Invitae Corp. v. Natera, Inc.

INVITAE CORPORATION, Plaintiff, v. NATERA, INC., Defendant.

FUTURE LINK SYSTEMS, LLC, Plaintiff, v. AMLOGIC HOLDINGS, LTD., Defendant.

CONSUMERON, LLC, Plaintiff, v. MAPLEBEAR INC., Defendant.

C.A. Nos. 21-669-LPS, 21-634-LPS, 21-1147-LPS

United States District Court, D. Delaware

November 29, 2021

MEMORANDUM ORDER

HONORABLE LEONARD RSTARK UNITED STATES DISTRICT JUDGE

WHEREAS Defendants in the above-listed cases filed Rule 12(b)(6) motions to dispose of patent infringement claims on the bases that certain patent claims are invalid under 35 U.S.C. § 101, because they are allegedly directed to patent ineligible subject matter WHEREAS the above-listed cases brought by Invitae Corporation (“Invitae”), Future Link Systems, LLC (“Future Link”), and Consumeron, LLC (“Consumeron”) are unrelated to each other;

WHEREAS, the Court heard oral argument in all the above-listed cases on November 22, 2021, and has considered the parties' respective briefs and related filings;

WHEREAS, the Court continues to find that its procedure of addressing multiple Section 101 motions from separate cases in one hearing is an efficient use of judicial resources and a beneficial tool for resolving the merits of Section 101 motions;

NOW, THEREFORE, IT IS HEREBY ORDERED that, with respect to the above-listed Invitae case, Defendant's motion (C. A. No. 21-669 D.I. 8) is DENIED;

IT IS FURTHER ORDERED that, with respect to the above-listed Future Link case, Defendant's motion (C. A. No. 21-634 D.I. 8) is DENIED WITHOUT PREJUDICE; and

IT IS FURTHER ORDERED that, with respect to the above-listed Consumeron case, Defendant's Rule 12 motion (C. A. No. 21-1147 D.I. 9) is DENIED WITHOUT PREJUDICE.

The Court's Order is consistent with the bench ruling announced at the conclusion of the hearing on November 22, 2021, pertinent excerpts of which follow:^[1]

All the motions, of course, present Section 101 patent eligibility issues arising under motions to dismiss governed by Federal Rule of Civil Procedure 12(b)(6).

I applied the well-known standards applicable to Rule 12(b)(6) motions, which [were] not disputed in any of the cases argued today. I also applied the familiar two-step framework for patent eligibility under 35 U.S.C. § 101, as set out by the Supreme Court in Alice.^[2]

At Step One, I determine if a claim is directed to a patent ineligible subject matter. In particular, I determine if the claim is directed to one of the patent ineligible concepts[:] a law of nature, a natural phenomenon, or an abstract idea.

If the claim is not directed to one of those patent ineligible concepts, then the motion is denied. If, however, the claim is directed to a patent ineligible concept, then at Step Two, the Court looks for an element or combination of elements that is sufficient to ensure that the claim in practice amounts to significantly more than a claim upon the ineligible concept itself. In other words, the Court looks at Step Two for an inventive concept.

If, but only if, the defendant prevails at both Steps One and Two, the Court may declare the claim ineligible for patenting and dismiss the patent infringement cause of action.

As further support for the legal standards, I hereby incorporate by reference the legal standards for Section 101 motions and motions to dismiss as outlined in the Federal Circuit's recent decision in CosmoKey Solutions v. Duo Security.^[3]

With that background, let me turn to the cases. I'll discuss them in the order that they were argued this morning.

So first up is Invitae v. Natera.

In this case, Invitae asserts that Natera infringes at least Claim 1 of U.S. Patent No. 10, 604, 799, the '799 patent. I understand Natera's motion to be challenging the eligibility of all 16 claims of the '799 patent. For reasons that I will explain, Natera's motion to dismiss is denied.

I start by noting that although each patent claim is presumptively valid, a District Court may analyze representative claims for patent eligibility where all of the asserted and challenged claims are substantially similar and linked to the same purported abstract idea. We get that concept from among other places the Content Extraction decision, ^[4] as well as Cleveland Clinic Foundation v. True Health Diagnostics.^[5]

Here, Natera contends that Claim 1 of the '799 patent is representative. In the complaint, Invitae indicated that Claim 1 is representative generally. And in its brief on the motion to dismiss, Invitae continued to refer to Claim 1 as representative and did not raise any issue with Natera's contention regarding Claim 1 being representative.

