Source: https://law.justia.com/cases/federal/district-courts/FSupp2/207/356/2346092/
Timestamp: 2019-04-24 14:42:41+00:00

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Justia › US Law › Case Law › Federal Courts › District Courts › Pennsylvania › Eastern District of Pennsylvania › 2002 › McNEIL-PPC, INC. v. L. Perrigo Co.
L. PERRIGO COMPANY, and Perrigo Company, Defendants.
*357 Dianne Brown Elderkin, Thomas D. Smith, Gwilym J.O. Attwell, Woodcock Washburn, LLP, Philadelphia, PA, Steven R. Trybus, Harry J. Roper, George S. Bosy, Sarah L. Taylor, Lisa M. Kattan, Aaron A. Barlow, Greg D. Bonifield, Timothy J. Baron, Eric L. Lohrenz, Raymond N. Nimrod, Roper & Quigg, Chicago, IL, for plaintiff.
Wayne A. Graver, Thomas Finarelli, Lavin, Coleman, O'Neill, Ricci, Finarelli & Gray, Philadelphia, PA, Douglas H. Siegel, *358 James A. Mitchell, Steven L. Underwood, Richena Y. Brown, Price, Heneveld, Cooper, DeWitt & Litton, Grand Rapids, MI, for defendants.
This is a patent infringement action. Plaintiff McNeil-PPC, Inc. ("McNeil") alleges Defendants L. Perrigo Company and Perrigo Company (collectively "Perrigo") infringe four McNeil patents covering a popular version of the Imodium® Advanced antidiarrheal. In a Memorandum and Order issued April 3, 2002, I construed certain disputed claim terms pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996). Beginning April 22, 2002, this matter was tried without a jury, and I enter the following Findings of Fact and Conclusions of Law as required by Rule 52(a) of the Federal Rules of Civil Procedure.
This action pits a manufacturer of national brand pharmaceuticals against its competitor, a generic drug manufacturer. Four patents owned by Plaintiff McNeil are at issue in this case: United States Patents 5,248,505 ("the '505 patent") (PTX1) and 5,612,054 ("the '054 patent") (PTX2) are referred to as "the Garwin patents"; United States Patents 5,679,376 ("the '376 patent") (PTX3) and 5,716,641 ("the '641 patent") (PTX4) are referred to as "the Stevens patents."
In November 2000, Perrigo filed an Abbreviated New Drug Application with the FDA seeking the approval of a loperamide-simethicone combination tablet. Thereafter, Perrigo sent a Patent Certification Notice Letter informing McNeil that McNeil's patents were invalid or not infringed by Perrigo's ANDA drug. (PTX14.) On March 7, 2001, McNeil filed suit against Perrigo, alleging the infringement of a host of patent claims. Subsequently, McNeil twice amended its complaint, narrowing the patent claims at issue.
[T]here was concern at McNeil that there might be other sleeper patents out there that could inhibit McNeil's ability to work in the area where McNeil was already working or planning to work, and if there were patents to be had, McNeil wanted to havewanted us to think of them first.
A method for treating a human suffering from an intestinal disorder characterized by the symptoms of diarrhea and flatulence or gas comprising administering to said human in a combined pharmaceutical composition, an effective amount of an antidiarrheal compound selected from the group consisting of loperamide, bismuth subsalicyclate, diphenoxylate, polycarbophil, their pharmaceutically acceptable salts and mixtures thereof; and an antiflatulent effective amount of simethicone, wherein the amount of simethicone administered is 125 mg per dosage unit and the amount of loperamide administered is 2 mg per dosage unit.
A composition of treating a human suffering from an intestinal disorder characterized by the symptoms of diarrhea and flatulence or gas comprising: an effective amount of an antidiarrheal compound selected from the group consisting of loperamide, bismuth subsalicyclate, diphenoxylate, polycarbophil, their pharmaceutically acceptable salts and mixtures thereof; and an antiflatulent effective amount of simethicone, comprising 125 mg of simethicone and 2 mg of loperamide.
It is Applicant's recognition of this problem, i.e., the concurrence of diarrhea and flatulence as indicated in a proprietary survey of patents which forms the basis of the present invention. The invention, therefore, lies not in the discovery of a novel solution to this problem, but in the discovery of the problem itself.
