UCB, Inc. v. Accord Healthcare, Inc. (201 F. Supp. 3d 491, 2016)

OPINION

STARK, United States District Judge:

Plaintiffs — UCB, Inc., UCB BioPharma SPRL, Research Corporation Technologies, Inc., and Harris FRC Corporation (collectively, “Plaintiffs”) — allege that Defendants — Accord Healthcare, Inc., Intas Pharmaceuticals Ltd., Alembic Pharmaceuticals, Ltd., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Aurobindo Pharma Ltd., Auro-bindo Pharma USA, Inc., Breckenridge Pharmaceutical, Inc., MSN Laboratories Pvt. Ltd., Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd., Watson Laboratories, Inc. — Florida (n/k/a Actavis Laboratories FL, Inc.), Watson Pharma, Inc. (n/k/a Actavis Pharma, Inc), Actavis, Inc., Apotex Corp., Apotex, Inc., Mylan Pharmaceuticals Inc., Mylan, Inc., Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Limited (collectively, “Defendants”) — infringe United States patent No. RE38,551 (JTX-1 (“the ’551 patent” or “the patent-in-suit”)). (D.I.l)

The ’551 patent generally relates to “an-ticonvulsant drugs,” which “control and prevent[ ] seizures associated with epilepsy or related central nervous system disorders.” (’551 patent at 1:26-29) Each of the Defendants has filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to market generic versions of Plaintiffs’ pharmaceutical product Vimpat®, which is an embodiment of claims of the patent-in-suit.

The Court construed the disputed claim terms in May 2015. (D.I. 240) In December 2015, the Court conducted a bench trial. (See D.I. 264-267 (“Tr.”)) The parties completed post-trial briefing on February 8, 2016. (D.I. 263, 271, 274, 277) In connection with the briefing, the parties submitted proposed findings of fact (D.I. 262, 270, 273) as well as a Stipulation of Uncontested Facts (“SUF”) (D.I. 272).

On May 23, 2016, the Patent Trial and Appeal Board (“PTAB”) instituted an inter partes review of the validity of claims 1-13 of the ’551 patent. (See D.I. 294, 294-1) On June 16, 2016, the U.S. Patent and Trademark Office (“PTO”) instituted an ex parte reexamination of the same claims. (See D.I. 300, 300-1)

Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the Court concludes that: (1) Defendants have stipulated that their proposed products infringe claims 9, 10, and 13 of the ’551 patent, and (2) Defendants have failed to prove that any of claims 9, 10, and 13 of the ’551 patent are invalid for obviousness-type double patenting, obviousness, anticipation, indefiniteness, or improper reissue. The Court’s findings of fact and conclusions of law are set forth in detail below.

I.FINDINGS OF FACT

This section contains the Court’s findings of fact for issues raised by the parties during trial. Certain findings of fact are also provided in connection with the Court’s conclusions of law.

A. The Parties

1. Plaintiff UCB, Inc. is a corporation organized and existing under the laws of Delaware, having a principal place of business at 1950 Lake Park Drive, Smyrna, Georgia 30080. (SUF ¶ 1)

2. Plaintiff UCB BioPharma SPRL (together with UCB, Inc., “UCB”), is a corporation organized and existing under the laws of Belgium, having a principal place of business at Allee de la Recherche 60, Brussels, 1070, Belgium. (SUF ¶ 2)

3. Plaintiff Research Corporation Technologies, Inc. (“RCT”) is a corporation organized and existing under the laws of Delaware, having a principal place of business at 5210 East Williams Circle, Suite 240, Tucson, Arizona 85711-4410. ■ (SUF ¶ 3)

4. Plaintiff Harris FRC Corporation (“Harris”) is a corporation organized and existing under the laws of New Jersey, having a principal place of business at 2137 State Highway 35, Holmdel, New Jersey 07733. (SUF ¶4)

