NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

GILEAD SCIENCES, INC., HOFFMANNLAROCHE INC., F. HOFFMANN-LA 

ROCHE LTD. and GENENTECH, INC.,

Plaintiffs,

v.

NATCO PHARMA LIMITED and NATCO 

PHARMA INC.,

Defendants.

 Civil Action No. 11-CV-1455 (SDW-

 MCA) 

 Consolidated with 

 Civil Action No. 11-CV-4969 (SDW- 

 MCA)

OPINION 

 December 21, 2012

WIGENTON, District Judge.

Before this Court is Plaintiffs Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. 

Hoffmann-La Roche Ltd. and Genentech, Inc.’s motion for summary judgment pursuant to 

Federal Rule of Civil Procedure 56 and Defendants Natco Pharma Limited and Natco Pharma 

Inc.’s cross-motion for summary judgment also pursuant to Federal Rule of Civil Procedure 56. 

This Court, having considered the parties’ submissions, decides this matter without oral 

argument pursuant to Federal Rule of Civil Procedure 78. For the reasons stated below, this 

Court GRANTS Plaintiffs’ motion and DENIES Defendants’ motion. 

I. BACKGROUND

This case concerns a dispute between Plaintiffs Gilead Sciences, Inc., Hoffmann-La 

Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. (“Gilead”) and Natco Pharma 

Limited and Natco Pharma Inc. (“Natco”) over access to a patented pharmaceutical 

product. Gilead owns the patent at issue and seeks to prevent Natco from marketing a generic 

version of Gilead’s patented product. The narrow issue before this Court concerns whether, 

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between two closely related patents, the later-issued but earlier-expiring patent can be used as a 

reference patent to invalidate the earlier-issued and later-expiring patent.

II. FACTS

Researchers at Gilead Sciences Inc., led by Dr. Choung Kim, developed Oseltamivir, a 

highly potent neuraminidase inhibitor. (See Pls.’ Statement of Uncontested Material Facts 

(“Pls.’ Facts”) ¶ 9.) Oseltamivir was developed in response to the “need for a potent and safe 

anti-influenza agent that could be used to treat a wide range of influenza strains, and be 

administered orally.” (Pls.’ Opening Mem. in Supp. of Motion for Summ. J. (“Pls.’ Br. in 

Supp.”) 2.) Oseltamivir is “the first of its kind to be orally bioavailable; having [an] excellent 

safety profile; and [is] broadly effective against various flu types.” (Id.) In June 1999, the 

United States Food and Drug Administration (“FDA”) approved Oseltamivir, which is currently 

marketed as TAMIFLU®. (See Pls.’ Facts ¶ 9.) U.S. Patent No. 5,763,483 (the “’483 patent”), 

titled Carbocylic Compounds, is assigned to Gilead Sciences, Inc. (See Pls.’ Facts ¶ 24.) The 

’483 patent “covers TAMIFLU® (oseltamivir phosphate), its metabolite (oseltamivir 

carboxylate), oseltamivir-based formulations, methods of inhibiting neuraminidase and treatment 

or prophylaxis of influenza infection.” (Pls.’ Br. in Supp. 3-4)(citing Pls.’ Facts ¶ 5-6). The 

’483 patent issued from non-provisional application 08/774,345 (the “’345 application”), which 

claimed the benefit of priority to provisional application 60/009,306 (the “’306 application”), 

which was filed on December 29, 1995. (See Pls.’ Facts ¶ 26.) The ’483 patent issued on June 

9, 1998, which is before any other patent in the Oseltamivir patent family was issued. (See id.)

U.S. Patent No. 5,952,375 (the “’375 patent”) and U.S. patent No. 5,866,601 (the “’601 

patent”) issued on September 14, 1999 from a series of continuation-in-part (“CIP”) applications 

(collectively the “’245 CIP family”). (See Pls.’ Facts ¶ 13.) The earliest of the ’245 CIP family 

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was application 08/395,245 (the “’245 application”), which was filed on February 27, 1995. (See 

id.) The ’375 patent and the ’601 patent both claim priority to: (1) the ’245 application; (2) CIP 

application 08/476,946 (the “’946 application”), which was filed on June 6, 1995, and issued as 

the ’601 patent; (3) and CIP application 08/580,567 (the “ ’567 application”), which was filed on 

December 29, 1995. (See id. at ¶ 14.) Application 08/606,624 (the “ ’624 application”) was 

filed on February 26, 1996 as a CIP of the ’567 application. (See id. at ¶ 21.) The ’624 

application eventually issued as the ’375 patent. (See id.) The ’375 patent is also assigned to 

Gilead Sciences, Inc. (See id.at ¶ 11.) The ’483 patent, ’375 patent, and ’601 patent are listed in 

the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly 

referred to as the “Orange Book”) as patents for TAMIFLU®. (See Pls.’ Facts ¶ 27.) Only the 

’375 and’483 patents are relevant to this opinion. 

