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EXHIBIT S

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EXHIBIT T

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MERCK & CO., INC. v. TEVA PHARMACEUTICALS USA
Cite as 288 F.Supp.2d 601 (D.Del. 2003)

601

than an angle normal to the surface being inspected. 15. The Magistrate Judge's construction of ``plurality of scan path segments'' is not adopted. ``Plurality of scan path segments'' means more than one distinct scan segment. The Court otherwise adopts the reasoning of the Magistrate Judge. The Magistrate Judge's construction of ``gallery definition means'' is adopted with modification. ``Gallery definition means'' is supported by the structure of conventional computer hardware and software with the function of determining what items may be displayed by the ``gallery display means'' of the claims. KLA's motion for partial summary judgment of the '259 patent for obviousness (D.I. 584) is denied. ADE's cross-motion of non-obviousness of the '259 patent (D.I. 602) is denied. KLA's motion for partial summary judgment of invalidity of the '259 patent under 35 U.S.C. § 112, ¶ 1 (D.I. 587) is denied. KLA's motion for partial summary judgment of non-infringement of the '259 patent by KLA's SP1­TBI device (D.I. 566) is granted, as KLA's SP1­TBI device does not satisfy the ``oblique zone'' limitation. KLA's motion for partial summary judgment of non-infringement of the '259 patent by KLA's SP1­TBI and SP1­DLS devices (D.I. 590) is moot as to the SP1­TBI device and denied as to the SP1­DLS device. The Magistrate Judge's finding that KLA's motion for partial sum-

mary judgment of non-willful infringement of the '525 patent (D.I. 249) is moot is adopted by the Court. 23. The Magistrate Judge's finding that KLA's motion to dismiss ADE's claims of willful infringement of the '525 and '259 patents (D.I. 253) is moot as to the '525 patent is adopted. As to the '259 patent, the motion (D.I. 253) is denied.

16.

,
MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. Defendant. No. CIV.A.01­048­JJF. United States District Court, D. Delaware. Aug. 28, 2003. As Amended Jan. 7, 2004. Patentee brought infringement action against competitor, alleging that its patent for an osteoporosis drug was infringed by competitor's proposed generic drug. The District Court, Farnan, J., held that: (1) determination of British court that European drug patent was invalid as obvious was not entitled to collateral estoppel effect; (2) claims in patent referring to dosage of ``about 70/35 mg'' of alendronic acid meant equivalent of 70/35 mg of alendronic acid when taking into account molecular weight variances; (3) newsletter article did not anticipate patent; (4) patent was not invalid as obvious; and (5) patentee's fail-

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ure to disclose newsletter article during application was not inequitable conduct. Ordered accordingly. 1. Judgment O713(1) Collateral estoppel is appropriate if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) plaintiff had a full and fair opportunity to litigate the issue in the first action. 2. Patents O327(13) Doctrine of collateral estoppel applies in patent cases. 3. Patents O327(21) Determination of British court that European drug patent was invalid as obvious was not entitled to collateral estoppel effect in action for infringement on the United States patent; standards for determining obviousness in the United States and Britain were different, and British court's factual findings relating to obviousness were not essential to its decision. 4. Patents O112.5 The party challenging the patent bears the burden of proving by clear and convincing evidence that the patent is invalid. 35 U.S.C.A. § 282. 5. Patents O112.5 Clear and convincing evidence necessary to establish a patent's invalidity is evidence that places in the fact finder an abiding conviction that the truth of the factual contentions are highly probable. 35 U.S.C.A. § 282. 6. Patents O314(5) The first step in any patent invalidity analysis is claim construction, which is an issue of law.

7. Patents O161 A patent claim term should be construed to mean what one of ordinary skill in the art at the time of the invention would have understood the term to mean. 8. Patents O157(2) When conducting a patent claim construction analysis, a district court should be cognizant of the fact that claims should be construed, if possible, to uphold their validity. 9. Patents O165(1), 167(1), 168(2.1) The starting point for a patent claim construction analysis is the claims themselves; then remainder of the intrinsic evidence should be examined, beginning with the specification and concluding with the prosecution history. 10. Patents O161, 162 Generally, there is a strong presumption in favor of the ordinary meaning of claim language as understood by those of ordinary skill in the art; however, a patentee may act as his own lexicographer and use the specification to supply implicit or explicit meanings for claim terms. 11. Patents O162 The patentee's lexicography must, appear with reasonable clarity, deliberateness, and precision before it can affect the claim. 12. Patents O159 If the meaning of a patent claim term is clear from the totality of the intrinsic evidence, than the claim may be construed; if, however, the meaning of a claim term is genuinely ambiguous after examining the intrinsic evidence, than a court may consult extrinsic evidence. 13. Patents O101(2) Claims in patent for osteoporosis drug, referring to dosage of ``about 70/35

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MERCK & CO., INC. v. TEVA PHARMACEUTICALS USA
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603

mg'' of alendronic acid, meant equivalent of 70/35 mg of alendronic acid when taking into account molecular weight variances for its derivatives that carried accessories; term ``about'' did not mean ``approximately,'' since patentee explicitly defined term so that tablets contained the same number of core molecules as 70/35 mg of alendronic acid regardless of the final weight of the actual active ingredient in tablet. 14. Patents O72(1) Anticipation is determined through a comparison of the patent claim language with a single prior art reference. 35 U.S.C.A. § 102(e)(2). 15. Patents O72(1) Anticipation requires that every element of the patent claim be found either expressly or inherently in a single prior art reference. 35 U.S.C.A. § 102(e). 16. Patents O68 If the prior art reference does not expressly state an element of patent claim, that reference may still anticipate if that element is inherent in its disclosure; inherency is established if the evidence makes clear that the missing descriptive matter is necessarily present in the thing described in the reference and, and that it would be so recognized by persons of ordinary skill. 35 U.S.C.A. § 102(e). 17. Patents O68 Although inherency cannot be established through probabilities, recognition by a person of ordinary skill in the art before the critical date of the patent is not required to show inherent anticipation. 35 U.S.C.A. § 102(e). 18. Patents O70 Newsletter article referencing weekly 40 or 80 mg dose of oral alendronate for treatment of osteoporosis did not anticipate patent for osteoporosis drug, which

