Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2014)

By Donald Zuhn --

Last month, in Promega Corp. v. Life Technologies Corp., the Federal Circuit determined that U.S. Patent Nos. 5,843,660; 6,221,598; 6,479,235; and 7,008,771, which are owned by Promega Corp., are invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement, and therefore reversed the District Court's denial of a motion for summary judgment by Life Technologies Corp., Invitrogen IP Holdings, Inc., and Applied Biosystems, LLC ("LifeTech").  The Federal Circuit also determined that substantial evidence supported the jury's finding that LifeTech infringed U.S. Patent No. RE37,984 ("the Tautz patent") under both 35 U.S.C. §§ 271(a) and 271(f)(1), and therefore reversed the District Court's grant of judgment as a matter of law (JMOL) of noninfringement.  In addition, the Federal Circuit affirmed the District Court's determination that certain sales of LifeTech's accused products are not covered by a license agreement between Promega and LifeTech.  Finally, finding four of the five asserted patents to be invalid, the Federal Circuit vacated the jury's damages award and remanded the case back to the District Court to determine damages for LifeTech's infringement of the Tautz patent.

The case involves five patents that relate to multiplex amplification of short tandem repeat (STR) loci (i.e., amplification of multiple STR loci in a single reaction).  In construing the asserted claims of the four patents owned by Promega, the District Court determined that a given claim recited either a "closed loci set," in which the claim was limited to only the loci listed in the claim, or an "open loci set," in which the claim was not limited to only the loci listed in the claim but rather encompassed any other loci combination that included at least the loci listed in the claim.  An example of a claim reciting a closed loci set is claim 25 of the '660 patent:

25.  A kit for simultaneously analyzing short tandem repeat sequences in at least three loci, comprising a container which has oligonucleotide primers for co-amplifying a set of at least three short tandem repeat loci, wherein the set of loci are selected from the sets of loci consisting of: [STR loci sets].

An example of a claim reciting an open loci set is claim 23 of the '598 patent:

23.  A kit for simultaneously analyzing short tandem repeat sequences in a set of short tandem repeat loci from one or more DNA samples, comprising:
    A single container containing oligonucleotide primers for each locus in a set of short tandem repeat loci which can be co-amplified, comprising HUMCSF1PO, HUMTPOX, and HUMTH01.

The District Court's construction turned on whether the claim recited "a set of . . . loci . . . consisting of . . ." or "a set of . . . loci . . . comprising . . .  ."  The distinction between the two types of claims is significant because developing a successful multiplex amplification reaction is more complicated than performing a series of separate amplification reactions.

The Tautz patent, which is owned by Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. and is exclusively licensed to Promega, claims a kit for testing at least one STR locus that contains: (1) a mixture of primers; (2) a polymerizing enzyme such as Taq polymerase; (3) nucleotides for forming replicated strands of DNA; (4) a buffer solution for the amplification; and (5) control DNA.

LifeTech manufactures genetic testing kits that provide components for carrying out a multiplex amplification of STR loci from DNA samples, wherein the kits contain (1) a primer mix; (2) Taq polymerase; (3) PCR reaction mix including nucleotides; (4) a buffer solution; and (5) control DNA.

In 2010, Promega sued LifeTech for infringement of the four Promega patents and the Tautz patent, alleging that LifeTech had sold kits that were not covered by the license agreement between the parties (the license agreement limited Lifetech's use of the patents-in-suit to activities related to legal proceedings, i.e., live forensic investigations conducted by police officers).  The parties moved for summary judgment on infringement and invalidity, with the District Court denying Lifetech's enablement challenge to the Promega patents and determining that LifeTech's sales outside the license agreement's field of use were infringing.  Following trial, the jury returned a verdict of willful infringement.  LifeTech then moved for JMOL and the District Court granted the motion, finding that Promega had failed to present sufficient evidence to sustain a jury verdict under §§ 271(a) and 271(f)(1), and vacated the finding of infringement.

In an opinion by Judge Chen, joined by Judge Mayer, with Chief Judge Prost dissenting as to the majority's finding of infringement under § 271(f)(1), the Federal Circuit reversed the District Court's denial of LifeTech's motion for summary judgment of invalidity, reversed the District Court's grant of JMOL of noninfringement, affirmed the District Court's determination that certain LifeTech sales were not covered by the parties' license agreement, vacated the jury's damages award, and remanded the case back to the District Court to determine damages for LifeTech's infringement of the Tautz patent.

