UNITED STATESDISTRICT COURT FORTHE DISTRICT OF COLUMBIA ADMINISTRATORS OFTHE TULANE EDUCATIONAL FUND (AlKIATULANE UNIVERSITY), 

### etal., Plaintiffs,


### v. IPSENPHARMA, S.A.S. (FIKfA SOCIETE CONSEILSDE RECHERCHES ET D'APPLICATIONS SCIENTIFIQUES SAS), 

### etal., Defendants. ) ) ) ) ) ) ) Civil CaseNo. 09-2428 (RJL) ) ) ) ) ) )

# MEMORANDU~INION (March

# n,2011) [#21] Plaintiffs in this case, the Administrators ofthe Tulane Educational Fund (alk/a Tulane University) ("Tulane") and David H. Coy ("Dr. Coy") (collectively, "plaintiffs") filed this action against Ipsen Pharma, S.A.S. ("Ipsen Pharma") and Ipsen, S.A. ("Ipsen") for correction ofinventorship ofseveral U.S. patents pursuant to 35 U.S.C. §256. The complaint also alleges three claims under Massachusetts state law for unfair business practices, unjust enrichment, and constructive trust. Ipsen Pharmahas alternatively moved to dismiss the complaint for failure to state a claim or for a more definite statement. Forthe following reasons, the motion to dismiss is GRANTED in part and DENIED in part, andthe motion for a more definite statement is DENIED.

1

### BACKGROUND The facts ofthis case, and the particularpatents at issue, have previously been described in an earlier opinion. See Memorandum Opinion, Mar. 14,2011,ECF No. 46. The following relate specifically to Ipsen Pharma and the claims that are subject to its motion to dismiss. Ipsen Pharma, a subsidiary ofIpsen, is a Societe parActions Simplifiee organized and existing under the laws ofFrance. Compl.**~** 12, ECF No.1. Ipsen Pharma is engaged in the business of, among other things, holding intellectualproperty rights for Ipsen, including the GLP-l patents. Id. Itwas formed in November 2008 as successor by merger ofSociete Conseils, de Recherches et d'Applications Scientifiques ("SCRAS") and another Ipsen affiliate. Id.**~** 13. Biomeasure, aMassachusetts corporation, is Ipsen Pharma's majority-owned subsidiary. Id.**~** 14. The initial research collaborations betweenDr. Coy, Tulane, and Biomeasurewere governed by a Research Funding Agreement dated July 1, 1984. Id.**~** 15. OnNovember 16, 1990, Dr. Coy, Tulane, and Biomeasure entered into an Amended and Restated Research Funding Agreement ("RFA") that superseded the 1984 agreement. Id.**~** 16. The RFA was further modified by several addenda in 1997 and 1998. Id.**~** 18. Under its terms, the RFA covered various peptide research and studies conducted by, orunder the supervision and control ofDr. Coy. Id.**~** 17. Tulane and Dr. Coy also agreed to undertake ajointresearch project on "glucagon like peptides," or GLP-l analogs. Id.**~** 18. In Section 6 ofthe RFA, the parties agree that "all Results shall be the property ofTulane subject, however, to the rights ofBiomeasure therein." Id.**~** 19. The 2RFA allows Biomeasure to "prepare, file and prosecutepatent applications

... subjectto the approval ofTulane." Id.**~** 20. Italso grants Biomeasure (or an affiliate) the right to