Second, McNeil's attorneys permitted the Examiner to believe mistakenly that Dr. Garwin was the first to combine an antidiarrheal with simethicone. In allowing the '054 patent application to issue, the Examiner stated: "The present application . . . is allowable because there was not any prior art or references showing a composition comprising an effective amount of an antidiarrheal compound and an antiflatulent compound." (DX13 at 186.) Despite having an opportunity to comment on the Examiner's reasons for allowance, McNeil *362 failed to take any action to correct this error. (DX13 at 184.) More importantly, as is explained below, prior artincluding prior art not presented to the Examiner disclosed such a combination.
One of ordinary skill in the art of the Garwin '054 and '505 patents would have been a medical doctor with pharmaceutical or clinical research experience, or a chemist, biochemist, or pharmacologist with a doctoral degree and with experience in the pharmaceutical industry, and either of which would also have had ability in identifying appropriate and acceptable combinations of active ingredients for commercial medications for symptoms of diarrhea in conjunction with one or more additional gastrointestinal symptoms.
(DX571, McNeil's Resp. to Interrog. 7).
[At the time of Dr. Garwin's claimed invention] you want to make a combination that treats diarrhea and gas. The concept is out there. The question is what products are you going to use, and you're very likely to use, obvious to use, the best-selling antidiarrheal in the United States and combine it with essentially the only compound you can combine it with, which is simethicone, which is the one compound that is approved as efficacious for gas problems in the United States.
The so-called "secondary considerations" are part of the obviousness analysis. Secondary considerations, which relate to objective evidence of nonobviousness, include evidence of commercial success, unexpected results, and copying of the claimed invention.
Moreover, in assessing McNeil's evidence of unexpected results, it is significant that as a self-limiting disease, diarrhea "go[es] away on its own, without any treatment." (Kaplan TT at 311.) Within forty-eight hours of its onset, diarrhea "tend[s] to go away." (Thibodeau TT at 547). Thus, the amelioration of symptoms may be due to pharmaceutical treatment or the mere passage of time. Among other things, this fact counsels against accepting McNeil's sweeping assertions that the clinical studies show unexpected results and synergy that are not merely statistically significant, but biologically and medically significant as well.
A therapeutically effective amount of simethicone wherein the oral dosage form has a first portion containing the pharmaceutical and a second portion containing simethicone and the first and second portions are separated by a pharmaceutically acceptable polymeric barrier, which is impermeable *367 to simethicone and the pharmaceutical.
2. The solid dosage form of claim 1 wherein the pharmaceutical comprises loperamide HCl.
providing the simethicone in a second portion of said dosage form; and separating said first and second portions with a pharmaceutically acceptable polymeric barrier which is impermeable to simethicone and the pharmaceutical.
2. The method of claim 1 wherein the pharmaceutical is selected from the group consisting of loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof.
3. The method of claim 1 wherein the pharmaceutical contains loperamide HCl.
Pursuant to Markman, I previously construed disputed claim terms. Specifically, the term "portion" was construed as "a part of the whole"; the term "polymeric barrier" was construed as "a material that is a polymer or contains polymers and which separates the first portion from the second portion"; and the term "impermeable to simethicone and the pharmaceutical" was interpreted as meaning "not permeable, impassable to simethicone and the pharmaceutical."
Simply, Perrigo's product does not contain an impermeable barrier. Rather than being buried in the granules, as McNeil contends, loperamide particles in Perrigo's ANDA product are exposed on the surface of the granules. (Celik TT at 888-90l; DX638.) Additionally, in at least three different ways, Perrigo's granules have been readily shown to be permeable. First, mercury porosity tests show that Perrigo's granules are highly permeable. (Celik TT at 897-99; DX670.) Second, the mercury porosity tests confirm that the loperamide granules have relatively large openings through which simethicone can pass. (Celik TT at 900; DX666.) Third, Perrigo's granules tend to wick, or soak up the simethicone. (Celik TT at 901-02; DX31 at MC6681.) That is, Perrigo's granules in fact absorb simethicone.
