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IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS HOUSTON DIVISION REPROS THERAPEUTICS INC., § § Plaintiff, § § vs. § § HARRY FISCH, § § Defendant. § § HARRY FISCH, § § Counterclaimant, § vs. § § JOSEPH S. PODOLSKI, RONALD § WIEHLE, AND REPROS THERAPEUTICS § INC., § § Counterclaim-Defendants. §

CASE NO. 4:13-CV-02266 JURY TRIAL DEMANDED

DEFENDANT-COUNTERCLAIMANT HARRY FISCH’S OPENING CLAIM CONSTRUCTION BRIEF

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TABLE OF CONTENTS I. II. INTRODUCTION .............................................................................................................. 1 BACKGROUND ................................................................................................................ 1 A. B. III. Nature And Stage Of The Proceedings ....................................................................1 Technology Background ..........................................................................................2

ARGUMENT ...................................................................................................................... 4 A. The Principles Of Claim Construction.....................................................................4 1. Claims Terms Are Given Their Ordinary And Customary Meaning As Understood By A Person Of Ordinary Skill In The Art At The Time Of The Invention. ...............................................................................5 Claims Must Be Construed In Light Of The Intrinsic Record .....................5 Extrinsic Evidence .......................................................................................6 Construing Claim Terms To Preserve Validity ...........................................7

2. 3. 4. B.

The Proper Construction Of The Disputed Claim Elements ...................................7 1. 2. 3. “A Human Male With Secondary Hypogonadism” .....................................7 “Treating Secondary Hypogonadism In A Human Male” .........................13 “Treating Wasting In A Hypogonadal Male” ............................................15

IV.

CONCLUSION ................................................................................................................. 17

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TABLE OF AUTHORITIES Cases C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858 (Fed. Cir. 2004)............................................................................................10, 13 Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996) .........................................................4 Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003)..................................................................................6, 9, 13, 15 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)............................................4, 5, 6, 7, 10, 11, 12, 13, 14, 15, 16 Rhine v. Casio, Inc., 183 F.3d 1342 (Fed.Cir.1999)....................................................................................................7 Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)....................................................................................................6 Federal Statutes 37 C.F.R. §§ 1.71-1.74.....................................................................................................................5 37 C.F.R. § 1.114 ...........................................................................................................................11

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I.

INTRODUCTION Claim construction is a question of law for the Court and will assist in determining

inventorship of the patents at issue. Pursuant to the Court’s Amended Scheduling Order (Dkt. No. 30), Defendant and Counterclaimant Harry Fisch (“Dr. Fisch”) submits this opening brief in support of his proposed constructions of the disputed claim elements of U.S. Patent Nos. 7,759,360 (“the ‘360 patent”) and 7,737,185 (“the ‘185 patent”) (collectively, “the Patentsin-Suit”), which have been assigned to Plaintiff and Counterclaim-Defendant Repros Therapeutics, Inc. (“Repros”). As shown below, Dr. Fisch’s proposed constructions are fully consistent with the plain language of the claims, the patent documents, and the law of claim construction. Repros, on the other hand, abandons the principles of claim construction and the plain language of the asserted claims by defining terms within the disputed claim elements out of context. For these reasons, and as fully discussed below, Dr. Fisch respectfully requests that the Court adopts his proposed constructions of the disputed claim elements. II. BACKGROUND A. Nature And Stage Of The Proceedings The parties seek a determination as to whether Dr. Fisch should be named as a joint inventor of the Patents-in-Suit. (Dkt. No. 1 at ¶¶ 45-58; Dkt. No.37 at p. 26.). The parties have been able to narrow the claim construction issues to three disputed elements appearing in claims 1 and 7 of the ‘360 patent and claim 1 of the ‘185 patent. (Dkt. No. 41-1.) The claims at issue are reproduced below with the disputed claim elements underscored for ease of reference by the Court: [Claim 1 of the ‘360 patent]. A method for increasing serum levels of testosterone in a human male with secondary hypogonadism, the method comprising administering to said male an effective amount of a composition consisting
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essentially of trans-clomiphene or pharmaceutically acceptable salts thereof and optionally one or more pharmaceutically acceptable diluents, adjuvants, carriers or excipients. [Claim 7 of the ‘360 patent]. A method for treating secondary hypogonadism in a human male, the method comprising administering to a human male in need thereof, an effective amount of a composition consisting essentially of transclomiphene or pharmaceutically acceptable salts thereof and optionally one or more pharmaceutically acceptable diluents, adjuvants, carriers or excipients. [Claim 1 of the ‘185 patent]. A method for treating wasting in a hypogonadal male, comprising administering to the male a composition consisting essentially of trans-clomiphene or pharmaceutically acceptable salts thereof and optionally one or more pharmaceutically acceptable diluents, adjuvants, carriers or excipients in an effective amount to treat said wasting in the hypogonadal male. (Ex. 1 1,‘360 patent, claims 1 and 7; Ex. 2, ‘185 patent, claim 1.) B. Technology Background Many men experience a gradual reduction in testosterone levels as they age. (See Ex. 1, ‘360 patent, col. 1, ll. 54 – col. 2, ll. 1.) Adult males with low testosterone may experience a variety of unwanted symptoms, including reduction of muscle mass, reduction of bone density, loss of libido, erectile dysfunction, fatigue, and depression. (Id. at. col. 2, ll. 8-14.)

