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CLONING ISSUES AND THE CURRENT
PATENT SYSTEMS IN THE
UNITED STATES AND EUROPE
MONIQUE MORNEAULT*
Thank you for having me today. I am going to focus on cloning and
the patent protection in both the United States and Europe, comparing and
contrasting some of the current laws that are in place.
My presentation today is going to generally cover the following:
Patentable subject matter in the United States and Europe; the clash of
patentability; the morality in the United States and Europe, the
harmonization, or not, between the laws of the United States and Europe;
and where we are today. Basically, I think everyone has a pretty good
understanding of where the controversy stands.
I want to start with the law in the United States, 35 U.S.C. § 101,1
which specifically states that, “[w]hoever invents or discovers any new and
useful process, machine, manufacture, or composition of matter … may
obtain a patent therefor, subject to the conditions and requirements of this
title.”2
The Supreme Court, initially, addressed the patentability of
bioscience inventions in Diamond v. Chakrabarty,3 where the Court
determined that section 101 was sufficiently broad to encompass a living
microorganism, and thus expanded patentability to this matter. The Court
stated that a patent can be granted on anything under the sun that is made
by man.
The utility requirements under the patent laws for bioscience
*
1.
2.
3.
Monique Morneault is a shareholder with Wallenstein, Wagner & Rockey, Ltd. Her
practice includes patent and trademark filing, prosecution, and counseling. Attorney
Morneault is also the Director of the firm’s International Patent Group. She earned
her J.D. from IIT/Chicago-Kent College of Law, and a B.S. in microbiology from the
University of Illinois at Urbana-Champaign.
35 U.S.C. § 101 (2000).
Id.
447 U.S. 303 (1980).
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inventions have typically received a slightly elevated standard. The
Supreme Court in Brenner v. Manson4 addressed the utility requirement.
More recently, the guidelines for examination set forth by the United States
Patent and Trademark Office (USPTO) delineate the requirement that
basically, the invention should be useful for any particular purpose
considered credible to a person of ordinary skill in the art.
However, the USPTO would prefer to treat patents related to biotech
inventions the same as other areas of technology, and has not set up
separate standards for biotechnology inventions. They all have to meet the
same requirements for patentability as other technologies. In Europe, the
patentable considerations are that the patent must have industrial
applicability, be new or novel, just as here in the United States, and involve
what they call an “inventive step,” or non-obviousness.
Europe, however, has put in a morality provision for the patentability
of inventions. Exceptions to patentability are inventions, the publication or
exploitation of which would be contrary to the “order public,” or morality.
This provision is codified in Article 53 of the European Patent
Convention.5
In 1998, in an effort to harmonize the laws within Europe, the
Biotechnology Directive was introduced.6 The Biotechnology Directive
includes a provision that addresses morality. Inventions are considered
unpatentable when their commercial exploitation would be contrary to
order public or morality, which is similar to the already codified Article
53.7 The Biotechnology Directive also specifically sets forth certain
exceptions from patentability, two of which are the process for human
cloning and the use of human embryos for industrial or commercial
purposes.
The United States also has a moral utility doctrine, which was set
forth in 1817 by Justice Story;8 however, the moral utility doctrine is not
typically used by the USPTO to reject applications or to invalidate existing
patents. Chakrabarty also did not address the morality issue of the
genetically engineered bacteria that was the focus of the application, but
rather addressed whether the invention was natural or man-made, making it
patentable. Europe, on the other hand, has codified morality provisions to
deny patents on the grounds of moral concerns, as I mentioned earlier, and
again specifically excludes processes for cloning human beings from
4.
5.
6.
7.
8.
383 U.S. 519 (1966).
European Patent Convention, art. 53, available at http://www.european-patentoffice.org/legal/epc/e/ar53.html#A53 (last visited Feb. 22, 2005).
Council and European Parliament Directive 98/44/EC, 1998 O.J. (L 213) 13.
Id. at art. 6.1.
Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568).
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patentability. The question is whether this ethical exclusion not only
prevents patenting, but inhibits commercial exploitation of inventions.