an exclusive, worldwide license from Tulane and Dr. Coy ofany results or any patent or patent application coveringthe results subjectto notification requirements. Id.**~~** 21-22. Biomeasure is also required topay Tulane a royalty fee, depending on the degree of collaboration between the parties. Id.**~~** 22-23. Duringthe relevant time period, Biomeasure and Tulane held routinejoint meetings. Id.**~** 25. One was held on October 10, 1997 in the United Kingdom (the "UK meeting") and another was held on March 20, 1998 in Milford, Massachusetts (the "Milfordmeeting"). Id. Representatives from Tulane and Biomeasure (includingjoint officers ofBiomeasure and Ipsen Pharma's predecessor company, SCRAS) attendedboth meetings. Id.**~~** 25-26. GLP-I analog developmentwas discussed at the UK meeting. Also at that meeting, Dr. Coy "specifically described to Biomeasure's researchers the genus ofGLP-1 analogs that encompasses analogs modified at positions 8 and 35, which includes BIM51077,"the subject ofthe'186 Patent, and instructed that such analogs should be made and tested. Id.**~** 28. Minutes from the UK meeting "reflect Biomeasure's acknowledgement that substitutions identified by Dr. Coy were unique and likely patentable." Id.**~** 29. Atthe Milford meeting approximately six months later, Tulane and Biomeasure researchers "again discussed current data on various GLP-1 analogs being made and tested in cell assays, and how substitutions at various positions affected activity. They 3also reviewedpharmaceuticalprofiles for treating non-insulin dependent (type II) diabetes [] with GLP-l analogs." 

### Id.,-r 30. Following those meetings, Tulane and Biomeasure 'Jointly implemented Dr. Coy's ideas, and made and tested several GLP-l (7-36) analogs with position 8 and other substitutions." 

### Id. ,-r 31. Tulane now sues for correction ofinventorship ofthe patent covering the BIM-51077 compound, which is expectedto be effective in diabetes and obesity treatment, as well as for unfair business practices, unjust enrichment, and constructive trust under Massachusetts law. ANALYSIS 1. Legal Standard A court may dismiss all orpart ofa complaintthat "fail[s] to state a claim upon which reliefcan be granted." Fed. R. Civ. P. 12(b)(6). In considering a motion to dismiss, the court may only consider "the facts alleged in the complaint, any documents either attached to or incorporated in the complaint and matters ofwhich [the court] may takejudicial notice." EE

### 0.C. v. St. FrancisXavier ParochialSch., 117 F.3d 621, 624 (D.C. Cir. 1997). To survive a motion to dismiss made pursuantto Rule 12(b)(6), a complaint must "plead[] factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroftv. Iqbal, 129 S.Ct. 1937,1949 (2009). In evaluating a Rule 12(b)(6) motion, the Court construes the complaint "in favor ofthe plaintiff, who must be granted the benefit ofall inferences that

can be derived from the facts alleged." Schuler v. UnitedStates, 617 F.2d 605, 608 (D.C. Cir. 1979) (internal quotation marks omitted). However, factual allegations, even though 4assumed to be true, must still "be enough to raise aright to reliefabove the speculative level." BellAtl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). Moreover, the Court "need not accept inferences drawn by plaintiftlJ ifsuch inferences are unsupported by the facts set out in the complaint. Nor must the court accept legal conclusions cast in the form offactual allegations." Kowalv. MCl Commc 'ns Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994). 

### 2. Claim for Inventorship under 35 U.S.C. 

### § 256 Ipsen Pharma contends that plaintiffs' correction ofinventorship claim fails for two reasons: first, because 35 U.S.C. §256 allows only for correction ofpatents already issued when the complaint was filed, and not the correction ofpendingpatent applications orpatents issued duringthe pendency ofthe litigation; and second, because plaintiffs have failed to allege "conception" sufficientto state a claim ofinventorship.



### a. Issued patentsvs. patentapplications Plaintiffs seek to have Dr. Coy "named as inventor or co-inventor on the' 186, '213, and '628 Patents, and all related U.S. patents and patent applications claiming priority to orthrough U.S. utility application serial no. 09/206,601 and/orprovisional application serial no. 601111,255." Compl.**~** 61. Section 256, however, "creates a cause ofaction in the district courts only to modify inventorship on issued patents." EliLilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1357 n.l (Fed. Cir. 2004) (noting that plaintiffdid not have cause ofaction under Section 256 for correction ofinventorship when the patent had not yet issued at the time plaintifffiled the complaint). Indeed, an entirely separate section ofthe statute provides for correction ofinventorship on patent applications. 5Compare 35 U.S.c. § 256 ("Wheneverthrough error a person is named in an issued patentas the inventor, or through error an inventor is not named in an issuedpatentand such error arose without any deceptive intention on his part ... ") (emphases added), with 35 U.S.C. § 116 ("Wheneverthrough error a person is named in an application/orpatent

as the inventor, orthrough error an inventor is not named in an application, and such

error arose without any deceptive intention on his part ... ") (emphases added). Plaintiffs have conceded in their opposition that they do not seek correction of inventorship ofpending U.S. applications. PIs.' Opp'n 11, ECF No. 26. Instead, they maintain thatthey only seek correction ofinventorship for (l) "patent applications claimingpriority to or through the Biomeasure Only Applications [that] issue as patents prior to final adjudication ofthis litigation"; and (2) "international (PCT) patent applications filed as counterparts to issued patents in the Biomeasure Only Patent Family." 

