Orange Book Blog

Federal Circuit Affirms Invalidity of Lilly's Gemzar Patent for Obviousness-Type Double Patenting

Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010)

The principle behind the doctrine of double patenting is simple:  a person may not obtain two patents on the same invention.  The doctrine "is intended to prevent a patentee from obtaining a timewise extension of [a] patent for the same invention or an obvious modification thereof."

The two patents at issue in this case are U.S. Patent No. 4,808,614 and 5,464,826.  Both are listed in the Orange Book with respect to Lilly's drug Gemzar (gemcitabine), a nucleoside analog used for the treatment of cancer.  The '614 patent claims gemcitabine, as well as a method of using gemcitabine for treating viral infections.  The '826 patent claims a method of using gemcitabine for treating cancer.  The '614 patent issued on February 28, 1989 and expired on May 15, 2010 (Lilly chose the '614 patent for a patent term extension under 35 USC 156), while the '614 patent issued on November 7, 1995 and will expire on November 7, 2012 -- two-and-a-half years after the expiration of the '614 patent.

In August 2009, the U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment that the asserted claims of the later-expiring '826 patent are invalid for obviousness-type double patenting over the earlier-expiring '614 patent.  The court found that given the '614 patent's disclosure of gemcitabine's anticancer use, claim 12 of the earlier '614 patent, which claims gemcitabine, and claims 2, 6 and 7 of the later '826 patent, which claim a method of using gemcitabine for cancer treatment, are not patentably distinct.

In an opinion released earlier today, the Federal Circuit affirmed the district court's decision of invalidity, and in doing so affirmed its prior holding of Pfizer v. Teva (Fed. Cir. 2008) and Geneva v. GlaxoSmithKline (Fed. Cir. 2003):  "a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use."  The Federal Circuit stated, "In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and the later patent claimed a method of using the compound for a use described in the specification of the earlier patent."

According to the Federal Circuit opinion, Lilly attempted to distinguish Pfizer and Geneva by contending "that in both cases, the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability."  By contrast, here, "the specification of the earlier '614 patent disclosed gemcitabine's use in treating both viral infections and cancer, [but] the antiviral use provided the essential utility necessary to the patentability of the '614 patent's claim to gemcitabine."  In other words, because the antiviral use was the key use in the earlier patent, the cancer use claimed in the later patent should be upheld.

The Federal Circuit, however, disagreed with Lilly's characterization of Pfizer, stating that in that case, "the earlier patent's specification unambiguously disclosed more than one utility for the claimed compound."  In addition, the court explained that Lilly's proposed "single, essential utility test" would be "unworkable," because "where an earlier patent specification describes multiple uses for a compound, a court would be unable to identify the one use that was 'essential' or 'necessary' to patentability."  According to the court, Lilly's counsel conceded this point at oral argument.

In a press release today, Lilly's general counsel stated that Lilly "strongly disagrees" with the Federal Circuit's ruling and "will consider all possible legal options," including a petition for rehearing.

RELATED READING:

• Bloomberg
• Wall St. Journal

D.C. District Court Sides With FDA/Hospira/Teva, Against Sanofi-Aventis, in Eloxatin Case

Sanofi-Aventis, et al. v. Food and Drug Administration, et al., No. 09-1495 (D.D.C. 2010)

The question in this case is "whether a vacatur entered by an appellate court overrides the terminating effect that the entry of district court judgment has on the thirty-month stay under the FDCA."  The answer is "no" -- the thirty-month stay is not reinstated.  Sanofi-Aventis filed the case against the FDA last summer, amid a flurry of activity in its ANDA litigation over Eloxatin (oxaliplatin), a $1.4 billion/year cancer drug.  Here is an abbreviated timeline of that activity:

• June 18, 2009:  New Jersey district court files Opinion granting Hospira's and Teva's motions for summary judgment of noninfringement of U.S. Patent No. 5,338,874, claiming optically pure oxaliplatin
• June 30, 2009:  New Jersey district court enters Final Judgment
• June 30, 2009:  Sanofi files notice of appeal, motion for stay pending appeal, and petition for writ of mandamus to vacate the district court's judgment with the Federal Circuit
• July 10, 2009:  Federal Circuit files Order granting Sanofi's motion for stay, pending appeal
• August 7, 2009:  FDA grants final approval of Hospira's ANDA for oxaliplatin
• August 7, 2009:  FDA grants final approval of Teva's 505(b)(2) application for oxaliplatin
• August 10, 2009:  Sanofi files emergency motion in Federal Circuit to enforce the July 10 Order granting stay
• August 10, 2009:  Sanofi files suit against FDA in D.C. district court, seeking declaratory and injunctive relief requiring FDA to rescind final approval of applications for generic oxaliplatin, and a motion for temporary restraining order and preliminary injunction against FDA
• August 11, 2009:  Federal Circuit files Order denying Sanofi's emergency motion
• August 11, 2009:  D.C. district court denies Sanofi's motion for temporary restraining order and preliminary injunction (opinion here)
• August 11, 2009:  Hospira announces launch of oxaliplatin; Teva announces launch of oxaliplatin shortly thereafter
• August 13, 2009:  Federal Circuit files Order denying Sanofi's motion for panel or en banc review of its August 11 Order denying Sanofi's emergency motion
• September 10, 2009:  Federal Circuit files Opinion vacating district court's June 20 final judgment of noninfringement and remanding to district court
• September 14, 2009:  Sanofi files Motion for Summary Judgment in D.C. district court, seeking an injunction ordering FDA to rescind all final approvals of generic oxaliplatin products
• April 1, 2010:  Hospira and Teva announce settlements of Eloxatin patent litigation with Sanofi
• July 26, 2010:  D.C. district court files Opinion denying Sanofi's motion for summary judgment

The relevant statute in this case provides that if, before the expiration of the automatic thirty-month stay in a Paragraph IV case, "the district court decides that the patent is invalid or not infringed . . . the [FDA] approval [of the generic drug application] shall be made effective on . . . the date on which the court enters judgment reflecting the decision."  In its summary judgment motion filed last September, Sanofi argued that FDA was wrong to conclude that a stayed judgment (which existed at the time FDA granted final approval to Hospira and Teva) is a "judgment" within the meaning of the statute.  The court disagreed.

In denying Sanofi's motion, the court explained that when read in context, the statute is clear:

In short, there are two ways the thirty-month stay can terminate prematurely.  The first -- addressed in the "entry of judgment" provision -- arises when the district court rules that the patent is invalid or not infringed. . . .  That scenario ends with the district court; there is no provision for what happens if the district court's judgment is appealed.  The other scenario occurs when the district court determines that the patent is valid and infringed, the judgment is appealed and the court of appeals reverses the district court judgment and determines that the patent is invalid or not infringed . . . .  When viewed in context, the omission of a discussion of the appellate process in the entry of judgment provision is glaring.  Accordingly, the court takes this omission to be intentional and concludes that Congress intended the thirty-month stay to terminate upon the entry of judgment by a district court that a patent is invalid or not infringed without regard to the appellate process.

The court concluded:

Given that the entry of judgment provisions have a plain meaning, the court will not read into the statute any implication a vacated judgment might have on those provisions.  . . .  The court thus determines that plain language of the statute dictates that the thirty-month stay terminates upon entry of judgment by a district court that a patent is invalid or not infringed, regardless of any subsequent appeal, and that the FDA was bound to follow this directive.

In view of the fact that Sanofi has settled its Eloxatin patent litigation, it is unclear whether Sanofi will appeal the decision to the D.C. Circuit.

RELATED READING:

• FDA Law Blog

Apotex Establishes Declaratory Judgment Jurisdiction in Lipitor Patent Challenge, Threatening the Pfizer-Ranbaxy Settlement, but Pfizer Reloads

Pfizer Inc. et al. v. Apotex Inc. et al., No. 08-7231 (N.D. Ill. 2010)

The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case, Ranbaxy).

Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011.  Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier.  In order to do so, the later filer must obtain a final decision of noninfringement or invalidity of the Lipitor patents.  But this isn't easy to do if the patent owner doesn't sue the later filer:  the later filer must obtain a declaratory judgment, which requires establishing declaratory judgement jurisdiction.

In this case, Pfizer listed six patents in the Orange Book for Lipitor.  Apotex filed a Paragraph III certification on U.S. Patent No. 4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five.  Pfizer sued Apotex on only two of the five challenged patents.  In its Answer, Apotex filed declaratory judgment counterclaims of noninfringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity.  Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution.  In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed.

In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims.  To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court.  Apotex alleged two injuries-in-fact:  first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market.  Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires."

Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a noninfringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents).

On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision.  In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision:  first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents [two of the three Unasserted Patents] and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on [the third Unasserted Patent, U.S. Patent No. 5,969,156], which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer."

According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent."  Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable.

Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity.  Pfizer might simply run out the clock.

RELATED READING:

• The American Lawyer