The Garwin patents, in Examples I and II, teach the separation of loperamide *369 from simethicone by putting the two into separate tablet layers. (PTX1, 2.) In these examples, the loperamide and the simethicone are separated by placing the two compounds in distinct layers.
The Garwin patents teach the separation of loperamide and simethicone into two separate layers, whereas the Stevens patents add an impermeable polymeric barrier between the two layers. The Rider patent separates simethicone from an antacid by employing an impermeable polymeric barrier.
It is significant that the parties in this action are a drug manufacturer and its generic competitor. In enacting the Drug Price Competition and Patent Term Restoration *370 Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360cc, and 35 U.S.C. §§ 156, 271 (the "Hatch-Waxman Act"), Congress struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs, and (2) enabling competitors to bring low-cost, generic copies of those drugs to market. Pursuant to the Hatch-Waxman Act, a manufacturer that seeks to market a generic drug may submit an ANDA for approval by the FDA, rather than submitting a full New Drug Application ("NDA") concerning the safety and efficacy of the generic drug. Likewise, the generic manufacturer may rely on safety and efficacy studies previously submitted by the pioneer manufacturer by submitting information showing the generic drug's bioequivalence with the previously approved drug product. See 21 U.S.C. § 355(j) (2) (A). See generally Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1370-71 (Fed. Cir.2002).
Here, as the holder of an approved NDA for a chewable loperamide and simethicone tablet, McNeil enjoys a period of exclusivity for its combination product without regard to the protection, if any, afforded by the patent laws. If the patent-holder files suit, the FDA will not approve a generic for marketing under an ANDA until the patent has expired, thirty months have passed since the patentee received notice of the ANDA, or the suit is resolved. See Merck & Co. v. Kessler, 80 F.3d 1543, 1552 (Fed.Cir.1996).
With respect to the earlier Garwin patents, Perrigo concedes that its ANDA product literally infringes claims 14 and 16 of the '505 patent, and claim 15 of the '054 patent, if they are valid. See 35 U.S.C. § 271(e) (2) (defining submission of ANDA as act of infringement). Therefore, the issue with respect to the Garwin patents is whether those patents are invalid as obvious.
Patents are presumed valid, and the law requires Perrigo, as the patent challenger, to prove invalidity by clear and convincing evidence. See, e.g., Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1367 (Fed.Cir. 2002). Having conceded infringement, Perrigo must clear this high hurdle in order to prove the invalidity of the Garwin patents.
[I]f the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.
35 U.S.C. § 103. "Although it is well settled that the ultimate determination of obviousness is a question of law, it is also well understood that there are factual issues underlying the ultimate obviousness decision." McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1349 (Fed.Cir.2001) *371 (citing Richardson-Vicks, 122 F.3d at 1479.) Specifically, the obviousness analysis is based on four underlying factual inquiries: (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) secondary considerations, if any, of nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S. Ct. 684, 15 L. Ed. 2d 545 (1966). "`[A] reasonable expectation of success, not absolute predictability' supports a conclusion of obviousness." Yamanouchi Pharm. Co. v. Danbury Pharmacal, Inc., 231 F.3d 1339, 1343 (Fed.Cir.2000) (quoting In re Longi, 759 F.2d 887, 896 (Fed.Cir.1985)).
"In holding an invention obvious in view of a combination of references, there must be some suggestion, motivation, or teaching in the prior art that would have led a person of ordinary skill in the art to select the references and combine them in the way that would produce the claimed invention." Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1385 (Fed.Cir.2001). Furthermore, "[the] case law makes clear that the best defense against the subtle but powerful attraction of a hindsight-based obviousness analysis is rigorous application of the requirement for a showing of the teaching or motivation to combine prior art references." In re Dembiczak, 175 F.3d 994, 999 (Fed.Cir. 1999). This evidence may flow from the prior art references themselves, the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. See Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573 (Fed.Cir.1996). Here, filtered through the knowledge of one skilled in the art, the prior art disclosed that flatulence is frequently a concurrent symptom of diarrhea, and that this problem can be addressed by combining a known antidiarrheal with simethicone. In addition, by the time of Dr. Garwin's claimed invention, loperamide was a well-known and successful antidiarrheal. Accordingly, there was a clear motivation to combine the loperamide and simethicone.
