If you’ve ever worked with university inventors, you know that the pressure to publish is intense. Sometimes, that drive to publish comes back to bite you.
An invention can only be protected by patent if it is novel (that is, no prior publication of the invention has been made by the inventor or others). While the U.S. allows a one-year grace period, most countries follow a policy of absolute novelty, that is, no patent can be obtained if the invention has been publicly disclosed. Therefore, it is essential not to disclose the invention publicly until after a formal patent application has been filed.
Any printed publication in a newspaper, scientific journal, or other written form available on an unrestricted basis is considered a public disclosure, as is an oral presentation at a public meeting. Note that an abstract and, in some cases, even a title may act to bar patentability if it discloses all the necessary elements of the invention.
This is the result in the recent case where the inventors published an abstract that disclosed the necessary elements of the invention even though they did not appreciate what they had at the time they published.
In Nichols Institute Diagnostics v. Scantibodies (06-1087; September 20, 2006), the Federal Circuit reversed a district court’s grant of summary judgment of no anticipation and held that all of the asserted claims were anticipated under 35 U.S.C. § 102 by an earlier published abstract.
Nichols’ patent, U.S. Patent No. 6,030,790, covered compositions of antibodies that selectively bind to specific peptide sequences of hPTH 1-37, methods of using the antibodies to detect biologically active hPTH, and immunoassay test kits containing the antibodies for detection of biologically active hPTH. Representative claim 17 recites:
A composition comprising an antibody or antibody fragment and a suitable carrier: wherein the antibody or antibody fragment selectively binds a peptide of human parathyroid hormone (hPTH) selected from the group consisting of peptides having SEQ. ID Nos. 1-6.
SEQ. ID Nos. 1-6 being the sequence for hPTH 1-10, hPTH 1-9, hPTH 1-8, hPTH 1-7, hPTH 1-6, and hPTH 1-5, respectively.
Human Parathyroid Hormone (hPTH) is a protein comprised of 84 amino acids that plays an important role in regulating calcium metabolism. Various fragments of hPTH may circulate in the bloodstream; however, to be biologically active, a fragment of hPTH must include the first two amino acids and must be at least 34 amino acids long. The amount of biologically active hPTH may be measured by creating antibodies that bind to specific amino acid sequences of hPTH and then using those antibodies in an immunoassay.
The inventors published an abstract disclosing that they created ten antisera, labeled K1 through K10, each of which contained a mixture of antibodies that bound to specific peptides of a fragment of hPTH that contained amino acids 1 through 37 (represented as hPTH 1-37).
The abstract explained that the disclosed sera “provide the possibility to specifically detect the physiologically circulating fragment of human PTH in serum.” The abstract discloses that some of the sera, labeled K1 through K3, bound predominantly to hPTH peptides having the first two amino acids. Because the antibodies in the K1 through K3 sera bound predominantly to peptides containing the first two amino acids, and the antibodies in the other sera bound to peptides of hPTH containing blocks of amino acid sequences through 37, the sera could be used in combination to specifically detect hPTH fragments that include the first two amino acids and are 37 amino acids long.
The abstract was published and distributed to the public on September 12, 1994. It was not until after that date that the authors of the abstract discovered that, to be biologically active, a fragment of hPTH must have both the first two amino acids and be at least 34 amino acids long. Thus, it was not until after the abstract was published that the authors recognized the significance of the disclosure in the abstract.
On September 22, 1995, they filed the patent application, more than one year after the publication of the abstract.
Basically, the sera disclosed in the abstract contained a mixture of antibodies and the claimed antibody was present in the K2 serum. At trial, the district court concluded that the abstract did not inherently anticipate the claimed antibody because the claimed antibody “differentiates between biologically active and inactive hPTH,” whereas the abstract “does not disclose or suggest the means of differentiating between biologically active and inactive hPTH.”
On appeal, Scantibodies argued that, because it is undisputed that the antiserum disclosed in the abstract contained the claimed antibody, and because it was well known how to isolate the claimed antibody from the other antibodies in the disclosed serum, the abstract inherently anticipates the asserted claims.
The CAFC agreed:
We also hold, for the reasons below, that the abstract anticipates the asserted claims, because no reasonable juror could have found that the abstract does not inherently disclose the claimed antibody. SmithKline, 403 F.3d at 1343. The abstract itself and the testimony of Dr. Magerlein conclusively demonstrate that the abstract expressly or inherently discloses each element of the asserted claims. The abstract states that the authors have obtained antibodies and that “the different regions of hPTH 1-37 are covered by the produced antibodies. Furthermore, the combinations of two antibodies in a two-side assay are tested.” The abstract also discloses that sera mixture K1 through K3, which contains the K2 antibody (and) … the claimed antibody was isolated from the K2 antiserum using affinity purification, which was well-known in the art.
It is thus beyond dispute that the K2 antibody disclosed in the abstract is the claimed antibody and the claimed antibody could be isolated from the K1 through K3 sera by a technique that was well-known in the art.
Because the abstract inherently meets each and every element of the asserted claims, the asserted claims are anticipated and hence invalid. Id. at 1379.
Nichols tried arguing that the abstract did not anticipate because it was not until after the abstract was submitted that the inventors appreciated the significance of the claimed antibody, namely that it could be used to detect biologically active hPTH.
The CAFC didn’t buy that argument holding that:
Nichols’s argument that the abstract does not anticipate because the significance of the claimed antibody was not known until after the abstract was submitted is without merit. “[I]nherent anticipation does not require a person of ordinary skill in the art to recognize the inherent disclosure in the prior art at the time the prior art is created.” SmithKline, 403 F.3d at 1343 (citations omitted); see also Schering, 339 F.3d at 1377 (holding that “inherent anticipation does not require that a person of ordinary skill in the art at the time would have recognized the inherent disclosure”); MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999) (“Where . . . the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).
Nichols also asserted that the abstract was not a printed publication under 35 U.S.C. § 102(b) because it was not adequately indexed but that was soundly rejected.
There is a lesson here for anyone rushing to publish their results. When faced with an abstract or paper that is to be published prior to filing a patent application, one might want to try to omit critical details from the manuscript in order to keep it from being enabling in a patent sense. But, this could be living dangerously. It’s always better to file an application first.
