By Kevin E. Noonan --
On October 23, 2007, Amgen procured a jury verdict that Hoffman-LaRoche's Mircera® drug product infringed several Amgen patents. That verdict found Mircera® infringed claims 3, 7, and 8 of Amgen's U.S. Patent No. 5,547,933 (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of U.S. Patent No. 5,441,868; and claims 6 through 9 of U.S. Patent No. 5,618,698. Amgen's infringed claims were directed to recombinant methods and recombinant EPO protein, and Roche's Mircera® drug product is a form of recombinant EPO that has been covalently linked to polyethylene glycol.
Since then, Amgen has moved in the District Court for a permanent injunction against Roche to prevent Mircera® from being sold in the U.S. until the last of Amgen's infringed patents has expired; Roche has opposed. Such an injunction is necessary to prevent Mircera® from going on the market, since the U.S. Food and Drug Administration last November granted approval for Roche to market Mircera® in the U.S. The Court granted a preliminary injunction barring Mircera® sales on February 28, 2008, but Judge Young left open the possibility that he would modify his order under certain circumstances. Although the District Court found that Amgen had fulfilled three of the four factors mandated for consideration by the Supreme Court in eBay Inc. v. MercExchange, L.L.C. (i.e., Amgen's asserted claims were infringed and not invalid; Amgen's injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction), the District Court did not decide in Amgen's favor as to the fourth prong, the public interest, particularly in view of Roche's representations of the advantages of its Mircera® product over Amgen's version of EPO (including inter alia less frequent dosing; see "Long-Acting Drug for Dialysis Anemia Equivalent to Weekly Agent").
The District Court also set forth five conditions that, if fulfilled by Roche, might persuade the Court to lift the injunction. First, Roche would pay Amgen a royalty of 22.5% (Amgen having already rejected an offer for a 20% royalty from Roche). Second, Roche could be introduced to the Medicare patient population at a cost no more than the average sales price of Amgen's EPO products (sold under the names Epogen® and Aranesp®) (a requirement that would prevent Roche from passing its royalty obligations onto patients, but would not prevent Roche from selling Mircera® at a bargain price relative to Epogen®). Third, Roche would have to provide clinical evidence to permit the Court to determine a "dosage conversion factor" between Mircera® and Epogen®. Fourth, Roche would pay for an independent agency to monitor sales and determine royalty payments owed to Amgen. Finally, Roche would agree to supply Mircera® to any patient needing it, at or below the authorized price (presumably, this is a provision that would prevent Roche from abandoning the Medicare market once it has entered it).
Roche agreed to these conditions in its court filing on March 20th (see "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction"). Despite Roche's acquiescence, and perhaps in the face of Amgen's vigorously-pressed argument that lifting the injunction under these circumstances was, in effect, a compulsory license (see "Court Still Cannot Decide on Amgen's Permanent Injunction"), the Court on Monday issued an order that the parties had fifteen days to submit an agreed list of potential special masters to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared. While not being related directly to the public interest question, the special master's report should further inform the Court of whether it will be practicable for the Court to conform its injunction (or compulsory license) to the economic realities of the marketplace for ESAs. The special master, once appointed, will have sixty days to make the inquiries necessary to provide his or her findings to the Court. Presumably, the Court will then make its ruling.
The Federal Circuit's decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (issued March 7, 2008; see Patent Docs report) has raised another potentially-dispositive issue, not on the injunction but on the validity of Amgen's patents-in-suit, and Amgen has responded proactively. On March 14th, Amgen filed a bench memorandum with the District Court explaining its understanding of the Pfizer decision, and arguing that this decision has no bearing on the Court's decisions that Amgen's patents-in-suit are not invalid under the judicially-created obviousness-type double patenting doctrine. In Pfizer, a three-judge panel of the Federal Circuit invalidated one of Pfizer's patents as being invalid for obviousness-type double patenting. In that case, the Federal Circuit opined that the "safe harbor" for divisional applications of 35 U.S.C. § 121 (i.e., that divisional applications are not subject to obviousness-type double patenting rejections) did not extend to continuation-in-part applications. The CAFC based its decision in part on the plain language of the statute (which is limited to divisional applications), and on the grounds that, unlike a divisional application, a continuation-in-part application is not identical in disclosure to its parent. Thus, the Federal Circuit held that Congress did not evince an intention to permit an application having additional disclosure to benefit from the § 121 safe harbor.
Although the Federal Circuit's rationale was clearly based on this distinction between divisional and CIP applications, the Court's language was less than crystal clear on the status of continuation applications. Such applications share with divisionals the limitation that their disclosure is coextensive with the disclosure of the parent application. Unlike a divisional application (whose filing is compelled by a determination by the U.S. Patent and Trademark Office that the application discloses more than one invention), however, continuation applications are filed at an applicant's volition, to pursue claims that the applicant has not been able to persuade the Patent Office are patentable within the examination time limit (i.e., before a final rejection has been issued).
Amgen argues in its bench memorandum that its patents do not fall within the ambit of the Pfizer Court's invalidating decision. First, Amgen argues that its applications are continuations, not CIPs, and that the Pfizer decision was limited to precluding the § 121 safe harbor from encompassing CIP applications. Second, Amgen argues that its applications, while termed "continuations" satisfy the requirements of divisional applications: "the '178 and '179 applications were 'later application[s]' (than the '298 application), 'carved out of a pending application' (the '298 application), containing claims to 'a distinct and independent invention' (restriction Groups I and V, not Group II), and 'disclosing and claiming only subject matter disclosed in the earlier or parent application' (as 37 C.F.R. § 1.60 applications, the disclosure and claim language was identical to that in the parent '298 application)" M.P.E.P. § 201.06. (Amgen further argues that Pfizer cannot be taken to mean that how an application is designated, as a "continuation" or a "divisional," can by itself be enough to determine whether or not an application was entitled to § 121 safe harbor. Indeed, Amgen notes that the District Court expressly rejected Roche's argument that the parent applications to the '933 and '349 patents were invalid for obviousness-type double patenting "because Amgen's patent counsel failed to check the 'divisional application' box on the application cover forms.") Amgen provides the following chart to show the relationship between its applications, as compared to the relationships between the Pfizer applications:
Amgen also argues that the Pfizer decision is inconsistent with Federal Circuit precedent, with regard to continuation applications, in Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563 (1996) and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991). In these cases, Amgen argues, the § 121 safe harbor was applied to continuations that fulfilled the statutory requirements, providing the following diagrams of the relationships between the patents in those decisions:
Amgen further argues that insofar as the Pfizer decision is inconsistent with either the Applied Materials or Symbol Technologies decisions, the Court is bound by the earlier decisions, citing Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988) ("This court has adopted the rule that prior decisions of a panel of the court are binding precedent on subsequent panels unless and until overturned in banc. Where there is direct conflict, the precedential decision is the first.").
Roche has not yet been heard on this issue. Interestingly, the lawyer representing Pfizer before the Federal Circuit, Leora Ben-Ami of Kaye Scholer LLP, is also the lead trial attorney representing Hoffman-LaRoche against Amgen.
For now, the answer to the title question is "probably not," but it is clear that Amgen will once again be forced to vigorously protect its EPO franchise.
Patent Docs thanks Calvert (Cal) Crary of Litigationnotes.com for alerting us to this issue.
For additional information regarding this topic, please see:
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007