expressly disclosed weekly doses of ``about 35 mg'' and ``about 70 mg'' of alendronate sodium ``on an alendronic acid basis,'' absent evidence that the dosages referred to in the article and the dosages referred to in the patent were equivalent. 35 U.S.C.A. § 102(e). 19. Patents O16(2, 3), 36.1(1), 36.2(1) The underlying factual inquiries in obviousness determination require consideration of: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the pertinent art; and (4) any secondary considerations of nonobviousness such as commercial success, long felt but unsolved need, failure of others, and acquiescence of others in the industry that the patent is valid. 35 U.S.C.A. § 103. 20. Patents O36(2) As with anticipation, the burden of demonstrating obviousness of patent is with the challenger and invalidity must be proven by clear and convincing evidence. 35 U.S.C.A. § 103. 21. Patents O16.25 Patent for osteoporosis drug, which expressly disclosed weekly doses of ``about 35 mg'' and ``about 70 mg'' of alendronate sodium, was not invalid as obvious, despite prior newsletter article that disclosed weekly 40 or 80 mg dose of oral alendronate for treatment of osteoporosis; newsletter article did not overcome the serious side effect concerns associated with the higher dosage levels it described, and weekly dosing regimen described in patent was commercially successful. 35 U.S.C.A. § 103. 22. Patents O26(1) In order to establish obviousness from a combination of elements disclosed in prior art, there must be some motivation,

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suggestion, or teaching of the desirability of making the specific combination that was made by the applicant. 35 U.S.C.A. § 103. 23. Patents O97 Duty of candor, good faith, and honesty imposed on patent applicants and their patent attorneys includes the duty to submit truthful information and the duty to disclose to the Patent and Trademark Office (PTO) information known to the patent applicants or their attorneys which is material to the examination of the patent application. 37 C.F.R. § 1.56(a). 24. Patents O97 Breach of the duty of candor, good faith, and honesty by patent applicant or patent attorney may constitute inequitable conduct. 37 C.F.R. § 1.56(a). 25. Patents O97 If it is established that a patent applicant engaged in inequitable conduct before the Patent and Trademark Office (PTO), the entire patent application so procured is rendered unenforceable. 37 C.F.R. § 1.56(a). 26. Patents O97 A patent applicant engages in inequitable conduct before the Patent and Trademark Office (PTO) when he withholds or misrepresents information material to the patentability of his invention, with an intent to deceive. 37 C.F.R. § 1.56(a). 27. Patents O97 Inequitable conduct by patent applicant encompasses affirmative misrepresentations of material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive. 37 C.F.R. § 1.56(a). 28. Patents O97 A reference withheld from patent application is considered material if there is a

substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent. 37 C.F.R. § 1.56(a). 29. Patents O97 After determining if patent applicant withheld information that is material, the court must then determine whether the evidence demonstrates a threshold level of intent to mislead the Patent and Trademark Office (PTO) in determining if patent is invalid because of inequitable conduct. 30. Patents O97 Once materiality and intent to deceive Patent and Trademark Office (PTO) are established, the court should then weigh the findings and their premises and determine, in its discretion, whether to hold the patent unenforceable because of inequitable conduct. 37 C.F.R. § 1.56(a). 31. Patents O97 Applicant's failure to disclose newsletter article that disclosed weekly 40 or 80 mg dose of oral alendronate for treatment of osteoporosis when applying for patent that disclosed weekly doses of ``about 35 mg'' and ``about 70 mg'' of alendronate sodium to treat osteoporosis was not inequitable conduct that rendered patent invalid; article did not reflect the claimed invention directly and did not render the claimed invention invalid as either obvious or anticipated, and evidence failed to establish intent to deceive. 37 C.F.R. § 1.56(a). 32. Patents O97 In a case involving an omission of a material reference to the Patent and Trademark Office (PTO), there must be clear and convincing evidence that the applicant made a deliberate decision to withhold a known reference to establish inequitable conduct. 37 C.F.R. § 1.56(a).

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MERCK & CO., INC. v. TEVA PHARMACEUTICALS USA
Cite as 288 F.Supp.2d 601 (D.Del. 2003)

605

Patents O328(2) 4,621,077. Cited. Patents O328(2) 5,994,329. Valid.

is set to expire on August 14, 2018. (PTX 1). Merck listed the '329 Patent in the Federal Drug Administration's (``FDA'') publication ``Approved Drug Products with Therapeutic Equivalence Evaluations'' (the ``Orange Book'') in connection with its 70 mg and 35 mg dosage for alendronate sodium, which Merck markets under the name ``Fosamax.'' On October 3, 2000, Teva filed a supplement to an existing Abbreviated New Drug Application (``ANDA'') seeking FDA approval to market generic versions of Merck's 70 mg alendronate sodium product for weekly administration. Included with Teva's ANDA filing were ``paragraph IV'' certifications (21 U.S.C. § 355(j)(2)(A)(vii)(IV)) asserting that the Patents listed in the Orange Book, including the '329 Patent, are invalid, unenforceable or would not be infringed by the commercial marketing of Teva's proposed product. Merck filed this action on January 21, 2001, alleging that Teva's filing of its supplement was an act of infringement under 35 U.S.C. § 271(e)(2)(A). Thereafter, Merck listed U.S. Patent No. 6,225,294 (the `` '294 Patent'') in the Orange book and Teva filed a paragraph IV certification asserting that the '294 Patent is invalid, unenforceable or would not be infringed by the commercial marketing of Teva's proposed 70 mg alendronate sodium product. On October 4, 2001, Merck filed Civil Action No. 01­675­JJF, alleging that Teva's filing of its supplemental ANDA was an act of infringement of the '294 Patent under 35 U.S.C. § 271(e)(2)(A). Subsequently, Teva filed another supplement to its ANDA, seeking approval to market a generic version of Merck's 35 mg Fosamax product. The supplement also included a paragraph IV certification asserting that all the listed patents were invalid, unenforceable or would not be infringed by Teva's commercial marketing of its proposed product. On November 6,

Mary B. Graham and Maryellen Noreika, Esquires of Morris, Nichols, Arsht & Tunnell, Wilmington, DE. Of Counsel: John F. Lynch, Nicolas G. Barzoukas, and Stephen E. Edwards, Esquires of Howrey Simon Arnold & White, LLP, Houston, TX. Paul D. Matukaitis, Edward W. Murray, and Gerard M. Devlin, Jr. Esquires of Merck & Co., Whitehouse Station, NJ, for Plaintiff. Josy W. Ingersoll, and Adam W. Poff Esquires of Young, Conaway Stargatt & Taylor, LLP, Wilmington, DE. Of Counsel: James Galbraith, Maria Luisa Palmese and William G. James, II, Esquires of Kenyon & Kenyon, New York City, for Defendant Teva Pharmaceuticals, USA, Inc. OPINION FARNAN, District Judge. I. Procedural Background