Considering the date of invention and level of ordinary skill in the art, the scope and content of the prior art, the differences between the accused product and prior art, and the motivation to combine, Perrigo has made out a strong prima facie case of obviousness.
A prima facie case of obviousness may be rebutted by secondary considerations. See, e.g., In re Rouffet, 149 F.3d 1350, 1355 (Fed.Cir.1998). Indeed, the secondary considerations "may often be the most probative and cogent evidence in the record" related to the issue of obviousness. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed.Cir.1983). "[S]econdary considerations, when present, must be considered in determining obviousness." Ruiz v. A.B. Chance Co., 234 F.3d 654, 667 (Fed.Cir.2000). In this case, McNeil has advanced a number of arguments in an effort to rebut Perrigo's strong prima facie case of obviousness. These efforts, however, are unavailing.
One way for a patent applicant to rebut a prima facie case of obviousness is to *372 make a showing of "unexpected results," i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected. The basic principle behind this rule is straightforward that which would have been surprising to a person of ordinary skill in a particular art would not have been obvious.
In re Soni, 54 F.3d 746, 750 (Fed.Cir. 1995). To show unexpected properties, McNeil must show enhancement in "one of a spectrum of common properties" when that enhancement would not have been expected by one of skill in the art. In re Chupp, 816 F.2d 643, 646 (Fed.Cir.1987). Here, although McNeil has presented evidence tending to show enhancement, there are compelling reasons to question the validity of the underlying clinical studies upon which that evidence is based, and McNeil's proposition that such evidence was unexpected is doubtful. The results of McNeil's clinical studies are also of limited relevance because they do not compare the loperamide-simethicone with the closest prior art, i.e., another antidiarrheal and simethicone. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.Cir.1991).
Sales of the Imodium Advanced tablet have been substantial, and the marketed product is the product disclosed in the Garwin patents. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed.Cir.1988) ("[A] prima facie case of nexus is generally made out when the patentee shows both that there is commercial success, and that the thing (product or method) that is commercially successful is the invention disclosed and claimed in the patent.") Nevertheless, the probative value of the commercial success of Imodium Advanced is significantly mitigated by the fact that Imodium Advanced's sales are the calculated result of an aggressive marketing campaign of unprecedented scope in the antidiarrheal market.
Given the strong prima facie case of obviousness, including the clear motivation to combine, and the limitations and defects in the secondary evidence presented by McNeil, Perrigo has proven by clear and convincing evidence that claims 14 and 16 of the '505 patent and claim 15 of the '054 patent are invalid for obviousness. See Richardson-Vicks, 122 F.3d at 1483-84.
After determining the meaning and scope of the asserted patent claims pursuant to Markman, an infringement analysis entails a determination of whether the accused product or method meets each and every limitation of the properly construed claim. See, e.g., Tate Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 964 (Fed.Cir.2000). See also Bai v. L & L Wings, 160 F.3d 1350, 1353 (Fed.Cir.1998) (determination of infringement is question of fact). For the reasons *373 set forth in the findings of fact, Perrigo does not literally infringe the asserted claims of the Stevens patents.
If a claim element is not literally infringed, infringement may be found under the doctrine of equivalents if the accused product or method contains the equivalent of that claim element. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40, 117 S. Ct. 1040, 137 L. Ed. 2d 146 (1997). As the law stood at the time of trial, when an amendment narrows the scope of a claim for a reason related to the statutory requirements for patentability, prosecution history estoppel acts as a complete bar to the application of the doctrine of equivalents to the amended claim element. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed.Cir.2000), vacated by 535 U.S. ___, 122 S. Ct. 1831, 152 L. Ed. 2d 944 (2002). McNeil admits that elements of the asserted claims of the Stevens patents were amended during prosecution for reasons related to patentability.
There are some cases . . . where the amendment cannot reasonably be viewed as surrendering a particular equivalent. The equivalent may have been unforeseeable at the time of the application; the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question; or there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question. In those cases the patentee can overcome the presumption that prosecution history estoppel bars a finding of equivalence.
