Nos , -1103, IN THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT MOMENTA PHARMACEUTICALS, INC., and SANDOZ, INC.

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1 Nos , -1103, IN THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT MOMENTA PHARMACEUTICALS, INC., and SANDOZ, INC., v. Plaintiff-Appellee, Plaintiff-Appellee, AMPHASTAR PHARMACEUTICALS, INC., INTERNATIONAL MEDICATION SYSTEMS, LTD., WATSON PHARMACEUTICALS, INC. AND WATSON PHARMA, INC., Defendants-Appellants. On Appeal From the United States District Court for the District of Massachusetts in Case No. 11-cv-11681, Judge Nathaniel M. Gorton. BRIEF OF AMICUS CURIAE CLASSEN IMMUNOTHERAPIES, INC. IN SUPPORT OF THE PETITION FOR REHEARING EN BANC Joseph J. Zito Emerson V. Briggs, III Zito, tip 1250 Connecticut Avenue, N.W. Suite 200 Washington, DC Counsel for Amicus Curiae Classen Immunotherapies, Inc.

2 CERTIFICATE OF COMPLIANCE The undersigned counsel for Amicus Curiae Classen Immunotherapies, Inc. hereby certifies that this Brief of Amicus Curiae Classen Immunotherapies, Inc. in Support ofthe Petition for Rehearing En Banc complies with the type and volume limitation of the Federal Rule of Appellate Procedure 32(a)(7)(B). The brief is ten (10) pages in length and contains 2435 words, excluding the parts of the brief exempted by Federal Rule ofappellate Procedure 32(a)(7)(B)(iii). This brief complies with the typeface requirements of Federal Rule of Appellate Procedure 32(a)(5) or Federal Rule of Appellate Procedure 28.1(e) and the type style requirements offederal Rule of Appellate Procedure 32(a)(6). The brief has been prepared in a proportionally spaced typeface using the Microsoft Word 2010 word processing program. Respectfully submitted Dated: September 18,2012 ~v.~ Joseph J. Zito Emerson V. Briggs, III Zito, tlp 1250 Connecticut Avenue, N.W. Suite 200 Washington, D.C Attorneys for Appellant Classen Immunotherapies, Inc.

3 CERTIFICATE OF INTEREST Counsel for amicus curiae Classen Immunotherapies, Inc., certifies the following: 1. The full name of every party or amicus represented by me is Amicus Classen Immunotherapies, Inc. 2. The name of the real party in interest (if the party named in the caption is not the real party in interest) represented by me is: NONE 3. All parent corporations and any publicly held companies that own 10 percent or more ofthe stock of the party or amicus curiae represented by me are: NONE 4. There is no such corporation as listed in paragraph 3. ii

4 5. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court are: Joseph J. Zito Emerson V. Briggs, III Zito, tip 1250 Connecticut Avenue, N.W. Suite 200 Washington, D.C Respectfully submitted Dated: September 18,2012 ~<s~v.~ Joseph J. Zito Emerson V. Briggs, III Zito, tip 1250 Connecticut Avenue, N.W. Suite 200 Washington, D.C Attorneys for Appellant Classen Immunotherapies, Inc. iii

5 STATEMENT OF INTEREST Classen has a direct and immediate interest in the granting of Plaintiff Appellees Momenta Pharmaceuticals, Inc. ("Momenta") and Sandoz, Inc. ("Sandoz") Petition for Rehearing En Banc. This is so because the panel's decision in this case, Momenta Pharm., Inc. v. Amphastar Pharm., Inc., Nos , -1103, (Fed. Cir. Aug. 3, 2012) is in direct and irreconcilable conflict with the decision of another panel of this Court in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), cert. pending, No , where Classen was the prevailing appellant, regarding the proper interpretation of the limited safe harbor from patent infringement provided by 35 U.S.C. 271(e)(1). The decision of this Court on whether to grant en banc review of the Momenta decision (and the outcome of any en banc review) will have a direct and immediate impact on whether the United States Supreme Court grants certiorari in GlaxoSmithKline v. Classen Immunotherapies, Inc., No (Feb. 28, 2012) or grants any petition for certiorari that may in the future be filed by a party to this case, or grants certiorari in both cases. The outcome in Momenta may also be outcome determinative in another case involving different Classen patents, where the District Court granted summary judgment to Defendant Elan Pharmaceuticals, Inc. on grounds that the Defendant's iv