Plaintiff, Merck & Co., Inc. (``Merck'') is a Delaware corporation with its principal place of business in New Jersey. Defendant, Teva Pharmaceuticals USA, Inc. (``Teva'') is a New Jesey corporation with its principal place of business in Pennsylvania. Merck is the owner of the entire right, title and interest in United States Patent No. 5,994,329, entitled ``Method for Inhibiting Bone Resorption'' (the `` '329 Patent''), which issued November 30, 1999, naming as inventors Anastasia G. Daifotis, Arthur C. Santora II, and John Yates. Merck filed the application for the '329 Patent on July 22, 1997. The '329 Patent

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2001, Merck filed Civil Action No. 01­728, alleging that the filing of Teva's supplement to the ANDA was an act of infringement under 35 U.S.C. § 271(e)(2)(A). On January 14, 2002, the Court consolidated all three cases under Civil Action No. 01­ 048. One of the listed patents against which Teva certified was U.S. Patent No. 4,621,077 (``the '077 Patent''), which had already been the subject of litigation between the parties in this Court (Civil Action No. 00­ 035­JJF) in connection with Teva's application to market alendronate sodium for daily administration. The Court entered judgment in favor of Merck in that case on December 2, 2002, and an appeal from that judgment is now pending in the United States Court of Appeals for the Federal Circuit. (D.I.123­1). The parties agreed that they will be bound in this case, with regard to issues concerning the '077 Patent, by a final decision in the prior litigation. (D.I.128). Prior to trial Merck stipulated that the only claims at issue in this litigation are claims 23 and 37 of the '329 Patent and further stipulated that it would not allege an invention date for those claims prior to July 22, 1997. (D.I.128). Teva stipulated that if found valid and enforceable, claims 23 and 37 of the '329 Patent would be infringed by the commercial marketing of Teva's proposed 70 mg and 35 mg alendronate sodium products for weekly administration. (D.I. 109, Pretrial Order, Tab 1, ¶¶ 8­9). The issues of validity and enforceability of the '329 Patent were tried before the Court from March 4­7, 2003. The Court has jurisdiction over the parties and the subject matter pursuant to 28 U.S.C. § 1338(a). Additionally, venue is appropriate under 28 U.S.C. § 1391(c) and
1. The bench trial transcript is cited throughout the Opinion by a notation to the witness

§ 1400(b). Neither jurisdiction nor venue are contested by the parties. This Opinion constitutes the Court's Findings of Fact and Conclusions of Law with respect to the issues tried before the Court. II. The '329 Patent and Bone Biology In General The '329 Patent discloses less-frequentthan daily administration of bisphosphonates (e.g., alendronate) to inhibit bone resorption. (D.I. 143 at 8). Claims 23 and 37, the only asserted claims, relate specifically to the treatment and prevention of osteoporosis by once-weekly administration of alendronate. Osteoporosis is related to processes that are imbalanced in bone, and therefore, the Court will discuss the background of bone biology as it relates to osteoporosis and the use of alendronate for treatment of the disease. Bone is the tissue that provides mechanical support to the body. It is made up of a protein matrix, which is overlaid with mineral to give it hardness. (Russell 1 at 108­109; DTX 523 at 2). Two principal types of cells maintain bone: 1) osteoclasts, which break down bone, and 2) osteoblasts, which build new bone. Id. The process of bone destruction and rebuilding is known as ``remodeling.'' In the bone remodeling process, osteoclasts attach to the bone surface, become activated, and erode away the bone material beneath them, leaving defects in the bone structure. The destruction of bone by osteoclasts is called bone ``resorption.'' Osteoblasts then attach to the eroded surface of these defects, lay down new bone, and then become inactive. In the normal healthy adult the remodeling process is balanced. In other words, bone is destroyed and
and the page number of the transcript.

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MERCK & CO., INC. v. TEVA PHARMACEUTICALS USA
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607

built at the same rate. 110; DTX 523 at 3­4).

(Russell at 109­

In osteoporosis, bone destruction and formation are no longer balanced and bone is destroyed faster than it is replaced. Therefore, osteoporosis can lead to bone that is thinner, weaker, more fragile and porous. (Russell at 110­115; DTX 523 at 7, 8). Osteoporosis is treated primarily by inhibiting bone resorption-thus restoring the balance between bone destruction and formation. Alendronate inhibits bone resorption by blocking the bone destroying effects of osteoclasts. (Russell at 116­ 117). A small portion of the ingested drug makes its way to and adheres to the bone surface, where it resides until it is taken up by osteoclasts. The alendronate then inhibits the osteoclasts from resorbing bone. (Russell at 121­122; DTX 523 at 10). Paget's disease is also a common bone disease characterized by increased bone resorption. In Paget's disease, increased bone remodeling occurs in localized areas of the skeleton. If Paget's disease is not detected and treated early it can lead to an increase in bone size, fractures, and deformity. (Russell at 97). Like osteoporosis, Paget's disease is treated by inhibiting bone resorption with alendronate. (Russell at 125­126). III. Teva's Motion in Limine to Preclude Merck From Relitigating the Factual Findings Underlying the Decision in Teva Pharmaceuticals Ltd. et al. v. Instituto Gentili Spa et al. (D.I.113). Teva filed a Motion in Limine to Preclude Merck from Relitigating the Factual Findings Underlying the Decision in Teva Pharmaceuticals Ltd et al. Istituto Gentili Spa et al., (High Court of Justice,
2. This claim is in the form of a ``Swiss claim.'' Such claims are used in attempts to avoid restrictions on claiming methods of treat-

Chancery Division, Patents Court, January 21, 2003)). (D.I.113). Accordingly, the Court will discuss the motion in limine before it delves into the issues of validity and enforceability of the '329 Patent. Teva's principal defense in this case is that claims 23 and 37 are invalid because the claimed invention is anticipated or would have been obvious in view of the prior art. At the same time that the parties were litigating the validity of the '329 Patent in this Court, they were also involved in a case in the British High Court of Justice (the ``High Court''). That case was a challenge by Teva and others to the validity of the European Patent No. 998,292 (the `` '292 Patent''), which corresponds to the '329 Patent, and is based on the same provisional applications filed in July 1997. Teva, by its motion, contends that the '292 Patent covers the identical concept as the '329 Patent: the once-weekly dosing of alendronate sodium to treat osteoporosis, using seven times the normal daily dose.2 The High Court conducted a full trial on the merits from November 5­8, 2002, and heard further arguments from counsel on November 12­13, 2002. The trial involved live testimony from Merck's expert Dr. Socrates Papapoulos, who is Merck's expert in this case. In addition, Merck offered the testimony of Dr. Yates, the principal inventor of the '329 Patent, who also testified in this case. On January 22, 2003, Justice Jacob of the High Court found that the claimed invention was invalid because it would have been obvious to a person skilled in the art, it claims a method of treatment, and is incapable of industrial application.
ment, which are unpatentable in many countries.

