In my recent post on the Centocor v. Abbott decision, I noted that the Fed. Cir. had at least preserved the “antibody exception,” which I define as permitting broad claims to structurally uncharacterized antibodies (monoclonal and polyclonal) if the structure of the antigen is known (and preferably is novel) and methods of preparing the antibodies are routine. This dicta has been recently “followed” by the Canadian Patent Appeal Board in an appeal involving Immunex.
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Late on March 8th, the Senate almost unanimously passed S. 23, which was only introduced in January. (A copy of the bill is available at the end of this post.) I last commented on the features of this bill in a January 20th post, and since then, other commentators have raised specific issues that the Senators and organizations lobbying for passage do not appear to have considered in depth. With most of the litigation-oriented sections gone – due to recent or impending court decisions on the various points of law like damages, venue and willfulness – the primary features of the bill are designed to make it more difficult to obtain patents. Not only will patent applications be subject to third party submissions of prior art, but there will be a nine-month period for opposition following issuance, streamlined inter partes examination and a “supplemental examination process” to help applicants fix flawed patents.
Commentators have pointed to serious flaws in the first-to-file system. Inventors may receive a grace period for disclosures they originate, but, when earlier-filed third party applications publish, they will be applied against the later-filed claims using an obviousness standard, not the “novelty-only” standard applied in most other countries. And we prosecutors are learning that, post-KSR, the bar to leap to establish unobviousness is very high.
Contributed by Jim Nelson, J.D., Ph.D. of Schwegman Lundberg & Woessner, P.A.
The Siemens Medical Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., (a copy is available at the end of this post) case presents a fundamental issue and holding about equivalents in the face of a patent covering the product alleged to infringe another patent under the DOE.
The Court said that an equivalent of the claims at issue is present even though that equivalent was literally claimed in another patent. Of course that holding tracks the rule we all have learned: domination. You can patent an improvement of an earlier patented invention but your patent will be dominated by that earlier patent. Usually, this domination rule is considered in terms of literal infringement, not doctrine of equivalents.
In this situation, the defendant offered a clever retort to the domination rule. The defendant said that because of the relation among equivalents, obviousness, the later patented product, the plaintiff needed to show equivalents by a higher degree of proof, clear and convincing evidence, not preponderance of evidence. The defendant based its argument upon the theory backed by case quotes such as that from Judge Nies: a substitution in a patented invention cannot be both nonobvious (leading to a patent on the substitution) and insubstantial (leading to infringement under DOE).
The majority of the Court disagreed. They said that obviousness is not tantamount to equivalents.
Now some of them are not yet carved in judicial stone, being at various stages of appeal, but the sum of KSR, Bilski (well, I guess it was more pro-patent than the strict M or T test it replaced with a test yet-to-be-determined), Ariad v. Lilly (WDR grows up), Lilly v. Sun,(broadened base for obviousness-type double patenting), Centocor v. Abbott (WDR rules), Microsoft v. i4i (lower evidentiary bar to patent invalidation), Janssen v. Teva (no utility for hypothetical bioactivity), Stanford v. Roche (weakens Bayh-Dole Act), Myriad (DNA and diagnostics are natural phenomena), Therasense v Becton Dickinson (more ways than ever to show inequitable conduct), and the WARF stem cell reexamination (WARF lost at the Board) do not bode well for the system Jefferson hoped would help modernize the young republic. The only bright spot on this judicial trial of tears was the Fed. Cir.’s affirmance in Prometheus v. Mayo in December that methods of medical treatment and monitoring past muster under Bilski. And yet, even this modest decision may be reconsidered by the Supreme Court.
Still, the last time the full court addressed the issue of patentable subject matter was in 2001 in Pioneer v. JEM Ag Supply, in which the patent eligibility of plants was affirmed, and the Court refused to back down from Chakrabarty. The issuance of the Chakrabarty patent was 30 years ago this month and most would agree that granting biotech patents has done our society a lot more good than it has rained evil upon us. Except, perhaps for the folks who are trying to block Obama’s order permitting funding for stem cell research. Or the Myriad plaintiffs. But they are in the minority. Aren’t they?
