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« Biotech/Pharma Docket | Main | Plaintiff(s) File Petition for Rehearing in AMP v. USPTO »

August 25, 2011

Comments

Kevin,

A "breath of fresh" air from the Federal Circuit on how to manage the nebulous, almost unusable guidelines in KSR International on how to determine obviousness. If only the Federal Circuit could be consistent on this subject.

The Pfizer v. Apotex decision was wrong, plain and simple. I am glad to see that the Fed. Cir. appears to be takine a more reasoned approach to chemical obviousness.

To me, these 103 cases demonstrate how critical presentation of the facts/evidence is in chem/bio cases. Recall that Rader had a hand in the In re Kubin debacle, and (I believe) even said that biochemistry is more like computer science than chemistry. *shudder*

Awesome victory for Big Pharma!!!!!

"In Pfizer, the Federal Circuit reversed a District Court finding of nonobviousness (determined under the TSM test), relying in part on a reference (Berge) that disclosed 53 FDA-approved anions for making pharmaceutically-acceptable salts, including the anion -- benzene sulphonate -- used to make amlodipine besylate. There, the choice of salt was considered merely to reflect a design choice and the beneficial and purportedly unexpected properties were discounted by the panel. In today's opinion, the Court appears to have returned to its prior tendency to understand that the pharmaceutical formulation arts are sufficiently unpredictable that there is a real threat of hindsight reconstruction in the face of successful novel formulations of known compounds."

Or the facts were simply better for the patentee in this case.

Pfizer seemed (and still seems) like a very reasonable decision.

"these 103 cases demonstrate how critical presentation of the facts/evidence is in chem/bio cases."

This is true of all litigated cases where a great deal is at stake and both parties are invested in the result.

"Recall that Rader had a hand in the In re Kubin debacle, and (I believe) even said that biochemistry is more like computer science than chemistry."

Oh yes, the "debacle" that destroyed the biotechnology industry overnight. Who can ever forget it?

It is really very interesting to know about the nonobviousness for Fortical. As a formulation scientist, I would like to state that we can only make a different formulation compositions but the real thing is the language (used to construct claim in patent), its interpretation and supportive arguments/cases which make the composition obvious or non-obvious.

Kevin and all, I am in-house IP counsel for Upsher-Smith (the co-plaintiff in this case), and I don't want to comment on this case for obvious reasons, but I will comment on Pfizer.

Pfizer was wrongly decided, by a court trying to save face in view of KSR. (One bit of supporting evidence is that the CAFC invalidated the patent THREE DAYS before its natural expiration. Why waste ink on an opinion in that situation?)

Steve Berge, the author of the notorious Berge reference, sits across the hall from me. I brought the Pfizer decision to his attention when it first came out. He was shocked that they would find the besylate salt obvious, because salts are inherently unpredictable. He was not pleased that his reference was actually used to support the contrary proposition. Frankly, I am surprised that no one from Pfizer contacted him for testimony. (But then again, they had three district court opinions in their favor.)

Pfizer was wrongly decided and should have been overturned en banc. It stands for the proposition that salts are not patentably distinct, regardless of secondary considerations. In short, the rationale to make any pharmaceutical salt is (supposedly) provided by Berge. That cannot be the right result. So any decisions that the CAFC makes now to distance itself from Pfizer are to the good.

It should never be forgotten that cases are fact specific.

As I remember in Pfizer there was a short list of about 7 anions with a realistic chance of success, amongst which besylate was prominent. That may have been true or false as a matter of technical reality, but it is what had been established on the trial record. Apparently (and not going too far into the specifics) this case was different.

There has been a run of CAFC decisions recently where rejections based on a combination of hindsight-selected references has been refuted. Some of these reference combinations could only realistically have been created using the infinite improbability drive of the Heart of Gold spaceship from the Hitchhiker's Guide to the Galaxy, see particularly In re Klein. If commonsense is to be applied in validity determinations then it should be exercised in the selection of the references on which rejections are based. Over-exuberant examiners in the USPTO and elsewhere should take note.

Paul, what does "chance of success" mean? Success with respect to what? I'm not trying to be argumentative. What I'm getting at is that the maleate salt was suitable (i.e., "successful") under some criteria, so why would one go beyond that? Recall, in addition to Pfizer's development of amlodipine maleate, DRL tried to develop (and maybe did develop) a maleate version, although it was never marketed.

