Manager's Amendment (and Others) to H.R. 1249 -- Human Patenting

By Kevin E. Noonan --

The patent community continues to wait for Rep. Lamar Smith (R-TX) to convince his brethren on the Appropriations Committee that the provisions of H.R. 1249 (formerly the "America Invents Act," now the "Leahy-Smith America Invents Act") that would put an end to patent fee diversion do not offend the Separation of Powers clause or the appropriators prerogatives, and thus that the bill should come to the House floor.  In the meantime, as part of the Manager's Amendment released by Rep. Smith, there is a provision that intends to codify the Weldon Amendment and prevent the patenting of human beings.

New Section 30 of the bill as amended is direct and to the point, providing a statutory prohibition against any claim "directed to or encompassing a human organism":

Sec. 30.  LIMITATION ON ISSUANCE OF PATENTS

(a)  LIMITATION. – Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.

(b)  EFFECTIVE DATE. –

(1)  IN GENERAL. – Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of enactment of this Act

(2)  PRIOR APPLICATIONS. – Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.

The impetus behind this amendment is apparently the same as the animus for the bill exhibited by House appropriators:  a fear that prohibiting USPTO fee diversion will release the Office from the financial strictures Congress has been able to impose as a way to influence patent policy.  One of these strictures is the Weldon Amendment, named for Rep. Dave Weldon (R-FL) (at left) and included in appropriations bills regarding the USPTO since 2003.  The language in Section 30 of the patent bill tracks the "human organism" language in the Weldon Amendment.  It may be recalled that several years ago Jeremy Rifkin filed a patent application (U.S. Patent Application Publication No. US 2003/0079240) on a human/animal chimera in an attempt to force the Patent Office to address the issue ("Human Animal Chimera Patent Challenge").

The USPTO has taken the position that the prohibitions in the Weldon amendment are precisely in line with its own policies and practices, as illustrated by a November 20, 2003 letter from USPTO Director Rogan to the late Sen. Ted Stevens, Chairman of the Senate Appropriations Committee at that time.  Rep. Weldon himself has said, during colloquy with Rep. Obey regarding the Manager's Amendment to the 2003 Appropriations bill, that the amendment would not interfere with any existing patents on human genes or stem cells.

Regarding the current patent "reform" bill, the scope of the prohibition appears to be limited to precisely those claims that the Patent Office has refused to patent (see M.P.E.P § 2105).  This provision reads (in pertinent part):

If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.  Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112 must also be made.

In their previous incarnation as an appropriations rider, these provisions were intended to exclude (i.e., not preclude patentability of):

1.  any chemical compound or composition, whether obtained from animals or human beings or produced synthetically, and whether identical to or distinct from a chemical structure as found in an animal or human being, including but not limited to nucleic acids, polypeptides, proteins, antibodies and hormones;

2.  cells, tissue, organs or other bodily components produced through human intervention, whether obtained from animals, human beings, or other sources; including but not limited to stem cells, stem cell derived tissues, stem cell lines, and viable synthetic organs;

3.  methods for creating, modifying, or treating human organisms, including but not limited to methods for creating embryos through in vitro fertilization, methods of somatic cell nuclear transfer, medical or genetic therapies, methods for enhancing fertility, and methods for implanting embryos;

4.  a nonhuman organism incorporating one or more genes taken from a human organism, including but not limited to a transgenic plant or animal, or animal models used for scientific research.

Presumably, the mere codification of 8-year-old appropriations language in the Patent Act itself does not signal a change in Congressional intent.  At any rate, cognoscenti will recognize that the 13th Amendment, which prohibits an ownership interest in a human being, should be sufficient to prevent patenting of human beings on Constitutional grounds and that the amendment to H.R. 1249 (as well as the Weldon Amendment to appropriations bills past and present) are not necessary.  The polarizing effects of a generation of abortion and anti-abortion debate and legislation makes inclusion of these provisions perhaps a political necessity; provided this Pandora remains firmly in a box limited to banning patenting of human beings (and written to ensure that no court will be able to expand the scope of the prohibition), inclusion of the provision would appear to raise no significant negative effect on protecting biotechnology inventions.

Analysis of additional portions of the Manager's Amendment, as well as other amendments, will be provided in future posts.

Comments

[EG]

Kevin,

Yet another misguided effort to ban patenting of living subject matter that is as perverse as the Becerra bills. Again, can only hope that this sort of nonsense will simply sink H.R. 1249 with no survivors.

[Skeptical]

Claims "directed to" human organisms?

Is medicine "directed to" a human organism?

Aside from any "tracking" or "apparant" link, the "direct" reading of this amendment is far more extensive than you might be inclined to think.

[Kevin E. Noonan]

Dear Skeptical:

No doubt - there is mischief to be made here, which is why the language of the bill needs work. I don't think legislative history will be sufficient.

Thanks for the comment.