Mass. Eye & Ear Infirmary v. Novartis
2006 WL 2860587 (Fed. Cir. 2006)
On October 6, 2006, the Court of Appeals for the Federal Circuit reversed the district court’s grant of QLT’s motion for summary judgment on a correction of inventorship motion in the ongoing infringement battle over Massachusetts Eye and Ear Infirmary’s (“MEEI”) U.S. Patent 6,225,303 (” the ‘303 patent”). The Court reversed and remanded for further proceedings because there were genuine issues of material fact as to whether the putative inventor, Dr. Levy, who QLT sought to add to the listed inventors in the ‘303 patent, had made a significant contribution. The Court rejected the district court’s ruling that the suggestion by Dr. Levy to test at the upper limit of a range of energies claimed in the patent constituted a significant contribution as a matter of law when “the upper limit [was] contained within a previously conceived broader range and is of no demonstrated significance.” Mass. Eye & Ear Infirmary v. Novartis, 2006 WL 2860587, *4 (Fed. Cir. 2006).
In 2001, MEEI sued Novartis and QLT for infringement of the ‘303 Patent. QLT filed a counterclaim in which it moved for a correction of inventorship under 35 U.S.C. Â§256 to add Dr. Levy of QLT as one of the listed inventors.
To be considered a joint inventor, a putative inventor “must prove their contribution to the conception of the claims by clear and convincing evidence.” Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998). “Conception is the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice. An idea is sufficiently ‘definite and permanent’ when only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation.” Id. at 1460
In 1993, Dr. Levy of QLT joined Dr. Miller of MEEI in a collaboration aimed at developing a procedure using photodynamic therapy (“PDT”) for the treatment of age-related macular degeneration in the eye. PDT is a procedure whereby a photosensitive drug is administered in the bloodstream and accumulated in the target tissue. The drug is then activated by low intensity laser light, measured in milli-Watts per centimeter squared (mW/ cm2), causing photochemical destruction of the target tissue.
MEEI’s patent ‘303 for curing age-related macular degeneration in the eye uses PDT with green porphyrins as the photosensitive drug, and the target tissue is the choroid, a vascular layer underlying the retina of the eye. The laser light energy range claimed in the ‘303 patent is from 300 to 900 mW/cm2.
The alleged contribution of Dr. Levy in 1993 was to “insist” that Dr. Miller test the procedure on diseased choroidal eye tissue at the 900 mW/cm2 energy level. In 1992, Dr. Miller had tested the procedure on undiseased tissue at 300, 600, 1200, and 1800 mW/cm2, a range of energies broad enough to include 900 mW/cm2.
The district court found that Dr. Levy’s insistence on testing at 900 mW/cm2 was a significant contribution as a matter of law because it found that 900 mW/cm2 was a critical value for determining the maximum energy level that is safe, and because it appeared to reason that Dr. Miller would not have tested at 900 mW/cm2 otherwise.
The Court of Appeals reversed because it found no evidence that 900 mW/cm2 was a critical value for safety and “the suggestion of an upper limit of a claim limitation does not necessarily constitute an inventive contribution if the upper limit is contained within a previously conceived broader range and is of no demonstrated significance.” Mass. Eye & Ear Infirmary, 2006 WL 2860587 at *4. Moreover, the Court explained, “[t]esting at exactly the end points of a range is not necessarily required for a conception of that range.” Id. In other words, the Court found that the fact that Dr. Miller tested a broader range, even if only of non-diseased tissue, provided evidence on which a trier of fact could find that Dr. Miller had conceived of 900 mW/cm2 as the upper limit as early as 1992. Thus, the Court held that summary judgment was improperly granted by the district court.