Patent Docs

In re Fallaux (Fed. Cir. 2009)

    By Donald Zuhn --

On May 6, the Federal Circuit affirmed a decision by the Board of Patent Appeals and Interferences affirming the final rejection of U.S. Application No. 10/618,526 for obviousness-type double patenting.  Appellants Frits Jacobus Fallaux, Robert Cornelis Hoeben, Alex Jan Van Der Eb, Abraham Bout, and Domenico Valerio are the named inventors on the '526 application (U.S. Patent Publication No. 2005/0260596), which is directed to an isolated adenovirus packaging cell comprising nucleic acid sequences encoding the adenovirus E1A and E1B gene products but lacking a nucleic acid sequence encoding adenovirus pIX.  Following the examiner's final rejection of the '526 application for obviousness-type double patenting in view U.S. Patent Nos. 6,340,595 and 6,413,776, Appellants appealed the rejection to the Board of Patent Appeals and Interferences, which affirmed the examiner's determination.

The '526 application, which was filed on July 11, 2003, claims the benefit of the following applications:

• U.S. Application No. 08/793,170, filed March 25, 1997, which issued as U.S. Patent No. 5,994,128 on November 30, 1999;
• U.S. Application No. 09/334,765, filed June 16, 1999, which issued as U.S. Patent No. 6,238,893 on May 29, 2001;
• U.S. Application No. 09/506,548, filed February 17, 2000, which issued as U.S. Patent No. 6,602,706 on August 5, 2003;
• U.S. Application No. 10/125,751, filed April 18, 2002, which issued as U.S. Patent No. 7,105,346 on September 12, 2006; and
• U.S. Application No. 10/219,414 (U.S. Patent Publication No. 2003/0104626), filed June 5, 2003.

The patents asserted in the double patenting rejection (i.e., the '595 and '776 patents) are related to the '526 application by way of a single common inventor:  Abraham Bout.  The '776 patent was filed on June 12, 1998 and issued on July 2, 2002, and the '595 patent was filed on July 21, 1999 and issued on January 22, 2002.  In rejecting the '526 application, the examiner applied the one-way test for obviousness-type double patenting.  During prosecution, Appellants argued that the two-way test for obviousness should have been applied.  The examiner, however, determined that Appellants had not provided evidence that the issuance of the '595 and '776 patents before the issuance of the '526 claims was not due to administrative delay on the part of the U.S. Patent and Trademark Office, and further, that the '526 claims could have been introduced (and then allowed) in any of the '526 application's four priority applications that had already issued.

On appeal to the Board, Appellants again argued for the two-way test, but the Board affirmed, determining that the '526 claims could have been filed during prosecution of the '170 application, which issued as the '128 patent before either of the patents asserted in the double patenting rejection.  Thus, the Board concluded that it was Appellants, and not the Patent Office, that dictated the rate of prosecution of the '526 claims.

In affirming the Board's decision, the Federal Circuit first noted that the two-way test for obviousness-type double patenting is a narrow exception to the general rule of the one-way test.  Quoting In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998), the Court also noted that the two-way test:

arose out of the concern "to prevent rejections for obviousness-type double patenting when the applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing, rejecting the basic application although it would have been allowed if the applications had been decided in the order of their filing."

As a result, "[t]he two-way test is only appropriate in the unusual circumstance where, inter alia, the United States Patent and Trademark Office (PTO) is 'solely responsible for the delay in causing the second-filed application to issue prior to the first'" (citing Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 n.7 (Fed. Cir. 2001) (quoting Berg, 140 F.3d at 1437)).

In the instant appeal, the Federal Circuit concluded that:

[Appellants] did not show -- nor is there any evidence to suggest -- that the PTO shared any responsibility for the delay.  There is no dispute that the specification of the '170 application would have supported the ['526] claims.  Nonetheless, [Appellants] elected to prosecute other applications and delay filing the ['526] application until six years after the '170 application was filed.

Thus, the Court found that there was substantial evidence to uphold the Board's finding that the entire delay was attributable to Appellants.

In re Fallaux (Fed. Cir. 2009)
Panel: Circuit Judges Schall, Archer, and Moore
Opinion by Circuit Judge Moore

Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)

    By Donald Zuhn --

The Federal Circuit today affirmed a determination by the District Court for the District of Delaware that U.S. Patent No. 5,583,122 was not invalid as obvious nor invalid for obviousness-type double patenting.  The '122 patent, which is owned by Plaintiff-Appellee Procter & Gamble Co. (P&G), relates to the compound risedronate, which is the active ingredient in P&G’s osteoporosis drug Actonel®.  Risedronate is a member of a class of compounds known as bisphosphonates, which are active in inhibiting bone resorption.