Conventionally, disorders related to testosterone deficiency had been treated by administering testosterone, which has serious side effects. (See id. at col. 2, ll. 14-27.) Dr. Fisch discovered another method for treating disorders related to testosterone deficiency, namely, administering clomiphene or clomiphene citrate to men in need of such treatment. (Ex. 3, Provisional Patent App. No. 60/207,496, May 26, 2000, at 4-5.) On May 26, 2000, Dr. Fisch filed Provisional Patent Application No. 60/207,496 covering his new treatment method. Dr. Fisch’s provisional application teaches as one example that tablets containing a mixture of 30-50% of cis-clomiphene citrate and 50-70-% of trans-clomiphene citrate could be administered for treatment.
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(Id. at 6.)

On May 21, 2002, The United States Patent and

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The exhibits cited herein are attached hereto and listed in the attached Appendix. 2

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Trademark Office granted Dr. Fisch a patent covering his treatment method. (See Ex. 4, U.S. Patent No. 6,391,920.) The Patents-in-Suit also relate to methods for treating symptoms related to testosterone deficiency in men. (See Ex. 1, ‘360 patent, col. 3, ll. 53-62; Ex. 2, ‘185 patent, claim 1 & Abstract.) All of the methods disclosed in the Patents-in-Suit involve the administration of “clomiphene enriched for trans-clomiphene” (i.e., “compositions having active ingredients comprising 0% to 29% weight/weight of cis-clomiphene and 100% to 71% [weight/weight] trans-clomiphene”) to men in need of such treatment. (Ex. 1, ‘360 patent, col. 2, ll. 53-62; Ex. 2, 185 patent, col. 3, ll. 66 – col. 4, ll. 5.) This is the same chemical (clomiphene or clomiphene citrate) exemplified in Dr. Fisch’s provisional patent application and subsequent patent, albeit Repros has enriched the chemical in trans-isomer as compared to Dr. Fisch’s example. The Patents-in-Suit do not claim the compound trans-clomiphene per se, but, rather, only the use of that known compound in the treatment methods claimed. In fact, not only had enriched trans-clomiphene been known for quite some time prior to the filings of the Patents-inSuit, but it had also been known that enriched trans-clomiphene could be used to increase testosterone levels in men. (See, e.g., Ex. 5, European Patent App. Publication No. 0 430 388, June 5, 1991, at p. 3, ll. 18-19 (hereinafter, “the Baird Application”) (describing “the use of the En isomer [i.e., trans-clomiphene] substantially free of the Zu isomer [i.e., cis-clomiphene] . . . [for] treatment of female infertility”); Ex. 6, Reyes, F.L., et al., “Long-Term Therapy with Lowdose Cisclomiphene 2 in Male Infertility: Effects on Semen, Serum FSH, LH, Testosterone and Estradiol, and Carbohydrate Tolerance,” 19 Int. J. Fertil. 49, 50-52 (1974) (teaching administration of enriched trans-clomiphene raises testosterone levels in men, including at least Prior to 1976, what is presently referred to as trans-clomiphene or enclomiphene had been referred to as cis-clomiphene. See Ex. 5, Baird Application at p. 2 (Table 1). 3
