*Somerset Pharmaceuticals v. Dudas* (Fed. Cir. 2007)

Somerset filed a Patent Term Extension Application with the PTO about one year before its pharmaceutical patent was set to expire. The PTO eventually denied the application with one month left on the patent term. (The PTO only acted in July 2007 – after Somerset filed an emergency motion with the CAFC).

On appeal, Somerset asked the appellate court for a preliminary injunction that would order the PTO director to issue an interim term extension pending the patent holder’s appeal of the extension denial.

In the Federal Circuit, preliminary relief is only granted where the moving party establishes at least a threshold “reasonable likelihood of success on the merits.” The appellate panel found no likelihood of success — thus denying the appeal.

Somerset had appealed the PTO’s failure to issue an interim extension. However, once the PTO denied the extension application, the director no longer had power to issue an interim extension. 35 U.S.C. § 156(e)(2). Consequently, the PTO’s denial of Somerset’s extension application means that the company’s case for an an interim order loses its merit.

Notes:

- This opinion was originally published on July 31, 2007, but was reissued as precedential on October 4, 2007.
- Perhaps without noticing, this case appears to raise the “threshold” level of potential success required for a preliminary injunction from “a likelihood” to “a reasonable likelihood.”
*See Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd.*, 357 F.3d 1319, 1325 (Fed. Cir. 2004) (“[A] movant is not entitled to a preliminary injunction if he fails to demonstrate a likelihood of success on the merits.”). - It appears that the formal positioning of the case – created by the PTO’s delay in issuing a decision – helped the PTO win the appeal. If Somerset has some likelihood of winning an appeal on the merits of the PTO’s extension denial then it might have asked the court to issue an interim extension (rather than ask the court order the PTO director to do so).
- This decision continues the formal reading of the PTE statute.
*See, Merck & Co. v. Hi-Tech Pharmacal Co.*, 482 F.3d 1317 (Fed. Cir. 2007). - Orange Book Blog on the decision

…can’t everyone tell the difference between a %60 likelihood and a 59% likelihood in a federal trial?… I suppose the court knows it when they sees it.

…a “reasonable” likelihood of success is something probably a good bit more than 51%, which is essentially a crap shoot. A %60 or greater likelihood *of success* is starting to get more “reasonable.”

If you analyze it a “likelihood of success,” by definition, constitutes a greater than %50 chance of winning, else it would be a likelihood of failure. Put it this way, the court will not grant an injunction if you can’t show that you have a good chance of winning your case (subject to any required showings related to the other factors as Dennis mentioned)

“I think I see what you’re driving at … but I don’t think it makes much sense. A “likelihood” is a “likelihood,” e.g., “more probable that not.” As for “some likelihood,” I think that is most reasonably construed as a “a degree of probability between 50 and 100%.”

I’d have to disagree

By dictionary definition, likelihood can mean the state of being likely (i.e. a probability somewhat than 50%) or it can simply refer to essentially any non-zero probability (e.g. “a 10% likelihood”). The expression “no likelihood” means a probability of success very near zero and would exclude probabilities in the close vicinity of 50%.

Accordingly, expressions like “reasonable likelihood” and “substantial likelihood” are ambiguous particularly when they are used in a balancing test.

In this case, the probability of success was exactly zero because the relief asked for was ungrantable. No matter what the definitions are for likelihood or reasonable likelihood, neither was present here.

Tom, what is the first definition in that dictionary for the term, “probable”?

Malcolm, your definition is not correct. A “likelihood” is not equivalent to “more likely than not.” The American Heritage Dictionary defines likelihood as:

1 The state of being probable; probability.

2 Something probable.

Maybe all this would make more sense if “likelihood” were replaced with “probability.”

I agree that I do not see any difference between “a likelihood” and “some likelihood.”

“I would consider a reasonable likelihood of success to be a greater requirement than “some” likelihood of success as well as “a” likelihood of success.”

I think I see what you’re driving at … but I don’t think it makes much sense. A “likelihood” is a “likelihood,” e.g., “more probable that not.” As for “some likelihood,” I think that is most reasonably construed as a “a degree of probability between 50 and 100%.”