5. Defendant Accord Healthcare, Inc. is a corporation organized and existing under the laws of North Carolina, having a principal place of business at 1009 Slater Road, Ste. 210-B, Durham, North Carolina 27703. (SUF ¶ 5)

6. Defendant Intas Pharmaceuticals Ltd. is a corporation organized and existing under the laws of India, having a principal place of business at Chinubhai Centre, off Nehru Bridge, Ashram Road, Ahmedabad 380009, Gujarat, India. (SUF ¶ 6)

7. Defendant Alembic Pharmaceuticals Ltd. is a corporation organized and existing under the laws of India, having a principal place of business at Alembic Road, Vadodara-390003, Gujarat, India. (SUF ¶ 7)

8. Defendant Amneal Pharmaceuticals, LLC is a corporation organized and existing under the laws of Delaware, having a principal place of business at 400 Crossing Boulevard, 3rd Floor, Bridgewater, New Jersey 08807. (SUF ¶ 8)

9. Defendant Amneal Pharmaceuticals of New York, LLC is a corporation organized and existing under the laws of Delaware, having a principal place of business at 85 Adams Avenue, Hauppauge, New York 11788. (SUF ¶ 9)

10. Defendant Aurobindo Pharma Ltd. is a corporation organized and existing under the laws of India, having a principal place of business at Plot # 2, Maitrivihar, Ameerpet, Hyderabad-500038, Telagana, India. (SUF ¶ 10)

11. Defendant Aurobindo Pharma USA, Inc. is a corporation organized and existing under the laws of Delaware, having a principal place of business at 6 Wheeling Road, Dayton, New Jersey 08810. (SUF ¶ 11)

12. Defendant Breckenridge Pharmaceutical, Inc. is a corporation organized and existing under the laws of Florida, having a principal place of business at 6111 Broken Sound Parkway NW, Suite 170, Boca Raton, Florida 33487. (SUF ¶ 12)

13. Defendant Vennoot Pharmaceuticals, LLC is a corporation organized and existing under the laws of Georgia, having a principal place of business at 11009 Estates Circle, Alpharetta, Georgia 30022. (SUF ¶ 13) On August 1, 2016, the Court granted the parties’ stipulation to substitute MSN Laboratories Ptv. Ltd. for Ven-noot. (D.I. 311)

14. Defendant Sun Pharma Global FZE is a corporation organized and existing under the laws of the United Arab Emirates, having a principal place of business at Executive Suite #43, Block Y, SAIF-Zone, P.O. Box 122304, Sharjah, U.A.E. (SUF ¶ 14)

15. Defendant Sun Pharmaceutical Industries, Ltd., is a corporation organized and existing under the laws of India, having a principal place of business at SUN HOUSE, CTS No. 201 BA, Western Express Highway, Goregaon (E), Mumbai 400063, India. (SUF ¶ 15)

16. Defendant Watson Laboratories, Inc. — Florida (nA300

amido (107b) C(Q)NH2 >300

ethyl ester (107c) C(0)0CH2CH3 >300

hydroxymethyl (107d) CH2OH >100, <300

methoxymethyl (107e) CH2OCH3 not tested

(See DTX-2019 at DEF_244-45)

111. LeGall recognized that heteroaro-matic compounds showed the most promise. In the conclusion of his thesis, he emphasized the “highly active” “five-mem-bered ring heteroaromatic” compounds; he did not mention the nonaromatic compound 107e. (DTX-2019 at DEF_254-55; Heathcock Tr. at 184-185; Roush Tr. at 583-85, 601) Dr. Heathcock described the heteroaromatic furan compound disclosed in the LeGall Thesis as Dr. Kohn’s “first big breakthrough.” based on its high potency. (Heathcock Tr. at 179-80)

112. Despite the fact that he did not have data for compound 107e, LeGall hypothesized that structural similarities between compound 107e and another compound, 86b, suggested that compound 107e “may have good anticonvulsant activity.” (DTX-2019 at DEF_245)

