King Pharmaceuticals v. Eon Labs v. Elan Pharmaceuticals (2009-1437, -1438) precedential

King acquired the patent rights from Elan. Elan had sued Eon for an earlier accused infringement.

Under 35 U.S.C. § 102 a claim is anticipated "if each and every limitation is found either expressly or inherently in a single prior art reference." Celeritas Techs. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1360 (Fed. Cir. 1998). "[A]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation. . . ." Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1373 (Fed. Cir. 2002) (emphasis in original). A claim is obvious when "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.

Moreover, "[t]he laws of nature, physical phenomena, and abstract ideas have been held not patentable." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). While a process may be patentable if "(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing," In re Bilski, 545 F.3d at 954, there is no exclusive test for determining patentability under § 101, Bilski, 130 S. Ct. at 3226-27.

The inherent anticipation dispute was over eating food contemporaneous with taking the drug.

In its summary judgment opinion, the district court rejected King's argument and found claim 1's preamble inherently anticipated. See King Pharms., Inc., 593 F. Supp. 2d at 507-09. According to the district court, an increase in the bioavailability of metaxalone is an inherent property of taking metaxalone with food, which is disclosed in each of Fathie II, Albanese, and Abrams. See id.

As an initial matter, King's attempt to link an increase in metaxalone's bioavailability to specific food conditions is untenable. While the '128 patent's written description discloses specific conditions for food consumption, its claims only recite taking metaxalone "with food." It would be improper to limit the broad terms used in the '128 patent's claims to the specific food conditions disclosed in the written description. See Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009) ("The claims, not specification embodiments, define the scope of patent protection. The patentee is entitled to the full scope of his claims, and we will not limit him to his preferred embodiment or import a limitation from the specification into the claims."). Moreover, the written description in no way suggests that the specific food conditions disclosed were necessary for increasing metaxalone's bioavailability. Rather, the written description teaches that the claimed increase in metaxalone's bioavailability can be achieved through the consumption of "a meal, such as breakfast, lunch or dinner." '128 patent col.2 ll.37-38. The district court was therefore correct in finding that "the '128 patent does not identify any additional conditions that must be present for the food effect to occur. Rather, it occurs naturally in most people when they take metaxalone with food." King Pharms., Inc., 593 F. Supp. 2d at 508; see also Verdegaal Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628, 632 (Fed. Cir. 1987) (holding reliance on non-claimed distinction between prior art method and claimed method "inappropriate" and insufficient to save the claim from inherent anticipation).

We have held that "[i]t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Such newly discovered benefits are not patentable because they are inherent in the prior art. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). While inherent anticipation "may not be established by probabilities or possibilities," In re Oelrich, 666 F.2d 578, 581 (CCPA 1981), if "the [prior art's] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well-settled that the disclosure should be regarded as sufficient," id. (alterations added).

According to the '128 patent, the natural result of taking metaxalone with food is an increase in the bioavailability of the drug. The prior art discloses taking metaxalone with food, but not the natural result of this process. However, because the prior art methods in their "normal and usual operation . . . perform the function which [King] claims in [the '128 patent], then such [patent] will be considered, to have been anticipated by the [prior art]." In re Ackenbach, 45 F.2d 437, 439 (CCPA 1930) (alterations added). As taught by the '128 patent, the only steps required to increase metaxalone's bioavailability are (1) ingesting metaxalone (2) with food. These steps are undeniably disclosed by the prior art. An increase in metaxalone's bioavailability is, therefore, an inherent aspect of the prior art. In other words, the increase in metaxalone's bioavailability is the "'natural result' flowing from the [prior art's] explicitly explicated limitations." Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed. Cir. 2001) (alterations added); see also MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1331, 1336 (Fed. Cir. 1999) ("[T]o the extent the embodiment in the patent achieves [the limitation], so does the [prior art].") (alterations added). Accordingly, claim 1's preamble is inherently anticipated.

King's experts' opinions that "even a disclosure of taking metaxalone with food would not inherently disclose increasing the bioavailability of metaxalone," do not undermine our analysis. To anticipate, the prior art need only meet the inherently disclosed limitation to the extent the patented method does. See Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1326 (Fed. Cir. 2003) ("[A] prior art product that sometimes, but not always, embodies a claimed method nonetheless teaches that aspect of the invention."). Because the '128 patent discloses no more than taking metaxalone with food, to the extent such a method increases the bioavailability of metaxalone, the identical prior art method does as well. As the district court aptly stated, "to inherently anticipate, the prior art need only give the same results as the patent, not better." King Pharms., Inc., 593 F. Supp. 2d at 509.

For the foregoing reasons, the district court's inherent anticipation analysis was proper. The preamble to claim 1 is inherently anticipated. To hold otherwise would remove from the public a method of treating muscle pain that has been performed for decades. See Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348 (Fed. Cir. 1999) ("The public remains free to make, use, or sell prior art compositions or processes, regardless of whether or not they understand their complete makeup or the underlying scientific principles which allow them to operate. The doctrine of anticipation by inherency, among other doctrines, enforces that basic principle."). Accordingly, the district court's finding that claim 1 is anticipated is affirmed.

Other claims fell by their dependence on claim 1. "Like claim 1, these claims are anticipated because their sole source of novelty is inherently disclosed by the prior art."

Still other dependent claims were more specific with regard to time lapse between drugging and munching.