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A.

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Applicable Legal Principles

[1, 2] Teva contends that the Court should adopt the High Court's factual findings concerning obviousness pursuant to the doctrine of collateral estoppel. Collateral estoppel is appropriate if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) plaintiff had a full and fair opportunity to litigate the issue in the first action. Micron Technology, Inc. v. Rambus, Inc., 189 F.Supp.2d 201, 209 (D.Del.2002) (citations omitted). Additionally, the doctrine of collateral estoppel applies in patent cases. See Blonder­Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28 L.Ed.2d 788 (1971). B. 1. Parties' Contentions Teva's Contentions

that all of the elements of collateral estoppel are met in this case with regard to the High Court's factual findings on obviousness. First, Teva contends that collateral estoppel applies to fact findings of foreign courts. Teva argues that courts have recently recognized that parties who litigate in a foreign court should be bound by the results of that litigation to the extent that the requirements of the collateral estoppel doctrine are met. For example, Teva points to Vas­Cath, Inc. v. Mahurkar, 745 F.Supp. 517 (N.D.Ill.1990), rev'd on other grounds, 935 F.2d 1555 (Fed.Cir.1991), where the parties extensively litigated the issue of obviousness in Canada, and the district court held that the parties were bound by the fact-finding of the Canadian Court. Additionally, Teva points to Northlake Marketing & Supply, Inc. v. Glaverbel, S.A., 958 F.Supp. 373, 379 (N.D.Ill. 1997) (``Northlake I'') and Northlake Marketing & Supply, Inc. v. Glaverbel, S.A., 986 F.Supp. 471, 475­76 (N.D.Ill.1997) (``Northlake II''), where the parties had previously litigated the validity of a Belgian patent that corresponded to the United States patent in suit. The district court in those cases held that the Belgian Court's conclusions about the scope and content of prior art were binding on the parties in the United States litigation. Further, Teva directs the Court to Oneac Corp. v. Raychem Corp., 20 F.Supp.2d 1233, 1242­1243 (N.D.Ill.1998), where a corresponding European patent was litigated in the High Court and the district court held that with respect to the United States patent, it would not give preclusive effect to questions of law or mixed questions of law and fact, but it would adopt the British Court's factual findings. Additionally, Teva points to Federal Circuit decisions that have declined to afford col-

By its motion, Teva contends that Merck had the identical motivation in litigating the British case as it does in the instant case: to discredit the Lunar News (a prior art reference) and Teva's reliance on its teachings. Moreover, Teva contends that Merck's barristers were afforded a full and fair opportunity to cross-examine all of Teva's witnesses and did so at length. Teva contends that the evidence was heard by Justice Jacob of the High Court, who is experienced in patents. On January 22, 2003, Justice Jacob found the '292 Patent invalid and entered judgment against Merck. In its motion, Teva concedes that the legal standard may vary between Britain and the United States; nevertheless, Teva contends that regardless of the differences, if any, between the legal standards for determining validity, collateral estoppel should still apply to the resolution of the underlying factual issues. Specifically, Teva contends

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lateral estoppel effects to judgments in foreign cases, but distinguishes them on the basis that those decisions were predicated on what the Federal Circuit views as different standards of patentability in other countries. See, e.g., Medtronic Inc. v. Daig Corp., 789 F.2d 903 (Fed.Cir.1986)(declining to adopt German tribunal's determination that corresponding German patent was invalid in view of different legal standards); In re Dulberg, 472 F.2d 1394 (Cust. & Pat.App.1973) (same). Second, Teva contends that the issues were the same in the British litigation; the obviousness of administering alendronate sodium once a week at a dose of about seven times the daily dose. Further, Teva argues that the issue of the scope and content of the prior art are the same in both cases; whether the Lunar News publications taught the administration of alendronate sodium once a week, and whether the prior art taught that the dose should approximate seven times the daily dose. In addition, Teva argues that Merck's fear defense is an issue in both cases. Merck claims that persons skilled in the art would have rejected the Lunar News teachings because of the fear that patients would not tolerate the larger dose. Merck raised the issue in Britain, and after considering the evidence, the High Court concluded that the ``fear defense fails''. For example, the High Court found that the rare instances of esophageal side effects were attributed primarily to failure to follow the dosing instructions (D.I.114, Ex. A, ¶ 65). Third, Teva argues that the same issues were actually litigated in the High Court. For instance, Teva contends, the parties fully aired all factual evidence, where both sides had qualified expert witnesses to explain the evidence to the Court. Further, Teva argues that all witnesses appeared live and were extensively cross-examined

and after the trial both parties provided written submissions and appeared for extensive argument before Justice Jacob. As a result, Teva argues, Merck cannot contend that these issues were not litigated. Fourth, Teva argues that the issues were determined by a valid and final judgment. Teva points out that the judgment of the High Court was the ``Approved Judgement of that Court.'' It was issued on January 21, 2003 and reissued in corrected form January 22, 2003. Teva notes that Merck has appealed the judgment, but that fact does not imply that the judgment is not final for purposes of collateral estoppel. In fact, Teva argues that it is well settled that the pendency of an appeal does not diminish the preclusive effect of an appealed judgment. (D.I. 114 at 13) (quoting Rice v. Department of Treasury, 998 F.2d 997, 999 (Fed.Cir.1993)). Lastly, Teva contends that the resolution of obviousness was essential to the judgment in the High Court. Specifically, it contends that Justice Jacobs was required to and did evaluate and interpret the prior art provided by Merck's witnesses, and that, all findings on these issues were necessary to his final judgment that the patent was invalid for obviousness. Based on this, Teva argues that the High Court's factual findings should be given preclusive effect. 2. Merck's Contentions

In response, Merck argues that there is no transnational collateral estoppel as to the validity of a United States Patent. First, Merck contends that Teva fails to point to a single Federal Circuit case where, a foreign court's judgment that the patent was invalid, or the factual underpinnings of such a judgment, was given collateral estoppel effect in a case litigating the validity of a United States Patent. In fact,