113. Compound 86b contained OCH2CH3 at R and had an ED60 value of 62.0 mg/kg. (DTX-2019 at DEF_196) While a more potent compound than the “polar analogue” compounds for which data was reported (see table above), by March 1996 a POSA would have found the potency of 86b to be uninteresting. (Heathcock Tr. at 186; Roush Tr. at 602-04)

114. “[A]ll fifteen molecules that Mr. LeGall synthesized had a benzyl group at R and a methyl group at R1;” making these “common structural elements]” in LeGall’s work. (Roush Tr. at 676-80) Le-Gall “didn’t consider any other options,” “only compounds with unsubstituted ben-zyls” at R and methyls at Rx. (Id. at 677-78)

115. The LeGall Thesis was not before the PTO when it examined the application that became the ’551 patent. (See Heath-cock Tr. at 76-77; JT-4; JTX-2)

116. For nine years after the LeGall Thesis, compound 107e was never mentioned in any article, patent, or other reference. (Heathcock Tr. at 159-61)

iii. U.S. Patent No. 5,378,729 (the “’729 patent”)

117. The ’729 patent, entitled “Amino Acid Derivative Anticonvulsant” was filed on June 4, 1991 and issued on January 3, 1995 to inventors Dr. Kohn and Dr. Darrell Watson. (’729 Patent (DTX-2012) at cover) The ’729 patent discloses a broad genus of millions or billions of compounds of the generic formula:

(Id. at 61:40-62:34; Roush Tr. at 749)

118. The ’729 patent includes many compounds and groups referred to as “preferred,” including a dozen sets of “preferred compounds” or “preferred embodiments,” and many preferred groups for each position of each compound or embodiment. (’729 patent at 5-10)

119. The first “[preferred compounds” of the ’729 patent define R as a benzyl group, which can be unsubstituted or substituted (up to 3 groups on the phenyl ring are described as “preferred” R groups of these preferred compounds). (’729 patent at 6:31-45; Roush Tr. at 746-48) A POSA reading the ’729 patent would understand this to mean that it is preferred that the benzyl group be either substituted or unsubstituted. (Roush Tr. at 746-47) Other classes of “preferred compounds” in the ’729 patent list the R groups as “aryl, aryl lower alkyl, heterocyclic or heterocyclic alkyl which is unsubstituted or substituted with at least one electron withdrawing group or at least one electron donating group” and the Rx groups as “hydrogen or lower alkyl which is unsubstituted or substituted with at least one electron withdrawing group or one electron donating group.” (’729 patent at 8:50-64, 9:20-22)

120. The ’729 patent also lists preferences for groups located at R3. The parameters for the preferred R3 groups encompass millions of possible groups. (See, e.g.,’729 patent at 6:14-31; Roush Tr. at 748-49) While lacosamide falls within the scope of the preferences of the ’729 patent (Heathcock Tr. at 125), neither methoxy-methyl nor any alkoxy alyl is explicitly listed as a preferred R3 group (’729 patent at 6:13-43, 8:65-9:2, 9:22-28).

121. The ’729 patent nowhere mentions lacosamide. (See generally ’729 Patent; Heathcock Tr. at 160)

122. The ’729 patent identifies scores of FAAs and provides pharmacological data for 54 FAAs in Table 1. None of these compounds is lacosamide, 107e, or any compound with a methoxymethyl group at R3. (Heathcock Tr. at 160, 197; Roush Tr. at 594-95, 741-42)

123. All 54 compounds for which data is provided have methyl at Rj. (Heathcock Tr. at 117; ’729 patent at Tbl.l) Forty-nine of these compounds have an unsubstituted benzyl at R; the other five have fluoro-substituted benzyls at R. (’729 patent at Tbl. 1) The pharmacological results for the compounds vary greatly. (See id.)