Then[, ] however, when we got to the post-briefing checklist letter, for the first time Invitae contended that Claims 1, 5, 8, and 9 must all be considered in order to fully represent all 16 asserted claims.

In my view, this contention comes too late, so I will consider only Claim 1 and I view it as representative of all 16 claims. Now, of course, given my decision to deny the motion, Invitae can hardly complain that there is any unfairness in me denying the motion in full based only on considering one patent claim.

With respect to claim construction, the Court agrees with Natera that no claim construction is necessary before deciding the motion to dismiss.

So let me turn now to application of the two-part Alice test.

At Step One, the Court must analyze the focus of the claim, that is its character as a whole and especially its purported claimed advance. And those concepts are found, among other places, in SAP v. Investpic, ^[6] and Finjan v. Blue Coat.^[7]

Natera argues that Claim 1 of the '799 patent is directed to the abstract idea of “an algorithmic method of manipulating and combining genetic sequence data using an [intermediate] data set.”^[8] What Natera has stated is, in fact, an abstract idea. The Federal Circuit has found patents claiming algorithmic transformation or combination of data into a new form to be directed to an abstract idea. Among other places, we see that in RecogniCorp v. Nintendo, ^[9] as well as Digitech.^[10] So [what] Natera has stated . . . is an abstract idea.

However, I do not agree with Natera that Claim 1 is directed to this abstract idea. Instead, I find that Claim 1 is directed to a specific solution to a technological problem in the field of sequence assembly. The claimed process enables the identification of mutations with positional accuracy in a computationally tractable manner.

So I agree with Invitae that Claim 1 is directed to a “technological solution to the technological problem of how to better assemble DNA sequences [. . .] in a more computationally efficient and overall improved way.”^[11] I have some ellipses in there but all of what I said is a quote from the plaintiff.

The specification of the '799 patent discloses technological problems in the field of sequence assembly[, ] including that where assembly provides accurate detection of [variants], the prior art assembly technique was often computationally intractable for high throughput data analysis.^[12]

By contrast, as the patent further states, [i]n the claimed process, [“]the need to compare each of the reads to all of the other reads is avoided, providing computational[] tractability even for very high throughput analyses.”^[13]

Hence, as I have already said, the claimed process provides solutions to technical problems in the prior art.

In my view, then, Claim 1 is analogous to claims the Federal Circuit found to be patent eligible in McRO.^[14] The claims there were [“]limited to rules with specific characteristics[”] that allow[ed] [“]computers to produce accurate and realistic lip synchronization and facial expressions in animated characters.[”^[15]

The claims in McRO went [“]beyond merely organizing existing information into a new form[”] and additionally used [“]a combined order of specific rules that render[ed] information into a specific format that [was] then used and applied to create desired results: a sequence of synchronized, animated characters.[”^[16]

Similar to this, here, Claim 1 sets forth [“]a set of concrete steps specific to the [‘]contig[' ]based assembly of DNA sequences to solve the technological problem of improved sequence assembly for better mutation detection.[”^[17] That is essentially a quote from . . . one of the briefs, and I agree with it.

I am not persuaded by Natera's analogy to the claims at issue in In re Board of Trustees of Leland Stanford Junior University.^[18]

In Stanford, the claims were drawn to a [“]computerized method of inferring haplotype phase in a collection of unrelated individuals.”^[19] The claimed method in Stanford invoked [mathematical] techniques but [“]recit[ed] no application, concrete other otherwise, beyond storing the haplotype phase.”^[20]

By contrast, here, Claim 1 not only recites an algorithmic method of manipulating and combining genetic sequence data, it also recites the application of the method “to map positional information of mutations found in the individual reads relative to the reference.”^[21] That's from . . . the last part of Claim 1.

Thus, contrary to Natera's suggestion, Stanford does not hold that claims drawn to new and improved computerized methods of analyzing genetic data can never be patent eligible. Instead, where, as here, the claims recite applying the new and improved computerized methods to practical technological improvements, such claims may be[, ] and here are[, ] patent eligible.

When Natera says that the claims before me are directed to just a mathematical result or simply involve using computers as tools rather than any improvement in computers or other technology, I disagree.

Natera also argues that the Court should not be giving credit to...