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one man who had low testosterone levels prior to treatment); Ex. 7, Wieland, R.G., et al., “Idiopathic Oligospermia: Control Observations And Response To Cisclomiphene 3,” Fertility and Serility 23:7, July 1972, at 473-73 (teaching administration of enriched trans-clomiphene raises testosterone levels in men).) The ‘360 patent is titled “Methods And Materials For The Treatment Of Testosterone Deficiency In Men.” The ‘360 patent teaches that “clomiphene enriched for trans-clomiphene” can be administered to men to increase testosterone levels and ameliorates symptoms associated with low testosterone levels. (Ex. 1, ‘360 patent, col. 1, ll. 10-17; id. at col. 2, ll. 53-63.) Joseph Podolski is the sole named inventor of the ‘360 patent. The ‘185 patent, titled “Methods And Compositions With Trans-Clomiphene,” issued from the same family of patent applications that also yielded the ‘360 patent. The ‘185 patent teaches that clomiphene enriched for trans-clomiphene can be administered to treat men experiencing wasting (i.e., loss of muscle mass) resulting from low testosterone levels. (Ex. 2, ‘185 patent, claim 1.) Mr. Podolski and Ronald Wiehle are the only named inventors of the ‘185 patent. III. ARGUMENT A. The Principles Of Claim Construction

Patent claim construction is a question of law for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff’d, 517 U.S. 370, 391 (1996). “Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim.” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc) (internal

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See note 1, supra.

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quotation marks omitted). Thus, claim terms should be construed in a manner that “stays true to the claim language and most naturally aligns with the patent’s description of the invention.” Id. 1. Claims Terms Are Given Their Ordinary And Customary Meaning As Understood By A Person Of Ordinary Skill In The Art At The Time Of The Invention.

In construing disputed claim terms, courts look first to the claims themselves, as “[i]t is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the patentee is entitled the right to exclude.’” Phillips, 415 F.3d at 1312. The words of a claim are generally given their “ordinary and customary meaning,” which is “the meaning that the term[s] would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1312-13. “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.” Id. at 1314. In many cases, however, the meaning of a term to a person skilled in the art will not be readily apparent, and courts must look to other sources to determine the term’s meaning. Id. 2. Claims Must Be Construed In Light Of The Intrinsic Record

Patent claims should not be construed “in a vacuum.” Phillips, 415 F.3d at 1314. Instead, claim terms must be construed in view of the intrinsic evidence: specification, and the prosecution history of the patent. Id. The patent specification includes the: (1) “Abstract” of the invention; (2) “Background of the Invention”; (3) “Summary of the Invention”; (4) patent drawings, if any; and (5) “Detailed Description of the Preferred Embodiments”. 37 C.F.R. §§ 1.71-1.74. The specification is “the primary basis for construing the claims.” Phillips, 415 F.3d at 1315 (internal citation omitted). “The claims must be construed so as to be consistent with the specification, of which they are a
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the claims, the

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part.” Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003). If the specification of a patent expressly defines a claim term, then “the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. The prosecution history of a patent “consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317. “Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.” Id. 3. Extrinsic Evidence

