G.D. SEARLE LLC, PFIZER ASIA PACIFIC PTE. LTD. v. LUPIN PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC., MYLAN PHARMACEUTICALS INC., WATSON LABORATORIES, INC., APOTEX INC., APOTEX CORP.
No. 2014-1476
United States Court of Appeals, Federal Circuit
June 23, 2015
790 F.3d 1349
Claims 2 and 10 depend from claims 1 and 9, respectively, and recite identical limitations. They read:
2[/10]. The method[/computer system] of claim 1[/9], wherein said displaying said dynamically generated online application form set comprises combining information from a template file and either a database or a conditional merge file or both to form said dynamically generated online application form set.
Claims 7, 15, and 23 depend from claims 1, 9, and 17, respectively, and recite identical limitations. They read:
7[/15/23]. The method[/computer system/computer-readable storage medium] of claim 1[/9/17], wherein said web page comprises quasi-static elements distinct from said dynamically generated online application form set, wherein said displaying said dynamically generated online application form set in response to the activation of said hyperlink affects the display of said quasi-static elements.
The additional limitations of these dependent claims do not add an inventive concept, for they represent merely generic data collection steps or siting the ineligible concept in a particular technological environment. See Alice, 134 S.Ct. at 2357 (explaining that “[s]imply appending conventional steps, specified at a high level of generality,” was not “enough” to supply an “inventive concept” (emphasis in original) (quoting Mayo, 132 S.Ct. at 1300, 1297, 1294)); id. at 2358 (“limiting the use of an abstract idea “to a particular technological environment” is “not enough for patent eligibility“) (quoting Bilski, 561 U.S. at 610-11, 130 S.Ct. 3218); CyberSource, 654 F.3d at 1370 (“mere [data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory“) (alterations in original) (quoting In re Grams, 888 F.2d 835, 840 (Fed.Cir.1989)).
The motion to dismiss addressed the dependent claims, arguing that they do not contain any limitations that make them patent-eligible. We have considered the arguments and conclude that the criteria of “inventive concept” are not met as to the dependent claims.
CONCLUSION
We affirm the district court‘s ruling that the claims of the ‘505 Patent are directed to ineligible subject matter. The judgment of invalidity of the ‘505 Patent claims in terms of section 101 is affirmed.
AFFIRMED
Kannon K. Shanmugam, Williams & Connolly LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by Allison B. Jones, David M. Krinsky, Christopher Alan Suarez; Aaron Stiefel, Soumitra Deka, Daniel Reisner, Jeffrey T. Martin, Daniel Dinapoli, Kaye Scholer LLP, New York, N.Y.
Beth D. Jacob, Kelley Drye & Warren, LLP, New York, N.Y., argued for defendant-appellee Lupin Pharmaceuticals, Inc. Also represented by Clifford Katz; Douglass C. Hochstetler, Chicago, IL.
Henry C. Dinger, Goodwin Procter LLP, Boston, MA, argued for defendant-appellee Teva Pharmaceuticals USA, Inc. Also represented by Keith A. Zullow, David M. Hashmall, New York, N.Y.; William M. Jay, Washington, DC.
Douglas H. Carsten, Wilson, Sonsini, Goodrich & Rosati, PC, San Diego, CA, argued for defendant-appellee Mylan Pharmaceuticals Inc. Also represented by Peter Soo Kang; Nancy L. Zhang, Palo Alto, CA.
Stephen Auten, Taft, Stettinius & Hollister, LLP, Chicago, IL, argued for defendants-appellees Apotex Inc., Apotex Corp. Also represented by Ian Scott, Richard T. Ruzich; Richard Hooper Ottinger, Vandeventer Black LLP, Norfolk, VA.
Before PROST, Chief Judge, BRYSON and HUGHES, Circuit Judges.
G.D. Searle LLC and Pfizer Asia Pacific Pte. Ltd. (collectively, “Pfizer“) appeal from a final judgment entered by the United States District Court for the Eastern District of Virginia. The court invalidated the relevant claims of Pfizer‘s reissued U.S. Patent No. RE44,048 (“the RE ‘048 patent“) for obviousness-type double patenting. We affirm.
I
The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent. Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed.Cir.2012). The double-patenting issue in this case turns on whether Pfizer is entitled to invoke section 121 of the Patent Act,
The ‘068 patent can be traced back to an application filed with the Patent and Trademark Office (“PTO“) in 1993. That application, Serial No. 08/160,594 (“the ‘594 application“), disclosed and claimed compounds, compositions, and methods of use regarding the treatment of pain and inflammation without the harmful side effects associated with certain traditional anti-inflammatory drugs.
In an office action dated July 12, 1994, the patent examiner imposed a three-way restriction requirement on the ‘594 appli-
Pfizer prosecuted the composition claims that had been restricted out of the ‘594 application in a divisional application filed in June 1995, Serial No. 08/457,059 (“the ‘059 application“). The ‘059 application matured into U.S. Patent No. 5,563,165 (“the ‘165 patent“) in October 1996.