With respect to the issue of enablement, the Federal Circuit disagreed with Promega's characterization of unrecited STR loci in the open loci set claims as merely unrecited elements, noting that "[i]n this field of technology, introducing even a single STR locus to an existing loci multiplex significantly alters the chemistry of, and has an unpredictable effect on, whether the resulting multiplex will successfully co-amplify."  The Court indicated that "[t]here is no genuine dispute that identifying STR loci multiplexes that will successfully co-amplify is a complex and unpredictable challenge, and as a result, undue experimentation may be required to identify a successfully co-amplifying multiplex that adds even a single new locus to an existing loci combination."

The Court found support for its determination in both its MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012), and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013), decisions.  With regard to MagSil, the Federal Circuit states that:

[W]e need not delineate the precise boundary at which Promega's claims are no longer enabled.  It is sufficient to conclude, based on Promega's own statements, that the teachings of Promega's patents would not have enabled a skilled artisan at the time of filing to identify significantly more complicated sets of STR loci combinations that would successfully coamplify -- such as those found in LifeTech's STR kits -- without undue experimentation.  Thus, like the patentee in MagSil, Promega's "difficulty in enabling the asserted claims is a problem of its own making."  687 F.3d at 1384.

As for its Wyeth decision, the Court noted that "[w]hile the claims of the Promega patents are not directed to a genus of compounds as in Wyeth, the claims at issue here similarly cover potentially thousands of undisclosed embodiments in an unpredictable field."

With respect to the issue of infringement under § 271(f)(1), the Federal Circuit began by noting that the District Court had determined that § 271(f)(1) requires (1) the involvement of another, unrelated party to "actively induce the combination of . . . components," and (2) that at least two components be supplied from the United States to satisfy the "substantial portion of the components" language of the statute.  In the instant case, the District Court determined that no other party was involved in LifeTech's assembly of the accused kits, and that Lifetech supplied only a single component from the U.S. (i.e., LifeTech manufactured the Taq polymerase component of its kits in the U.S. and shipped this component to its facility in the U.K. for incorporation into the kits).

In determining that the District Court erred in granting LifeTech's motion for JMOL, the Federal Circuit first concluded that "to actively induce the combination" does not require the involvement of a third party, noting that:

Had Congress wanted to limit "induce" to actions completed by two separate parties, it could easily have done so by assigning liability only where one party actively induced another "to combine the [patented] components."  Yet, "another" is absent from § 271(f)(1).  Instead, the focus of the statute is to induce "the combination of the components of the patented invention."

The Court also noted that:

Given Congress' choice of broadening language -- which focuses solely on the activity abroad ("the combination") rather than the actor performing the combination -- and acknowledgment of "the need for a legislative solution to close a loophole" identified in Deepsouth [Packing Co. v. Laitram Corp., 406 U.S. 518 (1972)], it is unlikely that Congress intended § 271(f)(1) to hold companies liable for shipping components overseas to third parties, but not for shipping those same components overseas to themselves or their foreign subsidiaries [citation omitted].

As for the issue of whether infringement under § 271(f)(1) requires that at least two components be supplied from the U.S., the Court stated that:

We hold that there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States.  And based on the facts of this particular case, we conclude that substantial evidence supports the jury's verdict that LifeTech is liable for infringement under § 271(f)(1) for shipping the Taq polymerase component of its accused genetic testing kits to its United Kingdom facility.

In so holding, the Court explained that "[n]othing in the ordinary meaning of 'portion' suggests that it necessarily requires a certain quantity or that a single component cannot be a 'portion' of a multi-component invention."

In dissenting from the majority's finding of infringement under § 271(f)(1), Chief Judge Prost indicated that she "read § 271(f)(1) and its requirement of active inducement to necessarily mean inducement of another" (emphasis in original), adding that "[i]ndeed, we have never before held -- in the context of either § 271(f) or § 271(b) -- that a party can induce itself to infringe."  The Chief Judge noted that "[t]wice the Supreme Court has held that inducement liability requires a third party," citing Global-Tech Appliances, Inc. v. SEB SA, 131 S. Ct. 2060 (2011), and Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005) (an analogous copyright case), and countered that "[t]he majority cannot point to a single case -- from the Supreme Court or other wise -- that supports its contrary interpretation of inducement."

Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2014)
Panel: Chief Judge Prost and Circuit Judges Mayer and Chen
Opinion by Circuit Judge Chen; dissenting-in-part opinion by Chief Judge Prost

Comments

[Kaptain Korwood]

Zuhn: "In so holding, the Court explained that "[n]othing in the ordinary meaning of 'portion' suggests that it necessarily requires a certain quantity or that a single component cannot be a 'portion' of a multi-component invention." "

While the "self-inducement" analysis has its own problems, this "single staple item of commerce" aspect of the majority's holding is the part of the holding that is certainly going to lead to reversal. Jason Rantanen does a decent job of explaining why on Patently-O, and there is more explanation in the comments there: http://patentlyo.com/patent/2015/01/promega-inducement-ones.html

The majority rests its holding on the fact that the term "portion", in the abstract, does not exclude single items. The problem with the majority's hyper-abbreviated analysis is that (1) it ignores the plain language in the remainder of the statute; (2) it ignores the relationship of 271(f)(1) to 271(f)(2); (3) it ignores the purpose and history of the statute; and (4) it leads to absurd results never contamplated by Congress or any other patent system on earth. As a result, we have a stillborn holding that is going to be nullified before you can say "boo".

Here's 271(f)(1) with irrelevant parts deleted:

"Whoever ... causes to be supplied ... from the United States ... a substantial portion of the components of a patented invention, where **such components** [plural] are uncombined ... in such manner as to actively induce the combination of ***such components*** [plural] outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer."

With respect to (1), the plain language of the statute is clear that "such components [which] are uncombined" must be "supplied" so as to actively induce their combination overseas. The plain use and meaning of the plural component*s* is emphasized by the recitation of the fact that the components (plural) are "uncombined", as only a plurality of components could be.

271(f)(1) was plainly meant by Congress to close the Deep South "loophole" whereby an entity could avoid infringement of an apparatus by exporting the parts (plural) of an apparatus in uncombined form. 271(f)(2), in contrast, was intended to address the narrower situation where infringement is avoided by exporting a single "component" (typically a nearly completed apparatus) without any other purpose except for completion (typically overseas) into an otherwise infringing apparatus/kit/composition. Critically, however, 271(f)(2) excludes single **staple** items of commerce from its reach. If Congress wanted to include single, **staple** components within the reach of 271, why would it have excluded them from 271(f)(2) which, in stark contrast to 271(f)(1), is plainly concerned with the supply of single items?

The disastrous expansion of liability for exporters of single staple components (including not only public domain polymerase but nucleic acids and vectors in addition to ball bearings, springs, fasteners and other components recited in hundreds of thousands of US patents) under the majority's holding should be evident to everyone.

[Skeptical]

There is no such "disastrous expansion of liability for exporters." For 271(f) to apply, there STILL needs (in both (f)(1) and (f)(2) the finding that the sum total action [to which section f applies] in that foreign locale to be infringement "if such combination occurred within the United States."

Your alter ego has had this point explained often and well to him on the linked website that you provide.

What should be evident to everyone is that your artificially constrained view eviscerates the singular notion of what the word "portion" plainly means, and renders "substantial" to an equally constrained and artificial view of mere "plurality."

As to "certainly going to lead to reversal," I have yet to see where you under the guise of Kaptain Korwood (here) or any other pseudonym (MM at Patently-O, or countless other sockpuppets here) have actually provided a substantive legal position that provides credence to that "certainly."

Will you actually address ALL of the points offered in the various discussions to actually make your case?

Well, I remain...

[Kaptain Korwood]

Skeptical: "What should be evident to everyone is that your artificially constrained view eviscerates the singular notion of what the word "portion" plainly means,"

There is no "artificial constraint" and there is no "evisceration" of the term "portion". The term's meaning does not change when the statute is properly construed. It's the majority's construction, in fact, that "eviscerates" the requirement that "uncombined" "components" be supplied (or caused to be supplied) by the infringer. If Congress intended to cover the export of single staple items of commerce with 271(f)(1), they could have done that easily. Nobody would have written 271(f) in the manner in which it is written if the goal was to include non-combined, solitary staple items of commerce.

Skeptical: "For 271(f) to apply, there STILL needs (in both (f)(1) and (f)(2) the finding that the sum total action [to which section f applies] in that foreign locale to be infringement "if such combination occurred within the United States.""

