The European Patent Convention: a moral roadblock to biotechnological innovation in Europe.

I. FROM WHENCE THEY CAME

A. In the Beginning, Logic Prevailed

B. Out of Right Field: A Radical Shift in Logic

C. The World Reacts: Perspectives on the Ideological

Shift

D. Ideology Realized: A Directive is Not Advisory

II. PATENTLY ILLOGICAL OR AN UNFORTUNATE

COMPROMISE III. A CASE FOR COMPARISON

A. European Patent Convention in Action

B. USPTO: A Different Story

C. A Consequence of Two Different Patent Systems

IV. EXEMPLARY CASE LAW AND CONFOUNDING MORAL

BLUNDERS

A. Harvard Oncomouse: Another Look

B. WARF/Stem Cells Case: Exiting the Cloud of

Confusion?

C. Edinburgh: How Far is Too Far?

D. Howard Florey / Relaxin: The Way We Were

E. Plant Genetic Systems: Pinnacle of

Understanding?

F. What Does It All Mean?

G. Where Do We Go From Here?

V. BEST LAID PLANS

A. Why Patent in the First Place?

B. What Does the European Patent Office Think?

C. What Happened: A New Direction for the Patent

System

VI. MINOTAURS, CHIMERAS, AND INGENIOUS STRATEGY

A. 50% Man, 50% Bull, 0% Patentable

B. Patenting on Abortion Technology: If You Can't

Beat 'Em, Join 'Em

C. What Good Can Come of the Minotaur? VII. IF YOU CAN'T SAY ANYTHING NICE, DON'T SAY

ANYTHING AT ALL

A. The Good Old Days: Prior to Enactment of

Directive 98/44

B. Post-Directive 98/44 Enactment: Cloud of

Confusion

C. Calling for a Return to Normalcy VIII. CONCLUSION

The purpose of this Comment is to question the vehicle by which the European Patent Convention (EPC) regulates biotechnological innovation involving human cloning research, stem cell research, and other innovative subject matter to which special interest groups object on moral grounds. (1) The moral debate surrounding controversial biotechnology, on the other hand, is far beyond the scope of this paper. (2) To that end, this Comment takes no stance pertaining to the issue of the merit of legislative regulation of biotechnological research. (3) Instead, this Comment will focus on critiquing the validity of the legislative means employed by the European Patent Office (EPO) to achieve its desired end of moral regulation of biotechnology research. (4)

To provide sufficient background necessary to appreciate the recurring theme of irony in the remaining sections, some basic characteristics of a patent system must be highlighted. Patents do not grant any positive rights to anything, but instead grant a limited negative right to exclude others from exploiting the patented subject matter (5) resulting in the now-old adage that patents are merely roadblocks. (6) Considering the roadblock role of patents in connection with the fact that most patents today are granted for improvements upon previous--and often patented--technology, (7) the purpose of patent rights is quite clear: negative exclusionary rights. (8) Improvement patents, the most common type of patent, often sit within previously patented technology meaning the holder of an improvement patent may not even be able to exploit his or her own innovation. (9) Given this context in which a patent holder not only has no positive rights by way of his patent, but he may even be precluded from exploiting his innovation due to the nature of the patent, it would be absurd to contend that denial of a patent that grants very limited negative rights to its holder would discourage research into a particular technology. (10)

Section VI of this Comment will detail a case illustrating that patents, functioning as roadblocks, grant exclusionary rather than positive rights upon a patent holder. (11) The discussion will specifically touch upon a widely recognized concept that even if a patent issued for some unimaginable morally objectionable innovation, the most the holder could do with the patent is prevent others from exploiting the innovation. (12) Now that the fundamental purpose of a patent is clear, the critique of the morality provisions of the EPC can proceed.

'Ordre' of Comment

This Comment will critique the logic behind relevant European Patent Office decisions, European directives, and EPC provisions, specifically Article 53(a) and Rule 23(d), that have shaped patent law in the European Union. (13) In that regard, Section I will analyze the opinions of advisors to the European Commission: The Group of Advisers on the Ethical Implications of Biotechnology (GAEIB) and later The European Group on Ethics in Science and New Technologies (EGE). (14)

Following the analysis of advisory opinions, and the comparison of the resulting European Directive and governing EPC provisions with the previously analyzed advisory opinions, Section II will highlight the disconnect between the opinions and directives and discuss the fundamental misuse of the patent system as a regulatory mechanism in the field of biotechnology, as noted in the academic literature. (15) Section III will provide a comparative analysis of European and U.S. patent systems by way of a recently decided biotech case. (16) Section IV of this Comment will analyze a group of exemplary cases handled by the European Patent Office illustrating the EPC in action and providing a platform upon which further critique of EPO methodology is built. (17) Section V will analyze the purposes and intended functions of a patent system. (18)

This Comment will shift gears in Section VI, considering two special cases in which ingenious tactics were employed by special interest groups thus exposing the logical flaws discussed throughout this Comment and highlighting the debate surrounding biotech innovation in both the United States and Europe. (19)

Finally, Section VII will set forth logical and effective alternatives to the current EPC that would improve the functioning of the EPC and enable the European Union to compete at a higher level in the field of biotechnological research while still addressing its moral and ethical concerns. (20)

I. FROM WHENCE THEY CAME

This section will analyze the opinions upon which the current statutory patent law in the European Union is based. (21) Subsection A will provide a detailed analysis of advisory opinions promulgated by the legislature regarding the inclusion of moral inquiry in the patent system. (22) Subsection B will reveal a radical shift in the logic behind the advisory opinions. (23) Subsection C will report the stance taken in the academic literature regarding the debate surrounding the shift in EPC ideology. (24) Subsection D will compare the resulting directive enacted by the same legislature that drafted the opinion upon which the directive is based, as well as highlight some of the glaring differences. (25)

A. In the Beginning, Logic Prevailed

To understand the governing EPC provisions and the European Union directive at issue, the opinions upon which their drafters relied must first be analyzed. (26) In 1993, a group of advisors to the European Commission issued an opinion on the ethical implications of biotechnology. (27) The advisors clearly understood the fundamental purpose of the patent system: to protect. (28) However, the advisors did not stop there, but proceeded a step further in pointing out what logically flows from the stated purpose of the patent system: (i) ethical and moral constraints placed upon the subject matter for which a patent is sought should be restricted to the advisory recitals of the directive issued by the European Commission, as opposed to the binding body of the directive itself; (29) and (ii) the regulation of research in specific morally or ethically sensitive areas should be affected by way of legislation governing such research as opposed to the patent system. (30) The advisors continued, after clearly articulating their position, in an attempt to lay to rest the widely held misconception that a relationship exists between cloning technology, patent law, and biodiversity. (31) The issue of biodiversity surfaced again as a central issue in the European Commission's objection to human cloning. (32) It is absurd that logical drafting, in reliance upon the clear recommendations of the advisory opinions discussed above, could result in directive provisions clearly taking the opposite position. (33) This logical gap is why this story does not end in 1993. (34)

B. Out of Right Field: A Radical Shift in Logic

In 1997, a group of advisors identical in membership to the advisory group who three years earlier issued the clear and logical opinion discussed above issued a subsequent opinion in what can only be described as a momentary lapse of reason, or possibly a state of temporary amnesia. (35) Already, the waters were muddied as the advisory group began to backpedal on their previous opinion. (36) Within the three-year period between the two opinions, the patent system, in a conceptual sense, must have evolved from a system designed to do no more than protect an invention into a vehicle through which society's ethical and moral concerns could be imposed upon the subject matter for which patent protection is sought. (37)

C. The World Reacts: Perspectives on the Ideological Shift