Id. at 1842. On the record before me, McNeil has not presented any evidence rebutting the presumption that prosecution history estoppel bars McNeil from claiming infringement under the doctrine of equivalents. Furthermore, Perrigo has proven the invalidity of the Stevens patents; therefore, I need not reach the issue of infringement under the doctrine of equivalents.
Given the strong prima facie case of obviousness and the minimal secondary evidence presented by McNeil, Perrigo has proven by clear and convincing evidence that claims 1 and 2 of the '376 patent and claims 1 through 3 of the '641 patent are invalid for obviousness.
An award of attorneys' fees to the prevailing party is authorized in an "exceptional" case. See 35 U.S.C. § 285. In assessing whether a case qualifies as exceptional, I must consider the totality of *374 the circumstances. See Kaufman Co., Inc. v. Lantech, Inc., 807 F.2d 970, 978-79 (Fed.Cir.1986). As the party seeking attorneys' fees, Perrigo must prove the exceptional nature of the case by clear and convincing evidence. See Eltech Sys. Corp. v. PPG Indus., Inc., 903 F.2d 805, 810-11 (Fed.Cir.1990). Exceptional cases are normally those involving bad faith litigation or misconduct by the patentee in procuring the patent. See Cambridge Prods., Ltd. v. Penn Nutrients, Inc., 962 F.2d 1048, 1050-51 (Fed.Cir.1992). Particularly during the prosecution of the patents in suit, McNeil's conduct was careless, irresponsible, and, at the very least, tantamount to studied and deceptive ignorance. See Brasseler, U.S.A. I, L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1384 (Fed.Cir. 2001). McNeil's repeated erroneous representations, failure to disclose relevant prior art, and overall persistence in prosecuting exceedingly obvious "inventions" make this case exceptional.
Although McNeil's misconduct during prosecution alone makes this case exceptional, there is further evidence warranting an award of attorneys' fees. It is significant that McNeil is a highly sophisticated party, readily capable of assessing not only the merits of its claimed invention, but also its expected profits as compared to the costs that would be incurred in the event that their patents were held invalid. Put differently, the Garwin and Stevens patents amount to a scheme for extending the life of a drug about to go off patent, and McNeil executed this scheme without the slightest regard for the intent and purposes of the patent laws. Indeed, McNeil's sole motive was to compromise these statutes and constitutional protections for the sake of profits.
The patent laws "promote the Progress of Science and useful Arts" by rewarding innovation with a temporary right to exclusivity. U.S. Const., art. I, § 8, cl. 8. See also Festo, 122 S. Ct. at 1837. Long ago, in Hotchkiss v. Greenwood, 52 U.S. 248, 11 How. 248, 267, 13 L. Ed. 683 (1850), the Supreme Court established that the sine qua non of patentability is invention, and as stated in 35 U.S.C. § 100(a), the legal definition of invention is synonymous with discovery. As is widely understood, a discovery is an act of "gaining knowledge of or ascertaining the existence of something previously unknown or unrecognized." Webster's Third New International Dictionary 647 (1993). Over time, patent law has developed its own, new language, and has even come to require special qualifications for lawyers appearing before the PTO. These developments tend to obscure *375 the fundamental notions of invention and discovery.
Acting within this often esoteric area of the law, patent lawyers are called upon to play the roles of chemists, engineers, physicians, and physicistsnow, they are also asked to be magicians. That is, patent lawyers are asked to defendwith smoke and incantations when necessarybusiness-driven decisions having nothing to do with inventing or discovering anything. Consistent with schemes to prolong the legally-protected period of exclusivity, companies hire highly talented attorneys to perform acts of legal legerdemain in order to make modest developments look and feel like inventions, when in reality the purported discovery is nothing more than a creation of an advertising and marketing department. In-house counsel should be cautioned that complicity in patent prosecution for unsanctioned legal purposes may give rise in the future to review of that behavior by the appropriate attorney disciplinary machinery. Advancing a client's economic interests is not a license to forget one's ethical responsibilities.