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Merck argues that the Federal Circuit and its predecessor court have rejected such attempts. For example in Medtronic Inc. v. Daig Corp., 789 F.2d 903 (Fed.Cir.1986), cert. denied, 479 U.S. 931, 107 S.Ct. 402, 93 L.Ed.2d 355 (1986), the Federal Circuit rejected the argument that it should adopt the conclusion of a German tribunal that a German counterpart was obvious and stated, ``[t]his argument is specious. The patent laws of the United States are the laws governing a determination of obviousness/nonobviousness of a United States patent in a federal court.'' Id. at 907­908. Additionally, Merck contends that the predecessor to the Federal Circuit came to the same conclusion in In re Dulberg 472 F.2d 1394, 1398 (Cust. & Pat.App.1973) and In re Larsen, 49 C.C.P.A. 711, 292 F.2d 531, 533 (Cust. & Pat.App.1961), where in both cases, the court refused to consider the actions of a foreign country's patent office with respect to the patentability of the subject matter before the court. Further, Merck argues that district courts have refused to give collateral estoppel effect to a foreign court's judgment. For example, Merck points to Cuno, Inc. v. Pall Corp., 729 F.Supp. 234 (E.D.N.Y. 1989), where the High Court found the European counterpart of the United States patent at issue to be valid and infringed, and when the plaintiff sought to have the United States district court give collateral estoppel effect to certain factual findings, the court denied the request and stated that: Even if the court were to apply collateral estoppel to certain factual findings made by the British Court--as opposed to importing its legal conclusions wholesale-it is not clear that the trial time would be significantly shortened. Furthermore, the Federal Circuit's reluctance to give collateral estoppel effect to

foreign judgments would seem to apply here to foreign findings of facts insofar as those findings involve mixed questions of fact and foreign law. Id. at 238­239. Moreover, Merck distinguishes the cases cited by Teva. First, in regard to the Oneac case, Merck points out that the court refused to give preclusive effect to questions of law or mixed questions of law and fact, and to the extent that certain factual findings were given collateral estoppel effect, it was because both parties to the suit agreed to be bound by those factual determinations. Oneac Corp., 20 F.Supp.2d at 1242­1243. Additionally, Merck points to the Vas­Cath case where the Northern District of Illinois adopted certain factual findings of a Canadian Court in regard to the validity of a patent, after parsing out the Canadian judgment, comparing the relative Canadian and United States' laws and making its own conclusions regarding the applicability of the factual determinations in the context of the United States' legal framework. Additionally, in the Northlake cases, Merck points out that the district court adopted only certain factual findings from a previous Belgian proceeding after careful review of those findings and contends that most importantly, the issues that were precluded limited the evidence that the patent challenger could rely on. See Northlake II, 986 F.Supp. at 475­ 476; Northlake I, 958 F.Supp. at 379. Next, Merck argues that the requirements for collateral estoppel have not been met. First, Merck contends that the High Court's factual findings regarding obviousness were not essential to the final judgment because the High Court found that the '292 was invalid based on three grounds: 1) invalid as a method of treatment; 2) incapable of industrial application; and 3) invalid as obviousnot obviousness alone.

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Lastly, Merck argues that the facts and applicable legal standard is different. Specifically, Merck contends that in the United States obviousness is ultimately a question of law which rests on the following factual inquiries: 1) the scope and content of prior art; 2) the level of ordinary skill in the art; 3) the differences between the claimed invention and the prior art; and 4) objective considerations of nonobviousness. See Advanced Display Systems, Inc. v. Kent State Univ., 212 F.3d 1272, 1284­85 (Fed.Cir.2000). On the other hand, Merck argues, in Britain, the determination of obviousness is based on the following factual inquiries: 1) identifying the inventive concept embodied in the patent in suit; 2) assuming the mantle of the normally skilled but unimaginative addressee in the art at the priority date and impute to him what was, at that date, common general knowledge in the art; 3) identifying what, if any, differences exist between the matter cited as being made available to the public and the alleged invention; 4) determining whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they required any degree of invention. (D.I. 126 at 17) (citing Windsurfing International, Inc. v. Tabur Marine (Great Britain) Ltd., 1985 R.P.C. 59, 60­61 (1985 Ct. Of Appeal)). Merck contends that although these standards are similar, the United States Court is required to consider objective considerations of obviousness, while in Britain they are not. Accordingly, Merck contends that collateral estoppel is improper. C. Discussion

standards for validity between the United States and Britain. Additionally, after reviewing the ``factual findings'' of the High Court, the Court finds that many of the principles are mixed questions of law and fact. The cases cited demonstrate that mixed questions of law and fact should not be adopted if there are two different legal standards, as in this case. See, e.g., Oneac Corp., 20 F.Supp.2d at 1242­1243 (declining to adopt mixed questions of law and fact). Additionally, in Oneac the court only adopted factual findings from a foreign tribunal where the parties agreed to be bound by such factual findings. Id. at 1242­43. This is not the situation in the instant case because Merck opposes any adoption of the High Court's factual findings. Also, the Court finds that Merck has successfully distinguished the Northlake cases from the instant case, where in the Northlake cases the issues that were precluded limited the evidence that the patent challenger could rely on and the adopted factual findings did not go to the validity of the patent in suit. The Court also concludes that all of the elements necessary for a finding of collateral estoppel are not present in this case. Specifically, the High Court's factual findings relating to obviousness were not essential to the High Court's decision because that decision was based on three separate grounds as detailed above. The Third Circuit has stated that ``if a judgment of a court of first instance is based on determinations of two issues, either of which standing independently would be sufficient to support the result, the judgment is not conclusive with respect to either issue standing alone.'' Arab African Int'l Bank v. Epstein, 958 F.2d 532, 535, (3d Cir.1992) (quoting Restatement (Second) of Judgments § 27, cmt. i), rev'd in part on other grounds, 10 F.3d 168 (3d Cir.1993). The Court concludes that based

[3] As outlined above, the standards for determining obviousness in the United States and Britain are different. In fact, for purposes of this motion, Teva concedes that there may be differences in the legal