The term “extrinsic evidence” refers to “that evidence which is external to the patent and file history, such as expert testimony, inventor testimony, dictionaries, and technical treatises and articles.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 (Fed. Cir. 1996). Extrinsic evidence “can assist the court in determining the meaning of particular terminology to those of skill in the art of the invention,” Phillips, 415 F.3d at 1323, and “has the value of being an unbiased source ‘accessible to the public in advance of litigation.’” Vitronics, 90 F.3d at 1585. That said, extrinsic evidence is entitled to less weight than intrinsic evidence, and therefore “may not be used to vary or contradict the claim language” or be used to “contradict the import of other parts of the specification.” Id. at 1584. The Federal Circuit has also cautioned that while extrinsic evidence in the form of expert testimony can be useful to a court for a variety of purposes, “conclusory, unsupported assertions by experts as to the definition of a claim term are not useful to a court. Similarly, a court should discount any expert testimony ‘that is clearly at odds with the claim construction mandated by the claims themselves, the written description, and the prosecution history, in other words, with the written record of the patent.’” Phillips, 415 F.3d at 1318 (citations omitted). 6

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4.

Construing Claim Terms To Preserve Validity

“[C]laims should be so construed, if possible, as to sustain their validity.” Phillips, 415 F.3d at 1327 (quoting Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed.Cir.1999)). This maxim applies in situations in which one plausible construction would render a claim invalid but another plausible construction would preserve the claim’s validity. In such circumstances, if “after applying all the available tools of claim construction, [a court concludes] that the claim is still ambiguous,” then the construction that preserves validity should be adopted. Phillips, 415 F.3d at 1327. B. The Proper Construction Of The Disputed Claim Elements 1. “A Human Male With Secondary Hypogonadism” Defendant-counterclaimant Dr. Harry Fisch’s Proposed Construction A human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.

Repros’s Proposed Construction A human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins and corresponding low or low normal LH and FSH levels.

The term “a human male with secondary hypogonadism” appears in claim 1 of the ‘360 patent. The parties’ dispute turns on whether the terms “human male” and “secondary hypogonadism” may be construed individually, as Repros contends, or whether “human male with secondary hypogonadism” must be construed as a single phrase, as Dr. Fisch contends. Per the Federal Circuit in Phillips, the analysis begins with an assessment of the ordinary and customary meaning of the disputed element. See Phillips, 415 F.3d at 1312-13. When

persons of ordinary skill in the art use the term “secondary hypogonadism” coupled with “human male” or “men”—for example, a “human male with secondary hypogonadism” or variants thereof such as “secondary hypogonadism in a human male,” “hypogonadism in men,” or “male 7

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hypogonadism”—they are referring to a clinical syndrome (i.e., a group of symptoms or features that characterize a disease): • “Definition of hypogonadism. Hypogonadism in men is a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone (androgen deficiency) and the normal number of spermatozoa die to disruption of one or more levels of the hypothalamis-pituitary-gonadal (HPG) axis.” (Ex. 8, Bhasin, S., et al., “Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline,” The Journal of Clinical Endocrinology & Metabolism 91(6):1995 (2006) (hereinafter, “2006 Clinical Practice Guideline”) (emphasis added); 4 • “Male hypogonadism, or testosterone deficiency syndrome (TDS), results from a failure of the testes to produce adequate androgen. Patients have low circulating testosterone in combinations with clinical symptoms such as fatigue, erectile dysfunction, and body composition changes.” (Ex. 10, Pinsky, M. R.,

“Hypogonadism, ADAM, and hormone replacement”, Ther. Adv. Urol. (2010) 2(3) 99 (hereinafter, “Pinsky Article”).) The clinical syndrome of “male hypogonadism,” as demonstrated by the extrinsic evidence below, requires both low testosterone levels due to inadequate secretion of pituitary gonadotropins, and, as Dr. Fisch’s proposed claim construction requires, “at least one related symptom”:

