Sepracor Inc. v. Dey LP et al

REPLY BRIEF re MOTION to Consolidate Cases

D. Del.November 15, 2006

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SEPRACOR, INC., Plaintiff, Counterclaim-Defendant v. DEY, L.P. and DEY, INC., Defendants, Counterclaim-Plaintiffs. ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No. 06-113-KAJ SEPRACOR, INC., Plaintiff, Counterclaim-Defendant v. DEY, L.P. and DEY, INC., Defendants, Counterclaim-Plaintiffs. ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No. 06-604 KAJ DEY’S REPLY IN SUPPORT OF ITS MOTION TO CONSOLIDATE I. INTRODUCTION Sepracor’s response to Dey’s motion to consolidate is simply another attempt by Sepracor to derail the schedule ordered by this Court. Sepracor essentially argues that if the two levalbuterol hydrochloride patent infringement actions it brought against Dey, Civil Action No. 06-113-KAJ (identified by Sepracor as Dey I) and Civil Action No. 06-604-KAJ (identified by Sepracor as Dey II) were consolidated, and the consolidated case used the Dey I scheduling order, Sepracor would be precluded “from having a fair and reasonable opportunity to discover Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 1 of 9 2 and prepare the issues on which it has the burden of proof in the Dey II case.” See Sepracor Answering Br. (D.I. 70) at 1. Sepracor never identifies how the products that are the subject of Dey’s two Abbreviated New Drug Applications (“ANDAs”) differ or why Sepracor’s infringement cases would differ. Instead, it simply argues that Dey’s filing of a second ANDA is some sort of an “October surprise” intended to prejudice Sepracor. As detailed below, consolidation of the two cases and adoption of the Dey I scheduling order will not prejudice Sepracor. First, Sepracor already has received sufficient information about both of Dey’s ANDA filings to ascertain an infringement position. Sepracor’s speculation that the products that are the subject of the two actions must be materially different because Dey filed two ANDAs, is therefore, disingenuous and misleading. Second, Sepracor improperly accuses Dey of gamesmanship. Sepracor essentially argues that Dey delayed filing the second ANDA to prejudice Sepracor. “[T]he ANDA applicant has control over the timing as to when the patentee files….” Sepracor Answering Br. (D.I. 70) at 2. There is no support for Sepracor’s allegation. Sepracor does not explain why it believes Dey would delay filing an ANDA and thereby risk the 180 days of product exclusivity given to the first to file pursuant to 35 U.S.C. § 355(j)(5)(B)(iv). This is because delay in filing its ANDA does not benefit Dey. In contrast, however, Sepracor benefits by a delay1 in resolving Dey I and Dey II because each day of delay means another day that Sepracor can maintain its monopoly on the sale of levalbuterol. 1 Sepracor’s attempts to delay resolution of this matter have been evident since it asked this Court to adopt the extended scheduling order in “Sepracor v. Breath Ltd., No. 06-10043-DPW (D. Mass.) (the “Breath action”), which this Court declined to do. At a recent hearing, the Massachusetts Court expressed concern about the length of the schedule. The court stated: “Now am I still right that it’s not a typographical error to say 2008 for Markman?” See Transcript of Motion Hearing held on 10/17/06 in the Breath action at p. 10 ll 4-5 (attached as Exhibit A). At a later point the court stated “I am concerned about, you know, making the case move along. And I don’t think I have anything [else] scheduled for 2008.” Id. at p. 12, ll 11-13. Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 2 of 9 3 Sepracor’s opposition to Dey’s motion to consolidate Dey I and Dey II using the Dey I scheduling order is consistent with its pattern of trying to delay resolution of this matter and contrary to the statutory mandate that the parties expedite Hatch-Waxman cases. Applying the Dey I schedule will give Sepracor 17 months from the filing of the action to prepare its case—a generous amount of time under this Court’s Local Rules. Moreover, although discovery has been ongoing since July 17, 2006, fact discovery is still in the early stages. For example, Sepracor has not yet provided complete interrogatory responses on its claim construction or infringement positions. Sepracor has no basis to support its claim that consolidation of the cases using the schedule in place for Dey I will prejudice it. In contrast, delay in the resolution of the cases is prejudicial to Dey and to the general public as it may result in the delay of generic levalbuterol going to market. II. ARGUMENT A. SEPRACOR WILL NOT BE PREJUDICED IF THE CONSOLIDATED CASE HAS THE DEY I SCHEDULE 1. Sepracor’s Theories of Infringement Will Be Similar if Not Identical in Dey I and Dey II In its carefully written response, Sepracor never states that its theories of infringement in Dey I will differ from its theories of infringement in Dey II. Rather, it makes statements such as: “as to the issues on which Sepracor has the burden (e.g., infringement of the patents-in-suit), the Dey I and II actions involve different ANDAs and different products”2 and “consolidation of the Dey I and Dey II actions would expand Sepracor’s proofs on issues of infringement.” While it is 2 Sepracor never defines “different products.” It never states that there is any difference between the ANDA products at issue in Dey I and those at issue in Dey II that impact its infringement position. The Dey ANDA products do differ in the concentration of the active ingredient. The concentration of the product itself is not claimed in any of the patents and, therefore cannot have any bearing on infringement. Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 3 of 9 4 not clear what Sepracor means by “expand Sepracor’s proofs,” it is clear what Sepracor never states. Sepracor never states that consolidation would expand or change its theories of infringement. That is because it will not. The formulation of Dey’s ANDA products are not a mystery to Sepracor. Under the provisions of the Hatch-Waxman Act, an ANDA filer (here Dey) must offer the patentee (here Sepracor) access to portions of the ANDA so that the patentee can determine whether or not to bring an infringement action. 21 U.S.C. § 355(j)(5)(C)(i)(III). Sepracor requested and received portions of Dey’s ANDA and samples of its ANDA products under this provision. Sepracor knows that any theories of infringement it may have for the products that are the subject of Dey I are going to be the same as its theories of infringement for the product that is the subject of Dey II. Consolidation and adoption of the Dey I scheduling order will not prejudice Sepracor. 2. Applying the Dey I Schedule to the Consolidated Action Will Give Sepracor 17 Months From the Filing of Dey II Until Trial Sepracor will not be prejudiced if the cases are consolidated and have the Dey I schedule because Sepracor will still have 17 months from when its complaint in Dey II was filed until trial. Delaware Local Rule 16.2 provides that “trial shall be scheduled to occur within 12 months, if practicable, and no later than 18 months, after the filing of the complaint, unless the Court certifies that, because of the complexity of the complaint” a longer period is required. Del. LR 16.2. Sepracor filed its complaint in Dey II on September 27, 2006. Under the scheduling order in Dey I, trial will not take place until February 25, 2008.3 Thus, applying the Dey I schedule to the consolidated case will result in a period of 17 months from the filing of the complaint in Dey II until trial. 3 In Dey I, Dey requested a trial date of 18 months from filing of the complaint. Sepracor had asked for a trial date 30 months after filing of the complaint. The Court entered a scheduling order providing for a trial date 24 months after filing of the complaint. Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 4 of 9 5 Given that the issues of law and fact are the same in the Dey I and Dey II actions, and that Sepracor already has the benefit of discovery from the Dey I action, a scheduling order in the Dey II action that gives Sepracor a trial date 17 months from filing its complaint is more than adequate for Sepracor to have a “fair and reasonable opportunity to discovery and prepare the issues on which it has the burden of proof in the Dey II case.” B. DEY WOULD BE PREJUDICED IF THE SCHEDULE FOR DEY I IS EXTENDED According to Sepracor “Dey will not be prejudiced by enlargement of the calendar in the Dey I matter since, in any event, Dey can not obtain FDA approval … until after the resolution of the Breath action in Massachusetts.” Sepracor Answering Br. (D.I. 70) at 7. This argument does not comport with the law. The Hatch-Waxman Act sets out the events which can trigger the 180-day exclusivity of the first ANDA filer. Several of those triggering events do not require the entry of a final unappealable court decision in the litigation involving the first-to-file applicant. See 21 U.S.C.