Pfizer did not file a divisional application to prosecute the restricted-out method-of-use claims of the ‘594 application. Instead, prior to receiving the restriction requirement, it filed a continuation-in-part of the ‘594 application in April 1994, Serial No. 08/223,629 (“the ‘629 application“) that included new matter. The ‘629 application contained all three classes of claims, i.e., compounds, compositions, and methods of use, including claims covering the new matter, and it issued as U.S. Patent No. 5,521,207 in May 1996.
In November 1994, Pfizer filed International Patent Application No. PCT/US94/12720 (“the PCT ‘720 application“), which was designated as a continuation-in-part of the ‘629 application and as a continuation-in-part of the original ‘594 application. The PCT ‘720 application contained all three classes of claims, and it encompassed much of the subject matter in the method-of-use claims that had been restricted out of the ‘594 application.
The PCT ‘720 application became a national stage application in the United States as U.S. Patent Application No. 08/648,113 (“the ‘113 application“) in September 1996. During the prosecution of the ‘113 application, the examiner issued a lack of unity rejection/restriction requirement in a telephone conference with the patentee. That restriction requirement again limited Pfizer to prosecuting only one of the three classes of claims—compounds, compositions, or methods of use. Pfizer elected to prosecute only method-of-use claims in the ‘113 application, which matured into the ‘068 patent in June 1998. The ‘068 patent describes itself as issuing from a continuation-in-part of the ‘629 application, which was a continuation-in-part of the original ‘594 application.
In Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed.Cir.2008), which addressed a patent infringement action filed by Pfizer on the ‘068 patent, we held the relevant claims of the ‘068 patent invalid for obviousness-type double patenting in light of the earlier issued ‘165 patent. In that case, Pfizer invoked the so-called “safe harbor” provision of section 121, which in certain circumstances protects a patent that issues on a divisional application from invalidation based on a related patent that issued on an application as to which a restriction requirement was made, or on an application filed as a result of such a requirement. We held that even though both the ‘165 patent and the ‘068 patent traced their lineage back to the original ‘594 application, the statutory safe harbor provision did not shield the ‘068 patent from the invalidating effect of the ‘165 patent. That was because “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications,” id. at 1362, and the ‘068 patent issued from a continuation-in-part, not a divisional application.
Pfizer sought to correct that alleged error by reissue. The preliminary amendment that accompanied the initial reissue declaration made the following changes to the ‘068 patent: (1) it deleted portions of the ‘068 patent specification that were not present in the ‘594 application; (2) it designated the ‘113 application as a divisional of the ‘594 application and removed the priority claim to the ‘629 application; (3) it amended claim 1 to be a method claim using only the compounds originally disclosed in the ‘594 application; (4) it canceled claims 2-12, which were method claims using compounds that were not present in the ‘594 application; (5) it canceled claim 18 (reciting a method of preventing colorectal cancer), which was not found in the ‘594 application; and (6) it added new method claims 19-23, which recited the use of the method disclosed in claim 1 to treat five specific types of inflammation-associated disorders. The preliminary amendment stated that those actions were taken to conform the ‘068 patent to a divisional of the ‘594 application.
The examiner rejected the preliminary amendment, finding that the “error” identified in Pfizer‘s reissue declaration was not correctable under
The examiner found that the later-identified technical errors provided a proper basis for reissue under
On the day the RE ‘048 patent issued, Pfizer filed the instant case against five
II
The parties present two principal issues on appeal: (1) whether
The safe harbor provision of
A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.
We apply “a strict test” for application of
Pfizer contends that the RE ‘048 patent is entitled to the protection of the safe harbor provision against invalidation by the ‘165 patent. We disagree.
A
The safe harbor provision of
The RE ‘048 patent issued from the ‘319 application, a reissue of the ‘068 patent, which in turn issued from the ‘113 application. The ‘113 application cannot be a divisional of the ‘594 application, despite
Moreover, when the ‘113 application issued as the ‘068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the ‘594 application. For years thereafter, the public was not free to practice that new matter (e.g., the now cancelled claims 2-12 and 18 of the ‘068 patent) because of that patent protection. Pfizer cannot now identify the ‘113 application as a divisional of the ‘594 application (for purposes of
The ‘113 application is a national stage application of the PCT ‘720 application. The PCT ‘720 application, like the ‘113 application, is not a division of the ‘594 application. PCT ‘720 identified itself as a continuation-in-part of the ‘594 application and as a continuation-in-part of the ‘629 application; it added compound, composition, and method-of-use claims that were not contained in those applications.