124. The ED60s of compounds in Table 1 with unsubstituted benzyl at R and unsubstituted methyl at Rx range from 3.3 mgdig to inactive. (Id.) Ten of the compounds with these substitutions showed no activity, while many others exhibited only weak activity. (Id.)

125. Of the 10 compounds with the best ED50 values, eight had heteroaromatic groups at Rs; the other two had nitrogen-based groups. (Heathcock Tr. at 198; Roush Tr. at 742-43; ’729 patent at Tbl.l (10 compounds with heteroaromatic groups at R3 shown as entries 9,10, 13, 18, 30, 32, 37, 45, 48, and 51)) The four compounds in Table 1 that had nonaromatic, carbon-based groups at R3 (the RS-, R-, and S-alanine compounds, and an allyl compound) had moderate to weak anticonvul-sant activity, with EDeos of 77, 55, 548, and 33.6 mg/kg, respectively. (Roush Tr. at 741-42; ’729 patent at Tbl.l) Thus, the data in the ’729 Patent would not have created an expectation in a POSA that nonaromatic, carbon-based groups at R3 would be promising. (Roush Tr. at 742-43)

126. The two compounds in the 729 patent with the best protective indices (PI) had fluoro-substituted benzyl groups at R. (Heathcock Tr. at 200; Roush Tr. at 593-94, 616-17) These compounds exhibited “basically no change in activity .,. but a strikingly large improvement in the neuro-toxicity data” relative to the compounds with unsubstituted benzyl at R. (Roush Tr. at 617) This suggested that substituted benzyl groups at R might confer desirable properties. (See JTX-7 at DEF_566, Tbl.4 (la vs. lm))

M. U.S. Patent No. 5,654,301 (the “’301 patent”)

127. The ’301 patent is a continuation-in-part of the ’729 patent and is entitled “Amino Acid Derivative Anticonvulsant.” (DTX-2016 (“’301 patent”) at DEF_337) The ’301 patent was filed on January 12, 1993. The ’301 patent is not prior art, but it is the reference patent for Defendants’ obviousness-type double patenting claim.

128. UCB listed the ’301 patent in the FDA’s “Orange Book” in association with ■NDA Nos. 022-253, 022-254 for Vimpat®. (DTX-2347 at DEF_9936)

129. Claim 39 of the ’301 patent is an FAA that covers many millions, if not billions, of compounds of the formula:

(Roush Tr. at 631; ’301 patent at 93:3-23)

130. Claim 39 defines the R group as “aryl, aryl lower alkyl, heterocyclic, heter-ocyclic lower alkyl, cycloalkyl, or lower cycloalkyl lower alkyl, wherein R is unsubstituted or is substituted with at least one electron withdrawing group or an electron donating group.” (’301 patent at 93:3-23) This broad definition permits R to be any of millions of possible groups. (See Heath-cock Tr. at 201-02)

131. Claim 39 defines the Rt group as “hydrogen or lower alkyl ... unsubstituted or substituted with at least one electron withdrawing group or at least one electron donating group.” (’301 patent at 93:3-23) The ’301 patent defines “lower alkyl” as “containing from 1 to 6 carbon atoms and may be straight chain or branched.” (Id. at 3:37-39) This definition of “lower alkyl” covers 32 different groups, which can be substituted at various positions with one or more electron donating or electron withdrawing groups. (Roush Tr. at 633-34) The number of possible Rx groups within claim 39 is thus very large. (Id. at 634)

132. Claim 39 requires one of R2 and R3 to be “hydrogen and the other is lower alkyl which is substituted with an electron donating group or a[n] electron withdrawing group.” (’301 patent at 93:3-23) Thus, the Rs of claim 39 can be any one of the large number of groups discussed above for R: — consisting of thousands, if not millions, of possible groups. (Roush Tr. at 634-35)

133. The ’301 patent lists categories of [t]he most preferred electron donating and electron withdrawing substi-tuent[s:] ... halo, nitro, alkanoyl, for-myl, arylalkanoyl, aryloyl, carboxyl, carbalkoxy, carboxamide, cyano, sul-fonyl, sulfoxide, heterocyclic, guani-dine, quaternary ammonium, lower alkenyl, lower alkynyl, sulfonium salts, hydroxy, lower alkoxy, lower al-kyl, amino, lower alkylamino, di(low-eralkyl)amino, amine lower alkyl mer-capto, mercaptoalkyl, alkylthio; and alkyldithio.