§ 355(j)(5)(D). Resolution of the Breath action is not, therefore, a necessary prerequisite to Dey obtaining FDA approval to market its product. Sepracor argues that Dey’s position that Dey I and Dey II should be consolidated is somehow inconsistent with its position that Dey I should not be consolidated with the case Sepracor brought against Breath. There is no inconsistency. First, the parties are the same in Dey I and Dey II whereas the defendants in Dey I and in the Breath action are not. Second, the patents asserted in Dey I and Dey II are different than the patents asserted in the Breath action. In Dey I and Dey II, five method-of-use patents are asserted against Dey. All five patents are related and have the same specification. Indeed, the claims of the patents-in-suit are so similar that the examiner determined that the claims of the different patents are simply obvious Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 5 of 9 6 variations of each other and required the applicants to file terminal disclaimers.4 In the Breath action six patents are asserted. In addition to the five patents asserted against Dey, Sepracor asserted a sixth and unrelated formulation patent—U.S. Patent No. 6,451,289 (the ’289 patent)— against Breath. (A copy of the ‘289 patent is attached as Exhibit B.) Sepracor has not asserted the ’289 patent against Dey, presumably because it has determined that it has no Rule 11 basis for doing so. This further highlights that there are differences between the products at issue in the Breath action and the products at issue in Dey I and Dey II. The differences between the Dey products and the Breath products provide yet another reason why Dey opposed consolidation of Dey I with the Breath action. In contrast to the Breath and Dey I litigations, Dey I and Dey II meet the requirements for consolidation—the issues of law and fact are the same. This is not true of Dey I and the Breath action which involve different parties, different products and different patents. As Sepracor’s counsel stated to the Massachusetts Court in the Breath action: Ms. Dadio: Our proofs obviously will be different in the two [Breath and Dey] cases ---- The Court: yes. Ms. Dadio: because it’s two different companies. However, the defenses – the allegations of validity and non-infringement – depend upon the particular product that are different generics… 4 A terminal disclaimer is used to dedicate a portion of the patent term to the public. The United States Patent and Trademark Office may order the entry of a terminal disclaimer to overcome obviousness-type double patenting rejections. The entry of a terminal disclaimer prevents an application for an obvious variation of an existing patent from being used to extend the patent term of that existing patent by disclaiming any part of the patent term granted for the patent issuing from the application which extends beyond the term of the existing patent. See 35 U.S.C. § 253 and 37 C.F.R. § 1.321. Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 6 of 9 7 C. CONSOLIDATING DEY I AND DEY II WITH THE SCHEDULE OF DEY I IS IN KEEPING WITH THE STATUTORY REQUIREMENT THAT THE PARTIES EXPEDITE THE ACTION The Hatch-Waxman Act provides that the parties shall “reasonably cooperate in expediting the action…” 21 U.S.C. §355 (j)(5)(B)(iii). Consolidation of Dey I and Dey II with the Dey I schedule is reasonable, will not prejudice either party, will increase judicial economy and will expedite the case as required by the statute. Accordingly, Dey respectfully requests Dey I and Dey II be consolidated for all purposes, and that the consolidated case remain on the Court ordered schedule in place in Dey I. III. CONCLUSION For the foregoing reasons, Dey respectfully requests this Court to Order Civil Action No. 06-604-KAJ be consolidated with Civil Action No. 06-113-KAJ and that the scheduling order already in place in Civil Action No. 06-113-KAJ be ordered for the consolidated case. Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 7 of 9 8 ASHBY & GEDDES /s/ Tiffany Geyer Lydon _____________________________________________ Steven J. Balick (I.D. #2114) John G. Day (I.D. #2403) Tiffany Geyer Lydon (I.D. #3950) 222 Delaware Avenue, 17th Floor P.O. Box 1150 Wilmington, Delaware 19899 (302) 654-1888 sbalick@ashby-geddes.com jday@ashby-geddes.com tlydon@ashby-geddes.com Of Counsel: Edgar H. Haug Kimberly J. McGraw FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue New York, New York 10151 (212) 588-0800 Elizabeth A. Leff FROMMER, LAWRENCE & HAUG LLP 1667 K Street, N.W. Washington, D.C. 20006 (202) 292-1530 Dated: November 15, 2006 175209.1 Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 8 of 9 CERTIFICATE OF SERVICE I hereby certify that on the 15th day of November, 2006, the attached DEY’S REPLY IN SUPPORT OF ITS MOTION TO CONSOLIDATE was served upon the below-named counsel of record at the address and in the manner indicated: Richard D. Kirk, Esquire HAND DELIVERY The Bayard Firm 222 Delaware Avenue, Suite 900 P.O. Box 25130 Wilmington, DE 19899 Jack M. Stover, Esquire VIA FEDERAL EXPRESS Buchanan Ingersoll & Rooney PC One South Market Square 213 Market Street, 3rd Floor Harrisburg, PA 17101-2121 Todd R. Walters, Esquire VIA FEDERAL EXPRESS Buchanan Ingersoll & Rooney PC 1737 King Street, Suite 500 Alexandria, VA 22314-2727 /s/ Tiffany Geyer Lydon ________________________ Tiffany Geyer Lydon Case 1:06-cv-00604-JJF Document 17 Filed 11/15/2006 Page 9 of 9 EXHIBIT A Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 1 of 33 sepracor V Breath L t d 100506.txt UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS * * * * * * * * * * * * * * * * * SEPRACOR, I N C . p l a i n t i f f VERSUS BREATH LIMITED BEFORE THE HONORABLE DOUGLAS P. WOODLOCK UNITED STATES DISTRICT COURT JUDGE MOTION HEARING OCTOBER 5 , 2006 APPEARANCES: SUSAN M. DADIO, ESQ. AND TURNER BUFORD, ESQ., Buchanan, I n g e r s o l l & Rooney, PC, 213 Market s t r e e t , 3 rd F loor , H a r r i sburg , pennsylvani a 17101, on beha l f o f t h e ~l a i n t i ff DEANNE M. MAZZOCHI, ESQ., Rakoczy, Mol ino, Mazzochi, s i w i k , LLP, 6 west Hubbard s t r e e t , s u i t e 500, c h i cago, I l l i n o i s 60610, on beha l f o f t h e Defendant MICHAEL L r CHINITZ, ESQ. , Rose, c h i n i t z & Rose, 29 commonwealth Avenue, Boston, Massachusetts 02116, on beha l f o f t h e Defendant Courtroom No. 1 - 3rd F loor 1 courthouse way Boston, Massachusetts 02210 10:30 A.M. - 11:25 A.M. Pamela R. Owens - O f f i c i a l c o u r t Re o r t e r 1 courthouse way - s u i t e 3200 R John Joseph Moakl ey ~i s t r i c t Court ouse Boston, ~ a s s a c h u s e t t s 02210 THE COURT: Well , I brought you i n p r i n c i p a l l y because 1 looked a t t h i s and thought I had t h i s k i n d o f s i n k i n g f e e l i n g t h a t t h i s was going t o be a h igh maintenance case because t h e p a r t i e s seemed i n t e r e s t e d i n exp lo r i ng t h e f u l l Page 1 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 2 of 33 Sepracor V Breath L t d 100506.txt dimensions o f Rule 9B and 12E. And I guess my hope i s t h a t you w i l l disabuse me o f t he prospect o f t h i s being a h igh maintenance case o r , i n t h e a l t e r n a t i v e , I w i l l disabuse you o f t h a t . And perhaps a way o f doing t h i s i s j u s t t o ask as a p r a c t i c a l mat ter what d i f f e r e n c e does i t make. I mean, I understand Judges have w r i t t e n t h i n g s saying you c a n ' t s a t i s f y 9B by d iscovery a t a l a t e r p o i n t . on t h e o ther hand, i s t he re something about t h i s case t h a t suggests t h a t an i n o r d i n a t e amount o f t ime should be spent pars ing t h e p leadings t o ge t t o t h e bottom o f what p rec i s e l y i t i s t h a t t h e i nequi t a b l e conduct c la ims cons i s t o f ? MS. DADIO: Your Honor, i f I might , Susan Dadio f o r sepracor . THE COURT: R igh t . MS. DADIO: Sepracor brought t h i s motion, Your Honor, w i t h the best o f i n t e n t . I bel ieve t h a t t h e motion, i n f a c t , shows t h e very j ud i c ious s e l e c t i o n which sepracor made. THE COURT: I ' m no t suggest ing bad f a i t h . I am suggest ing t h a t most o f us have o n l y 24 hours i n t h e day t o perform var ious k inds o f a c t i v i t i e s . ~ n d unless the re i s an absolute need f o r a c e r t a i n k i n d o f motion p r a c t i c e , 1 t h i n k i t ' s best 1 e f t undone. MS. DADIO: I understand. THE COURT: So what 's t h e need f o r t h i s ? MS. DADIO: he need here i s two- fo ld , Your Honor. The need i s f i r s t w i t h respect t o t he many o b l i g a t i o n s o f i nequi t a b l e conduct concerni ng patentabi 1 i t y , our se r i es o f s i x statements, very genera1 a t t h a t , t h a t anyone -- they de f i ne Sepracor as t h e inventors , anyone i n t h e company, any o f t h e i r a t to rneys . SO i f we l o o k a t t h i s motion, i t ' s n o t pu re l y Page 2 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 3 of 33 Sepracor V Breath L t d 100506.txt request ing a page and l i n e c i t a t i o n t o t h e p a r t i c u l a r s o f t h e f i l e record. Obviously, t h a t i s something t h a t should be requi red. ~ u t t h e r e a l process -- THE COURT: should be requi red -- , MS. DADIO: I t should be. THE COURT: -- i n the complaint? MS. DADIO: Yes, Your Honor. The crux o f o r t h e c r u c i a l p a r t here i s t h e f a c t u a l basi s f o r a1 1 egi ng each o f t h e patentabi 