It is not lost on this Court that by developing ("not inventing") a combination drug, the law automatically permitted McNeil a three-year period of exclusivity, which ran from October 1997 to October 2000. However, by concocting multiple patent applications and litigating their validity, this period of exclusivity has been extended by two years and, with an appeal, will extend even further, effectively doubling the initial period of exclusivity. The business-driven decision that it is worth the investment to "invent an invention" will continue unabated unless a vigorous PTO or a Court sees this transparent attempt to subvert the patent laws for what it is. The patent laws are not the private sandbox of pharmaceutical companies. Regrettably, I am constrained by law to award only counsel fees for Plaintiff's behavior, although I am not unmindful of the fact that while this patent litigation continues, competition in the marketplace is foreclosed and the public is forced to pay higher prices.
While the trial attorneys in this case have proven themselves informed, articulate, and instructive, in the end I was left to dispel the illusions concealing the true nature of the "invention" to reach my own conclusion: as Gertrude Stein phrased it, "there is no there there."
1. Plaintiff's Motion to Strike New Affirmative Defenses and Counterclaims (Document No. 90) is DENIED as moot.
2. Defendants' Motion for Attorney's Fees (Document No. 101) is GRANTED.
3. It is DECLARED that claims 14 and 16 of United States Patent 5,248,505 are invalid, and judgment is ENTERED in favor of Defendants and against Plaintiff on Plaintiff's claim for infringement of United States Patent 5,248,505.
4. It is DECLARED that claim 15 of United States Patent 5,612,054 is invalid, and judgment is ENTERED in favor of Defendants and against Plaintiff on Plaintiff's claim for infringement *376 of United States Patent 5,612,054.
5. Judgment is ENTERED in favor of Defendants and against Plaintiff on Plaintiff's claim for literal infringement of United States Patent 5,679,376.
6. Judgment is ENTERED in favor of Defendants and against Plaintiff on Plaintiff's claim for literal infringement of United States Patent 5,716,641.
7. It is DECLARED that claims 1 and 2 of United States Patent 5,679,376 are invalid.
8. It is DECLARED that claims 1, 2, and 3 of United States Patent 5,716,641 are invalid.
9. Defendants shall submit a petition for counsel fees by July 10, 2002. Plaintiff shall have until July 29, 2002 to file a response.
 This action arises under the patent laws of the United States. See 35 U.S.C. § 271(e) (2) and 21 U.S.C. § 355(j). Jurisdiction is based on 28 U.S.C. §§ 1331 and 1338(a). Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(c) and 1400(b).
 The '505 patent covers a method for treating gastrointestinal distress; the '054 patent covers the related pharmaceutical composition.
 The trial transcript is cited in the following format: (name of witness) TT at (transcript page(s)).
 Many exhibits contain multiple page number designations. Where more than one designation is present, the clearest page number designation is cited.
 In each of the four patents in suit, loperamide is among a list of antidiarrheals that may be combined with simethicone. No evidence suggests, however, that McNeil seriously considered any antidiarrheal other than loperamide for its Imodium products.
 Claim 14 of the '505 patent incorporates claims 1 and 2 and is set forth accordingly herein to include these limitations.
 Claim 15 of the '054 patent incorporates claims 1 and 2 and is set forth accordingly herein to include these limitations.
 McNeil argues that in the absence of inequitable conduct, evidence relating to improper patent prosecution is irrelevant. This argument appears to miss the mark. See Applied Materials v. Advanced Semiconductor Materials Am., 98 F.3d 1563, 1570 (Fed.Cir. 1996) ("facts relevant to the issue of obviousness were before the district court, including . . . prosecution history in the PTO"). In any event, what happened before the PTO in this case does not affect the statutory presumption that the Garwin patents are valid. The discussion of the prosecution history is primarily intended to highlight fundamental flaws in McNeil's contention that the Garwin patents are nonobvious. Lastly, the history of the Garwin patents' prosecution reveals that certain comments made by Judge Learned Hand seventy-five years ago are no less apt today: "[T]he antlike persistency of [patent] solicitors has overcome and . . . will continue to overcome, the patience of examiners, and there is apparently always but one outcome." Lyon v. Boh, 1 F.2d 48, 50 (S.D.N.Y.1924).
 McNeil's trial counsel did not represent McNeil during the prosecution of the Garwin or Stevens patents.