(’301 patent at 5:14-22) Many of these “substituents” are themselves generic categories, creating a very large group of possible preferred electron-donating and electron-withdrawing groups. (Roush Tr. at 632-33) These groups apply to any of the R, Rx, or R3 positions on the FAA molecule. (’301 patent at 93:3-23)

134. Claim 39 permits the repeating unit “n” — for the core C-CNH structure — to be one to four. (Id.)

135. Claim 39 does not specify a particular stereochemistry, so it encompasses R enantiomers, S enantiomers, and racemic mixtures of both. (Roush Tr. at 635-36)

136. Lacosamide is one species of the millions of compounds in the genus claimed by claim 39. (Roush Tr. at 636) The ’301 patent, however, does not mention lacosamide. (See ’301 Patent at Tbls. 1-4)

137. Claim 44 depends from claim 39 and defines the Rs group as methoxymethyl (’301 patent at 94:12-13; Roush Tr. at 636); thus, it covers compounds of the formula:

138. The R and Rj groups of claim 44 are the same broad genera as those defined for claim 39. (’301 patent at 93:3-23, 94:12-13) Like claim 39, claim 44 permits the value of “n” to be between one and four and the stereochemistry to be R, S, or a mixture thereof. (’301 patent at 94:12-13; Roush Tr. at 635-36) Claim 44 covers a genus of millions of compounds. (Roush Tr. at 637-38; see also Heathcock Tr. at 200-02)

139. The PTAB has found that the genus covered by claim 44 of the ’301 patent encompasses “thousands of compounds,” observing that “a skilled artisan still has to pick from unsubstituted and substituted R (and Rx), and if substituted, which substitution.” (JTX-88 at DEF_7503)

140. Claim 45 can depend from “any one of claims 39-44” and limits n to one. (’301 patent at 94:14-15) Thus, claim 45 covers a genus of compounds of the formula:

141. This genus covers “millions and millions if not billions” of compounds. (Roush Tr. at 637) Lacosamide is one species of this genus. (Heathcock Tr. at 201; Roush Tr. at 638)

142. Even when claim 45 is limited to depending from claim 44, which defines the R3 group as methoxymethyl, genus claim 45 still encompasses millions of possibilities due to the millions of possible choices for R and Rx. (Roush Tr. at 637-38)

143. Claim 46 of the ’301 patent should read as follows: “An anti-convulsant composition comprising an anti-convulsant effective amount of a compound from any one of claim[s] 39-44 and a pharmaceutical carrier therefor.” (SUF ¶ 89)

144. Claim 47 of the ’301 patent claims “[a] method of treating CNS disorders in an animal comprising administering to said animal an anti-convulsant effective amount of a compound of any one of claims 39-44.” (’301 patent at 94:19-21)

145. Claims 46 and 47 of the ’301 patent each cover millions of compounds. Both claims incorporate the large genera of possible R, R1; and R3 groups from claim 39. (See Heathcock Tr. at 206-07) Even if claims 46 and 47 are limited to the genus of claim 45 as it depends from claim 44, they would still each encompass millions of compounds, due to the millions of possible choices for the R and Rt groups. (See Roush Tr. at 637-38)

146. The ’301 patent provides tables of pharmacological data for FAA compounds. (’301 patent at Tbls.1-4) None of these tables discloses pharmacological data for lacosamide, 107e, or any compound with a methoxymethyl at R8. (See id.) Table 1 of the ’301 patent is the same as Table 1 of the ’729 patent. Table 1 demonstrates that not all of the compounds covered by the ’301 patent have good anticonvulsant activity. Indeed, some of the compounds listed have no activity at the highest tested dose. (Roush Tr. at 740) Similarly, Tables 3 and 4 of the ’301 patent include examples of 22 other compounds. (’301 patent at Tbls.3-4) Fifteen of these compounds had no anticonvulsant activity at the highest tested dose. (See id.)