On February 2, 2011, Natco sent a letter to Gilead, pursuant to 21 U.S.C. § 

355(j)(2)(vii)(IV), making Defendants aware that Natco filed Abbreviated New Drug 

Application (“ANDA”) No. 202-595 with the FDA seeking approval to market a generic version 

of TAMIFLU® 75 mg oseltamivir phosphate prior to the expiration of the ’483 patent. (See Pls.’ 

Facts ¶ 2.) On March, 15, 2011, Gilead filed a complaint in this Court against Natco, alleging, 

inter alia, that Natco’s filing of an ANDA infringed on the ’483 patent. (See id. at ¶ 3; Dkt. no. 

1.) On August 5, 2011, Natco notified Gilead that it submitted an amended ANDA seeking a 

generic version of TAMIFLU® but for dosages of 30mg and 45 mg instead of 75mg. (See id. at 

¶ 4.) On August 29, 2011, Gilead filed another complaint against Natco alleging that Natco’s

amended ANDA also infringed on the ’483 patent. (See id.) On September 30, 2011, Natco 

filed its answer and counterclaims, alleging, inter alia, that the claims of the ’483 patent are 

invalid due to obviousness-type double-patenting, thereby negating Gilead’s claim of patent 

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infringement. (See id. at ¶ 5.) Also, Natco alleged that the ’375 is the reference patent for its 

claim of double-patenting. (See id.) On January 20, 2012, Natco provided Gilead with its 

Invalidity and Non-Infringement Contentions, wherein Natco asserted that the claims of the ’483 

patent are invalid due to obviousness-type double-patenting of claim eight of the ’375 patent. 

(See id. at ¶ 6.)

III. LEGAL STANDARD

Summary judgment shall be granted “if the movant shows that there is no genuine dispute as to 

any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 

56(a). A factual dispute is genuine if a reasonable jury could return a verdict for the nonmovant, 

and it is material if, under the substantive law, it would affect the outcome of the suit. See

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The moving party must show that if 

the evidentiary material of record were reduced to admissible evidence in court, it would be 

insufficient to permit the nonmoving party to carry its burden of proof. See Celotex Corp. v. 

Catrett, 477 U.S. 317, 322-23 (1986).

Once the moving party meets the initial burden, the burden then shifts to the nonmovant 

who must set forth specific facts showing a genuine issue for trial and may not rest upon the 

mere allegations or denials of its pleadings. See Shields v. Zuccarini, 254 F.3d 476, 481 (3d Cir. 

2001). The court may not weigh the evidence and determine the truth of the matter but rather 

should determine whether there is a genuine issue as to a material fact. See Anderson, 477 U.S. 

at 249. In doing so, the court must construe the facts and inferences in “a light most favorable” 

to the nonmoving party. Masson v. New Yorker Magazine, Inc., 501 U.S. 496, 521 (1991). The 

nonmoving party “must present more than just ‘bare assertions, conclusory allegations or 

suspicions’ to show the existence of a genuine issue.” Podobnik v. United States Postal Serv., 

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409 F.3d 584, 594 (3d Cir. 2005) (quoting Celotex Corp., 477 U.S. at 325). If the nonmoving 

party “fail[s] to make a sufficient showing on an essential element of [its] case with respect to 

which [it] has the burden of proof,” then the moving party is entitled to judgment as a matter of 

law. Celotex Corp., 477 U.S. at 323. 

IV. DISCUSSION

Obviousness-type double-patenting is a judicially created doctrine that seeks to preclude 

an inventor from unjustifiably extending patent protection past the statutory limit. See In re 

Berg, 140 F.3d 1428, 1431-32 (Fed. Cir. 1998). “It requires rejection of an application claim 

when the claimed subject matter is not patentably distinct from the subject matter claimed in the 

commonly owned patent.” See id. (citing In re Braat, 937 F.2d 589, 592 (Fed. Cir. 1991). The 

obviousness-type double-patenting inquiry requires a two-step analysis: “[f]irst, as a matter of 

law, a court construes the claim in the earlier patent and the claim in the later patent and 

determines the differences.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 

2001). Second, a court must decide if the differences between the two claims demonstrate 

patentable distinction. See id. Regarding the second step, a later claim is “not patentably distinct 

from an earlier patent claim if the later claim is obvious over, or anticipated by, the earlier 

claim.” Eli Lilly, 251 F.3d at 968. The party asserting the defense of obviousness-type doublepatenting must prove it by clear and convincing evidence. See Symbol Tech., Inc. v. Opticon, 

Inc., 935 F.2d 1569, 1580 (Fed. Cir. 1991). While, on a macro level, the dispute between the 

parties concerns the issue of double-patenting, the narrow issue before this Court is whether the

’375 patent can be used as a reference patent for purposes of determining if the ’483 patent is an

unlawful extension of the ’375 patent.