1 i t y representat ions a re f a l s e and, moreover, who a t sepracor knew t h a t such representat ions were fa1 se. Those a re very important i tems t h a t , even g iven s o r t o f t h e volume o f paragraphs, s h a l l we say, o f Breath 's complaint, s t i l l cannot be deciphered from t h e pleadings. And we're a l l aware t h a t i n e q u i t a b l e conduct must be p l e d w i t h the l e v e l o f p a r t i c u l a r i t y . And standing here today, t he re cou ld be any number o f p o s s i b i l i t i e s o f i n e q u i t a b l e conduct t h a t I could fathom t h a t ~ r e a t h might be contemplat ing w i t h respect . THE COURT: So, why d i d n ' t you f i l e an i n t e r r o g a t o r y ? MS. DADIO: Because, Your Honor, t he re are so many here and we do have a l i m i t e d number o f i n t e r r o g a t o r i e s . I n essence, t h a t would be punishing sepracor. sepracor would have t o be cu r ing -- THE COURT: Y o u ' l l be t h e f i r s t lawyers i n America who haven' t asked f o r r e l i e f f rom l i m i t a t i o n s o f t h e number o f i n t e r r o g a t o r i e s i n a complex case. Th is i s a case i n which I looked a t my calendar and thought I had made a typographical e r r o r because t h e Markman hear ing i s i n 2008. MS. DADIO: That 's co r rec t , Your Honor. Page 3 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 4 of 33 sepracor V Breath L t d 100506.txt THE COURT: I suspect t h a t t h e p a r t i e s w i l l work ou t numbers o f i n t e r r o g a t o r i e s and t h a t s o r t o f t h i n g . I mean, you know, i t ' s one t h i n g t o f e e l constra ined. ~ t ' s another t h i n g t o use t h e customary cons t ra in t s f o r t he o rd ina ry case as a bas is f o r ask ing f o r something more a t t h e ou tse t . ' MS. DADIO: Your Honor, I don ' t t h i n k sepracor i s ask ing -- THE COURT: what do you want, a 700-page complaint; i s t h a t what you want? MS. DADIO: NO, Your Honor. We would j u s t l i k e what i s requi red by t h e law, f o r them t o c la im t h e i r p a r t i cu l a r a1 1 egat ions o f i nequi t a b l e conduct w i t h t h e requi s i t e 1 eve1 o f p a r t i cu l a r i t y . I f Breath chooses t o a1 1 ege umpteen m i 11 i o n a l l e g a t i o n s , then t h e volume o f i t i s and must be what i t i s . ~ u t again, t h e r e a re very s t rong p u b l i c p o l i c y issues t h a t t h e Federal c i r c u i t has a r t i cu l a ted w i t h respect t o c la iming i nequi t a b l e conduct w i t h p a r t i cu l a r i t y . THE COURT: what a re you doing i n your d iscovery now? MS. DADIO: ~ ' m so r r y , Your Honor? THE COURT: what 's going on i n d iscovery now? MS. DADIO: We a re i n document p roduct ion mode e s s e n t i a l l y a t t h i s p o i n t . I n t e r r o g a t o r i e s have been exchanged and document requests and document product ion. THE COURT: Do t h e i n t e r r o g a t o r i e s touch on i nequi t a b l e conduct? MS. DADIO: Yes, they do, Your Honor. THE COURT: what do they ask f o r ? MS. DADIO: Without havi ng them s p e c i f i c a l l y , again they do ask f o r a c e r t a i n l e v e l o f content ions w i t h respect Page 4 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 5 of 33 sepracor V ~ r e a t h L t d 100506.txt t o -- I would be s t a t i n g ou t o f t u r n here i f I sta ted s p e c i f i c a l l y . I know a t l e a s t they cover those c la ims t h a t we d i d no t s e t f o r t h i n t h i s complaint. AS t o whether o r n o t they d i d address these, I would have t o -- THE COURT: I ' m so r r y . I ' m misunderstanding. I don ' t f u l l y understand. You have content ion i n t e r r o g a t o r i es t h a t address so much o f t h e -- MS. DADIO: Inequ i tab1 e conduct. THE COURT: -- i n e q u i t a b l e conduct t h a t you t h i n k are adequately p led i n t h e complaint? MS. DADIO: I bel ieve t h a t ' s c o r r e c t , Your Honor. And I ' m no t a hundred percent accurate as t o whether o r n o t those i n t e r r o g a t o r i e s i nc lude t h e f u l l scope o r no t , so 1 would be speaking ou t o f t u r n by answering t h a t quest ion. THE COURT: okay. MS. DADIO: I bel ieve Ms. Mazzochi might know t h e answer t o t h a t because 1 be l i eve they were due yesterday. MS. MAZZOCHI: Your Honor, i f I may, I t h i n k t h e i r i n t e r r o g a t o r y number (7) speci f i c a l l y asked f o r Breath t o i d e n t i f y t he f a c t u a l bases f o r a l l o f t h e a l l e g a t i o n s s e t f o r t h i n t h i s count r e l a t i n g t o unenforceabi li t y . ~ n d we are, i n f a c t , p lanning on complying w i t h t h a t and p rov id ing a d e t a i l e d response, you know, t o t h e ex ten t t h a t we can. THE COURT: I s t h e d e t a i l e d response as complete as i s apparent ly asked f o r i n t h e motion f o r a more d e f i n i t e statement? MS. MAZZOCHI: Your Honor, I be l i eve t h a t our answer as i t p resen t l y stands does, i n f a c t , i nc lude some a d d i t i o n a l c i t a t i o n s t o p a r t i c u l a r t h ings w i t h i n t h e prosecut ion h i s to ry . Page 5 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 6 of 33 Sepracor V Breath L t d 100506. t x t THE COURT: Some, bu t why no t a l l ? 7 MS. MAZZOCHI: We can c e r t a i n l y do a l l o f them, Your Honor. I mean, t h e prosecut ion h i s t o r y conta ins a number o f dec la ra t ions and statements i n there . THE COURT: Well , t h a t may be t r u e . But t h i s i s f o r you as w e l l . u l t i m a t e l y , I ' m going t o have t o decide t h i s . u l t i m a t e l y , I ' m going t o have t o be po in ted i n t he d i r e c t i o n o f those statements t h a t you say a re misrepresentat ions. And t h a t ' s perhaps a ted ious process, b u t one t h a t b e t t e r be done here. NOW, what was t h e reason f o r no t i n c l u d i n g i t i n t h e counterclaim? MS. MAZZOCHI: Wel l , Your Honor, I t h i n k t h a t t h e p o i n t w i t h t h e counterc la im was t o i d e n t i f y t h e p a r t i cu l a r t o p i c s t h a t we f e l t had n o t been p rope r l y presented t o t h e Patent and Trademark O f f i c e and we d i d enumerate those i n t h e counterclaim. For example, t he statements re1 a t i ng t o t h e a1 1 egat ion o f reduced s ide e f f e c t s i n assoc ia t i on w i t h t h e R-i somer t h a t was claimed, t h a t ' s speci f i c a l l y i d e n t i f i e d . The f a c t t h a t t h e w r i t t e n d e s c r i p t i o n -- t h e representat ions t h a t sepracor made t o t h e Patent and Trademark O f f i c e t h a t t he w r i t t e n d e s c r i p t i o n o f t h e i r s p e c i f i c a t i o n adequately d isc losed t h e R-i somer, t h a t i s a1 so i d e n t i f i e d i n our counter1 caim. THE COURT: I d e n t i f i e d as a general p ropos i t i on . d i d n ' t i t ? MS. MAZZOCHI: I n what way does i t ? w e l l , t h e i s t h a t t h e w r i t t e n d e s c r i p t i o n does n o t support what way 1 ega t i on t h e i r statement. THE COURT: I n what p a r t i c u l a r ? Page 6 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 7 of 33 sepracor V Breath L t d 100506.txt MS. MAZZOCHI : We1 1 , because t h e speci f i c a t i o n doesn' t say anyth ing about how these reduced s ide e f f e c t s have been conceived o f as t h e i n v e n t i v e aspect o f t h e i n v e n t i o n by t h e i nven to r . THE COURT: And i s t h a t what your a l l e g a t i o n s a i d w i t h speci f i c i t y ? MS. MAZZOCHI: We be l i eve t h a t i t does, t h a t t h e w r i t t e n -- THE COURT: So you t h i n k you s a i d who, what, where and when -- MS. MAZZOCHI : R i gh t . THE COURT: -- w i t h s p e c i f i c i t y i n your complaint o r counterclaim? MS. MAZZOCHI: Right . The who a re the i n d i v i d u a l s who were making t h e arguments t o t h e Patent and Trademark o f f i c e -- THE COURT: Are they i d e n t i f i e d ? MS. MAZZOCHI: -- i . e . , t h e pa tent a t to rneys . THE COURT: Patent a t to rneys genera l l y a re i d e n t i f i e d . MS. MAZZOCHI: Wel l , I t h i n k the re was o n l y one o r two i nd i v i dual s . THE COURT: ~ n d i s t h e document i n which t h i s i s 9 made i den t i f i ed? MS. MAZZOCHI: w i t h i n the prosecut ion h i s t o r y ? THE COURT: NO, w i t h i n t h e complaint o r counterc la im. MS. MAZZOCHI: We1 1 , t h e complaint i d e n t i f i e s t h e prosecut ion h i s t o r y . The ac tua l -- THE COURT: How b i g i s t h e prosecut ion h i s t o r y ? Page 7 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 8 of 33 Sepracor V Breath L t d 100506.txt MS. MAZZOCHI: when you -- THE COURT: I t ' s somewhat b igger than a bread box, I would suspect? MS. MAZZOCHI: A c t u a l l y no t my bread box. No. The b u l k o f t h e prosecut ion h i s t o r y i s taken up w i t h the -- you know, what I would consider t o be some o f t h e procedural t h i n g s , you know, t h e records o f t h e f i l i n g fees. THE COURT: Look, t h i s i s f o r both o f you. I have no burn ing desi r e t o make my mark on p r o l i f e r a t i n g t h e meaning o f Rule 9B o r 12E. But i f pressed, o f course, I ' m r e a l l y i n t e r e s t e d i n making sure t h e cases move a long promptly, e f f i c i e n t l y , and t h e p a r t i e s ge t t o t he core o f what they a re e n t i t l e d t o . 