Source: Grill IP patents news
The Federal Circuit applied the Supreme Court’s instruction in upholding a U.S. Patent and Trademark Office (USPTO) decision last week, in the nonprecedential ruling of Apotex v. Wyeth. The Court held that the claims under scrutiny were not obvious, judging in favor of the defendant.
The Supreme Court’s decision in Dickinson v. Surko (1999) underlies the Circuit’s ruling. The case represents a significant decision for the working patent practitioner, whereby the Administration Procedure Act was interpreted to require the Circuit defer to any factual determinations by the USPTO, only overturning a determination for lack of evidence. The main concern of this case, as it applies to Apotex v. Wyeth, is whether a party can effectively challenge a USPTO decision.
The inter partes review involved U.S. Patent No. 7,879,828 (‘828), which claims a stabilized formulation of tigecycline, a drug that is crucial in treating drug resistant bacteria. Tigecycline is used only when other antibiotics prove ineffective. Apotex’s claim uses an acid in the presence of a carbohydrate to stabilize the drug’s formulation. The Board granted the patent according to three references:
- A Chinese patent application (“CN ‘550”) involving a comparable tetracycline-type antibiotic: minocycline.
- A reference by Pawelczyk on the kinetics of minocycline oxidative degeneration
- A reference by Naggar on the impact of stabilizers on tetracycline epimerization
The Board determined that Apotex did not assert a preponderance of evidence that its claims in ‘828 were obvious. According to the Board, Apotex provided no explanation of why the preparation of the drug should not have followed the procedure spelled out by Pawelczyk or Naggar, and why there would be a substitute of tigecycline for the Chinese minocycline. Further, there was no demonstration of why a “skilled worker” would group the instructions of CN ‘550 with the supporting references to come to the formulation present in the patent.
The Federal Circuit agreed, with Judge Lourie issuing a majority opinion that highlights Dickinson’s influence on the standards followed by the panel in coming to its decision:
“We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), and the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). Obviousness is a question of law based on underlying factual findings, In re Baxter Int’l, Inc. 678 F.3d 1357, 1361 (Fed. Cir. 2012), such as what a reference teaches, In re Beattie, 974 F.2d 1309, 1311 (Fed. Cir. 1992), and whether a skilled artisan would have had a reason to combine references, see In re Hyon, 679 F.3d 1363, 1365–66 (Fed. Cir. 2012).”
In response, Apotex argued two points. First, an “epimeric stabilization” limitation was added to the claim and used by the Board to justify its non-obviousness finding. This challenge was rejected by the panel, which countered that the claim lacked such a limitation. For the Board, the absence of this limitation meant that the “obviousness of the claims [could] be demonstrated without a showing of epimeric stability in the prior art.” Thus, the Federal Circuit found no basis for Apotex’s assertion that the Board’s non-obviousness ruling unsuitably relied on such a limitation. If epimeric stabilization was looked at, then it was in the context of finding motivation for Apotex’s combination of the references. The plaintiff’s second point, that the Supreme Court’s decision in KSR International Co. v. Teleflex Inc. (2007) was countered by the Board failing to consider a motivation to combine “beyond the problem the patentee was trying to solve,” was also rejected. The Board did make such a deliberation, but found Apotex’s evidence “wanting.” The Board viewed the evidence offered by Apotex’s expert as insufficient to justify the substitution of minocycline for tigecycline, opting to credit Wyeth’s expert with an account of differing oxidation and epimerization rates between the two substances.
In addition, the Court rejected to Apotex’s use of Senju Pharm. Co. v. Lupin Ltd. (2015) to assert that the skilled worker would be motivated to “make a simple substitution of generational drugs.” Senju was viewed as an inappropriate case to rely on, since its decision was based on “very factual findings that “are notably absent” in Apotex v. Wyeth. In sum, the Board held that a lack of disclosure of tigecycline on the part of the references in question proved that a skilled worker would not have been moved to combine them.
This decision is unique in positioning a pharmaceutical against an inter partes review, which is instituted over past art and led to a finding of non-obviousness according to that very art. This implies that factual distinctions persuasive to the Board may aid patent owners in countering invalidation challenges. Patentees undergoing inter partes review should, where feasible, use factual evidence and expert testimony to oppose obviousness assertions used by the Board to establish such a review against their interests.Tags: Apotex, CN ‘550, Dickinson v. Surko, drug patent, Federal Circuit, inter partes review, Judge Lourie, KSR International Co. v. Teleflex Inc., Senju Pharm. Co. v. Lupin Ltd., Supreme Court, United States Patent and Trade Office, US IP law, Wyeth