 Priority of invention "goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive the invention and that it exercised reasonable diligence in later reducing that invention to practice." Price v. Symsek, 988 F.2d 1187, 1190 (Fed.Cir.1993). While Dr. Garwin's notebook includes a memorandum of September 23, 1988 documenting his conception of combining loperamide and simethicone in a single composition to treat diarrhea and gas, at trial McNeil failed to produce any evidence of diligence in reducing the alleged invention to practice. However, because McNeil has not established when the claimed invention was actually reduced to practice, the filing date of the first Garwin patent application serves as the date of constructive reduction to practice. See Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed.Cir.1998). In light of this date of invention, the Chavkin patent is prior art.
 In view of the fact that the basic loperamide patent was nearing expiration, to a McNeil researcher, the motivation to combine loperamide with simethicone would have been overwhelming.
 McNeil's projections indicate that the total sales of all Imodium Advanced products will approach $200 million by the end of 2002. (PTX57, 455 at MC100885).
 After its claims had been twice rejected for obviousness, as predicted by Judge Learned Hand, McNeil returned to the PTO to argue that unexpected results proved that the Garwin patents were nonobviousness.
 To the extent that a generic drug manufacturer's attempt to create the bioequivalent of a pioneer manufacturer's drug, without more, may be considered copying, I note that a showing of copying is only equivocal evidence of nonobviousness. See Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1380 (Fed.Cir.2000) (citing In re GPAC, 57 F.3d 1573, 1580 (Fed.Cir.1995)).
 Perrigo has taken the position that certain materials used in its ANDA drug are not polymeric, and, on this basis, the Stevens patents are not infringed. At trial, both parties presented evidence related to whether certain materials should be considered "polymeric." At bottom, this dispute raises the question primarily of interest to a semanticistof whether "monomeric" and "polymeric" are mutually exclusive terms. In light of my construction of "polymeric" as "a material that is a polymer or contains polymers," Perrigo's product does contain polymeric materials.
 The figures included in the Stevens patents are identical to those in the earlier Rider patent.
 Significantly, Perrigo's ANDA product also employs the mechanism of adsorbtion to prevent simethicone migration.
Q: What do the Stevens' patents have to say about [the simethicone migration problem]?
A: Well, their invention prevents the simethicone from migrating into the pharmaceutical.
Q: [Y]ou would accept agree with me that Ryder [sic] discloses an invention for preventing simethicone from migrating into the pharmaceutical?
Put differently, Dr. Schwartz considered the Stevens patents and Rider patent as disclosing the same "invention," namely the prevention of simethicone migration into the pharmaceutical.
 In its Answer and Counterclaims, Perrigo pled defenses under 35 U.S.C. §§ 102 and 112. However, Perrigo failed to raise this defense in its claim-by-claim defenses or at trial. At trial, Perrigo's only defense to its admitted infringement of the Garwin patents was that the asserted claims are invalid for obviousness under 35 U.S.C. § 103.
 McNeil's marketing expenditures appear to be consistent with an overall strategy for stymieing generic competition. By heavily promoting the combination product, McNeil can in effect transfer sales from the nonpatent-protected loperamide product to its combination drug. Regardless of whether the combination drug ultimately gains patent protection, this combination drug enjoys a significant period of exclusivity pursuant to the Hatch-Waxman Act. Moreover, because loperamide is sold in generic form, McNeil benefits from the transference of sales from the loperamide-alone product to its combination drug.
 Because I have found that the Stevens patents are not infringed, I need not reach Perrigo's alternative arguments that the Stevens claim lack definiteness and fail to distinctly claim the invention. (Def. Post-Trial Br. at 75.) Furthermore, having found that the Stevens patents are invalid for obviousness, I need not reach the host of other arguments Perrigo advances in support of its position that the Stevens patents are invalid. See Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1369(Fed.Cir.1999).
[The idea's] peculiar character, too, is that no one possesses the less, because every other possesses the whole of it. He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me. That ideas should freely spread from one to another over the globe, for the moral and mutual instruction of man, and improvement of his condition, seems to have been peculiarly and benevolently designed by nature, when she made them, like fire, expansible over all space. . . .

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 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 § 285
 v. 
 v. 
 v. 
 v. 
 § 8
 v. 
 § 100
 § 271
 § 355
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 v. 
 v. 
 v. 
 v. 
 § 103
 v.