6 post-marketing approval study of the drug Skelaxon was covered by Section 271 (e)(1)'s safe harbor, based on a factual situation that was similar to the one in Momenta. Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., Civil Action No. WDQ (D. Md. Slip Op. August 17, 2006). The outcome in this case may adversely impact additional patent enforcement activities that Classen may undertake in the future. Classen submits this amicus curiae brief pursuant to Federal Circuit Rules 29 and 36(g). Pursuant to Rule 29( c )(5), Classen states the following: 1) A party's counsel did not author this amicus curiae brief in whole or in part; 2) A party or a party's counsel did not contribute money that was intended to fund preparing or submitting this amicus curiae brief; and 3) A person - other than amicus curiae, its members or its counsel - did not contribute money that was intended to fund preparing or submitting the brief. v

7 TABLE OF CONTENTS CERTIFICATE OF COMPLIANCE... i CERTIFICATE OF INTEREST....ii STATEMENT OF INTEREST.... iv TABLE OF CONTENTS...vi TABLE OF AUTHORlTIES... vii 1. INTRODUCTION... 1 II. ARGUMENT... 4 A. En Bane Review Is Required In Order To Read "Solely" and "Submission" Back Into The Interpretation Of Section 271(e)(l)... 4 B. En Bane Review Is Required To Ensure That Section 271(e)(l) Is Tethered To The Remainder Of The Statute And The Purposes For Which Congress Enacted It...6 C. En Bane Review Is Required To Ensure That Section 271(e)(1) Is Interpreted Within the Framework ofthe Statutory Structure Into Which It Falls... 6 CERTIFICATE OF SERVICE vi

8 TABLEOF AUTHORITIES Cases Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), cert. pending, No iii, 1,2,4,8,9 Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., Civil Action No. WDQ (D. Md. Slip Op. August 17,2006)... iv, 2 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990)...6, 7, 8 Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)... 5, 6, 8 Momenta Pharm., Inc. v. Amphastar Pharm., Inc., Nos , -1103, (Fed. CiT. Aug. 3, 2012)... passim Statutes 35 U.S.C. 271(e)(l)... "... passim 35 U.S.C. 271(e)(2)... 9,10 35 U.S.C. 271(e)(3)... 9,10 35 U.S.C. 271(e)(4) vii

9 INTRODUCTION Although Classen was the prevailing appellant in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), cert. pending, No ("Classen"), it agrees with Momenta and Sandoz that en banc review is warranted, because the panel decision in Momenta Pharm., Inc. v. Amphastar Pharm., lnc., Nos , -1103, (Fed. Cir. Aug. 3, 2012), is in direct conflict with the panel decision in Classen. This Court held in Classen that the narrowly-drawn safe harbor from patent infringement provided by the Hatch-Waxman Act, 35 U.S.C. 271 (e)(1), cannot be interpreted to extend protection to otherwise infringing conduct that occurs after the U.S. Food and Drug Administration grants approval to begin commercially marketing a drug. 659 F.3d at A majority panel of this Court in Momenta then announced an interpretation of Section 271(e)(I) that carves out a broad exception with ill defined parameters, without any textual support or legislative history for this novel interpretation of the statute. The panel majority in Momenta specifically held that post-approval studies that are 'reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs' fall within the scope of the 271(e)(1) safe harbor." Momenta, Slip op., p. 20. Notwithstanding the protestation of the majority panel in Momenta to the contrary, the conflict between these two decisions is irreconcilable, as the two 1