### ld. However, as discussed above, Section 256 only creates a cause ofaction for correction ofinventorship ofU.S. patents that have already issued at the time offiling of the complaint, and thus plaintiffs' first set ofclaims regarding U.S. patents that may issue during the pendency ofthis litigation must be dismissed. Plaintiffs can, however, seek correction ofinventorship for pending foreign applications. Chou v. Univ. o/Chi., 254 F.3d 1347, 1360 (Fed. CiT. 2001). Ipsen Pharma argues thatplaintiffs, by using the phrase "U.S. patents and patent applications" in the Complaint (CompI.**~** 61), requested reliefonly as to U.S. patent applications. However, a reasonable reading ofplaintiffs' requests encompasses both U.S. patents and

6all-U.S. and foreign-patent applications. Accordingly, plaintiffs have adequately stated a claim only as to foreign patent applications. b. Sole inventorship vs. co-inventorship Defendant also contends thatplaintiffs have not stated a claim for either sole or co-inventorship. Inventorshiprequires conception, which is "complete only when the idea is so clearly defined in the inventor's mind that only ordinary skill wouldbe necessary to reduce the invention to practice, without extensive research or experimentation." Burroughs Wellcome Co. v. BarrLabs. Inc., 40 FJd 1223, 1228 (Fed. Cir. 1994). In otherwords, the inventor must have "a specific, settled idea, a particular solution to the problem at hand, notjust a general goal or research planhe hopes to pursue." Id. (citations omitted). Plaintiffs contend that Dr. Coy invented the "genus ofcompounds with substitutions at positions 8 and 35,"which "substantially includes the analogs disclosed and claimed in the GLP-l patents." PIs.' Opp'n 13. To support this claim, plaintiffs included the following allegations in their complaint: in 1997, "Dr. Coy specifically describedto Biomeasure'sresearchers the genus ofGLP-l analogs that encompasses analogs modified at positions 8 and 35, which includes BIM-51077 (the Taspoglutide compound) as well as specific compounds with substitutions at positions 8 and 35, like those in BIM-51077. Dr. Coy further instructed that such substitution analogs should be made and tested for activity and stability." Compi.**~** 28. The complaint further alleges that in 1998 "Tulaneresearchers (Drs. David Coy and William Murphy) and Biomeasure researchers

... again discussed current data on various GLP-l analogs being made and 7tested in cell assays, and how substitutions at various positions affected activity. They also reviewed pharmaceutical profiles for treating non-insulin dependent (type II) diabetes [] with GLP-l analogs." ld. ,-; 30. As defendantpoints out, even drawing all inferences in favor ofthe plaintiffs, these allegations do not allege the level ofconception necessary to state a claim for sole inventorship. In particular, plaintiffs fail to allege thatthe idea for the genus ofGLP-l analogs encompassed by the patents at issue was "so clearly defined" that it could be reduce to practice without extensive research. Burroughs Wellcome, 40 F.3d at 1228. Indeed, by the very terms ofthe complaint itself, Dr. Coy instructed further research and experimentation. See Compi. ,-; 28. Thus, plaintiffs' claim for sole inventorship must be dismissed. Plaintiffs have, however, stated a claim forjointor co-inventorship. The standard forjoint inventorship is set forth in 35 U.S.C. § 116, which states in relevantpart: "Inventors may apply for apatentjointly even though (1) they did notphysically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter ofevery claim ofthe patent." As the Federal Circuit has noted, Section 116 was amended in 1984 to codify the principles set forth in Monsanto Co. v. Kamp, 269 F. Supp. 818 (D.D.C. 1967). Vanderbilt Univ. v. ICaS Corp., 601 F. 3d 1297, 1302 (Fed. Cir. 2010) (citing KimberlyClark Corp. v. Proctor & Gamble Distrib. Co., 973 F.2d 911, 916 (Fed. Cir. 1992)). Accordingly, ajointinvention: 8[I]s the product ofcollaboration ofthe inventive endeavors oftwo or more persons working toward the same end and producing an invention by their aggregate efforts. To constitute ajoint invention, it is necessary that each of the inventors work on the same subject matter and make some contribution to the inventive thought and to the final result. Each needs to perform but a part ofthe task ifan invention emerges from all ofthe steps taken together. Itis not necessary that the entire invention concept should occurto each of thejoint inventors, orthatthe two should physically work on the project together. One may take a step at one time, the other an approach at different times. Vanderbilt, 601 F.3d at 1302 (quotingMonsanto, 269 F. Supp. at 824). These guidelines