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The Endocrine Society’s updated clinical practice guidelines, published in 2010, set forth the same definition. (Ex. 9, Bhasin, S., “Testosterone Therapy in Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline,” J. Clin. Endocrinol. Metab., June 2010, 95(6):2536, at 2539 (hereinafter, “2010 Clinical Practice Guideline”).) 8
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“The diagnosis of hypogonadism relies on the combination of laboratory measurements of serum testosterone and clinical signs and symptoms of androgen deficiency.” (Ex. 10, Pinsky Article, at 99 (emphasis added));

“We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs of unequivocally low serum testosterone levels.” (Ex. 8, 2006 Clinical Practice Guidelines, at 1995 (emphasis added)) 5;

“Clinical hypogonadism is defined as symptoms + low testosterone (<300 ng/dL).” (Ex. 11, Kim, E.D., “Overview of the Endocrine Society Guidelines for the Treatment of Hypogonadism”, at 5 (available at http://www.reprosrx.com/investors_events.php).

“In the hypogonadal adult male, diagnosis is made based on the presence of signs or symptoms that accompany hypogonadism (Table 1), with confirmation by laboratory testing.” (Ex. 12, Tenover, J. Lisa, “Male Hormone Replacement Therapy Including ‘Andropause’,” Endocrinology and Metabolism Clinics – Vol. 27, Issue 4 (Dec. 1998), 974-975 (emphasis added)).

Accordingly, a person of ordinary skill in the art would understand the term “human male with secondary hypogonadism,” to refer to “a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom” as required by Dr. Fisch’s proposed claim construction. As Dr. Fisch’s proposed construction of “a human male with secondary hypogonadism” is consistent with the term’s plain and customary meaning to a person of ordinary skill in the art, the claim construction analysis proceeds further, as a claim “must be construed so as to be consistent with the specification, of which they are a part.” Merck & Co. v. Teva Pharms. USA,

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See also Ex. 9, 2010 Clinical Guidelines, at 2536 (same). 9

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Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003).

Here, the specification of the ‘360 patent

demonstrates that the term “a human male with secondary hypogonadism” was being used consistent with its ordinary meaning to persons of skill in the art—i.e., to refer to “a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.” Toward that end, the “Background of the Invention” section of the ‘360 patent states: Some of the sequelae of adult testosterone deficiency include a wide variety of symptoms including: loss of libido, erectile dysfunction, oligospermia or azoospermia, absence or regression of secondary sexual characteristics, progressive decrease in muscle mass, fatigue, depressed mood and increased risk of osteoporosis. (Ex 1, ‘360 patent, col. 2, ll. 8-14 (emphasis added).) The ‘360 patent repeatedly describes “present invention” as being “directed to methods for increasing serum testosterone levels … and for ameliorating or preventing the sequelae of low testosterone levels” (Ex. 1, ‘360, col. 3, ll. 13-16 (emphasis added); see also id. at col. 2, ll. 52-56). Such statements describing the entire “invention” are given significant weight during claim construction. See C.R. Bard, 388 F.3d at 864 (“Statements that describe the invention as a whole . . . are more likely to support a limiting definition of a claim term.”). In view of the above statements from the ‘360 patent, a person of ordinary skill in the art would understand “sequelae of low testosterone” to refer to “a wide variety of symptoms” including those listed above. Because the goal of the invention disclosed in the ‘360 patents is to ameliorate or prevent a wide variety of symptoms of low testosterone, a person of ordinary skill in the art would understand the term “human male with secondary hypogonadism” to refer to “a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.”