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on this standard, the High Court's finding of obviousness cannot be said to be essential to the final determination. There may be cases where ``the balance tips in favor of preclusion because of the fullness with which the issue was litigated and decided in the first action.'' Masco Corp. v. United States, 303 F.3d 1316, 1329­1330 (Fed.Cir.2002). However, the Court concludes that this is not such a case, especially in light of the fact that the Federal Circuit has cautioned courts against giving too much weight to foreign tribunals who are confronted with the same prior art. See Heidelberger Druckmaschinen AG v. Hantscho Comm. Prods., Inc., 21 F.3d 1068, 1072 (Fed.Cir.1994) (recognizing that theories and laws of patentability differ from country to country and stating that ``[c]aution is required when applying the action of a foreign patent examiner to deciding whether the requirements of 35 U.S.C. § 103 are met under United States law, for international uniformity in theory and practice has not been achieved.''). While the Court has reviewed Justice Jacob's factual findings in regard to obviousness, based on the aforementioned reasons, the Court declines to adopt them and will make independent findings of fact on the issue of validity. Accordingly, Teva's motion will be denied. IV. Invalidity [4, 5] Once issued a patent is presumed to be valid. See 35 U.S.C. § 282. The party challenging the patent bears the burden of proving by clear and convincing evidence that the patent is invalid. See Helifix Ltd. v. Blok­Lok Ltd., 208 F.3d 1339, 1346 (Fed.Cir.2000). Clear and convincing evidence is evidence that places in the fact finder ``an abiding conviction that the truth of [the] factual contentions are `highly probable.' '' Colorado v. New Mexico, 467 U.S. 310, 316, 104 S.Ct. 2433, 81 L.Ed.2d 247 (1984).

Defendants contend that the '329 Patent is invalid and therefore cannot be infringed. Defendants argue invalidity on two grounds: anticipation by the July 1996 Lunar News reference under 35 U.S.C. § 102(a), and obviousness under 35 U.S.C. § 103. For the reasons set forth below, the Court concludes that the '329 Patent is valid. A. Claim Construction

[6­8] The first step in any invalidity analysis is claim construction which is an issue of law. SIBIA Neurosciences, Inc. v. Cadus Pharmaceutical Corp., 225 F.3d 1349, 1355 (Fed.Cir.2000); Markman v. Westview Instruments, Inc., 52 F.3d 967, 970­71 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). A claim term should be construed to mean ``what one of ordinary skill in the art at the time of the invention would have understood the term to mean.'' E.g., Markman, 52 F.3d at 986. Further, when conducting a claim construction analysis, a district court should be cognizant of the fact that claims should be construed, if possible, to uphold their validity. In re Yamamoto, 740 F.2d 1569, 1571 n. * (Fed. Cir.1984) (citations omitted). [9] The starting point for a claim construction analysis is the claims themselves. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d at 1582; see also Pitney Bowes, Inc. v. Hewlett­Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999) (stating that ``[t]he starting point for any claim construction must be the claims themselves.''). Thereafter, the remainder of the intrinsic evidence should be examined beginning with the specification and concluding with the prosecution history. Vitronics, 90 F.3d at 1582 (outlining this order for examination in claim construction).

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[10, 11] Generally, there is a strong presumption in favor of the ordinary meaning of claim language as understood by those of ordinary skill in the art. Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001). However, it is wellsettled that a patentee may act as his own lexicographer and use the specification to supply implicit or explicit meanings for claim terms. Bell Atl. Network Servs., 262 F.3d at 1268 (Fed.Cir.2001); Vitronics Corp., 90 F.3d at 1582; Markman, 52 F.3d at 980 (noting that patentee is free to be his own lexicographer, but emphasizing that any special definitions given to words must be clearly set forth in patent). ``[T]he patentee's lexicography must, appear `with reasonable clarity, deliberateness, and precision' before it can affect the claim.'' Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir.1998) (quoting In re Paulsen, 30 F.3d 1475, 1480 (Fed.Cir.1994)). [12] If the meaning of a claim term is clear from the totality of the intrinsic evidence, than the claim may be construed. If, however, the meaning of a claim term is ``genuinely ambiguous'' after examining the intrinsic evidence, than a court may consult extrinsic evidence. Bell & Howell Document Mgmt. Prods. Co. v. Altek Sys., 132 F.3d 701, 706 (Fed.Cir.1997). Claim terms in claims 23 and 37 of the '329 Patent are disputed in this case. Accordingly, the Court will focus its discussion on these claims [13] In full, claim 23 of the '329 Patent provides, ``[a] method according to claim 22 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate on an alendronic acid active basis.'' (PTX 1, '329 Patent at col. 21, lines 24­27) (emphasis added).

In full, claim 37 of the '329 Patent provides, ``[a] method according to claim 36 wherein said bisphosphonate unit dosage comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.'' (PTX 1, '329 Patent at col. 22, lines 24­26) (emphasis added). Teva contends that the term ``about'' in claims 23 and 37 should be construed according to its ordinary meaning of ``approximately.'' (D.I. 147 at 3). Merck contends that the patentee in this case acted as his own lexicographer and set out the meaning of ``about'' in the specification where the specification explains that the term ``about'' accounts for the variability of weight of the active ingredient that would result from the use of different salts of alendronic acids. (D.I. 141 at 42). Thus, Merck contends that the phrase ``about 70 mg'' as used in claim 23 and ``about 35 mg'' as used in claim 37 means 70 and 35 mg respectively of the active ingredient on an alendronic acid active basis. Id. at 43. In other words, Merck contends that, regardless of the final weight of the actual active ingredient in the tablet, it contains the same number of alendronate core molecules as 70/35 mg of alendronic acid. In rebuttal, Teva contends that Merck's proffered construction makes no sense. Teva points out that according to Merck, the word ``about'' is used to account for the fact that different alendronate salts have different molecular weights, and that to deliver the same amount of physiologically active compound to the bone they must be delivered at slightly different dosage strengths. (D.I. 147 at 4). Teva contends that Merck's interpretation is nonsensical because the claim itself accounts for this phenomenon by directing that the compound be administered on the basis of a common denominator, i.e., ``on an alendronic active basis.'' Id. In other words, Teva contends that the claims require that

