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A European Union vote May 12th could open the door to transgenic animal and
plant patents

By BREFFNI BAGGOT

Microsoft Corp. chairman Bill Gates has said that the computer revolution is
unfolding at an exponential rate. But with respect to genetically engineered
plants and animals, there are many reasons to think that we are on the eve
of a biotechnological revolution that will unfold even faster.
How can that be?

While computer innovations cannot propagate themselves without human
intervention, transgenic plants and animals do reproduce, sometimes at an
astonishing rate. Allowed to unfold without fetter, we might look forward to
an era of self-propagating technological innovation.

Until now, this revolution has been limited by laws in Europe that prohibit
worldwide patenting of transgenic inventions. But the European Union voted
this May 12th in favor of the Biotechnology Patent Directive, a measure that
would remove legal prohibitions to patenting transgenics.

SOWING THE SEEDS OF DISCONTENT

In Europe, two laws bar the patentability of transgenics. The first is a
provision of the European Patent Convention -- EPC -- 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. Under
EPC 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.

The problem with the EPC is that interpretations of its provisions vary from
country to country. As a result, the EPO 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 transgenic mouse 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 "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 the patent
exclusion under Article 53(b). As a result, the EPO granted its first patent
on a transgenic nonhuman animal. An environmental group, Greenpeace, filed
an opposition asking the EPO to revoke the patent. The EPO is considering
the opposition.
The issue of morality was handled by weighing the environmental risks and
potential for cruelty to animals against the potential benefits to mankind.
With the Harvard mouse, the examining division found that the interest in
developing anti-cancer 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).

In the United States, the Animal Legal Defense Fund sued the U.S. patent
commissioner. But the case was dismissed because the ALDF had no standing to
sue. That is why the Harvard mouse patent did not face the same opposition
in the U.S. that it faced in Europe. In Europe, however, the directive's
prohibition on patents on products contrary to public policy will continue
to give Greenpeace legal standing to challenge biotechnology patents.

PATENTING A TRANSGENIC PLANT

After the Harvard mouse case, it appeared to most observers that Europe
favored patenting transgenic plants and animals. Plant Genetic Systems -- a
company based in Ghent, Belgium -- subsequently sought a patent for a
transgenic plant, which the EPO granted. Greenpeace again filed an
opposition. In this case, however, the board moved more quickly to
re-examine the patent. In making its decision, the EPO found nothing immoral
in the patenting of the plant under 53(a), but rejected the application
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 allows
the patenting of the product of a microbiological process. The board's
explanation for this ruling was that plant cells and seeds are classified as
"microorganisms." Under the board's definition, a single cell capable of
reproduction falls 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 thus are confronted with a dilemma. On the
one hand, the EPO has granted a patent for a transgenic in the case of the
Harvard mouse; on the other hand, the EPO has denied a patent for a
transgenic in the case of the PGS plant. These contradictory rulings have
created enough uncertainty that inventors and their investors are wary of
launching their commercially viable intellectual properties.

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 are set
forth in 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 they 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 pre-exists 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, 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 what 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, 927 F.2d 1200 (Fed. Cir. 1991). In that 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 U.S., inasmuch as the patent laws in Europe are
different from those in the U.S.

For example, the new EU directive will not change the usual requirements for
patentability: novelty, inventive activity and industrial application. In
the U.S., 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 law was enacted to protect American
inventors who failed to obtain a patent on a process or a product here from
suffering competitive losses where that product or process is patented
overseas and imported into the U.S.
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 U.S. Supreme Court rejected the patenting of an algorithm for converting
numbers from decimal to binary form -- a function performed by most software
today. The computer software industry overcame this obstacle by claiming a
mathematical algorithm in combination with a physical process. Those patents
were subsequently upheld by the Supreme Court.

The biotechnology industry, if it is to mount a similar challenge
successfully, 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.




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AUTHOR
BREFFNI BAGGOT is a solo practitioner in Manchester, Conn., specializing in
biotechnology law. He is an adjunct professor at the University of
Connecticut and teaches a course in patents and creativity. Baggot writes
the column "Patent Review" for The Journal of Human Gene Therapy.



Headings
Biotechnology law

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