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The prosecution history of the ‘360 patent provides additional corroborative evidence regarding “how the [named] inventor understood the invention.” Phillips, 415 F.3d at 1317. Specifically, during examination of the ‘360 patent, the named inventor argued that claim 1 was patentable because “contrary to the Examiner’s assertion, [the Young prior art patent] does not disclose administration of clomiphene or any other antiestrogen for treatment of male menopausal symptoms.” (Ex. 13, Patent App. No. 10/483,458, Response to Office Action Dated Nov. 19, 2008, Jan. 13, 2009, at 5-6 (hereinafter, “Jan. 13, 2009 Response”) (emphasis added).) In a later filing with the Patent Office, the named inventor argued that “the pending claims . . . require that the composition be administered to men who have a recognized diagnosis of secondary hypogonadism.” (Ex. 14, Patent App. No. 10/483,458, Submission Accompanying Request For Continued Examination (RCE) Under 37 C.F.R. § 1.114, May 19, 2009, at 6) (hereinafter, “May 19, 2009 Submission”) (emphasis added).) These statements demonstrate that the claim 1 is directed to treating “a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.” By excluding the phrase “at least one related symptom,” Repros’s proposed construction, if adopted, would render claim 1 of the ‘360 patent invalid. As discussed in Section II.B., supra, it had been known before the filing of the ‘360 patent that trans-clomiphene could be used to increase testosterone levels in men, including in men with low testosterone levels prior to treatment. Adopting Repros’s proposed construction, which does not require the presence of at least one symptom related to low testosterone, would result in a claim covering a use of transclomiphene for the same purpose that had been known in the prior art, thereby rendering the claim invalid. Accordingly, even if the Court finds Repros’s proposed construction to be

plausible, a conclusion that Dr. Fisch disagrees with for the reasons discussed above, the 11

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construction still must be rejected because it would render claim 1 invalid. See Phillips, 415 F.3d at 1327 (“[C]laims should be so construed, if possible, as to sustain their validity.”). In sum, Repros improperly defines the terms “human male” and “secondary hypogonadism” out of the context of claim 1 of the ‘360 patent. According to Repros,

“secondary hypogonadism” means “low testosterone levels due to inadequate secretion of pituitary gonadotropins and corresponding low or low normal LH and FSH levels.” But claim terms must be construed “in the context of the particular claim in which the disputed term appears.” Phillips, 415 F.3d at 1313. Here, a person of ordinary skill in the art reading “secondary hypogonadism” in context of the broader phrase “a human male with secondary hypogonadism” would understand it to refer to a particular syndrome suffered by men characterized by “low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.” Thus, the Court should reject Repros’s litigation-driven construction and adopt Dr. Fisch’s proposed construction, which is consistent with the claim element’s plain and customary meaning as understood by a person of ordinary skill in the art at the time of the invention, and is fully supported by the intrinsic record.

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2.

“Treating Secondary Hypogonadism In A Human Male” Defendant-counterclaimant Dr. Harry Fisch’s Proposed Construction Raising testosterone levels and at least ameliorating at least one symptom related to low testosterone levels in a human male wherein the low testosterone levels are caused by inadequate secretions of pituitary gonadotropins.

Repros’s Proposed Construction Therapeutic and prophylactic management of a human male with low testosterone levels and low to low normal FSH and LH levels due to inadequate secretion of pituitary gonadotropins.

As with the previous disputed claim element, the parties dispute whether “secondary hypogonadism” and “human male” may be construed individually, as Repros contends, or whether “secondary hypogonadism in a human male” must be construed as a single phrase that refers to a clinical syndrome, as Dr. Fisch contends. For the reasons discussed in

Section III.B.1., supra, “secondary hypogonadism in a human male” refers to “a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom.” The remaining dispute with respect to the term “treating secondary hypogonadism in a human male,” which appears in claim 7 of the ‘360 patent, turns on how the parties have defined “treating.” As detailed below, the specification of the ‘360 patent shows that “treating” as used in claim 7 means “raising testosterone levels and at least ameliorating at least one symptom related to low testosterone levels.” See Merck, 347 F.3d at 1371 (requiring claims to “be construed so as to be consistent with the specification, of which they are a part”). For example, the “Summary of the Invention” section of the ‘360 patent describes “present invention” as “directed to methods for increasing serum testosterone levels … and for ameliorating or preventing the sequelae of low testosterone levels” (Ex. 1, ‘360, col. 3, ll. 13-16 (emphasis added); see also id. at col. 2, ll. 13

