Diversion from the decision in Abbott Laboratories v. Sandoz, Inc
In the year 2009, an en banc panel of the United States Court of Appeals in Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1293 (Fed. Cir. 2009) (“Abott Labs”), clarified the conflicting US rulings for the analysis of PBP claims in infringement actions as per the previous decisions in Scripps Clinic & Research Foundation v. Genetech, Inc., 927 F.2d 1565 (Fed. Cir 1991) (“Scripps”) and Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992) (“Atlantic Thermoplastics”). In Scripps, the Federal Circuit Court had held that while analysing PBP claims, they should be construed the same way for validity as for infringement, and that PBP claims should not be limited to the process set forth in the claims. Whereas, in Atlantic Thermoplastics, the court had held that the PBP claims are limited by the recited claims.
The majority in Abbott Labs overruled the decision in Scripps and held that PBP claims are not infringed by products made by processes not meeting the claimed process limitations. The panel acknowledged that while determining the validity of a PBP claim, the focus is on the claimed product and not the process of making it. However, in determining infringement of a PBP claim, the focus is on the process of making the product as much as it is on the product itself. The panel also held that the use of the phrase “obtainable by” in Abbott’s patent also did not provide a “free pass” from the product-by-process rule. Therefore, in case someone makes an identical product from a different process, or if the identical process does not result in the claimed product, then the PBP claim is not infringed. However, the panel in Abbott Labs did not clarify whether the process steps affect the validity of PBP claims, or whether different rules of interpretation should guide the validity and infringement of PBP claims.
Soon after, a three-judge panel of the Federal Circuit Court in Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, held that in determining the validity of a PBP claim, the focus is on the product and not the process of making it, whereas in determining infringement of that claim, the focus is on the process of making the product as much as it is on the product itself. The court reasoned for its difference in the approach on the rationale that a product in the prior art made by a different process can anticipate a PBP claim, but an accused product made by a different process cannot infringe a PBP claim.
Even though the decisions in Abbott Labs and Amgen Inc. have not yet been overruled, the decisions forced jurists in the USA to question the benefits of drafting their patent claims as PBP claims, since every applicant of a PBP claim would be required to demonstrate the patentability of the product independent of its process, which would limit the enforcement of rights against infringement only to products that have been made by the cited process.
The Division Bench in Vifor v. MSN Laboratories did not agree with the majority decision in Abbott Labs, and noted that the decision did not find acceptance in any other jurisdictions as well. As per the Division Bench, it is unjustified that while an inventive characteristic of a product sets it apart from the claimed subject matter and prior art, the same should be disregarded when it comes to infringement analysis. It recognized that such an interpretation would lead to a situation where while a patent may be validly accepted to be a product at the stage of grant, it will become confined to a process for the purposes of examining infringement.
Source: Barandbench