The following is a discussion of a couple of examples of the lack of
harmonization between the United States and Europe in terms of patent
laws. The “Harvard Mouse” was a pre-Biotechnology Directive
application.9 The United States granted a patent for a transgenic mouse that
had been genetically engineered to make it more susceptible to cancer for
research purposes.10 In Europe, however, the application was initially
rejected as not patentable subject matter, but not under the morality
provision. On appeal, the examiner was reversed, and the court stated that
there was patentable subject matter and remanded the application back to
the examiner to determine whether it violated Article 53. However, the
examining division determined that there was no violation of the morality
provision. In 2004, the Appeal Board maintained the patents as to
“transgenic rodents” from “non-human mammalian animals,”11 the claims
that were eventually allowed in the applications.
A second example is the Edinburg Patent,12 which came postBiotechnology Directive. A European patent was granted on the isolation,
selection, and propagation of animal transgenic stem cells. The concern
there was that the claims encompassed human cloning because opponents
of the patent argued that the “animals” equal “humans.” Opposition
procedures are permitted in Europe, where once the patent is granted, it is
published, and third parties are permitted to oppose the patent application
before it is finally granted. In the case of the Edinburgh patent, oppositions
forced amendments to the claims to exclude embryonic stem cells. What
remained in the application were adult stem cells, animal stem cells, and
human stem cells, but embryonic stem cells were excluded in view of the
Directive. As you can see between the two cases, the European Patent
Office appears to be relatively reluctant to apply the morality provision in
the prosecution and granting of patents.
So where are we today? In the United States, there are no current bans
on patents for cloning technology or stem cells if they are modified or
isolated from their natural environment, in other words, “manmade.” The
9.
10.
11.
12.
U.S. Patent No. 4,736,866 (issued Apr. 12, 1988).
See Angela Furlanetto, The Harvard Mouse Case: Developments in the Patentability
of Life Forms, INTELL. PROP. SEC. NEWSLETTER (Canadian B. Ass’n), June 2003, at
http://www.cba.org/CBA/newsletters/ip-2003/ip2.asp.
Paula Park, EPO Restricts OncoMouse Patent, THE SCIENTIST, July 26, 2004,
available at htto://www.biomedcentral.com/news/2004/0726/03.
Graeme Laurie, Patenting Stem Cells of Human Origin, Remarks at International
Association for the Advancement of Teaching and Research in Intellectual Property
Congress 2003 (Aug. 4, 2003), available at http://www.atrip.org/upload/files/
activities/tokyo2003/s01-Laurie_art.doc.
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USPTO does ban patent claims encompassing human life forms. Of course,
that has caused a lot of debate as well, because how do you define human
life forms?
Then there was the Weldon Amendment, an appropriations bill that is
not part of the Patent Act, but which prohibits funding of patents that
encompass the human organism.13 Again, the biotechnology organizations
opposed this Amendment because how do you define what a human
organism is?
Europe does not allow patents to be granted on human cloning, just
like the United States. In a recent European Patent Office decision, the
European Group on Ethics denied patent protection for embryonic stem
cells, which may shadow the patenting of stem cells in Europe.14 However,
recently a European patent was granted for a method of storing frozen
biological specimens, including embryos, morulae and blastocysts, which
are the early stages of an embryo. There has been opposition filed against
this patent as well, arguing that it violates morality.15
Basically, the bottom line is that while there is the possibility of
getting patents on “controversial” technology both in the United States and
in Europe, both areas face uncertainty in clearly defining patentability.
Thank you.
13.
14.
15.
The Weldon Amendment is part of the Consolidated Appropriations Bill of 2004,
Pub. L. No. 108-199, 118 Stat. 3. See Chris Steinhardt, Special Committee on the
Weldon Amendment, Special Committee on the Weldon Amendment to H.R. 2799,
The Appropriation Bill for the Departments of Commerce, Justice, State and the
Judiciary (2003-2004), available at http://www.abanet.org/intelprop/weldon_
committee_report.doc (last visited Jan. 31, 2005).
Press Release, BioScience 2004, Patently Problematic: The European Patent Laws
May Dissuade Stem Cell Research (July 20, 2004), available at http://www.
bioscience2004.org/press/laurie.pdf.
Press Release, European Patent Office, Method for Vitrification of a Biological
Specimen (Apr. 5, 2004), available at http://www.european-patent-office.org/news/
pressrel/2004_04_05_e.htm.