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52-56). Such statements describing the entire “invention” are given significant weight during claim construction. See C.R. Bard, 388 F.3d at 864 (“Statements that describe the invention as a whole . . . are more likely to support a limiting definition of a claim term.”). Further, the ‘360 patent is titled “Methods And Materials For The Treatment Of Testosterone Deficiency In Men.” As such, a person of ordinary skill in the art would understand “treatment” to mean “raising testosterone levels and at least ameliorating at least one symptom related to low testosterone levels.” Repros construes “treating” to mean “therapeutic and prophylactic management.” This construction improperly defines “treating” “in a vacuum,” rather than in view of the intrinsic evidence. Phillips, 415 F.3d at 1314. Repros’s interpretation of “treating” is wrong for at least three reasons. First, the

definition is too broad given that the ‘360 patent specifically described the goals of treatment as increasing testosterone and ameliorating or preventing symptoms of low testosterone. (Ex. 1, ‘360 patent, col. 2, ll. 52-56; see also id. at col. 3, ll. 13-16.) Second, because the claims are directed to treating the clinical syndrome of secondary hypogonadism, the diagnosis of which necessarily requires at least one symptom related to low testosterone, the context of the claim suggests that treating is not directed to “prophylactic management” of a condition as Repros argues. Finally, Repros’s interpretation of “treating” makes no sense when, as required, the disputed claim element is read in context of entire claim. See Phillips, 415 F.3d at 1313 (“[T]he person of ordinary skill in the art is deemed to read the claim term . . . in the context of the particular claim in which the disputed term appears”). Claim 7 of the ‘360 patent requires “administering to a human male in need [of treatment], an effective amount of a 14

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composition . . . .” (emphasis added.)

If, as Repros contends, the purpose of treatment is

“therapeutic and prophylactic management” in the abstract, then it is impossible to determine an “effective amount” of the composition to administer to a human male with secondary hypogonadism for that purpose. Dr. Fisch’s proposed construction, which associates “treating” with raising testosterone levels and at least ameliorating at least one symptom related to low testosterone levels, does not suffer from this problem as one can monitor whether an “effective amount” of the claimed composition has been administered for this purpose. Accordingly, the Court should adopt Dr. Fisch’s construction of this disputed claim element. 3. “Treating Wasting In A Hypogonadal Male” Defendant-counterclaimant Dr. Harry Fisch’s Proposed Construction Therapeutic treatment and prophylactic or preventative measures, wherein the object is to prevent or slow down (lessen) progressive loss of weight or loss of muscle mass and/or progressive weakening and degeneration in a male having low testosterone levels.

Repros’s Proposed Construction Therapeutic and prophylactic or preventative measures to prevent or slow progressive loss of weight or muscle mass or progressive degeneration and weakening of muscle in a male with inadequate gonadal function.