With respect to 271(f)(2), in fact, the Federal Circuit found the **exact opposite** to be true in Waymark v. Porta Systems (Fed Cir 2001). The issue was not addressed with respect to 271(f)(1) but the language is similar in both statutes (e.g., 271(f)(2) recites that the infringer intends "that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable
as an infringer)."

Regardless, even if 271(f)(1) requires an actual combination overseas before infringement of the statute can be found, examples of overseas combinations that comprise at least *one* (!!!) US-derived staple items of commerce, where that combination would infringe a US patent, are hardly rare.

Make no mistake: this aspect of the majority's holding, at least, is going to be quickly nullified for all the reasons that I provided. I haven't done an exhaustive search but I can't find any examples where anyone even contemplates the statute having the scope given to it by the majority here.

It's odd that "EG" hasn't commented here on this topic. I thought he fancied himself some sort of expert on the topic.

[Skeptical]

Kaptain Korwood,

Did you even bother to read the case you cited (Waymark v Porta Systems)?

The case reads directly against your position here and at Patently-O. You appear to want to confuse the issue here by focusing on the "intend to ACTUALLY make" portion of the case, while ignoring all other aspects that fully indicate that you main view is simply not correct. In fact, the case actually provides even more credence AGAINST you.

Link to the case: http://www.finnegan.com/files/Publication/e29a29ea-240e-47af-8b14-eb583421b050/Presentation/PublicationAttachment/7370e820-3128-4948-ae4e-ec6939842615/00-1327-040601.pdf

I suggest that you spend less time searching to bolster your pre-conceived notions and more time simply listening to those attempting to educate you.

Will you listen to this sage advice?

Well, I remain...

[Kaptain Korwood]

"The case reads directly against your position here and at Patently-O."

No, it most certainly does not.

[Kaptain Korwood]

Skeptical: "You appear to want to confuse the issue here by focusing on the "intend to ACTUALLY make" portion of [Waymark]"

I don't know what you're talking about. My focus is plain: the majority in Promega reached the wrong conclusion and the decision is going to be nullified very soon for the reasons that I have stated here, and for the reasons that Professor Rantanen and Eric Guttag and others have stated on the PatentlyO thread.

I brought up Waymark only in response to your erroneous comment above, i.e., "there STILL needs ... in [271](f)(2) the finding that the sum total action [to which section f applies] in that foreign locale to be infringement 'if such combination occurred within the United States'".

Again, your statement is directly contradicted by the holding in Waymark. Infringement under 271(f)(2) does not require any "sum total action" overseas that would otherwise constitute patent infringement. As the Federal Circuit stated in Waymark, "At no point does the statutory language require or suggest that the infringer must actually combine or assemble the components. A party can intend that a shipped component will ultimately be included in an assembled product even if the combination never occurs."

And just so you aren't further confused, I'll repeat this to you again: regardless of whether the holding in Waymark regarding "actual combination" in the 271(f)(2) context applies equally to 271(f)(2), it doesn't change the fact that, for all the reasons I mentioned, 271(f)(1) plainly requires multiple components [plural] of a patented invention to be supplied in or from the US.

You are free to disagree, of course, with my conclusion, and Professor Rantanen's conclusion about the likelihood of reversal of this decision. And you are free to advise your clients accordingly. Have fun doing so and -- most importantly -- don't forget to collect your fees before the earth moves under your feet.

[Skeptical]

I see what you are doing here - and I have already noted the obfuscatory nature of "your argument."

You are conflating the "intend to do" portion of the case with the "act overseas" discussion that has been held so far.

Your attempt is akin to moving the goalposts of the discussion already held, and you wish to claim that this new wrinkle vindicates your views.

It simply does not.

All this new wrinkle does - as alluded to in the case itself - is ADD another possibility to the reach of infringement as "offer to sell" adds to an actual sale.

I suggest that you read the case again and see that it does not vindicate your views and there is no support - at all - for your conclusion that the current case of Promega is legally defective. You simply have not provided a LEGAL basis for your conclusion. Your attempted readings of the law violate statutory construction doctrines...

(for example 1 US 1)

...and you have simply "pounded the table" instead of pounding either law or fact. Your "reasons" are purely "emotive based" and lack a foundation and this can be easily seen with your refusal to actually address the counter points put to you in an intellectually honest manner (for example, refusing to admit just whom the law of 271(f) is aimed at - just who the inducer is).