9 ~ p r a c t i c e i s no t -- t o my mind, anyway -- p a r t i c u l a r l y p roduct ive o r d i n a r i l y . ~t j u s t suggests t h a t t h e p a r t i e s are s tuck i n t h e mud a t t h e s t a r t . I t h i n k my view i s t h a t t h e complaints i n t h e b a l l p a r k -- counterclaims i n the b a l l p a r k may be the re w i t h a hockey s t i c k i n terms o f p a r t i c u l a r i t y and t h i s can be handled by t h e i n t e r r o g a t o r i e s . ~ u t those i n t e r r o g a t o r i e s b e t t e r be ve ry s p e c i f i c because i f you don ' t have i t i n t h e i n t e r r o g a t o r i e s , you d o n ' t have i t . And I ' m n o t going t o l e t , you know, a re-reading o f t h e prosecut ion h i s t o r y come p e r c o l a t i n g up a t a l a t e r p o i n t i n t h i s case -- MS. MAZZOCHI: understood, Your Honor. THE COURT: -- as grounds f o r a very d i f f i c u l t t o prove c la im, d i f f i c u l t t o prove because t h e s t a t e o f t he p r o o f i s h igh. ~ u t t h a t then ra i ses the l a r g e r i ssue. why have t h e p leasure o f encounter ing these k i n d o f d isputes throughout t h i s very lengthy t ime pe r iod be fore we even get t o ark man? Page 8 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 9 of 33 sepracor V Breath L t d 100506.txt MS. MAZZOCHI: I hope t h a t , Your Honor. And t o t h a t end, we have a l ready produced a l l o f our documents. we've reproduced t h e f u l l ANDA t o Sepracor, R&D documents, p r i o r a r t documents, f i l e h i s t o r y documents. SO, we've produced, as f a r as I ' m aware, a l l o f t h e i n fo rma t ion t h a t they have asked f o r . THE COURT: That sounds good t o me. But you shou ldn ' t want t o be b r i n g i n g back d isputes on d iscovery here unless they are abso lu te l y necessary. YOU have got l o t s and l o t s o f t ime, more t ime than I would l e t a n t i - t r u s t cases go, t o develop t h i s case. I suggest you use t h e t ime w e l l . ~ n d i t would no t be used w e l l i n p re l im ina ry pos tu r i ng and t i p s which i s n o t t o say t h a t t he re i s n ' t a good f a i t h bas is f o r b r i n g i n g t h e motion o r t h a t t h e counterc la im i s beyond t h e pale. But 1 j u s t want t o ge t on w i t h i t . NOW I ' m t o l d t h a t t h e i n t e r r o g a t o r y answer was due yesterday, bu t i t ' s going t o appear manyana. Ms. MAZZOCHI: Monday. They w i l l have i t done on Monday. THE COURT: I mispronounced i t . Monday. MS. MAZZOCHI: Yes. THE COURT: But i t b e t t e r be s p e c i f i c about t h i s . MS. MAZZOCHI: r t w i l l be, Your Honor. THE COURT: ~ n d t h a t ' s t h e way 1 ' m going t o deal w i t h i t . you ' re apparent ly going t o ge t what you want i n t h i s . I c e r t a i n l y hope you do. MS. MAZZOCHI: I do, too , s i r . THE COURT: And I t h i n k i f you d o n ' t , then you j u s t ask them f o r some more. ~ u t t h a t ' s how we're going t o deal w i t h t h i s aspect o f t h e mat ter . so I ' m denying t h e motion f o r a more d e f i n i t e Page 9 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 10 of 33 Sepracor V Breath L t d 100506.txt statement w i t h recogn i t i on t h a t ref inements can be prov ided i n t h e i n t e r r o g a t o r y answers t o be f i l e d r e l a t i v e l y soon and t h a t y o u ' l l move on t o address t h e m e r i t s ra the r than be concerned w i t h t r y i n g t o b r i n g d iscovery o r such r e l a t e d p leading issues t o me. I ' m going t o deal w i t h i t on a p r a c t i c a l bas is as best I can here, which i s you ' re e n t i t l e d t o anyth ing t h a t bears on t h e case. w e ' l l t i d y up t h e pleadings when i t becomes necessary, al though I t h i n k you've go t n o t i c e o f some 12 suggestion o f problems f o r i nequi tab1 e conduct, n o t i ce o f what they t h i n k are some p o t e n t i a l f o r problems, and w e ' l l go from there . NOW, am I s t i l l r i g h t t h a t i t ' s no t a typographical e r r o r t o say 2008 f o r Markman? MS. DADIO: That 's co r rec t , Your Honor. I t ' s no t a typographi ca l e r r o r . THE COURT: So what 's going t o happen before then, an i n c r e d i b l e amount o f discovery? MS. MAZZOCHI: Your Honor, sepracor, f o r example, has i d e n t i f i e d 24 i n d i v i d u a l s i n t h e i r i n i t i a l d isc losures . so i t ' s our hope t h a t w i t h i n t h e next 30 days we're going t o ge t those depos i t ions underway. And w i t h t h e ho l idays , t h a t i s going t o keep us more than busy. THE COURT: We1 1 , t h a t j u s t gets you i n t o 2007. what ge ts you i n t o 2008? MS. MAZZOCHI: Wel l , then we've go t t he exper t phase and we expect, based on my personal experience w i t h cases s i m i l a r t o t h i s one, t h a t t he re a re going t o be mu1 t i p l e exper ts addressing a v a r i e t y o f issues. ~ n d t h a t i s going t o be t h e hea r t o f t h e case. THE COURT: okay. Now, should I be s tay ing awake Page 10 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 11 of 33 sepracor V ~ r e a t h L t d 100506.txt l a t e a t n i g h t throughout t h e year 2007 worry ing about t he number o f c laims t h a t need t o be construed here o r a re t h e p a r t i e s going t o work d i l i g e n t l y t o narrow t h a t t o o n l y those 1 3 t h a t a re t r u l y i n d ispute? MS. MAZZOCHI: I t ' s my a n t i c i p a t i o n , based on reading some o f t h e i r i n i t i a l p o s i t i o n s i n t h i s case, t h a t t he re i s l i k e l y t o be th ree terms t h a t a re going t o r e q u i r e cons t ruc t i on by t h e cou r t . I ' m going t o obv ious ly t r y t o work w i t h p l a i n t i f f t o see i f we can get p inpo in ted e x a c t l y where t h e d i f f e r e n c e i s between where t h e p a r t i e s l i e on t h a t so t h a t we can t r y t h a t . THE COURT: And i s t h i s a l l going t o happen before t h e Markman hear ing o r i s i t going t o happen before summary judgment o r i n connection w i t h summary judgment? DO you know? MS. MAZZOCHI: I t depends. MS. DADIO: Excuse me, Your Honor. when we negot ia ted t h e i n fo rma t ion t h a t we prov ided t o t h e c o u r t , we had agreed t h a t Markman would occur before summary judgment. THE COURT: NO, I understand t h a t . But has anyth ing happened t h a t would suggest t h a t maybe t h e r e could be con f l a ted summary judgment? MS. DADIO: We1 1 , depending upon t h e i r i n t e r r o g a t o r i e s w i t h i nequi tab1 e conduct. THE COURT: A1 1 r i g h t . we11 , i s i t a1 1 i n e q u i t a b l e conduct? That 's going t o be t h e issue. ~ t ' s c e r t a i n l y no t t h e i ssue f o r c la im const ruc t ion , i s i t ? MS. DADIO: NO, Your Honor. THE COURT: So i n e q u i t a b l e conduct i s something f o r summary judgment. Page 11 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 12 of 33 Sepracor V Breath L t d 100506.txt MS. DADIO: ~ u t w i thou t c la im const ruc t ion . c l a i m cons t ruc t i on w i l l be a t l e a s t -- we be l ieve , t o t h e ex ten t Breath be l ieves the re i s a d ispute w i t h respect t o t h e way the c la ims would be construed, t h a t i s necessary i n order t o have a determinat ion o f i n f r i ngement and v a l i d i t y . THE COURT: Well , I understand the way i n which sometimes cases a re developed o r pa ten t cases a re developed. And, f r a n k l y , I t h i n k I probably s a i d t h i s a t our schedul ing conference. I don ' t t h i n k t h a t I ' m aware o f t h e p e r f e c t t ime t o do Markman hearings. I am concerned about, you know, making t h e case move along. And 1 don ' t t h i n k I have anyth ing scheduled f o r 2008. NOW, t h a t may be something you should f e a r , b u t i t j u s t seems l i k e a l ong t ime away before I have t o deal w i t h t h i s i n a subs tant ive s o r t o f way. I defer t o counsel i n pa ten t cases on when t o do t h e Markman hear ing. But my overarching i n t e r e s t , as I ' v e i nd i ca ted , i s t o t r y t o ge t t h i s resolved as promptly as poss ib le o r a t l e a s t s t ra igh tened away as promptly as poss ib le . ~ u t those a re s imply random thoughts t h a t perhaps would be h e l p f u l i n o rgan iz ing your own thoughts about how t h e case proceeds f u r t h e r here. I s t h e r e anyth ing e l s e we need t o t a l k about? MS. DADIO: Deanne -- MS. MAZZOCHI: GO ahead. MS. DADIO: There i s a p o t e n t i a l , Your Honor. 