Full opinion text
Opinion and Order JONES, District Judge. I. Introduction Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation consolidated for pre-trial purposes before this court the patent infringement suits filed by Astra Aktiebolag, Aktiebolaget Hassle, Astra Merck Enterprises Inc., Astra Merck Inc., KBI-E Inc., KBI Inc., Astra Pharmaceuticals L.P., and AstraZeneca L.P. in response to various pharmaceutical companies’ requests for permission from the Food and Drug Administration (“FDA”) to market generic versions of Prilosec®, As-tra’s highly profitable gastric acid inhibiting drug. At various points in this litigation, Plaintiffs have asserted as many as eight different patents against Defendants. At the time of trial, five of those patents remained in the suit. This consolidated trial resolves claims raising issues of infringement and validity asserted in eight different lawsuits involving four groups of Defendants. The case was tried to the court sitting without a jury, for fifty-two trial days between December 6, 2001, and June 13, 2002. The court has considered over six thousand pages of trial testimony, volumes of deposition testimony, thousands of exhibits, and pre-trial and post-trial briefing submitted by all parties. The court has made determinations as to the relevance and materiality of the evidence and assessed the credibility of each witness. Upon the record before the court, pursuant to Federal Rule of Civil Procedure 52(a), the court finds the following facts to have been proven by the appropriate standard of proof and sets forth its conclusions of law. For the reasons stated below, the court finds the following: Defendant Genpharm literally infringes claims 1, 5, 6, 8, 9,10,12, and 14 of the ’505 patent and claims 1, 6, 7, 10, 11, 12, and 13 of the ’230 patent. Defendant Genpharm does not infringe claim 11 of the ’505 patent or claim 15 of the ’230 patent. Defendants Cheminor literally infringe claims 1, 5, 10, and 14 of the ’505 patent and claims 1, 6, 12, and 13 of the ’230 patent. Defendants Cheminor do not infringe claim 9 of the ’505 patent or claim 11 of the ’230 patent. Defendant Andrx literally infringes claims 1, 5, 6, 8, and 10 of the ’505 patent and claims 1, 6, 7, 10, and 13 of the ’230 patent. Defendant Andrx does not infringe claims 3 or 11 of the ’505 patent or claim 15 of the ’230 patent. Defendants KUDCo do not infringe the asserted claims of the ’505 and ’280 patents. The asserted claims of the ’505 and ’230 patents are valid. Claim 1 of the ’342 patent is invalid as anticipated. A. The Parties Plaintiff Astra Aktiebolag is a company organized and existing under the laws of Sweden, having its principal place of business at Sódertalje, Sweden. Plaintiff Ak-tiebolaget Hassle (“Hassle”) is a company organized and existing under the laws of Sweden, having its principal place of business at Molndal, Sweden. Plaintiff Astra Merck Enterprises, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff Astra Merck, Inc. is a Delaware corporation, having its principal place of business at Wayne, Pennsylvania. Plaintiff KBI-E, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff KBI, Inc. is a Delaware corporation having its principal place of business at Whitehouse Station, New Jersey. Plaintiff Astra Pharmaceuticals, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiff AstraZ-eneca, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiffs are referred to collectively as “Astra.” Defendant Andrx Pharmaceuticals, Inc. (“Andrx”) is a Florida corporation, having its principal place of business at Davie, Florida. Defendant Cheminor Drugs, Ltd. is a public, limited-liability company incorporated and existing under the laws of India and having a principal place of business in Hyderabad, India. Defendant Reddy-Cheminor, Inc. is a New Jersey corporation, having its principal place of business at Ridgewood, New Jersey. Defendant Schein Pharmaceutical, Inc. is a Delaware corporation, having its principal place of business at Florham Park, New Jersey. These three Defendants are referred to collectively as “Cheminor.” Defendant Genpharm Inc. (“Genpharm”) is a Canadian corporation, having its principal place of business in Ontario, Canada. Defendant Kremers Urban Development Co., a wholly-owned subsidiary of Schwarz Pharma, Inc. (“Schwarz”), is a Wisconsin corporation, having its principal place of business in Mequon, Wisconsin. Defendant Schwarz is a Delaware corporation, having its principal place of business at Mequon, Wisconsin. These last two Defendants are referred to collectively as “KUDCo.” B. Development of Omeprazole and Astra’s Formulations Omeprazole was the first of a class of medicines called “proton pump inhibitors.” (Carlsson Tr. 157:14-19.) Omeprazole is used in formulations to treat many acid-related diseases, including peptic ulcer disease, reflux disease, and Zollinger-Ellison syndrome. (Carlsson Tr. 159:13-19.) As-tra’s Prilosec® formulation is the result of more than twenty years of research by scientists at Astra’s predecessor company, Hassle, in Sweden. (Carlsson Tr. at 219:9-13.) The research that resulted in Prilosec® began in 1967 with the start of Project 826. The goal of Project 826 was to develop a drug that could inhibit gastric acid secretion. (Carlsson Tr. at 161:9-13; P656.) In January of 1979, twelve years after the start of Project 826, Astra scientists first made the compound omeprazole. (Carlsson Tr. at 160:11-12, 161:9-13, 171:1-2.) Omeprazole inhibits the production of gastric acid through a unique mechanism. It is taken up and concentrated within the acid-producing parietal cells that line the stomach. In the parietal cell, omeprazole is transformed to its active species, which binds to the proton pump, the enzyme that produces acid, thereby inhibiting acid production. (Carlsson Tr. at 167:16-168:19.) Even once the compound itself had been developed, the task of turning the compound omeprazole into a viable medicine proved to be formidable. (Carlsson Tr. at 170:10-171:20.) Before omeprazole could be used as a medicine, Astra had to establish the compound’s safety and efficacy in animals and in human beings. In addition, Astra’s scientists needed to develop a formulation or dosage form that would deliver the compound to the proper site of action in the body and remain stable both in the body and on the shelf. (Carlsson Tr. 171:8-20.) A group of Astra scientists set out to develop an oral dosage form for omeprazole and its related compounds, (Pilbrant Tr. 1587:2-5), and their work ultimately culminated in the patents at issue in this case. Drs. .Ake Pilbrant and Kurt Lovgren were a part of that team, and they are two of the named inventors on Astra’s ’505 and ’230 patents. (Lovgren Tr. 1741:8-18; Pilbrant Tr. 1317:12-14, 1318:21-22; PI, P2A.) Omeprazole proved to be a particularly difficult and challenging molecule to formulate. Omeprazole is an exceptionally acid labile compound, which means that it degrades quickly in acidic environments like the stomach. (Langer Tr. 295:1-23; Pilbrant Tr. 1587:6-15.) Omeprazole is also sensitive to heat, moisture, organic solvents, and, to some degree, light. (Carlsson Tr. 172:19-22, 179:14-21; Pilbrant Tr. 1323:25-1324:9, 1641:11-15; Lovgren Tr. 1747:4-11; P916 at 114.) Overcoming omeprazole’s multi-pie sensitivities