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Important to this Court’s consideration of the present issue is a brief discussion of the 

change in patent law concerning patent terms. The Uruguay Round Agreements Act of 1994, 

which became effective on June 8, 1995, changed the term for a U.S. patent from seventeen 

years from the patent issue date to twenty years from the earliest effective filing date. See 

Uruguay Round Agreements Act, Pub.L. No. 103-465, § 532(a), 108 Stat. 4809, 4983-85 (1994). 

Patents that issued prior to June 8, 1995 expire on the later of two dates: either (1) seventeen 

years from the issue date or (2) twenty years from the effective filing date. Patents issued after 

June 8, 1995 have a twenty year term set from the earliest effective filing date.

Here, Natco argues that the ’375 patent can serve as a double-patenting reference for the 

’483 patent. (See Defs.’ Opp’n to Pls.’ Summ. J. Mot. And Br. in Supp. of Defs.’ Cross-Mot. for 

Partial Summ. J. (“Defs.’ Opp’n” 6-7.) Following that premise, Natco also argues that the ’483 

patent unlawfully extends the terms of the ’375 patent. (See id. 4-5.) Gilead contends that 

Natco’s positions are untenable given the existing case law regarding obviousness-type doublepatenting. (See Pls.’ Opening Mem. In Supp. 2.) More specifically, Gilead argues that the ’375 

patent cannot serve as a reference for double-patenting because it issued after the ’483 patent and 

terminates before the ’483; thereby not making the ’483 patent an unlawful extension of the ’375

patent. (See id. at 10-12.)

Gilead relies on two district court decisions to support its contention that the ’375 patent 

cannot serve as double-patenting reference for the ’483 patent: (1) Abbott Labs. v. Lupin Ltd., 

Civ. A. No. 09-152,-LPS, 2011 WL 1897322 (D. Del. May 19, 2011) and (2) Brigham & 

Women’s Hosp. Inc. v. Teva Pharm. USA, Inc., 761 F. Supp. 2d 210 (D. Del. 2011). In both 

cases the district court in the district of Delaware had to address whether a later-issued but 

earlier-expiring patent can serve as a double-patenting reference against an earlier-issued but 

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later-expiring patent. Both times, the Delaware district court held that a later-issued but earlierexpiring patent cannot be used as an invalidating reference against an earlier-issued but laterexpiring patent because logically a later-issued patent cannot be extended by a patent that was 

already in existence. See Abbott Labs., 2011 WL 1897322 at * 8; Brigham & Women’s Hosp. 

Inc., 761 F. Supp. 2d at 226. Similarly here, the ’375 patent cannot serve as a reference patent as

it issued after and terminates before the ’483 patent. Therefore the ’483 does not unlawfully 

extend Gilead’s right to exclusivity.

In both cases, the district court also found that the extensions of the patent terms at issue 

were not unlawful because the extensions were not a result of gamesmanship, but instead were a 

result of changes to patent laws. See Abbott Labs., 2011 WL 1897322 at 10; Brigham & 

Women’s Hosp. Inc., 761 F. Supp. 2d at 225. Natco argues that Gilead obtained the ’483 patent 

in part because Gilead failed to disclose the ’624 application, which ultimately issued as the ’375 

patent, to the United States Patent and Trademark Office (“PTO”). (See Natco Opp. Br./Br. in 

Supp. of Cross-Motion (“Natco Opp. Br.”) 5.) Natco highlights this nondisclosure because the 

’567 application, the parent application to the ’624 application, contained a similar disclosure to 

the ’306 provisional application, which is the parent application for the ’483 patent. (See

Natco’s L.R. 56.1 Statement of Uncontested Facts (“NSOF”) ¶ 4; Decl. of Diane C. Ragosa 

(“Ragosa Decl.”) 11.) Natco contends that had the PTO known about the ’375 patent 

application, the patent examiner “would have conditioned the allowance of the ’483 patent on 

Gilead terminally disclaiming any term of the ’483 patent that extended beyond twenty years 

after the filing date of the ’375 patent. (Defs.’ Opp’n 5.) Natco’s argument, however, is 

ineffective.

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Gilead notified the PTO of the ’375 patent family of applications, including the ’567 

application, which contained a similar disclosure to the ’306 provisional application. (See

Gilead’s Reply Br. 8.) Therefore, the nondisclosure of the ’624 application, though it also 

contained a similar disclosure to the ’306 provisional application, is not detrimental to Gilead’s 

case because of Gilead’s disclosure of the ’567 application. Similar to Abbott Labs. and 

Brigham, the lifespan of Gilead’s patents seem to be a result of changes in patent law, and not 

any gamesmanship from Gilead. Since the issuance of the ’483 patent is not the result of any 

strategic abuse of the patent system by Gilead, the ’375 patent cannot serve as a reference patent 

to invalidate the ’483 patent because of obviousness-type double-patenting.

V. CONCLUSION

For the reasons set forth above, Plaintiffs’ motion for summary judgment is GRANTED

and Defendants’ cross-motion is DENIED.

s/Susan D. Wigenton, U.S.D.J.

Orig: Clerk

Cc: Madeline Cox Arleo, U.S.M.J.

Parties 

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