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November 27, 2023

Comments

Couldn't the court just as easily have found that Allgenesis *did* have standing? And given this decision, what additional evidence could the company have provided to establish injury in fact? Would it have been sufficient to state on the record that they were planning to move forward with phase III trials if they could be assured of noninfringement in taking the product to market (which seems to be implied by what they said and their filing the IPR), or would the judge have required evidence of some $$$ expenditure that was then halted awaiting a noninfringement decision? This decision seems to pose an unfixable problem for companies trying to avoid infringement without possibly wasting resources (by moving ahead regardless of the risk). Also it seems completely contradictory to the Supreme Court allowing standing in 303 Creative LLC (even though that was a first amendment case). This result also effectively confers additional deterrent power to patents such as Cloudbreak's that may be invalid but now are further insulated from challenge.

Bosco,

No - Allgeneis did not have standing. The Court asked that the allegation be substantiated, and Allgenesis chose not to.

A future choice is simply not enough to provide a present case or controversy.

There is NO implication as you seek with filing an IPR, as the AIA provided that standing is NOT REQUIRED to file an IPR. There is no bootstrapping to be found.

One simply does not obtain Article III standing merely because one might want to avoid "wasting resources." Our courts do not - and never have - worked that way.

I am not familiar with the 303 Creative LLC case that you speak of - can your elucidate your position that such a case would present?

Lastly, I am not grasping the alleged "may be invalid" position - apart from your seeming to want to eliminate Article III standing altogether.

Skeptical, I can't tell exactly what happened but I imagined that this question was asked late in the case, possibly during oral arguments when there was not further opportunity to present evidence, or it seems like Allgenesis would have done that. After all, they carried out a Phase II trial so they have already made a significant investment, and indicated that they still have plans to produce a commercial product. The court found these statements vague and conclusory. So what would be required to show "nonspeculative, concrete plans for future activity that creates a substantial risk of future infringement"? Do they have to bring in blueprints for a manufacturing facility? Do they have to put money in escrow that would go towards funding the phase III trial? How exactly can they establish injury-in-fact in this situation without having to put time and money into efforts that might later have to be discarded as infringing? I found a good review on this topic by some Finnegan attorneys: Mills, Corquindale, and Cooley (2021) IP Litigator, "Injury in Fact: Establishing IPR Petitioner Standing on Appeal," but it doesn't seem like the cases provide clear guidance on the exact requirements.

More than mere attorney statements - clearly.

I would even imagine as sufficient a "show me the receipts" position.

The fact remains that Allgenesis CHOSE not to do so.

They have to live with that choice.

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