Claimed 'plant cell' must enable monocots and dicots; CAFC affirms noninfringement and invalidity of Monsanto GM corn patents

Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir. 2007)

Monsanto and its Dekalb subsidiary hold three patents covering Roundup-Ready Corn.

• 4,940,835 covers a GM gene that confers glyphosate resistance to plants.
• 5,538,880 covers the process of producing herbicide and insect resistant corn.
• 6,013,863 covers the process of producing glyphosate resistant corn having a marker gene.

Syngenta grew Dekalb GM seeds that had been produced according to the patented methods and then grew genetically identical progeny exhibiting the same GM traits. 

In the ensuing infringement litigation, the district court held that the ‘835 patent invalid for under 35 USC 112 for lack of enablement and held that Syngenta did not infringe the two process patents because the accused infringer did not perform the initial step of the claims. (That initial step of “bombarding … cells with DNA-coated microprojectiles” was performed by Bayer prior to issuance of the patents).

Enablement: The ‘835 patent is not limited to corn. Rather, it claims to be applicable to ‘plant cells.’ During claim construction, the district court found that the patent scope extended to all plant cells – including both monocots and dicots. However, the ‘835 patent was filed before genetic transformation of monocot cells was possible.

“The claim requires transformation of the plant cell. Without the ability to transform a monocot cell, one skilled in the art could not determine whether the plant gene could carry out the claimed functions and thus fall within the scope of the claim.”

Thus, the ‘835 patent is invalid for lack of enablement.

Infringement of Dependent Process Claims: Generally, a dependent claim includes all the limitations of its parent.  Here, however, Monsanto argues that its process claim structure necessitates an alternative viewpoint.  In particular, Monsanto argued in the alternative that its Claim 4 is (1) not a dependent and (2) even if a dependent does not require all the limitations of Claim 1. The process claims line-up as follows:

• Claim 1: A process for producing a fertile transgenic Zea mays plant comprising the steps of …
• Claim 4: A process comprising obtaining progeny from a fertile transgenic plant obtained by the process of claim 1 which comprise said DNA.

Thus, Claim 4 is directed to a process of growing seeds from a plant that was produced according to the manner of claim 1.  This could be considered a claim directed to a process of using a product of a process.

The CAFC quickly shot-down Monsanto’s argument — holding that claim 4 is a dependent and the all element rule applies.

“Although in a somewhat unusual format, claim 4 is dependent from claim 1 because it only stands if all three steps recited in claim 1 have been performed. In other words, the additional fourth step of obtaining progeny depends on the performance of the process comprising the three steps recited in claim 1 for obtaining a fertile transgenic plant. Claim 4 contains each element of a dependent claim.”

The court also repeated its rule that one “cannot infringe” a dependent claim without also infringing the parent claim.

271(g) Infringement: Under 271(g), a product made by a patented process also creates infringement liability.  Here, however, Syngenta could not be held liable because several steps of the process were performed prior to issuance of the patent.

“Infringement is not possible under § 271(g) when the three first steps of the claimed process are performed before the issuance of the patent.”

Summary judgment of noninfringement and invalidity affirmed.

 

 

Comments

[Malcolm Mooney]

"In particular, Monsanto argued in the alternative that its Claim 4 is (1) not a dependent and (2) even if a dependent does not require all the limitations of Claim 1."

LOL!!!!!! The scent of desperation in the courtroom must have been visible as a thick brown cloud.

[Andrew Dhuey]

As it happens, I was at the court that day, as this case was heard right before mine. All I remember about this is being very confused about what Monsanto was arguing. The judges seemed to be having difficulty following Monsanto's argument as well.

[anonymous]

The court did not treat Claim 4 as a single-step method of using a product made by the three-step process recited in Claim 1. Instead, this court treated this as a four-step method and, since the three steps were performed prior to the issuance of the patent, there was no infringement.

What if -- instead of claiming "A process comprising obtaining progeny from a fertile transgenic plant obtained by the process of claim 1 which comprise said DNA." -- Claim 4 claimed "A process comprising obtaining a progeny from a fertile transgenic plant, the fertile transgenic plant having been previously obtained by [steps of process]."? Is there any way to draft claims to cover the use of a product-made-by-a-process where the user did not make the product?

[Malcolm Mooney]

"Is there any way to draft claims to cover the use of a product-made-by-a-process where the user did not make the product?
"

Yes. They're called "method claims."

Referring to the use of "a product-made-by-a-process" in a method claim, however, is just as silly as any product-by-process claim itself.

If you want a claim to the use of a product, describe the product in an unambiguous way, i.e., without resorting to a discussion of the product's history.

[me]

Maybe the drafter meant this to be a method claim, and to add a fourth step, and the litigation counsel decided to foist this argument on the court.

Can you imagine if all the alternative language used in dependent claims were read to not include all limitions of the incorporated claim? Chaos and uncertainty would ensue. Kinda hard to believe it was even argued.

[EG]

If there was novelty and unobviousness in doing the 4th step of dependent claim 4 (the main dependent claim), claim 4 could have been written as an independent claim to refer to the end product of the first 3 steps of claim 1. For example, claim 4 might have been written as "A process for obtaining progeny from a fertile transgenic plant comprising the steps of: (a) providing progeny from a fertile plant having the DNA created [by whatever the first 3 steps were in claim 1] ; and (b) obtaining progeny from the fertile plant of step (a). In other words, load all the steps that are practiced by the patentee into step (a) so that all that's needed for direct infringement is to do step (b). What surprises me is that, if the patentee was certain to practice the first 3 steps of claim 1, why the patentee didn't create such an independent claim 4 (as suggested) to cover the more likely infringement scenario. (It's possible that the patentee feared that step of claim 4 might not be patentable by itself and for this reason didn't put in such an independent claim, but it still might have been worth a try.)

[me]

Under the new rules you may be forced to write these claims as dependent to get under the 5/25 rule - but the PTO claims there is no effect on patents of the new rules.

I can find noone who thinks filing an ESD is a good idea.

[GK]

If the method claim had been directed to a product "obtain*able* by the process of cl.1" rather than "obtain*ed* by ...", would that have done the trick?

[me]

Who really knows, but I would not think so. If you write a dependent claim the case law is clear you bring in each and every limitation no matter the language. What makes this weird is the product by process angle though, as you point out.

[Malcolm Mooney]

"What makes this weird is the product by process angle"

Indeed. That is because the case law relating to product-by-process claims is very "weird" and will remain so until The Great Day When Such Claims Cease To Be.