On appeal, King argues that none of the claims' specific timeframe requirements is disclosed in [the prior art references] Fathie II, Albanese, or Abrams. Yet, according to King's own experts, "with food" could mean taking metaxalone "1 hour prior to up to about 2 hours after eating." J.A.3221 (Decl. of Dr. Elia). Under this common-sense definition of "with food," the prior art discloses a timeframe for ingesting metaxalone in relation to consuming food that falls within the timeframes claimed by claims 4-6. The district court's finding that claims 4-6 are anticipated is therefore affirmed. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) ("[It is] an elementary principle of patent law that when, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is 'anticipated' if one of them is in the prior art."); Fresenius USA, Inc. v. Baxter Int'l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009).

King had a better argument for the downfall of '128 dependent claim 21 with its jazzy "informing" limitation: look at the claim as a whole, not just one limitation. But the argument didn't go far enough to save the claim.

On appeal, King contends it was legal error for the district court to focus solely on the "informing" limitation in invalidating the claim. Instead, according to King, the district court should have examined the claim as a whole to determine whether it recited patent eligible subject matter. King is correct.

The Supreme Court has stated that a § 101 patentability analysis is directed to the claim as a whole, not individual limitations. See Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm." (alterations added)); see also In re Bilski, 545 F.3d at 958 ("[T]he [Supreme] Court has made clear that it is inappropriate to determine the patent-eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter." (alterations added)). Contrary to the Supreme Court's instructions, the district court ignored the claim as a whole and improperly focused on one limitation, the "informing" limitation, in invalidating the claim under § 101. Such an analysis is improper.

The CAFC pats itself on the back for "the wisdom behind" its Bilski ruling.

Reviewed as a whole, claim 21 teaches a method of treating patients with metaxalone, whereby the patient is administered metaxalone with food and informed that such treatment increases the bioavailability of the drug. Prior to the Supreme Court's decision in Bilski, this court held that such medical treatment methods were patentable processes under § 101 because they fell squarely within the machine-or-transformation test applied in In re Bilski. Specifically, we held that methods of treatment "are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition," because such methods transform the human body. Prometheus Labs., Inc. v. Mayo Collaborative Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert. granted and vacated, No. 09-490, 78 U.S.L.W. 3254 (U.S. June 29, 2010). While the Supreme Court in Bilski made clear that our machine-or-transformation test is not the exclusive test for patentability, Bilski, 130 S. Ct. 3226-27, it also made clear that the test "is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101," id. at 3227. We therefore understand the Supreme Court to have rejected the exclusive nature of our test, but not necessarily the wisdom behind it.

The CAFC panel goes after § 101 sideways, and roundabout, to come to the conclusion that "informing" isn't patentable.

The specific question before us is whether an otherwise anticipated method claim becomes patentable because it includes a step of "informing" someone about the existence of an inherent property of that method. We hold it does not. The "informing" limitation adds no novelty to the method, which is otherwise anticipated by the prior art. In other words, in light of our holding that the method of taking metaxalone with food to increase the drug's bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.

In an analogous context, we have held that "[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability." In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (alterations added). In such cases, we have recognized that the printed matter is not independently patentable, but have cautioned that the limitation must not be excised from the claim. See id. at 1385 ("[T]he board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole.") (alterations added). Instead, the relevant question is whether "there exists any new and unobvious functional relationship between the printed matter and the substrate." Id. at 1386 (citing In re Miller, 418 F.2d 1392, 1396 (CCPA 1969)). The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations. See In re Nagi, 367 F.3d at 1339.

Although these "printed matter" cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled reason for limiting their reasoning to that specific factual context. See In re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at 1385-87. Rather, we believe that the rationale underlying these cases extends to the situation presented in this case, wherein an instructional limitation is added to a method, as opposed to a product, known in the art. Thus, the relevant inquiry here is whether the additional instructional limitation of claim 21 has a "new and unobvious functional relationship" with the known method of administering metaxalone with food. See In re Ngai, 367 F.3d at 1338 (quoting In re Gulack, 703 F.2d at 1386).

King contends that there is a functional relationship between the "informing" limitation and the method. Specifically, at oral argument, King's counsel argued that the "informing" limitation increases the likelihood that the patient will take metaxalone with food, thereby in-creasing the efficiency of the method. See Oral Arg. at 7:30-8:26. This relationship, however, is not functional. Informing a patient about the benefits of a drug in no way transforms the process of taking the drug with food. Irrespective of whether the patient is informed about the benefits, the actual method, taking metaxalone with food, is the same. In other words, the "informing" limitation "in no way depends on the [method], and the [method] does not depend on the ['informing' limitation]." In re Nagi, 367 F.3d at 1339 (alterations added). "It is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945).

The district court's obviousness finding with respect to claim 5 of '102 was affirmed. The magic wand doctrine of inherent obviousness is that no articulated reasoning is needed to account for "a person of ordinary creativity."

Turning to the district court's obviousness analysis, the district court held that a prior art reference, Dent, disclosed taking metaxalone in a single 400 mg tablet four times a day. King Pharms., Inc., 593 F. Supp. 2d at 511. Dent does make such a disclosure. It would be obvious to a person of ordinary skill in the art to combine Dent's teaching of taking a tablet dosage of metaxalone four times a day with Albanese's teaching of administering metaxalone with food. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2008) ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").

The bottom line -

In summary, while the district court erred in invalidating several of the claims as unpatentable under § 101, all the claims of the '128 and '102 patents are ultimately anticipated under 35 U.S.C. § 102 or obvious under 35 U.S.C. § 103 in light of the prior art. Additionally, the district court erred in entering a judgment of invalidity against Elan because no case or controversy currently exists between Elan and Eon.

Affirmed and vacated-in-part.