were refined in Kimberly-Clark, which held that "[f]orpersons to bejointinventors under Section 116, there must be some element of jointbehavior.

. . . [Individuals] cannotbe totally independent ofeach other and bejoint inventors." Id. at 1303 (quoting KimberlyClark, 973 F.2d at 917 (alterations added)). Thus, eachjoint inventor "must contribute to thejoint arrival at a definite and permanent idea ofthe invention as it will be used in practice." Burroughs Wellcome, 40 F.3d at 1229. But, "each contributor need not have their own contemporaneous picture of the final claimed invention in order to qualify asjoint inventors." Vanderbilt, 601 F. 3d at 1303. For example, by statute,joint inventors need not contributeto every claim ofa patent-"[a] contributionto one claim is enough." Ethicon, Inc. v. Us. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998); 35 U.S.C. § 116. Indeed, "[o]ne need not alone conceive ofthe entire invention, for this would obviate the concept of joint inventorship." Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997). However, "[o]ne who simply provides the inventor with well-known principles or explains the state ofthe

9art without ever having 'a firm and definite idea' ofthe claimed combination as awhole does not qualify as ajointinventor." Ethicon, 135 F.3d at 1460. Thus, Tulane researchers' discussions with Biomeasure researchers regardingthe "current data on various GLP-l analogs being made and tested" do not rise to the level of joint inventorship because they were nothing more than discussions on the current state ofthe art. But, becauseplaintiffs claim that Dr. Coy described specific compounds with substitutions at positions 8 and 35 consistent with what was ultimately developed and patented, they have successfully stated a claim forjoint inventorship. 3. Massachusetts State Law Claims As discussed in the Memorandum Opinion granting Ipsen's Motion to Dismiss in this case, the Eastern District ofLouisiana has already adjudicated the issue ofwhether Ipsen Pharma is Biomeasure's alter ego. The standards for establishing the preclusive effect ofaprior holding are: (1) "the same issue now being raised must have been contested by the parties and submitted forjudicial determination in the prior case"; (2) "the issue must have been actually and necessarily determined by a court ofcompetent jurisdiction in that prior case"; and (3) "preclusion in the second case must not work a basic unfairness to the party bound by the first determination." Yamaha Corp. of Am. v. UnitedStates, 961 F.2d 245,254 (D.C. Cir.l992). "[I]fa court makes a substantive determination in order to arrive at ajurisdictional holding, the substantive determination

can have issue preclusive effect so long as it was 'actually litigated and determined in the prior action.'" NextWave Pers. Commc 'ns, Inc. V. FCC, 254 F.3d 130, 148 (D.C. Cir.

102001) (quotingI.A.M Nat 'IPension Fund, BenefitPlanA v. Indus. GearMIg. Co., 723 F.2d 994,947 n.3 (D.C. Cir. 1983)). Forthe same reasons discussed in the earlierMemorandum Opinion in this case, plaintiffs are barred from re-litigating this question by issue preclusion. Thus, in resolving Ipsen Pharma's motion to dismiss theremaining state law claims, the Court will look only to actions ofIpsen Pharma, not those ofBiomeasure.