Pfizer does not assert that the PCT ‘720 application can become a divisional application of the ‘594 application for
Because the RE ‘048 patent identifies itself as descended from the ‘113 application and the PCT ‘720 application, and because neither of those applications is a division of the original ‘594 application, the
When separate restriction requirements are imposed on separate applications and the record does not show that any of the various restriction requirements carried forward from one application to the next, the earlier restriction requirement cannot be viewed as having continued in effect with respect to the later-filed application. See Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1349-50 (Fed.Cir.2004).
In 1994, the examiner imposed a three-way restriction requirement on the original ‘594 application (the “1994 restriction requirement“), prohibiting Pfizer from prosecuting all three classes of claims—compounds, compositions, and methods of use—in the same application. Pfizer elected to prosecute the compound claims in the ‘594 application and separately prosecuted the composition claims in the ‘059 application, a division of the ‘594 application.
The ‘059 application matured into the ‘165 patent. It is undisputed that the ‘165 patent is derived from the 1994 restriction requirement. The RE ‘048 patent, on the other hand, identifies itself as being descended from the ‘113 application and the PCT ‘720 application. Both of those applications, as filed, contained three classes of claims: compounds, compositions, and methods of use. During the national stage prosecution of the ‘113 application, and in an April 8, 1997, supplemental amendment, Pfizer noted that the examiner had issued “[a] lack of unity rejection/restriction requirement” during a telephone conference (the “1997 restriction requirement“). The 1997 restriction requirement again limited Pfizer to an election among the claimed compounds, compositions, and methods of use. Pfizer elected to prosecute only method-of-use claims in the ‘113 application, which matured into the ‘068 patent. Appellants’ Br. 5 (“After the examiner issued a restriction requirement, Pfizer amended the ‘113 application to elect, with traverse, only the method-of-treatment claims.“).
The record thus shows that two separate restriction requirements affected the chain of applications involved in this case. The 1994 requirement, which was imposed on the original ‘594 application, led to the ‘165 patent. The 1997 requirement, which was imposed on the ‘113 application, led to the ‘068 patent and ultimately to the RE ‘048 patent. In order for
Pfizer admits that the ‘113 application contains claims directed at “subject matter that was newly added ... and had not been disclosed in the ... ‘594 application[].” Appellants’ Br. 22. Thus, while the 1994 restriction requirement and the 1997 restriction requirement both limited Pfizer to an election among compounds, compositions, and methods of use, they did not apply to the same compounds, compositions, and methods of use. They are therefore not the same restriction requirement.
Furthermore, the record is devoid of any evidence showing that the examiner “reinstate[d] or even advert[ed] to” the 1994 restriction requirement when issuing the 1997 restriction requirement. Bristol-Myers, 361 F.3d at 1348-49. There is no evidence that the examiner made any reference to the 1994 restriction requirement at all during prosecution of the ‘113 application. Without such evidence, the 1994 and the 1997 restriction requirements, although appearing similar, must be deemed to have been “separately imposed with respect to” the ‘594 and the ‘113 applications. Id. at 1349. Because the ‘165 patent and the RE ‘048 patent are derived from two separately imposed restriction requirements,
Pfizer contends that the 1994 restriction requirement nonetheless should be deemed to have carried forward to the ‘113 application because, “but for the [1994] restriction requirement” Pfizer could have pursued the claims contained in the RE ‘048 patent in the original ‘594 application. Pfizer relies on the Boehringer case for the proposition that if the claims at issue would have been prosecuted in the original application but for the restriction requirement, they must be deemed to have been derived from that restriction requirement. Appellants’ Reply Br. 24. Boehringer, however, does not go that far.
The issue in Boehringer was whether
In Boehringer, common lineage was not at issue, because that case involved a single restriction requirement imposed only on the grandparent application. Here, by contrast, the record shows two separate restriction requirements, one of which led to the reference ‘165 patent and the other of which led to the challenged RE ‘048 patent. This case requires us to answer the question whether the applications from which the two patents issued share “common lineage in the divisional chain“; in other words, we must determine whether the two patents are derived from the same restriction requirement. Boehringer, 592 F.3d at 1354; Pfizer, 518 F.3d at 1360.
As noted above, the 1994 and 1997 restriction requirements were not imposed
AFFIRMED
JBF RAK LLC, Plaintiff-Appellant v. UNITED STATES, Defendant-Appellee
Mitsubishi Polyester Film, Inc., Dupont Teijin Films, SKC, Inc., Defendants.
No. 2014-1774.
United States Court of Appeals, Federal Circuit.
June 24, 2015.
Notes
At the relevant time,
Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent.
35 U.S.C. § 251(a) .
The America Invents Act amended the statute by striking the words “without any deceptive intention.” Pub.L. No. 112-29, § 20, 125 Stat. 284, 333-34 (2011). The amendment took effect on September 16, 2012, after Pfizer had filed its reissue application on September 5, 2008. “Deceptive intention” is not at issue in this case.