10 decisions cannot logically coexist, because Section 271 (e)(1) cannot simultaneously be restricted to protecting only pre-marketing uses of a patented invention as it was written, and also be expanded to protect some post-marketing activities. Therefore, it is imperative that this Court, sitting en bane, resolve this conflict, and correct the errors in interpreting section 271 (e)(1) that were made in the panel majority's decision in Momenta. Classen agrees with Momenta and Sandoz that the questions presented by this case, and by Classen are extremely important. The proper construction ofthe safe harbor of section 271 (e)( 1) may be outcome-determinative in Momenta, in the currently-pending case of Classen v. Elan Pharmaceuticals, Inc., I and in dozens of other litigations. The proper interpretation of Section 271 (e)(1) will undoubtedly effect the enforceability of thousands of pharmaceutical patents, thereby distorting existing licensing agreements, business plans, research and development plans, and the future exploitation of intellectual property that is the result of tens ofbillions of dollars of investment. The panel's interpretation of section 271 (e)( 1) in Momenta extends the safe harbor into a phase of drug commercialization where the policies 1 A second litigation, Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., Civil Action No. WDQ , US District Court, (D.Md) (Slip Op., August 17,2006), currently pending in U.S. District Court for the District of Maryland is indicative of the types of patents and patent litigations which could be adversely impacted if the Momenta decision is left uncorrected by the denial of an en bane rehearing. 2

11 that concerned Congress, and the distortions to the patent tenn that prompted Congress to act are simply not implicated. Extending the safe harbor to cover post-approval activities, such as safety testing of phannaceuticals, sounds like a good idea for judicial legislation, which would appear to save lives. However, the net result of foreclosing this area to patent protection will be the loss of tens of billions of dollars that are annually invested in developing new methods and devices for ensuring the safety of drugs and medical devices which regularly save and improve the lives of countless people. In the short tenn, a few phannaceutical companies will avoid paying some licensing fees, in the long tenn, an entire area of medical research will be shut down. These investments are responsible for creating and maintaining tens of thousands ofjobs in the United States. All of these investments are (and should continue to be) protected by valuable patent rights. A patent grant is the public tradeoff for the advancement of science. A decision of this Court that would call the patents protecting those investments into question would be contrary to the purpose of the patent laws to protect inventions in the useful arts, and upset the carefully-crafted balance between patent owners, and users of the patented inventions who seek to innovate or develop cheaper drugs for the public. Inventors such as Dr. John Barthelow Classen, the named inventor of the Classen patents, would lose their incentive to invest large sums of money and countless hours of 3

12 their time to do the studies required to develop safer methods of administering vaccines and other drugs to patients. We will all be less well off as a result. As was correctly found by this Court in Classen, nothing in the text or purpose of Section 271 (e)( 1) warrants a wholesale expansion of the safe harbor into the post-marketing approval period, where it would be totally divorced from the balancing of interests, and concerns about distortions to the patent term that the safe harbor was intended to address. The danger of the unintended consequences described above are too stark to ignore or to allow to come to pass. Therefore, Classen strongly agrees with the Chief Judge's suggestion in Momenta that "the entire court [should] resolve this issue en bane. " ld. at 16. I. ARGUMENT A. En Bane Review Is Required In Order To Read "Solely" and "Submission" Back Into The Interpretation of Section 271(e)(1) The panel majority held in Momenta that "post-approval studies that are 'reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' falls within the scope of the 271 (e)( 1) safe harbor," regardless of whether or not that information is ever submitted to the FDA. Slip Op., p. 20. Of course, this is not how the statute reads. What the statute actually says is "... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs..." 35 U.S.C. 271(e)(1) (Emphasis 4

13 added). The panel's holding in Momenta ignores the meaning of the words "solely," and "submission" which are integral parts of the statute. Apparently, the panel majority in Momenta based its holding and rationale on an often cited (and equally as often misapplied) quotation from Merck KGaA v. Integra Lifesciences 1, Ltd., 545 U.S. 193, 206 (2005): Congress did not limit 271 (e)(1)' s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval ofa generic drug. Rather, it exempted from infringement all uses of patented compounds "reasonably related" to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs. Momenta, Slip Op., p. 17 (Quoting Merck). The panel majority in Momenta relied on this quotation from Merck to support its interpretation of the statute to exclude any reference to the term "solely" and to interpret "submission" as not requiring a submission and adding the interpretation that "patented invention" include methods. If the Momenta decision is allowed to stand, what is left would be a safe harbor that would protect any use of a patented invention which could arguably be "reasonably related" to the non-submission of information under any federal law that regulates the manufacture, use or distribution of drugs. This Court must rehear the Momenta case en banc in order to correct this clear misinterpretation of Section 271( e)(1). 5