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the amount ``alendronate sodium trihydrate'' be sufficient to deliver the same amount of active material as ``about 70/35 mg'' of alendronic acid. Id. As a result, Teva contends, the term ``about'' does not perform the function which Merck assigns to it, and must be in the claim for another purpose, that is, to have its ordinary meaning of ``approximately.'' After reviewing the claim terms and the specification, the Court concludes that the patentee explicitly and with reasonable clarity and precision defined the term ``about 70 mg'' in claim 23 and ``about 35 mg'' to mean the equivalent of 70/35 mg of alendronic acid when taking into account molecular weight variances for its derivatives that carry accessories. Simply put, no matter what the final weight of the actual active ingredient in the tablet is, it contains the same number of alendronate core molecules as 70/35 mg of alendronic acid. The relevant portion of the '329 Patent specification provides: Because of the mixed nomenclature currently in use by those or [sic] ordinary skill in the art, reference to a specific weight or percentage of bisphosphonate compound in the present invention is on an active weight basis unless otherwise indicated herein. For example the phrase ``about 70 mg of bone resorption inhibiting bisphosphonate selected from the group consisting of alendronate, pharmaceutically acceptable salts thereof and mixtures thereof, on an alendronic acid weight basis'' means that the amount of bisphosphonate compound selected is calculated based on 70 mg of alendronic acid. PTX 1, the '329 Patent, col. 10, 65­col. 11, line 8. (emphasis added). The Court concludes that the specification clearly indicates that the terms ``about 70 mg'' and ``about 35 mg'' refer to the fact that de-

pending on the derivative of the alendronic acid that could be used in the oral formulation, different weights will be needed in order to get the same effect as 70 or 35 mg of the seminal compound, alendronic acid. As Merck points out, the alendronate sodium in Fosamax includes an atom of sodium metal for each molecule of alendronate sodium. (D.I. 138 at 24). If a formulator was to select a different salt which includes a metal atom that is heavier than salt, e.g., a potassium or barium atom, the total amount of material in each tablet would have to increase if the amount of alendronic acid were to remain the same. By conforming the weight of the alendronate derivative in the claim of the '329 Patent to the equivalent weight of the alendronic acid, a formulator can consistently know how many basic units (alendronic acid units) are to be used, even though the final total weight may be different. Examples 7 and 8 of the '329 Patent reinforce this conclusion. They provide for oral formulations ``containing about 35 mg'' and ``about 70 mg'' of alendronate ``on an alendronic acid active basis.'' The claims at issue use the same phraseology and the ingredient tables in the examples are consistent with the premise that ``about'' accounts for the fact that alendronate derivatives have accessories that add to the weight of the molecules. Thus, in the examples ``about 35 mg'' turns out to be 45.68 mg of alendronate monosodium trihydrate and the ``about 70 mg'' turns out to be 91.35 mg of alendronate monosodium trihydrate. See PTX 1, the '329 Patent col. 19 lines 13­15, col. 19, lines 44­46, col. 19 lines 20­21, col. 19 lines 51­52. Although the Court finds that Dr. Russell, is competent in the area of bisphosphonates, it does not find his opinion as to the definition of the phrases ``about 70/35 mg'' in the '329 Patent persuasive. During

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cross examination on this issue, Dr. Russell testified as follows: Q. Now is it true that when you deal with the claims in this case, the claims recite 70 and 35; correct? That is 70 mg a week and 35? A. The claims say about 70 and about TTTT Q. And what does ``about'' mean to you? A. Well about to me depends how precise a definition we want. But for purposes of how close the 40 and 80 are to about 35 and 70, I've given you my opinion on that, that for practical purposes, those would be the same, they would be indistinguishable in their effects, given everything else we know about the properties of these drugs. Q. But the claim itself, what the claim really means, is 70, not 80; correct? A. It says about 70 and about 35. Q. Did you read the patent, Dr. Russell, the entire body of the patent? A. Yes, I have. Q. So in the patent, does it tell you what about 70 means? A. There is a reference somewhere to about in the patent as I recall, but I'd need to be directed to where it was. Q. Why don't you go to the first, in the patent, which is Defendant's Exhibit 1 and Plaintiff's Exhibit 1, at column 11, lines-about 1 through 9. It says here in the definitional context exactly what about 70 milligrams means; correct? A. It well, there's almost an intrinsic contradiction in this, because the definition here is talking about 70, and then referring to whatever salt form is used being referenced to the alendronic acid itself, yes. Q. But in the patent it gives you a precise reference and says when we say about 70 milligrams of a bone resorption

inhibiting bisphosphonate, what we mean is that amount of a bisphosphonate that will deliver an equivalent amount, the equivalent of 70 milligrams of alendronic acid; correct? A. Yes. I have difficulty with this statement because the reason if it's that precise at 70, why does it use the phrase about? Q. But they gave you that exact definition; correct? A. It's a curious use of the English language. Q. I understand, but it is what it says, and perhaps the person wanted to say if it's a certain salt one, you might use 71, and if it's a certain salt 2, you might use 73. Isn't that what's indicated in this? A. Possibly. Q. But that's what the definition says; right? A. That is the definition as it's described in the patent. Russell at 337­339. (emphasis added). Although Dr. Russell opined that the explicit definition of the disputed claim terms in the specification was ``a curious use of the English Language,'' he testified that Merck's proffered construction is the definition as it is described in the patent. The Court finds Dr. Russell's interpretation unpersuasive, especially in light of the fact that patentees may give special meanings to claim terms either explicitly or implicitly in patent specifications. Further, with regard to Teva's claim that there is no function to Merck's proffered construction, the Court finds this argument unpersuasive given the clear directive in the specification to construe the term ``about 70/35 mg'' to mean the equivalent of 70/35 mg of alendronic acid when taking into account molecular weight variances for its derivatives and the fact that depending on the derivative of alendronic acid used in the

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oral formulation, different weights will be needed in order to get the same effect as 70 or 35 mg of alendronic acid. See Bell Atl. Network Servs., 262 F.3d at 1268 (noting that the specification must express a clear intent to redefine a claim term). Accordingly, the Court will accept Merck's proffered construction and construe the disputed claim terms ``about 70/35 mg'' to mean the equivalent of 70/35 mg of alendronic acid when taking into account molecular weight variances for its derivatives that carry accessories. B. Anticipation

required to show inherent anticipation. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed.Cir.2003) (rejecting the contention that inherent anticipation requires recognition in the prior art before the critical date); In re Robertson, 169 F.3d at 745 (noting that inherent anticipation cannot be demonstrated through probabilities). 1. The Parties' Contentions

[14­17] Anticipation is determined through a comparison of the claim language with a single prior art reference. See Wesley Jessen Corp. v. Bausch & Lomb, Inc., 209 F.Supp.2d 348, 391 (D.Del. 2002). Anticipation under 35 U.S.C. § 102 requires that every element of the claim be found either expressly or inherently ``in a single prior art reference.'' In re Robertson, 169 F.3d 743, 745 (Fed.Cir.1999). Thus, if the prior art reference does not expressly state an element of the claim, ``that reference may still anticipate if that element is `inherent' in its disclosure.'' Id. Inherency is established if the evidence makes ``clear that the missing descriptive matter is necessarily present in the thing described in the reference and, and that it would be so recognized by persons of ordinary skill.'' Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.Cir. 1991). Although inherency cannot be established through probabilities, recognition by a person of ordinary skill in the art before the critical date of the patent is not

