By Kevin E. Noonan --
One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something other than a mammalian virus, these mice were susceptible to certain cancers due to the presence in their germline (and thus all somatic tissues) of an activated form of the c-myc oncogene.
Ultimately three patents arose from the disclosure of this invention, having the following representative claims:
• U.S. Patent No 4,736,866 (filed June 22, 1984, granted April 12, 1988, and expired on April 12, 2005):
1. A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.
(The perceptive will note the affirmative limitation that the transgenic animal must be a non-human animal, a limitation included in these and all transgenic animal claims under the mandate of the 13th Amendment.)
• U.S. Patent No. 5,087,571 (filed March, 22, 1988, granted February 11, 1992, and expired on April 12, 2005 as the result of a terminal disclaimer filed in this application, instead of February 11, 2009 which was 17 years from the issue date this application was filed as a "voluntary divisional" of the '866 patent, i.e. because there was no restriction requirement imposed by the Office during prosecution of the '866 patent):
1. A method of providing a cell culture comprising
(1) providing a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage; and
(2) culturing one or more of said somatic cells.
2. A cell derived from a somatic cell obtained from a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage which cell contains said recombinant activated oncogene sequence.
• U.S. Patent No. 5,925,803 (a continuation of the '571 patent, filed September 19, 1991, granted July 20, 1999; its expiry date is the subject of the Court's decision):
1. A method of testing a material suspected of being a carcinogen, comprising exposing a transgenic mouse to said material and detecting neoplasms as an indication of carcinogenicity, wherein the germ cells and somatic cells of said mouse contain an activated oncogene sequence introduced into said mouse, or an ancestor of said mouse, at an embryonic stage.
A Third Party Requestor filed an ex parte reexamination request against the '803 patent on the grounds that the '866 patent (in combination with one or several secondary references) rendered these claims invalid for obviousness-type double patenting (see "Re-examination Ordered on "Expired" Harvard Oncomouse Patent"). In the course of this reexamination the Examiner refused to enter seven additional claims on the grounds that the '803 patent had expired due to the terminal disclaimer filed in the '571 parent patent in response to an obviousness-type double patenting rejection asserted by the Examiner. Assignees Harvard and DuPont appealed to the Board of Patent Appeals and Interferences (now, the Patent Trial and Appeal Board) and then sued in district court, which granted summary judgment to the Patent and Trademark Office that the terminal disclaimer operated to cause the '803 patent to expire on April 12, 2005. This appeal followed.
The Federal Circuit affirmed, in an opinion by Judge Moore, joined by Judges Lourie and O'Malley. Applying the "arbitrary, capricious, contrary to law or abuse of discretion" standard under the Administrative Procedures Act, 5 U.S.C. § 706(2)(A), the panel held that this agency action fell within none of these invalidating standards. They rejected Harvard's contentions that there was no evidence of record that the fee required for a terminal disclaimer had ever been paid, and further that the '803 patent did not contain a Notice that the term of the patent was subject to a terminal disclaimer. One reason for rejecting these assertions was that the burden was on the patentee to establish that agency action was "arbitrary, capricious, contrary to law or abuse of discretion" and the only evidence presented was negative evidence that there was no affirmative evidence that, inter alia, the proper procedures were followed in 1988, based on affidavits from the prosecuting attorney and Controller of the firm that had prosecuted the patents. The Court also rejected arguments that the Patent Office's own record keeping provided no evidence that the terminal disclaimer had been properly entered in the '571 patent, in violation of procedures found in MPEP § 717.01 (5th ed. Rev. 6, Oct. 1987) (from the relevant time frame). Harvard even argued that the fact that the Examiner withdrew the obviousness-type double patenting rejection after the terminal disclaimer was not filed is not dispositive, because the Examiner noted in the record that she had withdrawn this rejection based on applicant argument and did not specifically cite the terminal disclaimer in this regard.
Judge Moore's opinion also relied on deference from the reviewing court to the trial court, saying that "[w]hile we might have reached a different result if we were weighing the evidence in the first instance, this we cannot do," citing Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). Citing In re Gartside, 203 F.3d 1305, 1312 (Fed. Cir. 2000), the opinion further noted that the "arbitrary and capricious" standard was the most deferential and would be satisfied only when "a reviewing court can conclude with 'definite and firm conviction' that a clear error of judgment or a mistake has been committed," citing PGBA, LLC v. United States, 389 F.3d 1219, 1231 (Fed. Cir. 2004).
The Court used a "rationality" test to come to its conclusion, explained in the opinion as those instances where "we must sustain an agency action evincing rational reasoning and consideration of relevant factors," ultimately based on the Supreme Court's dictates in Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S. 281, 285 (1974), and Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971). The Court found that the Patent Office's decision contained the required evidence of rationality based on 1) the plain meaning of the text in the terminal disclaimer, wherein Harvard purported to attest that the fees had been paid ("accompanying this disclaimer is the fee set forth in 37 C.F.R. § 1.20(d)"); 2) the Examiner's withdrawal of the obviousness-type double patenting rejection after Harvard filed the terminal disclaimer (noting that there was no other response to this rejection other than filing the terminal disclaimer); and 3) the evidence that the Patent Office had recorded the terminal disclaimer despite any other record keeping irregularities cited by patentee. "Collectively, this evidence provides a rational basis for the PTO's factual finding that the terminal disclaimer fee was filed" said the Court. Against that the Court assayed the declaration evidence from twenty years after the fact and these record-keeping irregularities, none of which provided the "overwhelming" evidence the panel stated was necessary to rise to a finding that the Patent Office's actions were arbitrary and capricious. What's more, the panel cited precedent directly contrary to Harvard's position: in Vectra Fitness, Inc. v. TWNK Corp., 162 F.3d 1379, 1381–82 (Fed. Cir. 1998), these same types of record keeping irregularities were held not to be enough to find that the terminal disclaimer in that case was without effect. Thus, "while the PTO may have procedurally mishandled the terminal disclaimer when placing it in the file, this does not render arbitrary and capricious the PTO's factual finding that the terminal disclaimer fee was nonetheless paid."
Thus ends the period of exclusivity for the Harvard Oncomouse patents.
"All things are artificial, for nature is the art of God." Sir Thomas Browne (Harvard patented mice).
President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)
Panel: Circuit Judges Lourie, Moore, and O'Malley
Opinion by Circuit Judge Moore