1 5 we're t r y i n g t o work ou t t h e p a r t i c u l a r i t i e s o f a p r o t e c t i v e order i n t h i s case. And we d o n ' t have complete c o n f i rmation from Breath as t o whether o r no t we a re poss ib le , bu t t he re appears t o be a t l e a s t two issues w i t h respect t o t h e e n t r y o f a p r o t e c t i v e order t h a t t h e p a r t i e s seem t o be a t an impasse w i t h respect t o . And we would a n t i c i p a t e t h a t a motion may be Page 12 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 13 of 33 Sepracor V Breath L t d 100506.txt necessary. THE COURT: So, g i v e me a sneak preview. what 's t h e problem? MS. DADIO: There a re two main issues w i t h respect t o -- I t h i n k t h a t a t l e a s t a re concrete. The f i r s t i ssue i s t h a t Breath s p e c i f i c a l l y wants t o p u t a r e s t r i c t i o n i n t h e p r o t e c t i v e order t h a t p r o h i b i t s sepracor from u t i 1 i z i ng i t s i n fo rma t ion t o go t o t h e FDA -- i n p a r t i c u l a r , USP. And the re i s a case from t h i s d i s t r i c t -- THE COURT: w a i t a minute. I j u s t want t o c r y s t a l 1 i ze t h i s. YOU received i n fo rma t ion i n d i scovery t h a t you would l i k e t o use w i t h t h e FDA? MS. DADIO: Yes, Your Honor. THE COURT: And you s a i d something about USP. MS. DADIO: That i s t h e Uni ted s ta tes Pharmacopoeia. I t i s -- f o r l a c k o f a b e t t e r term, i t ' s somewhat -- no t an arm. I t ' s n o t an agency, bu t i t has some l e v e l o f a f f i l i a t i o n w i t h respect t o FDA. These p a r t i c u l a r cases, Your Honor, t h e s t a t u t o r y na ture o f t h e Hatch-waxman, Breath had t o f i l e an abbreviated new drug a p p l i c a t i o n i n order t o seek approval t o go on t h e market w i t h i t s gener ic copy o f Sepracor's very successful XOPENEX product . And they have produced $hat ANDA t o US. And obv ious ly , i f the re a re some issues f o r which t h e FDA should be aware about, sepracor should have the a b i l i t y t o d iscuss t h a t w i t h t h e FDA. A case i n t h i s d i s t r i c t , Avent is v . coba l t , which counsel i s very f a m i l i a r w i th , d e a l t w i t h an i ssue on a p r o t e c t i v e order where the re was a c la im t h a t i n t h e p r o t e c t i v e order t h a t t h e i n fo rma t ion i n t h i s p r o t e c t i v e order -- c o n f i d e n t i a l i n fo rma t ion -- could on l y be used f o r purposes o f l i t i g a t i o n . The innovator drug company Page 1 3 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 14 of 33 Sepracor V Breath L t d 100506.txt wanted t o go t o t h e FDA w i t h c e r t a i n in fo rmat ion . And t h e i r argument, which would be the same as ours, i s t h a t t h a t i n fo rma t ion i s no t c o n f i d e n t i a l t o t h e FDA because they a re a l ready aware o f i t . And the re fo re , Sepracor should be e n t i t l e d t o go t o t h e FDA w i t h any o f t h a t ma te r i a l . THE COURT: what -- and open another f r o n t ; i s t h a t what -- MS. DADIO: From a sa fe ty i ssue f o r -- THE COURT: w e l l , bu t I mean, i t ' s opening another f r o n t . Am I t o understand t h a t t h e purpose o f going t o t h e FDA i s no t merely t o r a i s e a hue and c r y as a genera l l y i n t e r e s t e d c i t i z e n , bu t as a compet i tor who i s concerned about FDA a c t i o n adversely a f f e c t i n g you? MS. DADIO: Wel l , i t wouldn ' t be so much, Your Honor, an a c t i o n t h a t would be adverse. ~t would be i n t h e form o f a c i t i z e n ' s p e t i t i o n and no t even se t up -- i t ' s d i f f i c u l t f o r me t o a r t i c u l a t e what i t would be because c e r t a i n l y we have no i n t e n t i o n o r no plans, I should say, a t t h i s t ime t o be doing any o f t h i s type o f a c t i v i t y . However, i t ' s something t h a t once we do take a l o o k a t t h e i r documents -- I t h i n k MS. Mazzochi sa id some o f them are being produced today -- should the re become an issue, f o r instance, w i t h respect t o sa fe ty , t he re i s c e r t a i n l y a p u b l i c p o l i c y i ssue o f t h a t and t h e r e ' s a l s o t h e i ssue o f whether o r no t -- THE COURT: Just a moment. Le t me j u s t understand t h i s . L e t ' s assume you get t he documents under t h e c o n f i d e n t i a l agreement. You t u r n them over t o t h e FDA. I can conceive o f circumstances -- I ' m no t f u l l y f a m i l i a r w i t h t h i s dimension;of Avent is . You t u r n them over t o t h e FDA. Are they c o n f i d e n t i a l i n t h e hands o f t h e FDA? Page 14 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 15 of 33 Sepracor V Breath L t d 100506.txt MS. DADIO: I ' m so r r y , Your Honor? THE COURT: Are they c o n f i d e n t i a l i n t h e hands o f t h e FDA once they a re turned over t o t h e FDA? ; MS. DADIO: we1 1 , they ' r e n o t c o n f i den t i a1 , Your Honor, because t h e documents t h a t would be handed over a re a1 ready i n t h e possession o f t he FDA. They would be, f o r instance, p a r t o f t h e ANDA which t h e FDA a1 ready has. THE COURT: But a r e n ' t they c o n f i d e n t i a l ? Does t h e FDA have some s o r t o f c o n f i d e n t i a l i t y p rov i s ions w i t h respect 18 t o t h i s o r a re a l l these documents a1 ready i n t he p u b l i c record now? MS. DADIO: TO my understanding, they a re no t i n t h e p u b l i c record u n t i l approval i s obtained. so u n t i l -- go on the essent i a1 documents c i t i z e n ' s i n c l ud i ng THE COURT: But has approval been obtained? MS. DADIO: Approval cannot be obta ined, Your Honor, because t h i s l a w s u i t -- by t h e i n s t i t u t i o n o f t h i s l a w s u i t , t he re i s an automatic 30-month s tay f o r which ~ r e a t h cannot rece ive approval f o r i t s product and d i d the re fo re no t 'market. MS. MAZZOCHI: Your Honor, i f I can answer t h a t , l y i f Sepracor were t o take Breath 's c o n f i d e n t i a l and f i l e a c i t i z e n ' s p e t i t i o n w i t h FDA, t h a t p e t i t i o n would be p a r t o f t h e p u b l i c record, a l l t h e e x h i b i t s attached t o i t . THE COURT: Even i f the -- l e t me j u s t understand. L e t ' s assume t h a t t h e universe o f documents t h a t they submit i n connect ion w i t h t h e i r c i t i z e n ' s p e t i t i o n consi s t s s o l e l y o f ma te r i a l s t h a t you have a1 ready submitted t o t h e FDA. MS. MAZZOCHI: R igh t . THE COURT: There's no th ing e l s e ou t . AS I Page 15 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 16 of 33 sepracor v Breath L t d 100506.txt understand i t, r i g h t now, those a re c o n f i d e n t i a l documents i n t h e hands o f t h e FDA, remain c o n f i d e n t i a l u n t i l t h e FDA grants your p e t i t i o n ? MS. MAZZOCHI: R igh t . And even some o f those might 19 s t i 11 be mai n t a i ned as c o n f i d e n t i a1 , p a r t i cu l a r l y i f i t re1 ates t o manufactur ing methods and t h a t s o r t o f t h i n g . There a c t u a l l y a re p rov i s ions by which FDA can main ta in some in fo rma t ion as t rade secrets. And t h i s i s a c t u a l l y common, i n c l u d i n g w i t h t h e brand companies, i s t h a t when you f i l e f o r FOIA requests w i t h FDA, s p e c i f i c manufactur ing i n fo rma t ion i s o f t e n redacted ou t because i t ' s maintained as a t rade secre t under the s t a t u t e . BY con t ras t , i f sepracor were t o f i l e a c i t i z e n ' s p e t i t i o n w i t h FDA, t h a t i s p u b l i c . I t w i l l go up on the FDA website i n t h e i r docket ing department. There i s no p r o v i s i o n by which a c i t i z e n ' s p e t i t i o n t h a t sepracor submits t o FDA can be mai n t a i ned as c o n f i den t i a1 . THE COURT: ~ l l r i g h t . Now, what 's t h e s ta tus o f o ther 1 ess we1 1 -placed c i t i z e n s i n ob ta in ing i n fo rma t ion concerning a proceeding w i t h t h e FDA l i k e t h i s ? The FDA doesn' t have an adversar ia l proceeding taken w i t h respect t o t h i s ? MS. MAZZOCHI: oh, no. I mean, once FDA issues -- Once FDA issues -- THE COURT: what does FDA do? Does FDA j u s t l i s t e n t o you? Does sepracor as t h e brand have some r i g h t s t o ge t i n t he re and discuss t h e mat ter w i t h t h e FDA? MS. MAZZOCHI: I mean, t e c h n i c a l l y w i t h a c i t i z e n ' s p e t i t i o n -- Page 16 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 17 of 33 Sepracor V Breath L t d 100506.txt THE COURT: Put t o one s ide t h e c i t i z e n p e t i t i o n . L e t ' s assume a c i t i z e n ' s p e t i t i o n i s no t f i l e d . MS. MAZZOCHI: okay. THE COURT: You f i l e whatever i t i s t h a t you f i l e . MS. MAZZOCHI: R igh t . THE COURT: We're l ook ing f o r some s o r t o f speed-up t o ge t gener ic ou t t he re . The brand i s concerned about t h a t . so, does the brand have any way o f g e t t i n g i n t o -- invo l ved i n t h e FDA proceedi ng w i thou t a c i t i z e n ' s p e t i t i o n ? MS. MAZZOCHI: O f f i c i a l l y , I bel ieve t h e c o r r e c t rou te i s through t h e c i t i z e n ' s p e t i t i o n , you know, what they do u n o f f i c i a1 l y through c o n t r o l 1 ed correspondence o r somethi ng l i k e t h a t . I don ' t know a l l t h e d e t a i l s . THE COURT: But they are no t -- they are no t prov ided w i t h an oppor tun i t y t o comment on i t o f f i c i a l l y , whatever i t i s t h a t you submitted t o the FDA. MS. MAZZOCHI: Right . They don ' t ge t any preference above and beyond t h e general p u b l i c i n terms o f what we submit FDA r i g h t c o n f i dent t o FDA. THE COURT: ~ n d , SO, ;now -- every th ing t h a t i a l ? MS. MAZZOCHI: R igh t have submitted an ANDA t o FDA i s regard t o t