147. The ’301 patent does not mention liver toxicity. (See generally ’301 Patent)

148. The PTO Examiner who examined the application leading to the ’551 patent had the ’301 patent before her. (See Heath-cock Tr. at 148) Yet the Examiner never issued a double patenting rejection in her two reviews of the ’551 patent. (See generally JTX-2, JTX-4)

N. Others’ Exploration into FAAs

149. Dr. Kohn was not the only researcher to investigate FAAs. Drs. Parusz-ewski and Hinko also published on the subject. (JTX-53; JTX-54; JTX-87) While their articles are not prior art, they were published very shortly after the priority date, so they “show[] what other people had been thinking about” as of the priority date. (Heathcock Tr. at 163; see also Roush Tr. at 699)

150. Dr. Paruszewski was aware of Dr. Kohn’s work. (Roush Tr. at 613; JTX-53 at DEF_7495 (citing Kohn)) None of Parusz-ewski’s compounds had a methoxymethyl group at Rs. (Heathcock Tr. at 168-69; Roush Tr. at 613) While Paruszewski used groups at the R and Rj positions that were not benzyl and methyl, 18 out of 30 of Paruszewski’s compounds had unsubstituted benzyl (PDX-88; Roush Tr. at 703-04) and 19 out of 30 had a methyl at Rx. However, only six of his 30 compounds used the benzyl/methyl combination. (Roush Tr. at 617-18; JTX-53 at DEF_7493, Tbl.l; JTX-54 at KOHN_VIM33299, TbLl)

151. One change Paruszewski made was to remove the carbonyl (C=0) to which the Rx group is attached. (Roush Tr. at 620-21; PTX-80 at PLS-VIM20940-41) He included this modification in a prior art patent application published on May 2, 1995. (PTX-80 at PLS-VIM20938) The modification increased anticonvulsant activity (ED50 = 31.17 mg/kg) compared to Dr. Kohn’s otherwise analogous alanine compound (EDB0 = 76.54mg/kg). (Roush Tr. at 620-21)

152. Dr. Hinko was also aware of Dr. Kohn’s work. (JTX-87 at DEF_7475 (citing Kohn’s papers); Roush Tr. at 618) Hinko did not use a methoxymethyl group at the R3 position; nor did he use a methyl group at Rj. (Roush Tr. at 614; JTX-87 at DEF_7476, Fig. 1(1)) The compounds made by Hinko had a structure based on a piperidine ring, in which “the R3 is all tied back if you will, connected back into formally the remnants of where the R! group has been in Dr. Kohn’s structures.” (Roush Tr. at 614, 622; JTX-87 at DEF_7476, Fig. 1(D)

153. Hinko also made many modifications to the R group, including “fluorines, tri-fluoro-methyls at different positions, methyls, nitros, [and] chlorines.” (Roush Tr. at 618-23; JTX-87 at DEF_7480, Tbl.l) Hinko also “put additional substituents on the carbon connecting the phenyl group to the nitrogen. ... So these are not phenyl-methyl [i.e., benzyl], these ... are phenyl-ethyl substituents” at the R position. (Roush Tr. at 619; JTX-87 at DEF-7480, Tbl.l) Only two out of Hinko’s 21 compounds used unsubstituted benzyl. (Roush Tr. at 618-19)

0. The ’551 Patent-in-Suit

154. The patent-in-suit is United States Patent No. RE 38,551. (SUF ¶ 30) The ’551 patent was filed on January 28, 2002 as a reissue of U.S. patent No. 5,773,475. (Id.) The ’551 patent claims priority to provisional patent application No. 60/013,522, which was filed on March 15, 1996. The ’551 patent issued on July 6, 2004 and will expire no later than March 17, 2022.

