Boston Scientific Corp. v. Johnson & Johnson, Nos. 2010-1230, -1231, -1233, -1234 (Fed. Cir. June 7, 2011) (Judges Bryson, Gajarsa, and Moore)

The stent wars continue. . . . First J&J and Cordis filed four suits against Abbott in New Jersey, alleging that Abbott infringed four stent patents. This time, Boston Scientific filed four preemptive patent lawsuits against J& J and Cordis alleging the same patents are invalid. In the second round of lawsuits, the written description requirement became an insurmountable hurdle for the J&J medical device patents.

J&J asserted patents relating to drug-eluting stents that are used to prevent the narrowing of arteries after a catheter removes blockages. The Federal Circuit held that J&J is not entitled to have the jury consider whether its patents satisfy the written description requirement.

After reviewing this patentability requirement, which was discussed at length in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the court considered the evidence that J&J provided regarding knowledge of the structure, mechanism of action, and biological use of rapamycin (and related compounds) around the time that the first patent application was filed. Though the common patent specification discloses a large genus of compounds, it lacks sufficient description of a representative number of species or common structural features of the genus members. It specifically describes use of rapamycin in the stent, but it does not describe use of rapamycin analogs (related compounds) to inhibit artery-clogging activities. Moreover, the specification acknowledges the uncertainties surrounding rapamycin and drug-eluting stent usefulness as a treatment to prevent narrowing of arteries.

Given the scope of the genus of compounds identified in the specification and the fact that only a few of the rapamycin analogs were known in the industry at the time, the claims covering tens of thousands of compounds or sub-genuses did not meet the written description requirement. And the functional language present in some of the claims was insufficient to overcome these deficiencies.

Judge Gajarsa wrote separately to explain that he would decide that three of the four patents are invalid for lack of enablement. So he concurred in the judgment on those three patents.  He also expressed the view that the majority blurred the line between the enablement and written description requirements in its analysis of these three patents.

Read the Boston Scientific opinion here.

 

Siemens Medical Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., Nos. 2010-1145, -1177 (Fed. Cir. June 7, 2011) (en banc order)

Saint-Gobain asked the full court to consider the question of whether a patentee can use the doctrine of equivalents to expand its claim scope to cover a new and separately patented technology (i.e., make it a dominant patent through use of the doctrine of equivalents). The en banc request was denied, but a number of interesting opinions accompany the order.

Saint-Gobain received the support of Judges Dyk, Gajarsa, and Prost, who would take the case to consider the question of whether a patent’s claim scope can encompass a new and separately patented or patentable invention. They expressed the view that the doctrine of equivalents is not designed to enable the patent holder to secure rights to a new invention—so if technology is separately patentable, it cannot be covered under the doctrine of equivalents analysis for a different patent.

Judge Lourie (who was joined by 5 judges) disagreed with the dissent and characterized this case as one that involves the question of whether the burden of proving patent infringement should be raised to the higher clear and convincing standard rather than the current preponderance of the evidence standard when the accused subject matter is separately patented. The accused infringer, Saint-Gobain, obtained a license to a later-issued patent claiming technology that overlaps with the patent it was sued on.

Chief Judge Rader wrote separately (and was joined by three judges). He defended application of the doctrine of equivalents to cover after-arising technology developments using the patent statutes and a number of landmark decisions the court issued in the past that support this view.  Judge Newman (joined by two judges) also wrote separately to support the denial of the petition and cautioned against rebalancing the protections for the inventor vs. copier of technology, which could diminish the economic incentives to innovate and create new products.

Given the number of opinions that issued with the order denying Saint-Gobain’s request to take the case en banc, it seems that the court had a lively discussion regarding this petition. We will be tracking this case, to see if Saint-Gobain files a petition for certiorari.

Read the en banc order and opinions here and the errata here.

 

In re Klein, No. 2010-1411 (Fed. Cir. June 6, 2011) (Judges Newman, Schall, and Linn)

How sweet is victory! Mr. Klein won his appeal from a Board of Patent Appeals and Interferences (BPAI) decision that his patent application on a mixing device for use in preparation of sugar-water nectar for certain bird and butterfly feeders is obvious and not patentable. The Federal Circuit concluded that the BPAI’s determination that certain references used to reject the claims are analogous art was flawed. The BPAI failed to make a factual finding that these references are relevant to the multiple-ratio-mixing problem Mr. Klein addressed with his invention.

Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Since the BPAI failed to provide substantial evidence to support its conclusion that all five references are analogous art under either test, the decision was reversed and the case was returned to the patent office.

Read the Klein opinion here.

 

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