h e ac tua l contents o f i s maintained as c o n f i d e n t i a l by what you've submitted t o t h e you've submitted t o the FDA i s I be l i eve t h e f a c t t h a t we pub1 i c in fo rma t ion . But w i t h t h e a p p l i c a t i o n i t s e l f , t h a t 2 1 FDA. MS. DADIO: I would t h i n k -- MS. MAZZOCHI: And then i t ' s my understanding t h a t once our ANDA receives FDA approval -- Page 17 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 18 of 33 sepracor v ~ r e a t h L t d 100506.txt THE COURT: But i t c a n ' t dur ing t h e pendency o f t h i s case o r f o r 30 days -- MS. MAZZOCHI: For 30 months. THE COURT: T h i r t y months? MS. MAZZOCHI : R i gh t . ; THE COURT: T h i r t y months a f t e r t h e case i s f i l e d , i t ' s c a n ' t u n t i l i t s d i spos i t i on? MS. MAZZOCHI: Right . I t ' s no t a c t u a l l y -- i t ' s under ~atch-waxman, i t ' s 30 months from t h e day on which I be l i eve t h e n o t i c e o f paragraph (4) c e r t i f i c a t i o n i s received by sepracor and t h a t i s what s t a r t s t h e c lock t i c k i n g assuming t h a t they have f i l e d s u i t which obviously they d id . so we're c u r r e n t l y operat ing under a 30-month s tay o f f i n a l FDA approval. we can receive t e n t a t i v e FDA approval, bu t we c a n ' t rece ive t h e actual f i n a l FDA approval t h a t permi ts us t o go t o market. THE COURT: And what does t e n t a t i v e approval mean? MS. MAZZOCHI: Tenta t ive approval means t h a t our drug has passed a l l sa fe ty and e f f i c a c y standards and the FDA would otherwise be ab le t o approve t h e drug f i n a l l y bu t f o r t h e pendency o f t h i s ac t i on . Essen t ia l l y , we would -- t o get our 2 2 f i n a l FDA approval, t h e 30 months needs t o pass i n t h i s case o r we need t o secure a judgment i n our favor on a l l o f t h e patents e i t h e r based on non-i n f r i ngement , i nval i d i t y , o r unenforceab i l i t y . SO, f o r example, i f you were t o f i n d -- THE COURT: when was t h e -- you know, I ' m doing t h i s by horseback. MS. MAZZOCHI : Right . THE COURT: But t h e sec t ion 4 c e r t i f i c a t i o n which was -- Page 18 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 19 of 33 sepracor v ~ r e a t h L t d 100506.txt MS. MAZZOCHI: I be l i eve the paragraph (4) -- THE COURT: -- paragraph (4). MS. MAZZOCHI: -- c e r t i f i c a t i o n date was roughly November-December '05. I ' d have t o double-check t h e ac tua l date. THE COURT: And was i t more o r l e s s co inc ident w i t h t h e f i l i n g o f t h e s u i t ? MS. MAZZOCHI: I ' m sor ry? THE COURT: Was i t more o r l e s s co inc ident w i t h the f i l i n g o f t h e s u i t ? MS. MAZZOCHI: Yes. They have got 45 -- a f t e r we serve them w i t h t h e n o t i c e o f our paragraph (4) c e r t i f i c a t i o n , they have got 45 days t o f i 1 e t h e l a w s u i t . And i f they do, then t h a t means we're going t o be stayed f o r 30 months. And they d id . I bel ieve they d id , i n f a c t , f i l e w i t h i n t h e 45 days, so t h a t t r i g g e r e d t h e 30-month s tay p rov i s ions under Hatch-Waxman. THE COURT: Now, why would t h e FDA, i n t h e face o f t h e l a w s u i t , go forward w i t h t e n t a t i v e approval? MS. MAZZOCHI: I t ' s been -- THE COURT: IS it j u s t an e f f i c a c y determinat ion o r i s i t -- MS. MAZZOCHI: Yes. The d i s t i n c t i o n between an NDA and an ANDA i s t h a t w i t h an abbreviated new drug a p p l i c a t i o n , you are demonstrating t h a t your gener ic drug i s b io -equ iva len t t o t he re fe rence - l i s ted drug; i . e . , t h e brand drug. So t h e r e ' s -- you know, you don ' t have t o do t h e same types o f t ox i co logy s tud ies o r phase one, phase two, phase th ree c l i n i c a l s tud ies . so what we've done here i s we've done t h e c l i n i c a l i nves t i g a t i ons requi red t o be considered t o be b i o-equi v a l en t ; Page 19 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 20 of 33 Sepracor V Breath L t d 100506.txt i . e . , we should -- you know, i f someone takes t h e brand vers ion , i f they take t h e gener ic vers ion , they should experience t h e same the rapeu t i c e f f e c t s . I mean, t h e r e ' s some -- THE COURT: But t h a t ' s t h e concern o f t h e FDA. ~ h e FDA i s i n d i f f e r e n t on t h e quest ion o f patent , I mean, i n t h e sense i t ' s n o t going t o asse r t i t s e l f i n any way on t h e quest ion o f pa ten t . MS. MASSOCHI: NO, no. I mean, i t ' s been our experience t h a t t y p i c a l l y when FDA knows t h a t an ADNA i s t h e sub jec t o f l i t i g a t i o n , they tend t o move a b i t s lower. But 24 t y p i c a l l y , i t ' s around -- depending on the complexity o f t h e drug and t h e na ture o f t h e the rapeu t i c issues and t h e chemistry and how responsive you a re t o FDA, i t genera l l y takes anywhere between 18 t o 36 months t o ge t your t e n t a t i v e approval from FDA. And then once they i ssue t e n t a t i v e approval, t h a t would be t h e p o i n t i n t ime where we would be ab le t o say, you know, okay, what 's our l i t i g a t i o n s ta tus . I mean, as o f r i g h t now, you know, i f t h i s case were decided favorab ly on c o b a l t tomorrow, we cou ldn ' t go t o market because we d o n ' t have t e n t a t i v e approval from FDA. once we get t e n t a t i v e approval from FDA, 'you know, assuming t h a t t h a t does happen i n t h e f u t u r e , then i t w i l l become a quest ion what 's t h e s ta tus o f t h i s l i t i g a t i o n i n terms o r our being ab le t o en ter t h e market. THE COURT: ~ l l r i g h t . NOW, i n terms o f p r o t e c t i v e order , i s t h e r e any meaningful way t o r e s t r a i n the use o f t h e c o n f i d e n t i a l i n fo rma t ion by t h e FDA -- t h a t i s , r e s t r a i n t h e FDA from making d i sc losu re o f i t on t h e i r website? MS. MAZZOCH1: AS o f r i g h t now, FDA cannot Page 20 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 21 of 33 sepracor V Breath ~ t d 100506.txt d i s c l ose. THE COURT: NO. L e t ' s assume t h a t a c i t i z e n ' s proceeding o r whatever i t ' s c a l l e d -- MS. MAZZOCHI: Right . THE COURT: -- i s i n i t i a t e d . FDA would have t o be a p a r t y t o t h i s proceeding t o cons t ra in t h e i r d i sc losu re o f i t . 2 5 MS. MAZZOCHI: Right . THE COURT: And t h e o n l y way t o cons t ra in d i sc losu re would be on the p a r t i e s here f o r t h e i r use i n t h e l i t i g a t i o n . IS t h a t -- do I f a i r l y s t a t e t h a t ? MS. MAZZOCHI: Right . I mean, we would have no a b i l i t y t o go t o FDA and say "please p lace t h e documents they a t t a c h t o t h e i r c i t i z e n ' s p e t i t i o n under seal . " I mean, you know, FDA wouldn ' t -- they wouldn ' t care. THE COURT: Well , they may not . The quest ion i s can they be made a p a r t y t o t h i s case f o r t h a t purpose. MS. MAZZOCHI: I don ' t know i f t h a t ' s ever been attempted. And i t ' s because -- THE COURT: They have a supervening s t a t u t e t h a t d i r e c t s what t h e y ' r e supposed t o do? MS. MAZZOCHI: Yes. I mean, you know, I ' m assuming t h a t FDA i s going t o say t h a t here 's our regu la t i ons when we get a c i t i z e n ' s p e t i t i o n i n . Here's what we do and we present . ~ t ' s p a r t o f t h e p u b l i c record. So, I d o n ' t necessa r i l y see t h a t . I mean -- THE COURT: Apar t from the des i re o f a l l p a r t i e s t o avoid d i sc losu re o f documents, what 's i t t o you? MS. MAZZOCHI: The reason why i t ' s impor tan t t o us, separate and apa r t from mai n t a i n i ng c o n f i den t i a1 i t y o f documents -- because obv ious ly we're no t t h e o n l y gener ic Page 2 1 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 22 of 33 sepracor v Breath L t d 100506.txt company ou t there . I mean, sepracor i s l i t i g a t i n g against another gener ic company on t h i s very drug. ~ u t i ' s been my experience w i t h o ther brand companies -- and, again, I ' m no t saying t h i s t o t r y t o impune sepracor i n any way -- t h a t w i t h FDA and w i t h t h e USP -- because t h e USP does, i n f a c t , a c t as a s tandard-se t t ing o rgan iza t i on -- the re have been i n t h e past i n my own personal experience instances where t h e brand company, once they know t h a t t e n t a t i v e approval i s coming down t h e l i n e , they, t r y t o run t h e FDA t o f i l e a c i t i z e n ' s p e t i t i o n making a l l e g a t i o n s o f s a f e t y and e f f i c a c y concerns. And what t h a t w i l l wind up doing i s i f FDA -- THE COURT: I s n ' t t h a t going t o happen sooner o r 1 a t e r ? MS. MAZZOCHI: Yes. To me, I d o n ' t necessa r i l y t h i n k t h a t -- THE COURT: They have a -- you know, they have a compet i t i ve i n t e r e s t i n no t having you on t h e market, you and everybody e l s e on t h e market, a l l t h e o the r gener ics on t h e market. MS. MAZZOCHI: Right . THE COURT: hat e x i s t s no mat te r what stage t h i s l i t i g a t i o n i s i n . ~t becomes more s a l i e n t when t h e r e ' s