Lastly, your "you are free to disagree" statement, replete with the implicit insult of "collect your bogusly charged fees while you can" has NO PLACE in this discussion. Please leave such out and instead focus on the points of law. Thanks.

Will you constrain yourself appropriately? Sadly, I remain...

[Kaptain Korwood]

And just like that:

http://www.law360.com/articles/612264/promega-life-tech-both-urge-fed-circ-to-review-ip-ruling

one of the very worst Federal Circuit decisions in recent memory is going to be wiped off the books.

[Kaptain Korwood]

Promega's petition for en banc rehearing (which will certainly be granted and which will certainly nullify the CAFC's misguided and ridiculous attempt to broaden 271(f)(1)) includes the exact arguments made here and the arguments made in the above-mentioned PatentlyO thread. Try to remember where you first read those arguments and try to remember where you didn't read them.

There's also this nugget:

"Remarkably, the Supreme Court has directly addressed this issue and arrived at a conclusion contrary to the Majority’s. The Supreme Court explained that “the two paragraphs differ, among other things, on the quantity of components that must be ‘supplie[d]... from the United States’ for liability to attach.” Microsoft v. AT&T, 550 U.S. at 454 n.16; see id. at 458 n.18 (contrasting § 271(f)(1), which applies to all or a substantial portion of a patented invention’s components, with § 271(f)(2), which “applies to the export of even a single component” under certain circumstances). There is no valid reason to defy such clear Supreme Court guidance, especially when the Supreme Court has expressly stated that there is a special presumption against a broad construction of this particular provision."

Oops.

[Skeptical]

Your quote from the dissent misses the on-point rebuttal from the majority opinion.

[Kaptain Korwood]

Skeptical: "Your quote from the dissent misses the on-point rebuttal from the majority opinion."

Speaking of obfuscation -- please try explaining to readers what you're talking about. What "quote" from what "dissent"? What "on-point rebuttal"?

It seems to me that it's you that "missing something" here. Keep digging, though. Maybe you'll find some blue sky eventually.

[Skeptical]

Kaptain Korwood, aka KK, aka MM aka Malcolm Mooney, aka any of dozens of sockpuppets (all the while pretending that sockpuppets are the worst thing ever),

Pretending to not understand where you grabbed your "nugget" wile also pretending that the majority position did not dispel the logic of that nugget, and then projecting "obfuscation" on someone else is clearly your hallmark.

It does not work over at Patently-O, and it surely does not work here.

Dr. Noonan, I hope you recover soon from the infestation.

[Kaptain Korwood]

Skeptical: "Pretending to not understand where you grabbed your nugget"

I don't even know what "nugget" you are referring to. And I haven't "pretended to grab" anything.

I did ask you a simple direct question, however, asking you to explain what you are talking about. And I notice you haven't answered it but instead you launched into a stream of weird insults.

[Skeptical]

More of the usual "Patently-O" tricks being put on display...

I did not say "pretend to grab" - clearly.

There is only one "nugget" that you have referred to. It is simply not believable that you do not understand the reference. Kicking up dust as to the very "Vinnie Barbarino" style, "Huh, what?" while ignoring the actual points of discussion is classic Malcolm Mooney claptrap.

There is no "stream of weird insults" from me. Your so-called "simple direct question" was already met with an even more simple directive to view the words used by the majority. Clearly, the majority having already dispelled with your "nugget" rebuts that "nugget," and is on point for what the "nugget" purports to stand for.

Overall, your latest post is much like the rest of your posts: not very interesting, lacking in legal "oomph," and heavy in meaningless ad hominem.

I will say this though: you are undeterred by your constant failure to make an actual legal point. I guess that counts for something... somewhere...

[Kaptain Korwood]

I'm still waiting for you the answer to my question. You wrote: ""Your quote from the dissent misses the on-point rebuttal from the majority opinion."

What "quote" from what "dissent" were you referring to? What "on-point rebuttal" were you referring to?

Skeptical: "you are undeterred by your constant failure to make an actual legal point."

My points are going to be adopted by the Federal Circuit en banc or the Supreme Court. Where will that leave you?

[Skeptical]

The games continue...

Same as it ever was with the poster otherwise known as Malcolm Mooney.