After Defendant-Appellant Teva Pharmaceuticals USA, Inc. notified P&G of its intent to market a generic version of risedronate, P&G filed suit against Teva for patent infringement.  In response, Teva argued that the '122 patent was invalid as obvious in view of P&G's expired U.S. Patent No. 4,761,406, and alternatively, that the '122 patent was invalid for obviousness-type double patenting.  The '406 patent relates to an intermittent dosing method for treating osteoporosis, which allows bisphosphonates to be used in the treatment of osteoporosis without the unwanted side effect of anti-mineralization.  The '406 patent specifies 36 bisphosphonates for use in the claimed method, eight of which are preferred compounds, and one of which is the compound 2-pyr EHDP.  Teva argued that the disclosure of 2-pyr EHDP in the '406 patent rendered the claims of the '122 patent obvious (risedronate and 2-pyr EHDP are positional isomers, with risedronate having a hydroxy-ethane-diphosphonate group connected to the #3 carbon of its pyridine ring, and 2-pyr EHDP having the hydroxy-ethane-diphosphonate group connected to the #2 carbon).

After a bench trial, the District Court determined that the '406 patent would not have led a person of ordinary skill in the art to identify 2-pyr EHDP as a lead compound, the skilled artisan would not have been motivated to modify 2-pyr EHDP to generate risedronate (at left), and unexpected results of risedronate's potency and toxicity rebutted Teva's assertion of obviousness.  As a result, the District Court found the claims of the '122 patent to be non-obvious.  The District Court also determined that the '122 patent was not invalid for obviousness-type double patenting.

The Federal Circuit began its analysis by first noting that the evidence of record did not establish that it would have been obvious to modify 2-pyr EHDP to create risedronate, and therefore, that the Court did not need to reach the question of whether the '406 patent would have led a skilled artisan to identify 2-pyr EHDP as a lead compound.  The panel noted that Dr. Herbert Fleisch, a preeminent authority on bisphosphonates during the relevant time period, wrote in 1984 that "every compound, while remaining a bisphosphonate, exhibits its own physical-chemical, biological and therapeutic characteristics, so that each bisphosphonate has to be considered on its own," and thus, "[t]o infer from one compound the effects in another is dangerous and can be misleading."  The Federal Circuit therefore determined that the District Court had not erred in finding that a person of ordinary skill would not have been motivated to synthesize and test risedronate, and would not have had a reasonable expectation of success in synthesizing and testing risedronate.  Moreover, the panel determined that there was no credible evidence that the structural modification of 2-pyr EHDP would have been routine.  Thus, the Federal Circuit concluded that the District Court did not clearly err in finding that Teva had failed to establish a prima facie case of obviousness.

Notwithstanding Teva's failure to establish a prima facie case of obviousness, the Federal Circuit also determined that P&G had introduced sufficient evidence of unexpected results.  Among these unexpected results were risedronate's potency at low doses and lack of toxicity at higher doses than 2-pyr EHDP could be safely used.  The Federal Circuit also determined that the District Court had not erred in considering evidence that risedronate had satisfied a long-felt but unmet need.

With respect to the issue of obviousness-type double patenting, the Federal Circuit determined that the District Court had correctly found the '406 patent to be prior art to the '122 patent, since P&G's evidence that risedronate had been synthesized in May of 1985 was uncorroborated (i.e., laboratory notebook pages describing the synthesis were unwitnessed).  The panel noted that "the obviousness analysis applies to double patenting," with the exception that non-statutory double patenting compares claims in an earlier patent to claims in a later patent or application, double patenting does not require inquiry into a motivation to modify the prior art, and double patenting does not require inquiry into objective criteria suggesting non-obviousness.  Thus, because risedronate was deemed to be non-obvious in view of the '406 patent, the Federal Circuit concluded that the '122 patent was also not invalid for obviousness-type double patenting in view of the '406 patent.  In addition, the panel determined that Teva failed to present clear and convincing evidence of overlap between the claims of the '122 patent (directed to compounds, including risedronate) and the '406 patent (directed to an intermittent dosing regimen, with no compound claims).

Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
Panel: Circuit Judges Mayer and Dyk, and District Judge Huff
Opinion by District Judge Huff