MARKEY, Chief Judge. Merck Co., Inc. (Merck) appeals from a judgment of the United States District Court for the District of Delaware (Schwartz, C.J.), 694 F. Supp. 1 (D.Del. 1988), holding its U.S. Patent No. 3,882,246 ('246) unenforceable because of inequitable conduct. We affirm.
Both the FDA and the Federal Circuit recognize that a certification that a patent is "unenforceable" suffices for purposes of the Paragraph IV certification, see 21 C.F.R. ยง 314.94(a)(12)(i)(A)(4); Merck Co. v. Danbury Pharmacal, Inc., 694 F. Supp. 1, 2-3 (D. Del. 1988), aff'd, 873 F.2d 1418 (Fed. Cir. 1989), even though the statute provides that such certification must state that the patent is "invalid" or "will not be infringed," see 21 U.S.C. ยง 355(j)(2)(A)(vii)(IV). When it promulgated the final regulations on ANDA applications, the FDA explained that it included "unenforceability" because "[t]he alternative interpretation, precluding applicants challenging patents as unenforceable from filing certifications under paragraph IV, would be contrary to Congress' obvious intent in allowing patent challenges under [ANDA] and would lead to absurd results."
ls of a clinician or medical professional. See, e.g., Merck & Co., Inc. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003) (POSA for a patented method of treating osteoporosis had a medical degree, experience treating patients, and knowledge of pharmacology); Eli Lilly & Co. v. Teva Pharms. USA, Inc., 2004 WL 1724632, at *33 (S.D. Ind. July 29, 2004) (POSA for a patented method of using fluoxetine to treat premenstrual syndrome was not limited to clinical researchers but included a medical doctorโan OB/GYN, family practice physician, or psychiatristโwho regularly saw and treated patients suffering from PMS and was familiar with the prior art); Boots Labs., Inc. v. Burroughs Wellcome Co., 223 U.S.P.Q. 840, 845, 848 (E.D. Va. 1984) (defining POSA as a chemist or medical doctor with practical experience in testing pharmaceutical products; crediting testimony of physician, but discounting testimony of biochemist who did not address evidence of medical difficulties involved); Merck & Co., Inc. v. Danbury Pharmacal, Inc., 694 F. Supp. 1, 30 (D. Del. 1988) (for method of using cyclobenzaprine to treat muscle disorders, defining the art as "skeletal muscle relaxants" and the level of ordinary skill to include "some degree of clinical or experimental seasoning to an understanding of the pace of development and sticking points in the art"), aff'd, 873 F.2d 1418 (Fed. Cir. 1989)). In sum, "a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art."
Thus, a defendant seeking to remove a case may file a "notice of removal," 28 U.S.C. ยง 1446(a), but that defendant bears the burden of: (a) establishing removal jurisdiction; and (b) demonstrating compliance with all pertinent procedural requirements. See, e.g., Boyer v. Snap-On Tools Corp., 913 F. 2d 108, 111 (3d Cir. 1990); see also Capone v. Harris Com., 694 F. Supp. 1ll, 112 (E.D. Pa. 1988). The removal statute is "strictly construed against removal and all doubts should be resolved in favor of remand."
Lastly, plaintiffs state that consistent with their position is the fact that when they filed a second FDA 501(k) notification pertaining to a cementless implant (the patent in-suit is cementless), it did not cite to the Whiteside implant. See Exh. 14 to Plts' Response; seeMerck & Co., Inc. v. Danbury Pharmacal, Inc., 694 F.Supp. 1, 21-35 (D.Del.1988) (statements made to the FDA and not revealed to the PTO found disturbing and persuasive evidence of an intent to mislead, supporting finding of inequitable conduct), aff'd, 873 F.2d 1418, 1420, 1422 (Fed.Cir.1989) (the " simultaneous submission" of a certain date to the FDA and its withholding from the PTO is evidence of intent to deceive); see alsoGenentech, Inc. v. Wellcome Foundation Ltd., 14 U.S.P.Q.2d 1363, 1369-70, 1990 WL 69187 (D.Del.1990); Syntex (U.S.A.) Inc. v. Paragon Optical Inc., 7 U.S.P.Q.2d 1001, 1020, 1987 WL 124333 (D.Ariz.1987). Based on these arguments, the court finds no evidence of " intent to deceive" the PTO.
This notion is incredible in light of Hahn's citations to the Reynolds' work as the closest prior art to plasma flame spray technique. PX-6; PX-31 at 1; See e.g., Merck Co., Inc. v. Danbury Pharmacal, Inc., 694 F. Supp. 1, 34-35 (D.Del. 1988). 3.