it under 53(b) as an "animal variety." The examining division then went on to consider whether the Harvard mouse might also violate public policy under 53(a).

Unable to arrive at a decision on that issue, the examining division passed the buck up to the EPO's board of appeals. The board sent the case back, stating that the question under 53(b) was not whether the claims embraced an "animals," but whether the claims embraced an animal "variety." The Harvard mouse decision, which recognized a distinction between "animal" and "animal variety," laid the groundwork for circumventing patent exclusion under Article 53(b). The issue of morality was handled by weighing the environmental risks and potential for cruelty to animals against he potential benefits to mankind. With the Harvard mouse, the Examining Division found that the interest in developing anticancer treatments was of great value, and that overall animal suffering would actually decrease, since fewer animals would be needed for such experimentation with the patented mouse available. Furthermore, it found no danger to the environment, since testing would only be done under controlled circumstances and by qualified staff, and no release into the wild was intended. Although the Examining Division allowed the patent, it made it clear that its opinion applied solely to the Harvard mouse patent and that other cases of transgenic animals could result in a different conclusion when applying EPC Article 53(a).

As a result, the EPO granted its first patent on a transgenic nonhuman animal, the Harvard mouse. An environmental group, Greenpeace, filed an opposition to the patent in which it asked the EPO to revoke the patent it had just granted. The EPO is considering the matter and has made no decision on the opposition (2).

After the Harvard mouse case, it appeared to most observers that Europe favored patenting transgenic plants and animals. Plant Genetic Systems(PGS:Ghent, Belgium) subsequently sought a patent for a trangenic plant patent. The EPO granted the patent. Greenpeace again filed an opposition. However, in this case, the board moved more quickly to reexamine the patent. In making its decision, it found nothing immoral in the patenting of a plant under 54(a), but rejected under 53(b) because it interpreted the PGS plant as an unpatentable "plant variety."

Despite this rejection, the board went on to grant a patent on the transgenic plant cells and seeds under a second section of 53(b) that allowed the patenting of the product of a microbiological process. The board's explanation for this ruling was that plant cells and seeds were classified as "microorganisms." Under the board's definition, a single cell capable of reproduction fell into this category no matter what the biology of the parent organism. In summary, claims to genetically modified plant cells, and to a process for producing genetically modified plants, were held to be patentable, whereas claims to genetically modified plants themselves were held unpatentable.

Applicants for European patents were thus faced with a dilemma. On the one hand, the EPO had granted a patent for a transgenic in the case of the Harvard mouse, but on the other, it had denied a patent for a trangenic in the case of the PGS plant. These contradictory rulings made investors wary of entering into this legal minefield with commercially viable intellectual property.

The Biotechnology Patent Directive

These issues came to a head when the president of the EPO had difficulty reconciling the Harvard mouse and PGS cases publicly. Discontent over this inability to explain the law finally fueled the drafting of new legislation known as the EU Biotechnology Patent Directive.

The directive establishes more clear-cut definitions and rules than had its predecessor, the EPC; these rules are more favorable toward patenting transgenics and less subject to idiosyncratic interpretation.

The directive redefines EPC Article 53 to avoid the result in PGS and defines both patentable plants and animals and those that are either patentable plant and animal varieties or unpatentable procedures for breeding plants and animals. For example, a variety is now defined as a whole genome that is individual and distinct from other varieties.

What's more, the directive goes on to state clearly that inventions capable of industrial application - even when the concern a product made of or containing biological material or a procedure for producing, processing, or using biological material - are clearly patentable. Even if a biological material preexists in the natural state, if it is separated from its natural environment or produced with a technical procedure it may still form the subject matter for an invention. For example, a naturally occurring human protein, if separated from the human body or produced by a technical procedure, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The one provision is that the industrial application must be clearly specified in the application for a patent. In the case of full-length sequence or the partial sequence of a gene, the function of the gene must be disclosed.

Patenting Strategy

Careful patent drafting will be important for obtaining long-lasting patent protection in Europe. Many definitions that seem routine in the scientific community need to be carefully scrutinized when applied to the EU Biotechnology Patent Directive. For example, as we have seen, under European Patent law, microbiology is not the same as biology. Microbiological processes were patentable under EPC decisions even before PGS. Although the proposed directive reverses the PGS decision, the PGS story highlights the importance of avoiding definitional land mines. One such land mine can be set off by ignoring the legal distinction between what is and is not "essentially biological." So if practicable, a patent on an invention related to breeding should avoid characterization of the invention as "essentially biological."

Patent claims should encompass the invention while avoiding a characterization of the invention that will lead to rejection. Further, just as a product can be marketed in different ways, an invention can be viewed in different ways. A patent on an animal or plant should describe the invention several different ways: as a process, a product, or perhaps a product resulting from a process. A patent's claims should be definite, not vague, so that a judge will not throw them out as he did in the case of Amgen v. Chugai (3). In this case, the patent claimed an erythropoietin preparation having a specific activity of "at least about 160,000." The judge ruled that "about" was too indefinite, saying that in a close case, where the literature was close to the invention patented, an indefinite claim would be held invalid.

In addition, companies will want to ensure that for a particular invention, the patent application written for Europe is different from the patent application written for the US; the patent laws n Europe are different from those in the US. For example, the new EU directive will not change the usual requirements for patentability: novelty, inventive activity, and industrial application. In the US, however, under the Biotechnological Process Patent Act of 1995, a biotechnology process patent can claim obvious subject matter if a composition (such as a host cell) that is used or produced by the obvious process is novel and not obvious. That US law was enacted because, unless a patent on a process (or a patent on the final product) was obtained, the final product could be produced overseas and imported into the US without infringing a patent on the materials used in the process.

Conclusions

If sorting out this legal process seems unduly burdensome for the biotechnology industry, one can take solace in the fact that the computer industry went through similar growing pains. Long before personal computers, the US Supreme Court rejected the patenting of an algorithm for converting numbers from decimal to binary form - a function performed by most software. The computer software industry overcame this obstacle by claiming a mathematical algorithm in combination with a physical processes. Those patents were upheld by the US Supreme Court. The biotechnology industry, if it is to successfully mount a similar challenge, would do well to take a page from this legal history by demonstrating the industrial application of biological materials, particularly if those materials are naturally occurring.

Footnotes

1. The European Patent Convention (EPC) is a treaty that predates the EU and was signed by the nations that are now members of the EU. Under this convention, a single European Patent Office(EPO) was established as a central location for examining all European patent applications.
2. In the US, the Animal Legal Defense Fund (ALDF) sued the US Patent Commissioner; the case was summarily dismissed because the ALDF was told it had no standing to sue. That is why the Harvard mouse patent did not face the same opposition that it faced in Europe. In Europe, however, the directive's prohibition on patents against public policy will continue to give Greeenpeace legal standing to challenge biotechnology patents. Amgen v. Chugai, 927 F.2d 1200(Fed. Cir. 1991).

   BREFFNI BAGGOT
   Intellectual Property Law
   P.O. BOX 1215
   MANCHESTER, CT 06045-1215 USA
   PATENTE.COM
   TELEPHONE: (860) 644-6974
   FAX: (860) 644-3477

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   Last Updated on5/2/98
   By Karen Lutz
   Email: karen@hillnet.com