proved to be a substantial challenge, and Astra considered a number of different approaches to make an oral formulation. (Pilbrant Tr. 1328:12-20.) First, Astra’s formulation scientists tried dissolving omeprazole in oil to protect the omeprazole from gastric juice, but this approach did not work because omeprazole is unstable in oil. (Pilbrant Tr. 1328:21— 1329:11.) A very rapidly dissolving dosage form was investigated on the theory that the rate of absorption of omeprazole into the body would be faster than the rate of degradation in the stomach. That also did not work; more than 50% of the drug was lost due to degradation. (Pilbrant Tr. 1329:12-1330:8.) Omeprazole was administered with food on the theory that food would increase the pH in the stomach and allow the omeprazole to survive long enough to be absorbed. This approach also failed; almost 90% of the dose was lost. (Pilbrant Tr. 1330:9-1331:2.) Studies to determine the target point in the digestive system for omeprazole release were undertaken, and Astra’s formulation scientists concluded that omeprazole should be released in the proximal part of the small intestine. (Pilbrant Tr. 1326:25-1328:7; 1587:16-21.) When Astra first tested omeprazole in humans, a buffered suspension was used to make the highly acidic stomach environment more alkaline. (Carlsson Tr. 172:4-13.) Although this buffered suspension was not practical for commercial use, it was used in initial studies in humans, the “Phase I” studies. (Carlsson Tr. 172:14-18.) Drs. Pilbrant and Lovgren decided to try enteric-coated formulations to see if an enteric coat would protect the omeprazole from gastric acid in the stomach. (Pil-brant Tr. 1331:3-1332:4, 1587:25-1588:5.) An enteric coating is typically a polymer film that is insoluble in stomach acid, but soluble in the intestine, (Pilbrant Tr. 1331:8-22, 1332:5-11), so the enteric-coat-ing protects material that degrades in the acidic environment of the stomach until it reaches the small intestine. Drs. Pilbrant and Lovgren did a number of pre-formulation studies to determine whether enteric coatings, which are polymeric polyacids, would have a deleterious effect on omepra-zole. The results of the studies showed that the enteric coating materials had approximately the same interaction as most other common pharmaceutical excipients if these excipients did not contain a lot of water. Astra determined that an enteric coating was a viable approach to explore further. (Pilbrant Tr. 1331:17-1333:9.) The Astra scientists studied a number of different types of cores to be used in formulation, including tablet and pellet-type cores. (Pilbrant Tr. 1333:21-24.) Astra also tried a number of different processes for making pellet-type cores. First, Dr. Pilbrant and his group tested cores formed by compressing omeprazole together with pharmaceutical excipients. The Astra scientists also experimented with melt granu-lations, in which omeprazole was dissolved or dispersed in material that had been heated to its melting point and then cooled down to form a solid core. Dr. Pilbrant and his group constructed cores by depositing an active' drug layer of omeprazole onto an inert sugar sphere. Finally, the Astra scientists experimented with extrusion spheronization. Astra eventually settled on that extrusion spheronization process for preparing its cores. (Pilbrant Tr. 1333:25-1335:4.) In Astra’s extrusion spheronization work, water was added to a powder mixture to make a dough. When the plasticity was suitable, the dough was pressed through a machine to make spaghetti-like strings. These strings were then sectioned in small parts that were put on a rotating plate where the small parts were rounded. (Pilbrant Tr. 1335:5-14.) After making and testing numerous formulations, Astra eventually arrived at a formulation used in Phase II clinical experiments. The Phase II formulation consisted of a core containing omeprazole mixed together with some excipients and alkaline reacting compounds (“ARCs”) and an enteric coating that covered the core and included hydroxypropyl methylcellu-lose phthalate (“HPMCP”). (Pilbrant Tr. 1339:6-11; Lovgren Tr. 1747:22-1748:6.) While the Phase II formulation was adequate for conducting short term Phase II clinical trials, it did not solve all the issues related to omeprazole formulation. (Carls-son Tr. 174:6-11.) For example, Dr. Pil-brant and other Astra scientists realized that the Phase II formulation would discol- or on long term storage. Also, although Phase II formulations were ordinarily colored off-white to light beige, Dr. Pilbrant and others observed that sometimes the formulation would become discolored during the enteric coating process. (PI, col. 1:52-56; Pilbrant Tr. 1339:18-1340:22, 1591:15-25; Lovgren Tr. 1751:3-13.) The Astra scientists were also concerned because the Phase II formulation had limited gastric acid stability. Gastric acid resistance is a measure of how effective the formulation is in resisting attack by acidic solutions. (Pilbrant Tr. 1341:18-1342:14.) The Phase II formulation had inferior gastric acid resistance and often proved to be below Astra’s requirement of greater than 85% gastric acid resistance. (Lovgren Tr. 4941:14-4942:2.) An orally-administered formulation can remain in the patient’s stomach for as long as two hours. If the enteric coating fails during that time, the omeprazole will be destroyed. Testing for gastric resistance is, therefore, a requirement. If, as with the Phase II formulation, only 75% of the production batch passes the test, a very large percentage of the production cannot be sold. (Pilbrant Tr. 1341:9-1342:20.) Thus, Astra was not satisfied with the Phase II formulation’s gastric resistance (too much of it degraded in the stomach) or with its long-term storage stability (the omeprazole degraded and became discolored) and concluded that the formulation would not be suitable for marketing as a dosage form. (Pilbrant Tr. 1339:21-1340:22, 1341:8-17, 1342:10-14; Carlsson Tr. 174:10-12, 183:20-21, 213:1-7.) The shelf-life of the Phase II formulation would be no more than about 18 months. (Lovgren Tr. 1732:24-1733:5.) There were also concerns expressed by foreign regulators about discoloration. (Carlsson Tr. 216:14-20, 217:13-16; Pil-brant Tr. 1381:6-10.) Accordingly, even after developing the Phase II formulation, Astra sought to solve these problems. To develop a new formulation that could be used in Phase III long term clinical trials and sold commercially, Astra tested many potential formulations. Some had good stability in the gastric juice in the stomach, but inadequate shelf-life stability. Others had adequate shelf-life stability but inadequate stability in the stomach. (Carlsson Tr. 183:20-184:10; P609.) Drs. Pilbrant and Lovgren and the other Astra scientists tried numerous approaches to solve the dual, and apparently conflicting, problems of long term stability and adequate gastric acid resistance. (Pilbrant Tr. 1344:3-1345:23.) Including certain alkaline substances in the core as with the Phase II formulation solved the problem of the chemical stability of omeprazole by stabilizing the omeprazole during manufacturing and storage, but it exacerbated the problem of gastric acid resistance. (Pil-brant Tr. 1344:9-23.) During development, the Astra scientists learned that if the