The term “treating wasting in a hypogonadal male” appears in claim 1 of the ‘185 patent. Dr. Fisch’s proposed construction of this disputed claim element should be adopted because it is consistent with the intrinsic evidence and the ordinary meaning of the claim language as would be understood by a person of ordinary skill in the art at the time of the invention. Patent claim terms “must be construed so as to be consistent with the specification, of which they are a part.” Merck, 347 F.3d at 1371. Here, the specification of the ‘185 patent expressly defines the terms “treating” and “wasting”: The terms ‘treat’ or ‘treatment’ . . . refer to both therapeutic treatment and prophylactic or preventative measures, wherein the object is to prevent or slow
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down (lessen) an undesired physiological or psychological change or disorder, such as symptoms associated with COPD or the treatment thereof. (Ex. 2, ‘185 patent, col. 7, ll. 41-46 (emphasis added).) “Wasting” refers to catabolism and/or progressive loss of weight in a subject, or to loss of muscle mass and/or its progressive weakening and degeneration. (Id. at col. 6, ll. 50-52 (emphasis added).) It is well-settled tenet of claim construction law that when an inventor defines a claim term in the specification of the patent at issue, “the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. Dr. Fisch’s proposed construction utilizes the ‘185 patent’s definition of “treating” but replaces “an undesired physiological or psychological change or disorder” with the ‘185 patent’s definition of “wasting” (i.e., the particular undesired physiological disorder the claim seeks to treat). Dr. Fisch’s proposed construction is also consistent with the plain and customary meaning of “hypogonadal male.” As discussed above in Section III.B.1., “hypogonadal male” refers to a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom. In the case of the ‘185 patent, the “at least one symptom” being treated is wasting (i.e., the loss of muscle mass). (See Section II.B., supra.) As such, a person of ordinary skill in the art would understand the term “treating wasting in a hypogonadal male” to refer to treating a male suffering from the clinical syndrome of hypogonadism, wherein the male has low testosterone levels and the related symptom of wasting. As with the previous two disputed claim elements, Repros’s proposed construction improperly defines “hypogonadal” out of the context of claim 1 of the ‘185 patent. While “hypogonadism”—a condition not specific to men or humans—refers to poor gonadal function, claim terms must be construed “in the context of the particular claim in which the disputed term appears.” Phillips, 415 F.3d at 1313. Here, “hypogonadal” appears as part of the broader phrase
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“hypogonadal male.” For the reasons discussed above, a person of ordinary skill in the art would understand the phrase “hypogonadal male” to a human male with low testosterone levels due to inadequate secretion of pituitary gonadotropins, and at least one related symptom (in this case, wasting). Accordingly, the Court should therefore reject Repros’s construction of “treating wasting in a hypogonadal male” and adopt Dr. Fisch’s construction of this disputed claim element, which is consistent with the intrinsic evidence and the term’s ordinary and customary meaning to a person of ordinary skill in the art. IV. CONCLUSION Repros’s proposed claim constructions define claim terms out of context in order to advance Repros’s litigation positions. Dr. Fisch’s proposed constructions, on the other hand, are consistent with the intrinsic evidence and the disputed claim elements’ ordinary meaning as understood by persons of ordinary skill at the art. Dr. Fisch’s proposed construction in their entirety. Accordingly, the Court should adopt

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Case 4:13-cv-02266 Document 49 Filed in TXSD on 03/07/14 Page 21 of 22

Date: March 7, 2014

Respectfully submitted, GREENBERG TRAURIG, LLP By: ___/s/ Julie P. Bookbinder__________ Ira R. Hatton State Bar No.: 24054282 Fed. Bar No.: 898995 E-Mail: hattoni@gtlaw.com Mary-Olga Lovett State Bar No.: 00789289 Fed. Bar No.: 17743 E-Mail: lovettm@gtlaw.com Dwayne L. Mason State Bar No.: 00787977 Fed. Bar No.: 18697 E-Mail: masondl@gtlaw.com 1000 Louisiana, Suite 1800 Houston, Texas 77002 Telephone: 713.374.3500 Facsimile: 713.374.3505 Of counsel: Barry J. Schindler (pro hac vice) E-Mail: schindlerb@gtlaw.com Greenberg Traurig, LLP 200 Park Avenue P.O. Box 677 Florham Park, NJ 07932-0677 Telephone: 973.360.7900 Facsimile: 973.301.8410 Julie P. Bookbinder (pro hac vice) E-Mail: bookbinder@gtlaw.com Greenberg Traurig, LLP MetLife Building 200 Park Avenue New York, New York 10166 Telephone: 212.801.9200 Facsimile: 212.801.6400 ATTORNEYS FOR HARRY FISCH 18

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CERTIFICATE OF SERVICE This is to certify that I have this day served the foregoing Defendant-Counterclaimant Harry Fisch’s Opening Claim Construction Brief upon all counsel of record by the Courts CM/ECF system. This 7th day of March, 2014. /s/ Julie P. Bookbinder Julie Bookbinder

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