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September 21, 2006

Publish, Then Discover

Nichols Institute Diagnostics sued Scantibodies Laboratory for infringing 6,030,790. The problem was that the inventors had published an early abstract of work later patented. The delay in patenting was caused by not realizing the significance of what they had discovered and published. Oops.

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 circulating in a patient’s bloodstream may be measured by creating antibodies that bind to specific amino acid sequences, also referred to as peptides, of hPTH and then incorporating those antibodies into a well-known immunoassay test.

In September of 1994, Dr. Marcus Magerlein and five of his colleagues 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 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, Dr. Magerlein and his colleagues filed the patent application that is the subject of this litigation.

At trial, the jury found the patent "invalid for failure to disclose the best mode, and for lack of enablement and written description." Pretty crappy patent (actually, it is).

Appeal (CAFC 06-1087); bad to worse.

Because the district court erred in denying partial summary judgment that the ’790 patent is anticipated and granting partial summary judgment that the ’790 patent is not anticipated, we reverse the grant of summary judgment of no anticipation, hold that all of the asserted claims (i.e., independent claim 17 and its dependent claims 20 through 25) are anticipated under 35 U.S.C. § 102, and direct entry of judgment for Scantibodies.

Nichols also contends that the abstract does 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. Nichols also asserts that the abstract is not a “printed publication” under 35 U.S.C. § 102(b) because it was not adequately indexed.

The "not a printed publication because it wasn't adequately indexed" got a laugh. Hell, to the appeals court, cave drawings practically qualify as published prior art, the bar is set so low.

Not realizing the significance of what they had published, then trying to patent it over a year later, is pathetically laughable.

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, shows predominant binding to peptides having the first two amino acids. Dr. Magerlein testified, and Nichols does not dispute, that the K2 antibody is the same as the claimed antibody.

[T]he abstract inherently anticipates. See Schering, 339 F.3d at 1377 (holding that “a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference”). Because the abstract inherently meets each and every element of the asserted claims, the asserted claims are anticipated and hence invalid. Id. at 1379.

Posted by Patent Hawk at September 21, 2006 12:10 AM | Prior Art