amount of alkaline material in the core was increased, this could weaken the en-teric coat and decrease gastric acid resistance. This would increase the risk that water would leak in through the enteric coating and promote a reaction between the acidic enteric coating and the alkaline material in the core, which in turn would cause degradation of the enteric coating and worsen gastric acid resistance. (Pil-brant Tr. 1344:24-1345:23, 1610:1-5.) Water permeation has a deleterious effect on the omeprazole core because, if sufficient water diffuses in, it may cause an alkaline solution inside the coating to dissolve the enteric coating from the inside, which, in turn, will worsen gastric acid resistance. (Pilbrant Tr. 1345:12-23.) To solve the gastric resistance problem without sacrificing stability, Astra tried numerous modifications to the formulation. (See Pilbrant Tr. 1345:24-1349:15.) For example, Drs. Pilbrant and Lovgren tried to make the enteric coating tighter — less permeable to gastric juice. (Pilbrant Tr. 1345:24:-1346:4.) Dr. Pilbrant tried a thicker enteric coating, and he tried to make the enteric coating more hydrophobic, or water-repellent, by adding hydrophobic plasticizers of different kinds. (Pil-brant Tr. 1346:5-1347:4.) Dr. Pilbrant tried adding a water insoluble polymer within the enteric-coating itself to see if that would improve diffusion tightness. (Pilbrant Tr. 1347:5-18.) He tried mixing different enteric coating materials. He even tried putting one enteric coating on top of another to see if that would improve tightness. (Pilbrant Tr. 1347:19-1348:4.) Dr. Pilbrant tried putting an outer coating with a hydrophobic substance on top of the enteric coating, and he tried this with different amounts of the hydrophobic substance. Astra found, however, that if they used only a small amount of hydrophobic substance, it did not improve gastric acid resistance. On the other hand, if they used a large amount of hydrophobic substance outside the enteric coating, this improved gastric acid resistance, but it caused reduced omeprazole release. (Pil-brant Tr. 1348:5-17.) None of these things worked to improve gastric resistance, and repeated attempts to improve the tightness of the enteric coat had failed. (Pilbrant Tr. 1345:9-1349:15.) Ultimately, Drs. Pilbrant and Lovgren decided to try to use a subcoating between the omeprazole-containing core and the enteric coating. (Pilbrant Tr. 1348:18-22; Lovgren 1786:7-25.) It was thought that a hydrophobic coating, one which would be impermeable to water, might solve the problem, but Astra did not try that approach because they had already experimented with a hydrophobic outer coating and found that it did not work. (Pilbrant 1348:18-1349:11.) Eventually, the Astra scientists decided to experiment with a water soluble subcoat, but it was thought that the approach would not keep water from leaking in through the enteric coating. (Pilbrant Tr. 1349:16-1350:2.) Experimenting with the water soluble subcoat, however, revealed that it actually increased both gastric acid resistance and long term stability. (Pil-brant Tr. 1349:16-1350:6.) The Astra scientists also noticed that the subcoat reduced the sporadic discoloration that could occur during the enteric-coating process as well as the discoloration upon long term storage, which had been observed in the Phase II formulation. (Pilbrant Tr. 1592:6-22.) A formulation that included omeprazole with an alkaline reacting compound (“ARC”) in the core, a water soluble subcoat, and an enteric coating was selected for Phase III clinical trials. (Pil-brant Tr. 1339:6-11, 1351:5-10; Lovgren Tr. 1747:22-1748:6.) After testing its Phase III formulation, Astra patented its invention and obtained FDA approval to market Prilosec®. The Phase III formulation proved to be more stable than the Phase II formulation. (Pilbrant Tr. 1720:22-1721:16, 1731:16-19.) The Phase III formulation is the same as the one that Astra ultimately has used on the market, except that the amount of the enteric-coating polymer is slightly increased in the market formulation. (Pil-brant Tr. 1597:5-12.) There are no differences in long term stability between the Phase III formulation and the market formulation. (Pilbrant Tr. 1600:6-20.) The gastric acid resistance data for the Phase II (not subcoated) omeprazole pellets formulation were typically in the 82%-89% range. (P934; Lovgren Tr. 4937:7-11.) This level of gastric acid resistance was considered unacceptable because, with an 85% gastric acid resistance test limit, many batches would fail the test and have to be discarded. (Lovgren Tr. 4938:12-4939:22.) The formulation ultimately claimed in the ’505 patent, the Phase III formulation, typically exhibited gastric acid resistance of about 96%. (P907; Lovgren Tr. 4940:12-4941:13.) This improved gastric acid resistance was considered important because it greatly reduced the risk of discarding borderline batches. (Lovgren Tr. 4941:14-4942:7.) The Phase III formulation proved to have consistent gastric acid resistance that was well above Astra’s 85% requirement and remained stable for over three years on storage. (P907 at AA00075815; Lovgren Tr. 4941:3-4942:2, 4942:10-16.) The first application for ome-prazole was filed with the FDA in 1986, and Prilosec® was finally approved for use in the United States in 1989. (Carlsson Tr. 186:12-17.) Astra filed patent applications for its omeprazole formulation inventions in 1986. The formulation described in U.S. Patent Nos. 4,786,505 (the “ ’505 patent”) and 4,853,230 (the “ ’230 patent”) includes the three main elements that Drs. Pilbrant and Lovgren employed to make the Phase III formulation. (Pilbrant Tr. 1321:2-16; PI; P2A.) The commercial Pri-losec® formulation is covered by the ’505 and ’230 patents and is substantially identical to Example 2 of the ’505 patent. C. Patent Litigation Under the Hateh-Waxman Act These infringement actions arise out of Abbreviated New Drug Applications (“AN-DAs”) filed by Defendants. The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) (1994)), also known as the Hateh-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act (“FDCA”), Pub.L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397 (1994)), to permit filing of an ANDA to expedite FDA approval of a generic version of a drug previously approved by the FDA. See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1244 (Fed.Cir.2000). Under the Hateh-Waxman Act, an applicant may file an ANDA with the FDA requesting approval to market a generic drug without undergoing the same expensive and time-consuming FDA approval process undergone by the maker of the branded version of the drug, often called the pioneer drug, by (1) demonstrating that the generic drug is the bioequivalent of the branded drug and (2) certifying that manufacturing, marketing and selling the drug will not infringe the patent rights held by the patentee of the pioneer drug. The statute prescribes a precisely defined four-step procedure for litigating patent disputes between the innovator drug company and the generic applicant. See 21 U.S.C. § 355(j)(2)(A)(vn) et seq. The holder of the New Drug Application for the pioneer drug lists all of its patents that claim the drug or a use of the drug in the book entitled New Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”) published by the FDA. See 21 U.S.C. § 355(b)(1). In its ANDA, a generic applicant must certify one of the following four statements with respect to the patents listed under the pioneer drug in the Orange Book: no patent information has been filed (“Paragraph I” certification), the patent has expired (“Paragraph II” certification), the patent soon will expire on a specified date (“Paragraph III” certification), or the patent “is invalid or will not be infringed by the manufacture, use, or sale of the new drug” covered by the ANDA (“Paragraph IV” certification). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). Only one type of certification is pertinent here: a so-called “Paragraph IV” certification. In a Paragraph IV certification, the generic manufacturer seeks to obtain FDA approval before a listed patent expires and asserts that the patent listed in the Orange Book is either not infringed or invalid. Following the issuance of a Paragraph IV certification, the Hateh-Waxman Act requires the generic company to give notice of the Paragraph IV certification to the innovator who listed the patent with the FDA. 21 U.S.C. § 355(j)(2)(B). The FDA can approve an ANDA containing a Paragraph IV certification unless the patent holder files suit within forty-five days of receiving notice of a Paragraph IV certification having been filed with the FDA. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). If a patent infringement action is timely brought, final marketing approval of the ANDA cannot occur before expiration of thirty months or a decision of a court. See 21 U.S.C. § 355(j)(5)(B)(iii). The term of Astra’s basic omeprazole patent covering the chemical formula for omeprazole and its administration for gastric acid inhibition, U.S. Patent No. 4,255,-431 (the “ ’431 patent”) expired on October 5, 2001. The ’431 patent is not, however, the only patent Astra has listed for ome-prazole in the Orange Book. The other patents at issue in this litigation were also listed. Defendants have each issued Paragraph IV certifications against the patents-in-suit. Defendants certified in their ANDA submissions for generic omeprazole that the patents-in-suit are “invalid or will not be infringed by the manufacture, use, or sale” of their generic products. See 21 U.S.C. § 3550')(2)(A)(vii)(IV). Based on those ANDA filings, Astra filed a patent infringement suit pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that the generic omeprazole formulations for which Defendants seek approval will infringe or induce infringement of the asserted claims. Although no actual infringement has taken place because Defendants’ omepra-zole products have not been released in the market, section 271(e)(2)(A) “definefs] a new (and somewhat artificial) act of infringement for a very limited and technical purpose that relates only to certain drug applications.” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). Section 271(e)(2)(A) provides a patentee with a cause of action for patent infringement based solely upon the filing of an ANDA containing a Paragraph IV certification implicating a plaintiffs patent rights. The artificial infringement arising by operation of law is an integral part of a statutory scheme designed to allow pharmaceutical manufacturers to market, and the public to purchase, generic drugs as soon as possible after the expiration of patents covering the pioneer drug. The infringement suit under section 271(e)(2) permits the paten-tee, in this ease Astra, “to challenge the certification — i.e. to assert inter alia that the commercial manufacture, use or sale of the new drug would infringe its patent.” Glaxo, Inc. v. Boehringer Ingelheim Corp., 954 F.Supp. 469, 473 (D.Conn.1996) (emphasis added). The patentee’s challenge to the certification provides the court with a justiciable controversy, permitting it to efficiently resolve patent issues in advance of the generic drug’s release. As an initial matter, Defendants challenge Astra’s standing to assert any method of treatment claims against Defendants on the grounds that there has been no direct infringement, so Astra cannot prove actual intent to induce infringement on Defendants’ part. In response, Astra argues that no proof of intent is required because the infringement claims are all cognizable under 35 U.S.C. § 271(e)(2)(A). The question of whether a pioneer drug company holding a patent covering a method of using a drug may sue a generic manufacturer based solely on an ANDA filing is a novel issue of law. See Allergan, Inc. v. Alcon Labs., Inc., 200 F.Supp.2d 1219, 1225 (C.D.Cal.2002). This court knows of only two other cases dealing squarely with this issue. See Allergan, 200 F.Supp.2d 1219; Warner-Lambert Co. v. Apotex Corp., No. 98 C 4293, 1999 WL 259946 (N.D.Ill. Apr. 8, 1999). “Statutory interpretation begins with the plain language of the statute. If the text of the statute is clear, this Court looks no further in determining the statute’s meaning.” United States v. Mendoza, 244 F.3d 1037, 1042 (9th Cir.2001). When the language of the statute is plain, the duty of interpretation does not arise, and the court is limited to enforcing the statute according to its own terms. Manley v. Secretary of HHS, 18 Cl.Ct. 799, 813 (1989). Consequently, this court looks to the plain language of section 271(e)(2)(A) to determine whether Astra has alleged infringement properly. Section 271(e)(2)(A) states that “it shall be an act of infringement to submit an [ANDA] for a drug claimed in a patent or the use of which is claimed in a patent.” 35 U.S.C. § 271(e)(2)(A). The plain language of section 271(e)(2)(A) makes clear that the contemplated act of infringement is the submission of an ANDA for a drug, the use of which is claimed in a patent. Here, Astra filed suit pursuant to section 271(e)(2)(A) alleging that the generic omeprazole products for which Defendants were seeking approval would infringe Astra’s patents because Defendants were seeking approval for uses of omeprazole falling squarely within the scope of the asserted method of use claims. Thus, Astra claims that Defendants directly infringed the method of use claims by filing their AND As. At least one other court has concluded that a pioneer drug company may properly bring suit for direct infringement of a patent when an ANDA filed by a generic drug maker directly covers a method of use claimed in the pioneer drug company’s patent. In Allergan, the patent at issue covered the drug which was the subject of the ANDA, but it did not cover the particular method of use for which the generic drug company sought approval. In concluding that section 271(e)(2) did not apply, the Allergan court noted that under the Hateh-Waxman statutory framework, it is “the filing of a Paragraph IV certification that puts into process the notice to the patentee allowing it to bring suit under Section 271(e)(2).” Allergan, 200 F.Supp.2d at 1230. When a generic drug company seeks approval for an indication that is not protected by the patent, that generic should not be required to file a Paragraph IV certification, so section 271(e)(2) is not implicated. See Allergan, 200 F.Supp.2d at 1230. Conversely, where a generic drug company seeks approval for an indication that is covered by a patent, a Paragraph IV certification is required, and section 