14 B. En Banc Review Is Required To Ensure That Section 271(e)(1) Is Tethered To The remainder Of The Statute And The Purposes For Which Congress Enacted It The interpretation of Section 271 (e)(1) announced in Momenta strays far from the purposes for which Congress enacted it and the policies that that it was intended to foster. The panel majority in Momenta relies almost exclusively on the Supreme Court's decisions in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), and Merck to support its holding that the 271 (e)( 1) safe harbor is not, and should not be, limited to the premarketing period. But those Supreme Court precedents do not address post-market studies, nor support the wholesale untethering of the safe harbor from its moorings and they do not suggest that the intended purposes and pre-marketing roots be ignored. In this respect as well, the Momenta decision is contrary to a proper reading of Merck, and to Eli Lilly. The fact remains that every controlling decision examining the statute even Eli Lilly and Merck - has appreciated that 271 (e)(1) is directed to the premarketing approval ofnew drugs or generic counterparts before patent expiration. The Supreme Court applied this limitation to medical devices in Eli Lilly, 496 U.S. at 671, stating that 271 (e)(1) "allows competitors, prior to the expiration of a patent, to engage in otherwise infringing activities necessary to obtain regulatory approval." (Emphasis added) The Court in Eli Lilly & Co. also found that activities "could not constitute infringement if they had been undertaken 6

15 to develop information reasonably related to the development and submission of information necessary to obtain regulatory approval under the {Food, Drug, and Cosmetic Act]." ld. at 664 (Emphasis added). More fundamentally, the Court went on to explain that "the [Hatch Waxman] Act was designed to respond to two unintended distortions ofthe 17 year patent term produced by the requirement that certain products must receive premarket regulatory approval." ld. at 669. With the Hatch-Waxman Act, Congress remedied both distortions, striking a careful balance that is embodied in the entire statute and reflected throughout the Supreme Court's and the Federal Circuit's precedent. The first "distortion" was the exhaustion ofpatent life while the patentee was obtaining regulatory approval by procedures that usually consumed several years. However, when the patented brand name drug or medical device is approved for commercial sale, the patentee can now profitably exploit its patented invention in the marketplace, and thus the de Jacto reduction in the patent term ceases. The second distortion was that would-be competitors experienced delay in market entry while obtaining regulatory approval for their generic counterparts after patent expiration. However, when competing generic imitations of a drug are approved, the dejacto extension of the patent term ceases and thus the applicability of 271 (e)( 1) ceases. Therefore, in Eli Lilly, the Supreme Court 7

16 declined to interpret and apply Section 271 (e)(1) outside of Congress' intended purposes. The Momenta decision ignores the fact that, once a brand name or generic drug or a medical device is approved for commercial marketing, these two distortions are no longer present, and the patent term distortions cease. In Merck KGaA, the Supreme Court again analyzed the statutory purpose and held that 271 (e)(1 ) applies to pre-approval and pre-marketing activities using a patented drug to compile information in anticipation of an IND and an NDA to be submitted to the FDA: We decline to read the "reasonable relation" requirement so narrowly as to render 271(e)(1)'s stated protection of activities leading to FDA approval for all drugs illusory. Properly construed, 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval... " 545 U.S. at 207 (emphasis added). Under Merck, preclinical research, whether or not ultimately included in a submission to the Food and Drug Administration, is exempted from infringement by Section 271 (e )(1) "as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an IND or NDA. '" Id. at 208 (quoting Brief for United States as Amicus Curiae 23). Nowhere does Merck discuss that post-approval activities would be covered by Section 271(e)(1). The Classen Court read the Eli Lilly and Merck precedents and reached the exact opposite decision from Momenta. The Court should review Momenta en bane and reaffirm its Classen decision. 8