Teva contends that a July 1996 Lunar News article expressly anticipates claims 23 and 37 of the '329 Patent. Teva points out that since Merck has stipulated that it does not assert an invention date before July, 22, 1997, the July 1996 Lunar News is prior art under 35 U.S.C. § 102(a). (D.I. 143 at 19). Further, Teva points out that although it has the burden of proving invalidity by clear and convincing evidence, that burden is more easily met in this situation because Merck failed to provide the PTO with the July 1996 Lunar News. Teva contends that the July 1996 Lunar News discloses every element of claims 23 and 37 of the '329 Patent. Teva points out that claim 23 defines a method of treating osteoporosis which comprises of oral administration of ``about 70 mg'' alendronate monosodium trihydrate, on an active alendronic acid basis, once-weekly. Similarly, Teva argues the July 1996 Lunar News discloses the same elements where it discusses the use of bisphosphonates, including alendronate, ``in dealing with osteoporosis,'' which means the treatment and prevention of osteoporosis. (D.I. 143 at 21; Russell at 137). Further, Teva contends that the July 1996 Lunar News also specifies that the alendronate therapy it is

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discussing includes ``oral'' alendronate therapy, and that the term ``alendronate'' refers to ``Fosamax by Merck.'' Teva also contends that the active ingredient of Fosamax was well known to be alendronate monosodium trihydrate, and the dosage strength of Fosamax was known to be reported on an alendronic acid basis. (D.I. 143 at 21; DTX 394; Russell at 138­39). Teva also points out that the article specifies that the drug can be administered on a weekly basis at a dose of 80 mg where it states that, ``TTToral alendronate potentially could be given in a 40 or 80 mg dose once/week.'' (D.I. 143 at 21)(quoting DTX 418 at 23). Teva directs the Court to Dr. Russell's testimony where he opines that to a person skilled in the art, 80 mg of alendronate once per week is clinically indistinguishable from 70 mg once a week, and is therefore ``about 70 mg.'' (D.I. 143 at 21; Russell at 138). Teva also contends that Merck itself viewed 80 mg and 70 mg as the same weekly dose. (D.I. 143 at 21; DTX 147 at MK0158265). Thus, Teva contends the July 1996 Lunar News Article discloses every element of claim 23: treatment of osteoporosis by the administration of about 70 mg monosodium trihydrate on an alendronic acid basis once-weekly. (D.I. 143 at 22). Teva further contends that the July 1996 Lunar News anticipates claim 37 of the '329 Patent. Claim 37 claims a method for preventing osteoporosis in a human being comprising of orally administering about 35 mg of alendronate sodium on an alendronic acid basis as a unit dosage according to a continuous schedule having a dosage interval of once-weekly. (D.I. 143 at 22; DTX 1). Teva points out that the only difference between the two claims is that claim 23 is directed to ``treatment'' of osteoporosis with a 70 mg weekly dose, and claim 37 is directed to ``prevention'' with a 35 mg weekly dose. Teva reiterates the contention that the July 1996 Lunar

News deals with both the treatment and prevention of osteoporosis and discloses the use of a 40 mg once-weekly oral dose. (D.I. 143 at 22). Teva again directs the Court to Dr. Russell's testimony where he testified that to a person skilled in the art, a 40 mg dose of alendronate once per week is clinically indistinguishable from 35 mg once per week and is therefore ``about 35 mg.'' (D.I. 143 at 22; Russell at 140; DTX 147 at MKO158265). As a result, Teva contends that the July 1996 Lunar News discloses every element of claim 37: prevention of osteoporosis by oral administration of about 35 mg alendronate monosodium trihydrate on an alendronic acid basis once weekly. (D.I. 143 at 22). Teva contends that Merck's ``fear defense'' is irrelevant to anticipation. First, Teva points out that claims 23 and 37 do not require that once-weekly administration of alendronate meet any standard of safety or tolerability. (D.I. 143 at 23). Even if they did, Teva argues, such a requirement would not avoid anticipation because the property of tolerability is inherent in the method disclosed in prior art. Further, Teva argues that the concept of ``teaching away'' from an invention is inapplicable in an anticipation analysis, and therefore, the Court should not consider it. (D.I. 143 at 24). Based on this, Teva contends that claims 23 and 37 are anticipated by the July 1996 Lunar News, and are therefore, invalid. In reply, Merck contends that the July 1996 Lunar News fails to anticipate claims 23 and 37 of the '329 Patent. Merck points out that the claims require the use of 70 or 35 mg of alendronate sodium on an alendronic acid active basis and even if one were to read the July 1996 Lunar News suggestion that ``[e]ven alendronate potentially could be given in a 40 or 80 mg dose once/week'' as referring to the amount on an alendronic acid active basis,

Case 1:04-cv-00939-GMS

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80 mg is not the same as 70 mg and 40 mg is not the same as 35 mg. Merck argues that the unambiguous weight requirement for alendronate in claims 23 and 37 is not met by the Lunar News ' suggestion of 80 or 40 mg, and therefore, it fails to anticipate claims 23 and 37. (D.I. 138 at 27). Further, Merck argues that the July 1996 Lunar News is not enabling, and therefore, cannot anticipate. Specifically, Merck contends that in order for a disclosure to be enabling it must allow one of skill in the art to practice the invention, and the July 1996 Lunar News falls short of this standard because it fails to address the expectation by physicians in the field during 1996­1997 that alendronate sodium at doses over 20 mg would not be welltolerated in the prevention and treatment of osteoporosis. Merck points to Dr. Fennerty's testimony to establish that a knowledgeable gastroenterologist during the applicable period would have been ``extraordinarily concerned'' about suggesting 40 or 80 mg of alendronate to treat osteoporosis. (D.I. 138 at 28; Fennerty at 270­ 271). Further, Merck argues that Dr. Papapoulos, Merck's expert with extensive bisphosphonate and clinical osteoporosis experience, corroborates this sentiment. (D.I. 138 at 28). Merck argues that given the state of the medical knowledge at the time, a physician would not administer those high dosages when managing osteoporosis, and as a result, the July 1996
1. Dr. Mazess does not possess an MD, has no formal training in pharmacology, and obtained his bachelors degree and Ph.D. in anthropology. (Mazess Dep. at 30­32). The Court understands that Teva is not contending that the April 1996 edition of the Lunar News anticipates the '329 Patent. See D.I. 143, Opening Brief at 19­24 (failing to assert that the April 1996 Lunar News anticipates claims 23 and 37 of the '329 Patent).

Lunar News fails to anticipate claims 23 and 37 of the '329 Patent. 2. Whether the