a temporary approval i n t h e p i p e l i n e , bu t they always have t h e i n t e r e s t i n f i l i n g a c i t i z e n ' s p e t i t i o n . And then i t ' s r e a l l y a quest ion, I guess, o f t i m i n g when they do i t . But 1 s t i l l d o n ' t understand e x a c t l y what you ga in o r what you l o s e from t h e d i sc losu re o f whatever i t i s t h a t you've submitted t o t h e FDA. Now, I can see i f i t ' s t h a t you' r e d i s c l o s i n g your chemical fo rmula t ions t o o ther gener ics who can do what you've Page 22 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 23 of 33 Sepracor V Breath L t d 100506.txt done -- you know, a k i n d o f knockof f o f whatever i t i s t h a t they have got -- b u t I don ' t understand what e l s e would be o f va lue t o you. MS. MAZZOCHI : R ight . we1 1 , f o r exampl e, w i t h the u n i t e d s ta tes Pharmacopoeia, t he USP, one s t ra tegy t h a t we've seen i s what t h e brand company w i l l t r y t o do i s se t up what 's -- t h e usP i s a s tandard-se t t i ng organ iza t ion . THE COURT: I ' m sor ry? MS. MAZZOCHI: The USP i s a s tandard-se t t ing -- THE COURT: I s a standard s e t t i n g -- okay. MS. MAZZOCHI: -- organ iza t ion . THE COURT: R igh t . MS. MAZZOCHI: And what they do i s they w i l l s e t standards f o r your drug has t o comply w i t h x, Y and z i n o rder t o be c e r t i f i e d as USP. For a l l p r a c t i c a l purposes, i f t h e r e ' s a monograph i n t h e u n i t e d s ta tes Pharmacopoeia t h a t says here 's c e r t a i n standards t h a t your drug has t o meet, i f i t doesn' t meet them,. you w i l l no t have a market, your drug w i l l no t be -- THE COURT: I r r e s p e c t i v e o f whether t he FDA approves -- MS. MAZZOCHI: I r r e s p e c t i v e o f whether FDA approves i t . ~t j u s t doesn' t happen. So, what brands have attempted t o do i n t he pas t i s because they a re t h e ones who e f f e c t i v e l y c r a f t t h e monograph i s they w i l l t r y t o pu t t h ings i n t h e monograph where you c a n ' t make a drug unless you ' re i n f r i n g i n g t h e i r pa tent . THE COURT: okay. But I s t i l l d o n ' t understand what t he t t o do t h a t im ing i ssue i s on t h a t . sooner o r l a t e r , they want , I guess. MS. MAZZOCHI: ~ i g h t . page 23 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 24 of 33 sepracor V Breath L t d 100506.txt THE COURT: It makes sense t h a t t h a t ' s what they want t o do. MS. MAZZOCHI: Sure. And, Your Honor, i f t h a t ' s what they want t o do, t o me they shou ldn ' t be ab le t o use our c o n f i d e n t i a l i n fo rma t ion t h a t they ge t . THE COURT: ~ u t i s n ' t your c o n f i d e n t i a l i n fo rma t ion sooner o r l a t e r going t o ge t out? I s n ' t i t -- MS. MAZZOCHI: No, no t necessar i l y . That 's what I ' m saying i s t h a t FDA, even f o r p a r t s o f our a p p l i c a t i o n t h a t want t o be made p u b l i c subsequent t o FDA approval, they w i l l mai n t a i n as c o n f i den t i a1 c e r t a i n t rade secre t i n fo rma t ion such as r e l a t i n g t o c e r t a i n manufactur ing s p e c i f i c s and t h a t s o r t o f t h i n g . THE COURT: okay. w e l l , b u t doesn' t t h a t b r i n g me back around t o t h e dimensions o f t h e p r o t e c t i v e order , a p r o t e c t i v e order dea l i ng w i t h t r a d i t i o n a l t r ade secre t i n fo rma t ion . Manufactur ing in fo rmat ion , f o r example, could be covered, cou ldn ' t i t , and o thers no t , o ther s t u f f t h a t would otherwise be d isc losed i n any event. MS. MAZZOCHI: Right . w e l l , I mean, we' re n o t l ook ing t o designate as c o n f i d e n t i a l under t h e p r o t e c t i v e order t h i n g s t h a t -- you know, i n fo rma t ion t h a t we don ' t consider t o be p r i v a t e . THE COURT: Wel l , l e t me j u s t suggest a standard which i s t o say t h a t those ma te r ia l s which would otherwise be mai n t a i ned c o n f i den t i a1 by t h e FDA would be mai n t a i ned c o n f i d e n t i a l under a p r o t e c t i v e order i f submitted t o the FDA. MS. MAZZOCHI: I f o l l o w YOU. THE COURT: ~ n d t h a t would permi t , I guess -- I d o n ' t know enough about c i t i z e n ' s p e t i t i o n s o r whether t h i s Page 24 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 25 of 33 sepracor V Breath ~ t d 100506.txt would be inadequate f o r a c i t i z e n ' s p e t i t i o n , bu t t h a t would permi t them t o f i l e t h e i r c i t i z e n ' s p e t i t i o n i f they t h i n k t h a t t h a t ' s appropr iate. MS. MAZZOCHI: Right . THE COURT: I mean, I ' m j u s t t r y i n g t o t h i n k through. Th is i s a l l t e n t a t i v e . AS you know, t h i s i s t h e f i r s t I ' v e heard o f i t . I ' m j u s t t r y i n g t o t h i n k through so t h a t perhaps I'll f e e l o r shape the way i n which you approach i t . one way o f l ook ing a t t h i s -- I mean, c e r t a i n l y you don ' t want t o use discovery. Discovery ought no t t o be a v a i l a b l e f o r purposes o f l i t i g a t i n g some o ther crime. AS i t appears now, the re i s an i n c e n t i v e t o f i l e one o f these lawsu i t s because i t 30 gives you another 30 months by doing so w h i l e some poor federa l judge i s bedevi 1 ed w i t h c la im const ruc t ion t a k i n g p lace perhaps no t even i n h i s own l i f e t i m e . Ms. DADIO: I f I might say something i n t h a t regard, Your Honor, t h e idea o f f i 1 i n g t h e l a w s u i t w i t h patents t h a t a re s t i l l l i s t e d i n t h e orange book f o r p a r t i c u l a r innovator company -- we p r e f e r t o use t h e innovator as opposed t o brand -- company, they s t i l l have t o deal w i t h t h e patent issues. so, i t ' s an i n c e n t i v e f o r t h e gener ic t o deal w i t h t h e patents up f r o n t as opposed t o ramping up, going on t o market, and then be t h e innovator company coming i n and suing them f o r pa tent in f r ingement . THE COURT: I t h i n k I understand what t h e var ious compromises are i n t h e Hatch-Waxman Act . But I ' m r e a l l y t r y i n g t o understand t h e f a i r eva luat ion o f t h e a v a i l a b i l i t y o f in fo rmat ion t h a t I would otherwise not permi t . MS. DADIO: That 's co r rec t , Your Honor. And we have attempted and w i t h your guidance maybe we could go back Page 25 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 26 of 33 sepracor V Breath L t d 100506.txt w i t h them. Because we had attempted t o f a l l i n l i n e w i t h t h e Avent is case. I f I ' m co r rec t , t h a t ' s c i t e d a t 355 F.Supp.2d 586. That 's from t h e D i s t r i c t o f Massachusetts. That p a r t i c u l a r case, we have t r i e d t o propose language such t h a t i t would fa11 w i t h i n t h e gamut o f t h a t . Maybe we w i l l t r y agai n . THE COURT: w e l l , 1'11 have t o l o o k a t i t , I ' m 3 1 sure, a t some p o i n t . ~ u t t h a t ' s one aspect. what 's t h e o ther? You s a i d the re were two t h i n g s t h a t were causing problems i n t h e p r o t e c t i v e order . what 's t h e o ther one? MS. MAZZOCHI: The o n l y o ther t h i n g , Your Honor, i s we j u s t wanted t o have a two- t i e red system f o r p a r t i c u l a r in fo rmat ion . I mean, t h e b u l k o f i t r e a l l y has go t t o be designated as c o n f i d e n t i a l and they have got in-house people who a re going t o be ab le t o access i t . ~ u t w i t h respect t o a couple o f p a r t i c u l a r s f o r t h e manufactur ing process -- and i n p a r t i c u l a r , f o r our f o rmu la t i on f o r how we a c t u a l l y make these nebular capsules t h a t go i n t h e i n h a l e r s and any s p e c i f i c s w i t h regard t o a p o t e n t i a l f u t u r e commercial launch date, we wanted t h e oppor tun i t y t o be ab le t o designate t h a t t ype o f extremely s e n s i t i v e commerci a1 i nformat i on as ou ts ide counsel . And we spoke w i t h Ms. Dadio and sa id , l ook , i f i t gets t o a s i t u a t i o n where you . f e e l t h e need t o discuss t h i s w i t h your in-house counsel, we're p e r f e c t l y happy t o work w i t h you so t h a t you can get them whatever i n fo rma t ion they need t o know. But, you know, we would p r e f e r t o have t h a t second t i e r i n t h e p r o t e c t i v e order j u s t so t h a t we d o n ' t have t o keep coming back be fore Your Honor t o say, can we please have leave from t h i s aspect o f t h e p r o t e c t i v e order so t h a t t h e i r in-house people don ' t ga in access t o i t . so, t h a t ' s -- 1 mean, t h a t ' s Page 26 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 27 of 33 Sepracor V Breath L t d 100506.txt b a s i c a l l y t h e i ssue on t h e p r o t e c t i v e order . THE COURT: what i s t he problem w i t h t h a t ? MS. DADIO: There's two pr imary issues, Your Honor. The f i r s t , as Ms. Mazzochi had r e f e r r e d t o , t he re i s another p a r a l l e l paragraph (4) case on t h i s product which Sepracor -- THE COURT: where i s t h a t ? MS. DADIO: That i s i n t he D i s t r i c t o f ela aware aga ins t a gener ic company c a l l e d