35 U.S.C. §101 and the presumption of validity, and the effect on 12(b)(6) Motions

With the number of patents being invalidated under 35 U.S.C. § 101 on Motions to Dismiss after Mayo and Alice, there’s a fair question – what happened to the presumption of validity that is owed to a patent?  Seemingly, it still exists. 

35 U.S.C. § 282 states:

A patent shall be presumed valid. Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.

The Federal Circuit has reasoned that a finding of patent ineligible subject matter is rare at the pleading stage of a patent infringement suit, because there is a presumption that a patent was properly issued absent clear and convincing evidence to the contrary.[1]  Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1338 (Fed. Cir. 2013).  Thus, to dismiss a complaint, “the only plausible reading of the patent must be that there is clear and convincing evidence of ineligibility,” making a Rule 12(b)(6) dismissal for lack of eligible subject matter the exception, not the rule.  Id.  The court also reasoned that while a § 101 analysis requires a legal determination; it also requires consideration of many factual issues.  Id. at 1339.  Thus, when there are significant factual issues underlying a 12(b)(6) motion, a dismissal is not possible.  Moreover, the court reasoned that “because judicially acknowledged [§ 101] exceptions could eviscerate the statute, application of this presumption and its attendant evidentiary burden is consistent with the Supreme Court’s admonition to cabin exceptions to § 101.”  Id. at 1342. 

A recent case from the District of Delaware dealt with 35 U.S.C. §101, the presumption of validity, and the effect on 12(b)(6) Motions.  Bristol-Myers Squibb Co., et al. v. Merck & Co., Inc., et al., C.A. No. 15-560-GMS (D. Del. Mar. 17, 2016).  The opinion can be found here

Merck asserted that U.S. Patent No. 9,067,999 claims ineligible subject matter under § 101.  Specifically, Merck asserted that the patent claims were directed to a natural phenomenon, and the remaining claim elements did not transform the claimed invention into patent eligible subject matter. The patent has one independent claim:

1.   A method of treating a lung cancer comprising administering a composition comprising a human or humanized anti-PD-1 monoclonal antibody to a human with the lung cancer, wherein the administration of the composition treats the lung cancer in the human.

The court first reasoned that the claimed invention “touches upon” a natural phenomenon.  The claimed antibody inhibits the PD-1 pathway from suppressing the immune system, which then allows the patient’s immune system (T cells) to kill the cancer cells. 

Then, the court had to answer the second question of the § 101 analysis; whether the patent claims added enough to transform the claims to patent eligible subject matter.  See Mayo Collaborative Servs. v Prometheus Labs. Inc., 132 S. Ct. 1289, 1297 (2012); see also, Alice Corp. Pty. v. CLS Bank Int'l, 134 S. Ct. 2347, 2349 (2014). The parties disputed whether the additional steps were merely an “administering” step (Merck - arguing it was similar to that in Mayo), or provided the treatment itself (Bristol-Meyers).   The court determined that this was a factual question, which could be answered after discovery, but could not be answered in response to a motion to dismiss.  The court additionally reasoned that with the presumption of validity, it had to presume that the Patent Office was correct in its finding that the patent claims were patent eligible.  Thus, Merck did not meet its burden of proving by “clear and convincing evidence that ineligibility is the only plausible reading of the patent.” 

Some patents, especially biotech patents, have factual issues for consideration under a §101 analysis, because part of the Mayo approach is to consider whether the additional element(s) of the claim are routine, well-understood, and conventional.  Determining whether something is “routine, well-understood and conventional” necessitates a factual inquiry, which may require discovery.  Thus, a complaint asserting patent infringement should never be dismissed for lack of patent eligible subject matter under §101, if the underlying §101 analysis requires the discovery and consideration of facts, especially in view of the presumption of validity that is afforded to a patent. 

[1] For an opposing view regarding the presumption of validity, see, Ultramercial, Inc. v.Hulu, LLC, 772 F.3d 709, 720 (Fed. Cir. 2014) (Mayer, J., concur.) (“[b]ecause the PTO has for many years applied an insufficiently rigorous subject matter eligibility standard, no presumption of eligibility should attach when assessing whether claims meet the demands of section 101”).  



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