### a. Unfair business practices A party may be liable under Section 11 ofMassachusetts General Laws chapter 93A for using orengaging in "anunfair method ofcompetition or an unfair ordeceptive act orpractice." Mass. Gen. Laws ch. 93A § 11; see also id. § 2; Mass. Eye andEar Infirmary v. QLTPhototherapeutics, Inc. ("MEEIII"), 552 F.3d 47,69 (1st Cir. 2009). To be liable, those actions must "occur[] primarily and substantially within the commonwealth." Mass. Gen. Laws. ch. 93A § 11. Moreover, the inquiry underthe statute is fact-specific: "[b]ecause '[t]here is no limit to human inventiveness in this field,' Massachusetts courts evaluate unfair and deceptive tradepractice claims based on the circumstances ofeach case. In so doing, Massachusetts leaves the determination of what constitutes an unfairtradepracticeto the finder offact, subjectto the court's performance ofalegal gate-keeping function." MEEI11,552 F.3d at 69 (citations omitted.). "An act orpractice is 'unfair' within the meaning ofthe statute ifit is (1) within the penumbra ofa common law, statutory, or other established concept ofunfaimess; (2) immoral, unethical, oppressive, or unscrupulous; or (3) causes substantial injury to 11competitors or other business people." Vieira v. FirstAm. Title Ins. Co., 668 F. Supp. 2d 282,292 (D. Mass. 2009) (quotations omitted); see also MEEJII, 552 F.3d at 69. In other words, "the objectionable conduct must attain a level ofrascality that would raise

an eyebrow ofsomeone inured to the rough and tumble ofthe world ofcommerce." Mass. Sch. of LawatAndover, Inc. v. Am. BarAss 'n, 142 F.3d 26, 41-42 (1st Cir. 1998) (citation omitted). Plaintiffs claim that "[t]heknowing and willful misrepresentations by Ipsen and/or Ipsen Pharmaregarding inventorship and ownership ofthe Biomeasure OnlyPatent Family constitute unfair methods ofcompetition and unfair and deceptive acts and practices." CompI.**~** 65; see also id.**~** 6. In addition, they allege that Ipsen Pharma engaged in unfair business practice by acquiring the patent rights ofits Massachusetts subsidiary, Biomeasure and subsequently entering into the exclusive licensing agreement for Taspoglutide without notifying Tulane. PIs.' Opp'n 15-16. Ipsen Pharmaurges the Court to dismiss this claim because plaintiffs have notpledthat any ofIpsen Pharma's acts occurred within Massachusetts. Def.'s Mot. 17. However, plaintiffs pointto following allegations in the complaint regarding the conduct ofIpsen Pharma (and its predecessor) in Massachusetts to argue that their cause ofaction arises out ofthe agreements between Ipsen Pharma and its subsidiary: (1) Ipsen Pharma's funding of Biomeasure's research that led to the GLP-l patents; and (2) Ipsen Pharma's acquisition ofthe GLP-l patentrights from a Massachusetts company. CompI.**~~** 24,45-46. Thus, plaintiffs have pled thatthe allegedly unfair practices substantially occurred in the Commonwealth. 12Ipsen Pharma further argues that plaintiffs' allegations fail to rise to the necessary "level ofrascality" sufficientto state a claim because they have pled no facts regarding Dr. Coy's inventorship. However, for the reasons discussed above, plaintiffs' claim for co-inventorship is sustained. Accordingly, defendant's motion to dismiss plaintiffs' claim for unfair business practices must also be DENIED. b. Unjust enrichment "Unjust enrichment is defined as 'retention ofmoney orproperty ofanother against the fundamental principles of justice or equity and good conscience.'" Santagate

v. Tower, 833 N.E.2d 171, 176 (2005) (quoting Taylor Woodrow Blitman Constr. Corp.

v. Southfield Gardens Co., 534 F. Supp. 340, 347 (D. Mass. 1982)). "Aclaim ofunjust enrichment is appropriate 'where an agreement is too indefinite to be enforced