Dey, D-e-y. THE COURT: And where i s t h a t i n terms o f i t s t r a v e l a t t h i s p o i n t ? MS. DADIO: ~ e c h n i c a l l y , i t was f i l e d a f t e r , b u t t he re a re c e r t a i n aspects o f t h a t t h a t a re f u r t h e r along. For instance, t he re i s a p r o t e c t i v e order a l ready agreed t o and i n p lace signed o f f by t h e Judge i n t h i s case. And t h a t i s t h e p r o t e c t i v e order t h a t we were t r y i n g t o -- THE COURT: And j u s t so I understand, t h a t case was f i l e d more o r l e s s a t t h e same t ime as t h i s one o r not? MS. DADIO: I t was f i l e d s h o r t l y a f t e r t h i s p a r t i c u l a r case. THE COURT: And i s Markman t a k i n g p lace i n t h a t case i n 2008? MS. DADIO: I d o n ' t be l i eve t h a t ' s c o r r e c t , Your Honor . THE COURT: ~ 1 1 r i g h t . why i s i t no t co r rec t? MS. DADIO: ~t i s no t occu r r i ng i n 2008 i f memory serves me c o r r e c t l y . THE COURT: Why? Page 27 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 28 of 33 sepracor V Breath L t d 100506.txt MS. DADIO: Because t h e Judge i n t h a t p a r t i c u l a r case s e t a d i f f e r e n t schedule w i t h respect t o t h i s p a r t i c u l a r mat te r . THE COURT: SO I ' m as s o f t as a grape as opposed t o the Judge i n ela aware on t h i s ? MS. DADIO: NO, Your Honor. w i t h a l l due respect , c e r t a i n l y t h e schedul ing order t h a t we had negot ia ted and agreed upon f o r t he p a r t i e s f o r t h i s p a r t i c u l a r s case was a c t u a l l y longer than what Your Honor had granted us. The p a r t i e s had i n i t i a1 1 y negot ia ted and proposed a 1 onger ti me frame . THE COURT: Yes. But -- MS. DADIO: And, so, i n answer t o your -- THE CUORT: -- why i s i t f a s t e r t h e r e than i t i s here, apar t from t h a t t he Judge was f i r m e r ? I s t h e r e any o ther reason? MS. DADIO: P r i m a r i l y , no. THE COURT: why shou ldn ' t t h i s case then f o l l o w t h e schedule t h a t i s i n p lace i n Delaware? MS. DADIO: w e l l , f i r s t o f a l l , i t ' s s e t up q u i t e a b i t d i f f e r e n t l y as f a r as t h e way d iscovery has taken p lace. so, i t would be d i f f i c u l t t o go back a t t h i s p o i n t and rearrange -- THE COURT: what does t h a t mean? MS. DADIO: I n t h a t case, t he re i s an over lap o f f a c t d iscovery and expert d iscovery. And i n t h i s case, t he re i s f a c t d iscovery then a f t e r t h a t . THE COURT: But why i s n ' t a good deal o f what 's going on the re s i m i l a r t o what 's going on here, s i m i l a r o r almost t h e same. I mean, d iscovery review, I would assume i s Page 28 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 29 of 33 sepracor V Breath L t d 100506.txt t h e same. MS. DADIO: Wel l , a l a r g e p o r t i o n o f t h e documents w i l l be t h e same. And f o r t h a t ve ry reason, we'd l i k e t o have t h e same p r o t e c t i v e order i n t h i s case as i n t h a t case, t h a t case havi ng a one - t i e r p r o t e c t i v e order o f c o n f i den t i a1 i t y and t o t h e i n-house counsel . THE COURT: You've touched on what 's i n t h e back o f my mind, which i s t h e whipsaw dimension t o two cases i n v o l v i n g e s s e n t i a l l y t h e same o r i n which t h e subs tan t i a l substance o f t he case i s t h e same. MS. DADIO: Our p roofs obv ious ly w i l l be d i f f e r e n t i n t h e two cases -- THE COURT: Yes. MS. DADIO: -- because i t ' s two d i f f e r e n t companies. However, t h e defenses -- t h e a l l e g a t i o n s o f v a l i d i t y and non-i n f r i ngement -- obv ious ly depend upon t h e p a r t i c u l a r product t h a t a re d i f f e r e n t gener ics. So, from t h e gener ic ' s perspect ive, they can once again almost piggyback o f f o f each o ther . ~ u t from our perspect ive, we have t o prove separate1 y . THE COURT: I understand t h a t , too . w e l l , i n any event, I guess I understand t h e two issues -- MS. DADIO: 1f I could j u s t -- THE COURT: -- i n t h e p r o t e c t i v e order . I want t o -- I guess apar t from -- a t some p o i n t , 1'11 stop needl ing you about 2008. But I guess -- unless t h e p a r t i e s want p rec i se co i n c i dents i n t h e schedul ing orders and methods o f dea l i ng w i t h these cases, i t ' s l e s s persuasive t o me t h a t something i s n o t i n p lace i n Delaware t h a t i s sought here. And I'll simply ask t h e quest ion a re the re any p r a c t i c a l reasons why -- what page 29 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 30 of 33 sepracor V Breath L t d 100506.txt d i f f e r e n c e does i t make t o you i f c e r t a i n o f t h e i r commercial i n fo rma t ion , i n c l u d i n g launch date, i s o n l y f o r your eyes? MS. DADIO: TWO reasons, Your Honor. Our i dea i s more than j u s t convenience as f a r as between the two cases. c e r t a i n l y , Sepracor i s going t o be producing hundreds o f thousands o f pages i n t h i s case. And, so, obv ious ly i t would be much more convenient i f they could produce t h e same type o f documents w i thou t having t o re - labe l and re-mark d i f f e r e n t l e v e l s o f c o n f i d e n t i a l i t y . ~ u t i ' s more than pure convenience. ~t r e a l l y i s a subs tant ive i ssue w i t h respect t o t h e access t h a t t h e two in-house counsel can have. Sepracor's two in-house counsel would be precluded from seeing t h e i n fo rma t ion t h a t i s ou ts ide counsel on ly . And i ron i c a l l y , they have a c t u a l l y seen -- pursuant t o an o f f e r o f access o f 3 6 i n fo rma t ion -- h i g h l y - c o n f i d e n t i a l i n fo rma t ion o f Breath. And some o f t h a t same in fo rma t ion , Breath i s now t r y i n g t o say they c a n ' t see i t o r use i t i n t h i s case. ~ u t t h a t as ide, t he two in-house counsel o f sepracor a re a c t i v e l y i nvo l ved i n t he l i t i g a t i o n o f t h i s mat ter and they need t o be ab le -- we need t o be ab le t o r e l y upon them f o r t h e i r expe r t i se on these mat ters. They're both pa tent a t to rneys . And i t ' s -- Sepracor w i l l be severely disadvantaged i f i t could n o t be ab le t o r e l y upon t h e i r expe r t i se i n eva lua t ing t h e very manufactur ing process. THE COURT: I t h i n k I understand t h e broad d r i f t o f i t . I t r y t o t h i n k th ings r a t h e r than words. And, so, t o t h e degree t h a t t h e r e ' s go do want t o see i t i n a th ings . L i k e 9e p r a c t i s n o t what drew me t o i n g t o be a d ispute about t h i s , 1 r e a l l y p a r t i cu l a r context i n v o l v i n g p a r t i cu l a r i c e , motion f o r p r o t e c t i v e order p r a c t i c e t h e fede ra l bench, so 1 would encourage Page 30 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 31 of 33 Sepracor V Breath L t d 100506.txt t h e p a r t i e s t o work hard a t t r y i n g t o work t h a t aspect o f i t ou t . ~ u t 1'11 deal w i t h whatever I have t o deal w i t h here. NOW, a t t h e r i s k o f l ea rn ing , i s t he re anyth ing e l s e I should be concerned about? MS. MAZZOCHI: No, Your Honor, a l though we would ask t h a t i f we c a n ' t come t o agreement promptly on t h i s p r o t e c t i v e order , t h a t we are w i l l i n g t o accept sepracor 's documents on an "outs ide a t to rney ' s eyes on ly " bas is u n t i l a p r o t e c t i v e order i s entered. so we j u s t d o n ' t want t h a t t o be a reason why sepracor 's document p roduct ion gets he ld up. THE COURT: okay. w e l l , t e n t a t i v e l y , you have acceded t e n t a t i v e l y w i t h i n commi tti ng y o u r s e l f t o acceding t o t h e i r view on t h a t . Then I d o n ' t see any reason why ma te r ia l s c a n ' t be tu rned over sub jec t t o ref inement o f t he p r o t e c t i v e order i n t h e ways t h a t t he p a r t i e s want. MS. DADIO: And i n f a c t , t h e p a r t i e s have p rev ious l y agreed t o t h a t , Your Honor. THE COURT: okay. Then t h a t seems f i n e . And i f you f i l e something, 1'11 deal w i t h i t . ~ u t you w i l l , I ' m sure, t h i n k l ong and hard about t h e f i l i n g s . ~ l l r i g h t . okay. I f t h e r e ' s no th ing f u r t h e r , w e ' l l be i n recess. MS. DADIO: Thank you, Your Honor. RECESSED AT 11:25 A.M. CERTIFICATION I c e r t i f y t h a t t he foregoing i s a c o r r e c t t r a n s c r i p t o f t h e record o f proceedings i n t h e above-ent i t led mat te r t o t h e bes t o f my s k i l l and a b i l i t y . Page 3 1 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 32 of 33 sepracor v Breath ~ t d 100506.txt 2 2 pame1 a R. Owens Date 2 3 O f f i c i a1 Court ~ e p o r t e r Page 32 Case 1:06-cv-00604-JJF Document 17-2 Filed 11/15/2006 Page 33 of 33 EXHIBIT B Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 1 of 6 Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 2 of 6 Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 3 of 6 Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 4 of 6 Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 5 of 6 Case 1:06-cv-00604-JJF Document 17-3 Filed 11/15/2006 Page 6 of 6