271(e)(2), which entitles a pioneer drug company to bring suit for direct infringement, is implicated. Allergan, 200 F.Supp.2d at 1229-30 (“Infringement actions under Section 271(e)(2) must therefore be limited to the Controlling Use Patents,” which that court defined as “all use patents which claim an indication for the drug which the applicant is seeking approval.”) (quoting H.R.Rep. No. 98-857(11) at 13, 1984 U.S.C.C.A.N. at 2697). Since the method of use claims for which the court considers infringement proof in this case are controlling use claims, Astra has properly brought suit under section 271(e)(2)(A) for direct infringement. As such, the court need not consider issues related to a claim for inducement under section 271(b), and Astra need not establish any inducement or intent on the part of Defendants to establish infringement of either claim 10 of the ’505 patent or claim 13 of the ’230 patent, both methods of treating gastrointestinal disease. II. Claim Construction A. Legal Standards In the first of the two steps necessary to the infringement analysis, the court construes the allegedly infringed patent claims to establish their meaning and scope. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir.1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996); Graco, Inc. v. Binks Mfg. Co., 60 F.3d 785, 791 (Fed.Cir.1995). The interpretation of patent claims through claim construction is a determination made as a matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The court construes the claims of each patent according to the hierarchy of evidence articulated in Markman, looking first to the intrinsic evidence of the patent. 52 F.3d at 979 (“To ascertain the meaning of claims, we consider three sources: The claims, the specification, and the prosecution history.”) (internal citations omitted). The court begins with the language of the disputed claims, which define the scope of the invention and the rights of the paten-tee. Markman, 517 U.S. at 373-74, 116 S.Ct. 1384; Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir.1999); Bell Comms. Research, Inc. v. Vitalink Comms. Corp., 55 F.3d 615, 619 (Fed.Cir.1995). It is the claims that define the invention. See Autogiro Co. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 395-96 (1967). They are the measure against which validity and infringement are gauged. See SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed.Cir.1985). The court may consider not only the language of the disputed claims themselves, but also the language of the unasserted claims. Claims should be construed as they would by a person of ordinary skill in the art. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1302 (Fed.Cir.1997). Moreover, the court must construe the words of the claim as of the time of the invention or when the application was first filed. Leggett & Platt, Inc. v. Hickory Springs Mfg. Co., 285 F.3d 1353, 1357 (Fed.Cir.2002). Thus, the focus in construing disputed claim terms is not the subjective intent of the inventor or examiner; rather, it is the objective test of what one of ordinary skill in the art at the time of the invention would have understood a claim term to mean. See Markman, 52 F.3d at 977. Each and every word in a claim must be construed to have meaning. Exxon Chemical Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557 (Fed.Cir.1995). The terms of a claim are generally given their ordinary and customary meaning as of the date of the application for the patent. See Kopykake Enters. v. Lucks Co., 264 F.3d 1377, 1383 (Fed.Cir.2001). They must also be read in accordance with the precepts of English grammar. In re Hyatt, 708 F.2d 712, 714 (Fed.Cir.1983). This strong presumption “in favor of the ordinary meaning of claim language as understood by one of ordinary skill in the art” may be overcome where: “1) the pat-entee has chosen to become his or her own lexicographer by clearly and explicitly defining the claim term; or 2) where a claim term would deprives the claim of clarity such that there is no means by which the scope of the claim may be ascertained from the language used.” Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001) (quotations omitted). When a patentee chooses to be his own lexicographer and uses terms in a manner other than their ordinary meaning, the intended definition of the term must be “clearly stated in the patent specification or file history.” Vitronics, 90 F.3d at 1582; see also Novo Nordisk of N. Am. v. Genentech, Inc., 77 F.3d 1364, 1368 (Fed.Cir.1996); Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387 (Fed.Cir.1992). In that respect, resort to the specification provides guidance. See Vi-tronics, 90 F.3d at 1582. The court must look to the specification and the file history to see if the inventor varied the ordinary meaning of particular claim terms or if a claim term is unclear. Phonometrics, Inc. v. N. Telecom Inc., 133 F.3d 1459, 1466 (Fed.Cir.1998). Specifications can be the “single best guide to the meaning of a disputed term” and, therefore, are “always highly relevant to the claim construction analysis.” Novo Nordisk A/S v. Becton Dickinson & Co., No. 96 Civ. 9506, 2000 WL 294852, at *2 (S.D.N.Y. Mar. 21, 2000); see Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed.Cir. 1998) (using specifications to ascertain the meaning of the claim term as it is used by the inventor in the context of the entirety of his invention); Amhil Enters. Ltd. v. Wawa, Inc., 81 F.3d 1554, 1559 (Fed.Cir.1996) (recognizing that the “entire specification” should be considered in interpreting claim language). A patentee need not deliberately or precisely define a term in a lexicographical manner, but may provide a definition by implication. Vitronics, 90 F.3d at 1582. Thus, the Court of Appeals for the Federal Circuit has “specifically held that the written description of the preferred embodiments can provide guidance as to the meaning of the claims” that are to be construed, “even if the guidance is not provided in explicit definitional format.” Bell Atlantic Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268-70 (Fed.Cir.2001) (citing SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed.Cir.2001)). This court must be careful when turning to the specification for guidance during claim construction. Examples may aid in the proper construction of a claim term; however, the scope of a claim is not necessarily limited by the examples. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed.Cir.1997). Similarly, preferred embodiments like those often present in a specification are not claim limitations. Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855, 865 (Fed.Cir.1988). It is improper either to limit the claim to preferred embodiments or examples in the specification or to broaden the scope of a claim to include embodiments not covered by the claim language. See Novo Nordisk of N. Am. v. Genentech, 77 F.3d 1364, 1369 (Fed.Cir.1996); Transmatic, Inc. v. Gulton Indus., Inc., 53 F.3d 1270, 1278 (Fed.Cir.1995); compare Ekchian, 104 F.3d at 1303, with Philip v. Mayer Rothkopf Indus., Inc., 635 F.2d 1056, 1061 (2d Cir.1980). This is not to say that resort to the specification should be avoided. The court can and should use the specification to define claim terms. See Phonometrics, Inc. v. Northern Telecom, Inc., 133 F.3d 1459, 1466 (Fed.Cir.1998) (“[Patentee] of course argues that additional limitations cannot be imported into a claim from the written description. We may, however, construe a specifically claimed limitation in light of the specification, which is all we do here.”); Ethicon Endo-Surgery, Inc. v. United States Surgical Corp., 93 F.3d 1572, 1578 (Fed.Cir.1996) (“Here, the district court did not import an additional limitation into the claim; instead, it looked to the specification to aid its interpretation of a term already in the claim, an entirely appropriate practice.”). As noted, aside from the claim language and the specification, a proper claim construction analysis requires consideration of the patent prosecution history. Markman, 52 F.3d at 980 (“The court has broad power to look as a matter of law to the prosecution history of the patent in order to ascertain the true meaning of language used in the patent claims.”). The specification and prosecution history are toth important evidence of “the problem the inventor was attempting to solve,” which is critical to properly construing the scope and meaning of the claims of the patent. CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146, 1160 (Fed.Cir.1997) (citing Applied Materials v. Advanced Semiconductor Materials, 98 F.3d 1563, 1573 (Fed.Cir.1996)). Like the specification, the prosecution history is intrinsic evidence and is “often of critical significance in determining the meaning of the claims.” Vitronics, 90 F.3d at 1582; see Alpex Computer Corp. v. Nintendo Co. Ltd., 102 F.3d at 1220. In addition, prior art considered by the United States Patent and Trademark Office (“USPTO”) during prosecution of a patent comprises intrinsic evidence for claim construction. Vitronics, 90 F.3d at 1583. These three items — the claim language, the specification, and the prosecution history — are the intrinsic evidence and are the primary evidentiary sources for claim construction. In most situations, a thorough consideration of the intrinsic evidence will resolve any ambiguity in a disputed claim term. Vitronics, 90 F.3d at 1583. When the meaning cannot be determined by intrinsic evidence, a court may turn to extrinsic evidence to construe the claims in a patent. Vitronics, 90 F.3d at 1584. Extrinsic evidence “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises” and may be useful to show the state of the art at the time of the invention. Markman, 52 F.3d at 980. “The court may, in its discretion, receive extrinsic evidence in order ‘to aid the court in coming to a correct conclusion’ as to the ‘true meaning of the language employed’ in the patent.” Markman, 52 F.3d at 980 (internal quotations omitted); see also Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed.Cir.1998) (holding that trial court can hear extrinsic evidence to educate itself about patent and relevant technology, but may not use extrinsic evidence to vary or contradict claim terms). When consideration of extrinsic evidence is necessary to understand the meaning of claim terms, the court may consider testimony on how people skilled in the art would understand technical terms in the claims. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1475 (Fed.Cir.1998) (“The objective of claim interpretation is to discern the meaning of the claim terms to one of ordinary skill in the art at the time of the invention.”) Where the intrinsic evidence unambiguously describes the scope of the patent, however, it is improper to rely on extrinsic evidence to alter the meaning of the claims. See Vitronics, 90 F.3d at 1584. Thus, in most instances, a thorough consideration of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term, and the court may not rely on extrinsic evidence to construe the scope of a claim term unless the court first finds that the term is ambiguous even in light of the intrinsic evidence. See Vitronics, 90 F.3d at 1583-85. B. The ’505 and ’230 Patents Astra filed the patent application that led to the ’505 patent in the USPTO on April 20, 1987. Astra also filed the patent application that led to the ’230 patent on April 20, 1987. Both applications claim priority based on a United Kingdom patent application filed on April 30, 1986. There are no substantive differences between either the ’505 patent application or the ’230 patent application and the British priority document. (Lovgren Tr. 1742:24-1743:3, 1745:3-8; compare PI, and P2A, mth P1056 and P8A.) The ’505 patent discloses particular oral pharmaceutical formulations for the drug molecule ome-prazole, processes for making those formulations, and methods of treating gastrointestinal disease using those formulations. (PI, col. 1:5-11.) The ’505 patent also describes some of the difficulties involved in making an omeprazole formulation. (See, e.g., PI, col. 1:21-34.) The problems discussed in the specifications of the ’505 and ’230 patents include the very same problems identified in the development history described above. (See PI, cols. 1-15; P2A cols. 1-4.) For example, omepra-zole is unstable in stomach acid, where it degrades rapidly unless special precautions are followed. (See, e.g., PI, col. 1:17-39.) The omeprazole molecule is also sensitive to moisture and organic solvents. (PI, col. 1:33-34.) Despite that sensitivity to solvents, omeprazole is not very soluble in the water found in bodily fluids. (Pil-brant Tr. 1325:1-3.) Consequently, the drug is difficult to handle and formulate. The ’505 patent claims a new formulation that, among other things, permits the omeprazole drug molecule to pass unharmed through the stomach’s acidic environment and to dissolve rapidly in the upper portion of the small intestine. (PI, col. 3:14-18, col. 5:19-58.) The ’505 patent inventors were faced with multiple problems of improving manufacturing stability, storage stability, and stability of the formulation in the stomach while maintaining the bioavailability of the omeprazole molecule. (PI, col. 1:40 — col. 2:13, col. 14:64 — col. 16:40.) The solution to the multiple stability problems associated with omeprazole devised by the inventors was a formulation that comprises (1) a core region containing omeprazole and an ARC or an alkaline salt of omeprazole optionally mixed with an ARC; (2) an inert subcoat-ing that is water soluble or rapidly disintegrating in water and disposed on the core region; and (c) an outer enteric layer disposed on the subcoating. (See, e.g., PI, col. 3:20-32.) As a result, the omeprazole in the patented formulation is available for absorption into the bloodstream, while, at the same time, possessing superior stability. (PI, col. 3:14-20.) Like the ’505 patent, the ’230 patent relates to particular oral pharmaceutical formulations, processes for making those formulations, and methods of treating gastrointestinal disease using those formulations. (P2A, col. 1:5-12.) The ’230 patent differs from the ’505 patent in that it covers a class of benzimidazole compounds, including omeprazole, and their salts, not just omeprazole. (P2A, col. 1:28 — col. 2:33.) The intrinsic evidence for both patents overlaps. The ’505 and ’230 patent claims share much common language, common background provided by their specifications, and prosecution histories that overlapped both in time and in substance. Not surprisingly, because the ’505 and ’230 patents have the same inventors and their inventive and claimed subject matters overlap, the claim language for those two patents also overlaps. The court acknowledges that the claims in each of these patents must be construed independently. Lemelson v. TRW, Inc., 760 F.2d 1254, 1267 (Fed.Cir.1985) (“[T]he scope of each individual claim must be examined on its own merits, apart from that of other claims, even in the same patent.”). However, the claims of the ’505 and ’230 patents that have been asserted against Defendants often are directly paired together with no material differences between the corresponding claims in the two patents; moreover, the parties’ claim construction arguments are, for the most part, identical for the paired claims of the ’505 and ’230 patents. Therefore, the court will analyze the disputed terms within the ’505 and ’230 patents by first addressing the terms occurring within corresponding claims in both patents. The court will then address the few remaining claim construction issues that are pertinent to the ’230 patent alone. Astra asserts claims 1, 5, 6, 8-12, and 14 of the ’505 patent against all Defendants. Astra also asserts claim 3 of the ’505 patent against Defendant Andrx alone. Claims 2 through 9 and claims 11 through 13 of the ’505 patent are product claims that depend on claim 1, but then add other features. In contrast to product claims like claim 1, claim 10 of the ’505 patent is a method of treatment claim, and claim 14 is a process claim. Astra asserts claims 1, 6, and 13 of the ’230 patent against all Defendants. Astra also asserts claims 7, 10-13, and 15 of the ’230 patent against various Defendants. Dependent product claims add features to claim 1 of the ’230 patent. Claim 12 of the ’230 patent is an independent process claim. The first claim of the ’505 patent specifies a pharmaceutical product that includes three elements: 1. An oral pharmaceutical preparation comprising (a) a core region comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone; (b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoat-ing comprising one or more layers of materials selected from among tablet ex-cipients and polymeric film-forming compounds; and (c) an outer layer disposed on said sub-coating comprising an enteric coating. (PI, col. 16:42-54.) Claim 1 of the ’230 patent, also a product claim, specifies: 1. A pharmaceutical preparation comprising: (a)an alkaline reacting core comprising an acid-labile pharmaceutically active substance and an alkaline reacting compound different from said active substance, an alkaline salt of an acid-labile pharmaceutically active substance, or an alkaline salt of an acid-labile pharmaceu-tically active substance and an alkaline reacting compound different from said active substance; (b) an inert subcoating which rapidly dissolves or disintegrates in water disposed on said core region, said subcoat-ing comprising one or more layers comprising materials selected from the group consisting of tablet excipients, film-forming compounds and alkaline compounds; and (c) an enteric coating layer surrounding said subcoating layer, wherein the sub-coating layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced. (P2A, col. 13:1-20.) The preamble of both claims 1 calls for a “pharmaceutical preparation,” which must be oral in the case of the ’505 patent. This simply means any dosage form taken via the mouth. (See, e.g., PI, Ex. 2, col. 7:55— col. 8:34 (pellets); PI, Exs. 9, 10, col. 11:43 — col. 12:36 (tablets).) “Comprising” is a transitional term used in patent claims to mean that the claim includes, but is not limited to, the elements thereafter presented. Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348 (Fed.Cir.2001) (“In the parlance of patent law, the transition ‘comprising’ creates a presumption that the recited elements are only a part of the device, that the claim does not exclude additional, unrecited elements.”). In the context of the preamble of claims 1 of the ’505 and ’230 patents, then, “comprising” means that parts (a), (b), and (c) of claims 1 must be present, but that other elements may also be present. Thus, claims 1 contain three common structural components that are recited in subpara-graphs (a), (b), and (c) in both the patents. Subparagraphs (a) and (b) of each claim contain the claim limitations that are strongly contested by the parties. C. Part “(a)” of Claims 1 1. The Terms “Core” and “Core Region” The court finds that the terms “core” and “core region” are synonymous in the context of the ’505 and ’230 patents; thus, the court construes the term “core region” to have the same meaning as the term “core.” This construction is apparent from the language of the claims themselves. The term “core region” does not appeal’ anywhere in either patent except in certain claims, including claims 1 of the ’505 and ’230 patents. In those claims of the ’505 and ’230 patents where the terms “core region” and “core” appear, they are used interchangeably. For example, claim 1 of the ’505 patent requires “[a]n oral pharmaceutical preparation comprising (a) a core region.” (PI, col. 16:42-43 (emphasis added).) Claim 5 of the ’505 patent, however, requires “[a] preparation according to claim 1 wherein the alkaline core comprises .... ” Claim 5 depends from claim 1 and references “the alkaline core.” (PI, col. 16:65-66 (emphasis added).) Thus, the term “core” in claim 5 must be referring to the “core region” in claim 1. Claim 12 of the ’505 patent also refers back to the “core region” in claim 1 when it requires “[a] preparation according to claim 1, wherein the core comprises (PI, col. 18:4-5 (emphasis added).) Similar examples occur in the claims of the ’230 patent. Indeed, the only place where the term “core region” appears in the ’230 patent is in element (b) of claim 1, where the term “core region” is preceded by the word “said,” which in patent claim drafting indicates that the specific claim term “core region” has been previously introduced. Manual of Patent Examining Procedure, 7th ed., § 2173.05(e), at 2100-168. Since the phrase “said core region” in claim 1(b) has no antecedent basis and refers back to the term “alkaline reacting core” in element (a), the term “core region” in element (b) must be referring to the term “core” in element (a). Finally, there is no language in the specification or the claims of either patent to suggest what, if anything, beyond the core region would be encompassed by the term “core”; accordingly, “core region” must be defined to be synonymous with the term “core” because “a patent claim may be interpreted only as broadly as its unambiguous scope.” Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1581 (Fed.Cir.1996) (citations omitted). The court defines the terms “core” and “core region” to mean the portion of the patented preparation that lies beneath the subcoating and contains the active ingredient and, in the case of omeprazole as the active ingredient, an ARC. The claim language itself expressly states that the “core region” is the portion of the formulation that lies beneath the inert subcoating, which is “disposed on” the core region. (PI, col. 16:48-50; P2A, col. 13:10-11.) Also, the discussion of the subcoating in the patents makes it clear that the entire mixture, whether called the “alkaline core” or the “alkaline reacting core” is the core to which the subeoating is applied. (PI, col. 4:3-58, see particularly col. 4:4, 13, 31; P2A, col. 8:66 — col. 9:52, see particularly col. 8:67, col. 9:6-8.) The court’s construction of the terms “core” and “core region” includes cores made by conventional pharmaceutical procedures. (See PI, col. 3:1-11, col. 16:43-47.) The primary dispute concerning these terms is whether they encompass cores wherein the active substance is coated or sprayed onto a sugar seed. Based on the briefing submitted on claim construction as well as the evidence introduced at trial, the court finds that, in the abstract, a person of ordinary skill in the art could consider the sugar sphere itself to be a “core,” but that same person could also consider the sugar sphere plus the active layer sprayed onto it to be a “core.” Defendant Genpharm’s construction for the term “core,” which would exclude cores made by layering onto sugar spheres, incorrectly focuses attention on this abstract situation and away from the meaning a person of ordinary skill in the art reading these two patents would attach to the term “core.” For example, Genp-harm cites to a definition for the term “core” in a non-technical dictionary. Cf. Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1580-81 (Fed.Cir.1996) (finding general dictionary definition secondary to specific meaning of technical term as used and understood by those of ordinary skill in the art). Even though the term “core” when applied to coated sugar spheres might be limited to the sphere itself in the abstract, the court finds that in the context of these two patents a person of ordinary skill in the art would understand the term “core” to encompass not only the sugar sphere but also the active layer sprayed or coated onto the sugar sphere. The patent specifications expressly state that cores may be made “by conventional pharmaceutical procedures,” (PI, col. 3:66-68; P2A, col. 8:62-64), and some of the conventional pharmaceutical procedures that may be used to prepare cores are expressly disclosed in the patent specifications and file histories. Conventional pharmaceutical procedures for making cores may include, but are not necessarily limited to, cores formed by extrusion and spheronization, cores made by layering on sugar seeds, and cores made by tabletting techniques. (See, e.g., PI, col. 1:57 — col. 2:4, col. 3:1 — col. 4:2, col. 16:43-47 (the powder mixture is formulated into pellets, tablets or capsules, which are used as cores for further processing, such as applying the subcoat) (emphasis added); see also Story Tr. 3737:10-13 (testifying that the technique of layering active drug on sugar sphere seeds was known prior to 1986); P921 at 12:3-4, 14:20-15:3.) Tablet cores are found in Example 1 of the ’505 patent. (PI, col. 6:29-65.) Extruded and spheronized cores are described in Example 2. (PI, col. 7:55 — col. 8:34.) The ’505 patent specification also expressly references active-coated sugar seeds as “cores.” The ’505 patent specification states that WO No. 85/03436 (the “ ’436 application”) describes pharmaceutical preparations containing cores, (PI, col. 3:1-2), and the ’436 application, a part of the prosecution history, acknowledges that active coated sugar seeds are a type of core “widely used in the known art.” (Astra’s Cl. Constr. Mem., Ex. 4, ’436 application at 12:4-19; App. 1, ’505 Prosecution History at 166.) Contrary to arguments made by Second Wave Defendants Mylan and Eon, Astra’s citation to the ’436 application in the ’505 and ’230 patents and their file histories does not serve as a disclaimer of a sugar core with a layer of the active ingredient. The ’505 and ’230 patents never explicitly adopt an active-coated sugar core as part of one of the examples or preferred embodiments for the claimed invention described in the specification; however, the specification need not describe every possible way of making the product. SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121-22 (Fed.Cir.1985). Far from expressly disclaiming the method of laying the active ingredient on a sugar sphere that is described in the ’436 application cited in the patents, Astra claimed cores formed by that method in its patent by claiming any formulation with cores made by conventional pharmaceutical techniques. Defendant Genpharm would graft onto the claims a requirement of homogeneity in order to exclude a core that is built on a sugar seed. {See Story Tr. 3712:4-18, 3719:7-3720:5, 3725:2-13, 3720:12-3721:5 (testifying that one of ordinary skill in the art would conclude that “core” as used in the ’505 and ’230 patents is a homogenous mixture of omeprazole, alkaline compounds, and excipients, with the omepra-zole uniformly distributed throughout the core).) For intrinsic support within the ’505 patent, Genpharm relies on the sentences bridging columns 3 and 4 of the ’505 patent, which describe using a mixture of omeprazole and other materials to form “small beads” by conventional procedures, which are “used as cores for further processing.” {See PI, col. 3:66 — col. 4:2; see also P2A, col. 8:62-65.) The flaw in Genpharm’s logic is reading the reference to a powder mixture “formulated into small beads” as excluding a mixture coated onto sugar seeds. There is no question that coating a sugar seed with an active substance is a conventional procedure, and nothing in the language Genpharm highlights excludes coating the mixture onto sugar seeds to form the small beads. Genpharm also relies on references in the patents to the subcoating as the “first layer.” {See, e.g., P2A, col. 8:1-3.) Those references, however, concern the first layer of the invention — the subcoating. They do not exclude making small beads using the conventional sugar seed process before applying the “first layer” of the invention, which is the subcoating. Genpharm’s definition is also based on consideration of a subset of the examples included in the ’505 patent specification. By requiring a homogenous core, Genpharm adopts a definition for “core” and “core region” that is limited to those cores made by particular processes, which do not include cores made by spraying active ingredients onto a sugar seed. Since it is improper to read a limitation from the specification into the claims or to limit the claims to examples in the specification, see Tate Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 966-67 (Fed.Cir.2000); Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed.Cir.1997), the court will not limit the definition of the terms “core” and “core region” to exclude cores made by spraying or coating a sugar seed. The claims themselves do not contain any process limitations, and, as such, cores produced by any “conventional pharmaceutical procedure” are covered by claim 1. Genpharm’s construction is not only inconsistent with the intrinsic evidence but also with the testimony of those skilled in the art, who testified, both at the trial and throughout discovery, that the terms “core” and “core region” mean the portion of the pharmaceutical preparation that lies beneath the subcoat. Dr. Auslander, KUDCo’s expert, understood the term “core region” to refer to “everything under the subcoat ... [I]t contains all the ome-prazole plus the alkaline-reacting compound.” (Auslander Tr