Patentability and Pro-life Politics
The United States is on the verge of enactment of a law that would inject "pro-life" politics squarely into the patent arena. Indeed, a bill sponsored by Rep. David Joseph Weldon (R-Fla.) would codify the U.S. Patent and Trademark Office's existing policy that human organisms are ineligible subject matter to patent. In other words, if the bill becomes law, then the USPTO would be barred from issuing patents claiming human organisms, including genetically engineered embryos, fetuses, and human beings. HR 7274 (2003).
Both the House and the Senate have considered such legislation, which were part of an omnibus spending bill, which will be considered again early in 2004. Furthermore, according to the Associated Press, James E. Rogan, Under Secretary and PTO Director, said the Patent Office viewed the Weldon amendment as "fully consistent with USPTO's policy on the non-patentability of human life-forms." On top of that, there is no apparent pulse in the intellectual property community to block this legislation. 1 Meeting little resistance, the "Weldon amendment" has a significant chance of becoming law, because the House, Senate, and the President (as represented by the Under Secretary) have agreed upon the amendment's wording, and the amendment is part of the current omnibus spending bill that will eventually have to pass the Congress to keep the federal government funded.
Yet some members of the patent bar have questioned whether or not the Patent Office has the authority to deny patents claiming human life-forms. Others have questioned whether or not a pro-life law is necessary. Yet others are concerned about the reaction to pro-life laws in the international community.
Those questioning the authority might urge that the Patent Office must issue a patent if certain statutory criteria are met. The statutory criterion barring patenting human organisms, according to the Patent Office, is that human organisms are ineligible subject matter.
Yet, according to those questioning authority, the Patent Office's position conflicts with the reasonable legal interpretation of what is and is not eligible subject matter for patenting. Eligible subject matter includes "anything under the sun made by man." 2 Thus, according to this group, the only reasonable choice is that eligible subject matter includes man-made human organisms.
And if all man-made human organisms are eligible subject matter, then this statutory criterion will not bar patenting human organisms. In other words, this group would argue that the Patent Office must issue a patent if the remaining statutory criteria are met.
On the other hand, others would argue that the Patent Office's position reflects the pro-life policy view of what is and is not eligible subject matter for patenting. This group would argue that the Chakrabarty Court decided a narrow issue, whether bacteria were eligible subject matter, not whether humans are eligible subject matter. Furthermore, this group would contend that there are competing interests that Congress could not have resolved and therefore left it to the agency for decision. Indeed, in 1952, when the Patent Act was written, human organisms were not within the realm of possible subject matter. As a result, Congress could not have resolved whether or not human organisms were eligible subject matter and left the agency to decide the issue. And while the agency is not accountable to the people, the President is. Thus, it would be appropriate to hold the President accountable for the agency's pro-life policies.
But whatever side of the eligible subject matter issue suits you, one has to question whether the law is needed. The Patent Office has already indicated it will not grant a patent claiming a human organism. Furthermore, the amendment seems to have been motivated by a misunderstanding of what rights patent law grants to the patent holder. Specifically, Rep. Weldon stated that "[a] patent on [ ] human organisms would last for 20 years. We should not allow [rogue] researchers to gain financially by granting them an exclusive right to practice such ghoulish research." Id. (emphasis added). But a patent is only a negative right to exclude others from practicing an invention. It gives the rogue researcher no license, no right to practice his Transylvanian-like trade or in any way to anything contrary to the laws set forth by other agencies such as Health and Human Services. "The public, therefore, is in no way protected either by the granting or withholding of a patent." In re Hartop, 311 F.2d 249, 263 (CCPA 1962).
The United States needs to set a leadership example for the world in promoting the broad, non-exclusionary scope of patent-eligible subject mater. As the world's technology leader, American high technology leadership is at stake. If we cannot sell our products in foreign markets, we force all the costs of development onto domestic consumers and industry. If the United States as the leading proponent of strong patent rights – up until now – enacts legislation that restricts biotechnology research, then the anti-patent countries of the developing world are sure to jump on the Weldon Law bandwagon. But instead of merely banning patents dealing with "humans" they may as well ban patents on any animal. Furthermore, they will be within the literal scope of the W.T.O. and TRIPS in doing so, as there is an express caveat permitting any country of the W.T.O. to TRIPS, to "exclude from patentability *** animals other than micro-organisms ***." TRIPS Art. 27(3)(b). But, instead of merely excluding human organisms, developing countries could just as easily go much further.
The views expressed in this article are those of the authors and do not necessarily represent the view of anyone else, including any attorney of Foley & Lardner and their clients.
[1] While BIO initially protested, it is now reported in the press as not pushing against the legislation. In fact, no group–the American Intellectual Property Law Association, Intellectual Property Owners, the American Bar Association, BIO, or any organization–has made any major fight against this law.
[2] Diamond v. Chakrabarty, 447 U. S. 303 (1980) (quoting language from a congressional Committee Report indicating that "Congress intended statutory subject matter to `include anything under the sun that is made by man.' " Id., at 309 (quoting S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H. R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952))).