155. RCT is the current owner of the ’551 patent. Harris is the exclusive licensee of the ’551 patent. UCB BioPhar-ma SPRL is the exclusive sublicensee of the ’551 patent for use in humans. (SUF ¶ 31)

156. In the FDA’s “Orange Book,” the ’551 patent is listed in the entries for Vimpat®, as is the ’301 patent. (SUF ¶ 32)

157. It is undisputed that the ’551 patent was the first public description of lacosam-ide and that lacosamide was not described in any prior art, including the ’301 patent. (Heathcock Tr. at 167, 177; Roush Tr. at 561) The ’551 patent provides methods of synthesizing lacosamide. (’551 patent at 11:22-13:14) It also provides physical and spectroscopic data on lacosamide. (Id. at 12:17-32,13:6-14)

158. The ’551 patent also contains the first publication of any pharmacological data for lacosamide. (Id. at Tbl.l (listing ED60 and TDfi0 data for lacosamide in mice and rats)) The ’551 patent compares the physical and pharmacological properties of lacosamide against a number of other compounds to demonstrate lacosamide’s superior properties. (’551 patent at Tbls.1,6)

159. Claim 9 of the ’551 patent covers one compound, lacosamide. Claim 9, which depends from claims 1 and 8, discloses:

I. A compound in the R configuration having the formula: wherein Ar is phenyl which is unsubstituted or substituted with at least one halo group; Q is lower alkoxy, and Q1 is methyl.

8. The compound according to claim 1 which is (R)-N Benzyl 2-Acetamido-3-methoxypropionamide.

9. The compound according to claim 8 which contains at least 90% (w/w) R stereoisomer.

160. Claims 10 through 13 disclose:

10. A therapeutic composition comprising an anticonvulsant effective amount of a compound according to any one of claims 1-9 and a pharmaceutical carrier therefor.

11. A method of treating central nervous system disorders in an animal comprising administering to said animal in need thereof an anticonvulsant effective amount of a compound according to any one of claims 1-9.

12. The method according to claim 11 wherein the animal is a mammal.

13. The method according to claim 12 wherein the mammal is a human.

161. After the ’551 patent issued, RCT told the PTO that the ’301 patent covered lacosamide. In an application to extend the term of the ’301 patent, RCT represented that “claims 39-45” of the patent “claim the active ingredient ... lacosamide.” (DTX-2095 at DEF_4996) That document also represented that claim 46 of the ’301 patent “cover[s] a therapeutic composition” of lacosamide and that “[c]laim 47[ ] cover[s] a method of treating central nervous system disorders” with lacosamide. (DTK-2095 at DEF_4997-98)

162. The PTO accepted RCT’s representations, concluding that “U.S. Patent No. 5,654,301, which claims the human drug product Vimpat® (lacosamide) Tablet and a method of using” it, “is eligible for patent term extension.” (DTX-2218 at DEFJ5206) The PTO noted, however, that RCT “also ha[d] applied for patent term extension of U.S. Patent No. RE38561” based on Vimpat®’s approval, and that “the certificate of extension is issued to the patent having the earliest date of issuance unless applicant elects a different patent.” (Id.) RCT elected to extend the ’551 patent — the later-expiring patent. (See id. at DEF_5209)

P. Differences Between the ’301 and ’551 Patents

163. The differences between claims 44 and 45 of the ’301 patent, on the one hand, and claim 9 of the ’551 patent, on the other, are that claim 9 fills in the variables of the claim 44/45 equation, so as to narrow the genus of