17 C. En Bane Review Is Required To Ensure That Section 271(e)(1) Is Interpreted Within the Framework of the Statutory Structure Into Which It Fa)]s The panel majority in Momenta interpreted Section 271 (e)( 1) in isolation, without referencing the statutory structure into which it falls. Other provisions were added to 35 U.S.C. 271 contemporaneously as part of the Hatch-Waxman Act amendments, all of which confirm that Section 271 (e)( 1) is limited temporally to the pre-marketing approval period, as the Classen panel correctly found. Although it has been taken as a given that the "safe harbor" isolates a party from suit for patent infringement, that is simply not the case, because the activities covered by Section 271 (e)( 1), while isolated from an injunction and damages during the FDA pre-market approval process/ remain subject to an injunction from commercial sale after FDA approval is obtained. Therefore, section 271 (e)( 1 ) must be read in combination with the other subsections of Section 271 ( e) which make the limitations of the safe harbor clear. For instance, Section 271(e)(2) provides that a party can still be sued for patent infringement, with limited remedies as set forth in 271 (e )(3), even for activities covered under 271(e)(l), as is explicitly set forth in 271(e)(3) "for an 2 See Section 271(e)(3) "In any action for patent infringement brought under this section, no injunctive or other relief may be granted which would prohibit the making, using, offering to sell, or selling within the United States or importing into the United States of a patented invention under paragraph (1)." 9

18 action for patent infringement brought under this section... under paragraph 1," based on activities excluded from a full scale patent suit under Section 271 (e)( 1). Section 271 (e)(3) explicitly recognizes that a cause of action can arise for activities listed in paragraph 271(e)(1), even where the safe harbor is found to apply. Thus, Sections 271 (e)(1), (2) and (3) must be read together to obtain the balance struck by Congress. Crucially, Section 271(e)(4) then defines the timing of when damages and an injunction may be awarded in a suit under Section 271 (e)(2), which is the delay of the date on which the application under Section 505(b )(2) and 505(j) of the FDCA is approved and ends on the date on which the patent in question expires. The clear language of the entire text of Section 271 (e) demonstrates that the Classen panel is correct that Section 271 (e)( 1) does not apply beyond the approval ofthe drug product in question. The provisions of Section 271 (e) - when viewed as a whole - consider all uses of a patented invention by a potential infringer to be commercial in nature (and thus prohibited) if it occurs after the drug has been approved. En Bane review is thus warranted to fully consider the effect that these additional provisions of Section 271 (e) have on determining the proper temporal and operational scope of the Section 271 (e)( 1) safe harbor. 10

19 Respectfully Submitted by: Dated: September 18, 2012 ~V,Rb~ Joseph J. Zito ~70 Emerson V. Briggs, III ZITO tlp 1250 Connecticut Avenue, NE Suite 200 Washington, DC Tel: (202) Counsel for Amicus Curiae Classen Immunotherapies, Inc. 11

20 CERTIFICATE OF SERVICE I hereby certify that on September 18, 2012, I caused two copies ofthe foregoing BRIEF OF AMICUS CURIAE CLASSEN IMMUNOTHERAPIES, INC. IN SUPPORT OF PETITION FOR REHEARING IN BANC to be mailed, first-class postage prepaid, through the United States Postal Service to counsel for the parties, addressed as follows: Robert S. Frank, Jr. Choate, Hall & Stewart, LLP Two International Place Boston, MA Deanne E. Maynard Morrison & Foerster, LLP 2000 Pennsylvania Avenue, N.W. Suite 6000 Washington, D.C Thomas P. Steindler McDermott, Will & Emery th Street, N.W. Suite 1200 Washington, D.C Patricia A. Millett Akin, Gump, Strauss, Hauer & Feld, LLP 1333 New Hampshire Avenue, N.W. Washington, D.C ~U'~0/7 Emerson V. Briggs, III 12