I agree that “a likelihood” or “a reasonable likelihood” is more probable than “a theoretical possibility.” In your analysis, you appear to be equating “a likelihood” with “a theoretical possibility.” If so, then there can’t be any difference between “a likelihood” and “some likelihood.”

We’re talking about two different standards here. Preliminary injunctive relief generally requires that the moving party satisfy the traditional four-factor test of equitable relief. Those four factors include a “reasonable likelihood of success on the merits;” irreparable harm to the moving party if an injuunction is not granted; a balance of hardships weighing in favor of the moving party; and the public interest supporting a preliminary injunction.

Remember, this is a four-factor test, not a four part test. (Think standards vs. rules). It turns out that not all four factors need to be shown in order to receive preliminary relief. For instance, a court might issue a preliminary injunction if the moving party shows only three of the four factors.

Some courts, including the CAFC, were wary of these factors and hoped to make them more rule-like. Thus, there has been a continued movement to say that some of the factors must be proven to at least a threshold level. According to the CAFC, the moving party must prove at least a likelihood of success on the merits as well as some irreparable harm. The other two factors are presumably less important, and a preliminary injunction can issue without proof of those two factors.

Part of this case was about the ‘threshold’ to what extent must the ‘likelihood of success’ be proven? Historically, the court has required simply some likelihood of success on the merits of the case. In my view, that meant that the moving party must at least prove that it has a defensible legal position. In this case, the court requires a ‘reasonable’ likelihood of success to even meet the threshold minimum. I would consider a reasonable likelihood of success to be a greater requirement than “some” likelihood of success as well as “a” likelihood of success. This makes sense because we’re talking about a threshold level of proof to even be considered. The threshold likelihood must be shown even before a court will consider the four factor test.

The quote from Nat’l Steel Car, e.g. “…movant is not entitled to a preliminary injunction if he fails to demonstrate a likelihood of success on the merits” does not articulate a standard. Rather it is a statement that would be consistent under a rule that required a reasonable likelihood standard.

In Nat’l Steel Car, IMHO, the CAFC is essentially stating that if the movant fails to show a likelihood, e.g. any likelihood, then they are not entitled to an injunction. I think a failure to show ANY likelihood is separate from whether the likelihood that is shown is sufficiently “reasonable” to support the grant of injunction. It sounds like in Nat’t steel there was no showing.

It reminds me of Maurice Mitchell, who failed to put on any evidence of a structure amounting to the claimed means even when given several chances at trial court.

sorry, not sure why my comment was repeated twice…

Mr. Roethal, Mooney’s smarmy comment goes to notes author of this article and not the clerk. As far as I can recall the standard has always been reasonable likelihood or substantial likelihood. Any standard would be further subject to the local rules of procedure for each federal district court.

I’m having some trouble with the fact that I am actually in agreement with Mooney. I have to go wash up now…

Mr. Roethal, Mooney’s smarmy comment goes to notes author of this article and not the clerk. As far as I can recall the standard has always been reasonable likelihood or substantial likelihood. Any standard would be further subject to the local rules of procedure for each federal district court.

I’m having some trouble with the fact that I am actually in agreement with Mooney. I have to go wash up now…

Adding “reasonable” does not raise the bar. You cannot have a likelihood that is not reasonable, otherwise it would not be a likelihood at all.

Notwithstanding Malcolm’s smarmy comment, his point is well taken. Opinion writing (as well as specification, claim and agreement writing) should not be creative writing. Unless it is the court’s intent to inject confusion into the case law, the court’s law clerks should stick to the same exact language that was contained in the precedential decision upon which the current decision relies. And the judges might wish to read the decision before they sign it.

“Perhaps without noticing, this case appears to raise the “threshold” level of potential success required for a preliminary injunction from “a likelihood” to “a reasonable likelihood.”

How does the use of the term “reasonable” constitute a “raise” in the threshold? Was it the case before that an “unreasonable likelihood” was sufficient?