... [or] where no contract is madebecause each ofthe parties had a materially different understanding ofthe terms.' Unjust enrichmentprovides an equitable stopgap for occasional inadequacies in contractual remedies at law by mandating that'[a] person who has been unjustly enriched at the expense ofanother is required to make restitution to the other.'" Mass. Eye andEarInfirmary v. QLTPhototherapeutics ("MEEII"), 412 F.3d 215,233 (IstCir. 2005) (citations omitted) (alteration in original). Thus, to state a claim ofunjust enrichment under Massachusetts law, aplaintiffmust allege the following: "(1)

abenefit conferred upon [the defendant] by Plaintiffs; (2) an appreciation or knowledge ofthe benefit by [the defendant]; and (3) the acceptance orretention ofthe benefit by [the defendant] under circumstances which make such acceptance orretention inequitable."

13Vieira, 668 F. Supp. 2d at 294 (citation omitted).1 Atthe pleading stage, plaintiffs may plead inconsistent alternative theories ofliability even ifthey can only recover under one. Id. at 295 (citing Fed. R. Civ. P. 8(d)). Plaintiffs allege that Tulane and Dr. Coyprovided Ipsen Pharma with the benefit ofthe conception ofthe research that led to the GLP-l patents, which Ipsen Pharmahas appreciated by patenting the rights to the compound. Plaintiffs further allege that Ipsen Pharma has inequitably retained the benefit by refusing to acknowledge Tulane as a coinventor and pay royalties pursuantto the RFA. Itis difficult to see why, ifTulane's claim is successful, it would not be adequately compensatedthrough that contract. However, at this stage ofthe litigation, plaintiffs are entitled to plead an inconsistent theory and, making all inferences in their favor, they have successfully stated an unjust enrichment claim.



### c. Constructive trust Constructive trust is imposed to avoid "unjust enrichmentresulting from fraud, a violation of

### afiduciary duty or confidential relationship, mistake, or 'other circumstances' in which a recipient's acquisition oflegal title to property amounts to unjust enrichment." Maffei v. Roman CatholicArchbishop of Boston, 867 N.E.2d 300, 312 (Mass. 2007) (citing Fortin v. Roman CatholicBishop o/Worcester, 625 N.E.2d

1The District Court ofMassachusetts has also alternatively described an unjust enrichment claim as requiring: "(1) an enrichment, (2) an impoverishment, (3) a relation between the enrichment and the impoverishment, (4) the absence of justification and (5) the absence ofa remedy provided by law." Moore v. La-ZBoy, Inc., 639 F. Supp. 2d 136, 143-44 (D. Mass. 2009) (quotingIn re Lupron Mktg. andSalesPracticesLitig., 295 F. Supp. 2d 148,182 (D. Mass 2003)). 14l352, 1358-59 (Mass. 1994), cert. denied, 511 U.S. 1142 (1994)). Plaintiffs have failed to allege fraud, existence ofa fiduciary or confidential relationship, or mistake. They have, however, alleged unjust enrichment. Thus, because that claim survives, so does their claim for constructive trust based on unjust enrichment. 4. More Definite Statement In the alternative, Ipsen Pharma moves for a more definite statementpursuant to Federal Rule ofCivil Procedure 12(e). Though Rule 8(a) requires only a "short and plain statement ofthe claim showingthat the pleader is entitled to relief," it must nevertheless be "detailed enough to 'givethe defendant fair notice ofwhat the

... claim is and the grounds upon which it rests[.]''' Dorseyv. Am. Express Co., 499 F. Supp. 2d 1,3 (D.D.C. 2007) (quoting Twombly, 550 U.S. at 555) (alteration in original). Under Rule 12(e), the Court may grant the requested reliefifthe complaint "is so vague or ambiguous that the party cannot reasonably prepare aresponse." Fed. R. Civ. P. 12(e). Given the generous nature ofRule 8, the complaint gives Ipsen Pharma fair notice ofthe claims plaintiffs make against it. The complaint is not "so vague or ambiguous" that Ipsen Pharma cannot respond. Accordingly, the motion for a more definite statement is DENIED.

15CONCLUSION For all the foregoing reasons, Ipsen Pharma's Motionto Dismiss is hereby GRANTED in part and DENIED in part, and its Motion for a More Definite Statement is DENIED. An appropriate order shall accompany this memorandum opinion.

16