The besylate solved problems OTHER THAN those that were outlined in the specification or the earlier patent, and problems that were likely known only to Pfizer at the time of filing. In short, the CAFC used Pfizer's own knowledge to establish its motivation to look for a different salt form. In addition, they used Pfizer's own knowledge and testimony to establish reasonable expectation of success. There is (to my knowledge) nothing in the prior art that indicated the problems with the maleate salt, nor anything that would have specifically indicated "success" in overcoming those specific problems (known only to Pfizer) by switching to besylate.

There are plenty of indicia of nonobviousness. In the Pfizer case, the appellate judges substituted their view for the PTO and for three district court judges who found nonobviousness over the same prior art. The CAFC panel went so far as to say that it was nearly an unrebuttable prima facie case. So to save face for themselves in view of the impending KSR decision, they had to denigrate the prior decisions of three judges and at least one examiner.

@Sean

Courts do not decide cases on objective technical reality, but as I have said, on the record before them. A court is essentially a machine for evaluating testimony in the light of the arguments of counsel. Here are the key quotes from Pfizer

"Dr. Wells readily compiled a list of seven alternative anions—including the besylate—each of which he expected would form an amlodipine acid addition salt:

Q. And one of the reasons why you chose these various salts [sic], or suggested these various salts [sic], is because you expected that they would be able to make a salt of them, correct?

A. There was an expectation, but that wasn’t guaranteed.

Q. And when you chose these salts . . . you believed that if you could, in fact, make an amlodipine salt out of them, these might be a cure for the problems you were having with maleate, correct?

A. Indeed."

With this testimony, no doubt elicited by skilled and well-prepared counsel, there was clear evidence on the record that besylate was obvious and that its advantages was what we Europeans would describe as a mere bonus effect.

I fully accept that there was politics at the relevant time, and that the “choice from a few logical alternatives” language in KSR was inspired by Pfizer. But that case was decided according to the trial testimony. If you are in any doubt about that have a look at the little gem of trial testimony at footnote 13 of Graham v John Deere:

"Q. . . . Do you regard the small degree of flex in the forward end of the shank that lies between the pivot point and the point of spring attachment to be of any significance or any importance to the functioning of a device such as 798?

A. Unless you are approaching the elastic limit, I think this flexing will reduce the maximum stress at the point of pivot there, where the maximum stress does occur. I think it will reduce that. I don't know how much.

Q. Do you think it is a substantial factor, a factor of importance in the functioning of the structure?"

"A. Not a great factor, no."

With that testimony on the record, counsel for Graham must have just wanted a dark place within which to hide and nurse his grief: the case had been lost in an instant. However well you prepare and however meritorious the case, it can be lost in a few moments of testimony, and that is a reality that we all face.

On reflection, Pfizer was lost on a single word: "indeed".

If Dr Wells had said that although you might get a salt there was no way of knowing in advance what its properties would be, whether it would be better or worse than maleate, or whether a salt with better properties than maleate even existed, then the decision should have been otherwise. Scientific caution would have suggested this view. But he went along with counsel, probably without realizing the significance of what he had said, and the decision followed.

You can discuss a case at length with a witness. You can ask him the questions the other side might ask, and ascertain what the answers are likely to be. But when the witness goes into the box and is asked questions by opposing counsel it is like a child's paper boat launched on a pond: the wind will blow it where it will.

It is exactly the same before the UK courts because our two legal systems are in essential respects the same. And it is no different in the EPO: if you have a witness testifying or if a technical expert is asked a question by a member of the examining or opposition division or appeal board, the case can be lost (or equally possibly won) on a word.

@Paul, you seem to be slipping into the same trap as the Pfizer CAFC panel, which is to treat the inventor's testimony as determinative of what was obvious to the person skilled in the art. There is no way Wells' testimony regarding how he arrived at the invention should be used against Pfizer (see 103(a)).

I will note that Rader's opinion in Unigene is careful not to confuse Dr. Stern with the POSA -- see page 18.

Had Dr. Berge (who would be an expert who could testify as to the knowledge of a POSA) been asked, he would have stated exactly what you wrote -- there was no way of knowing in advance what the salt's properties would be, whether it would be better or worse than maleate, or whether a salt with better properties than maleate even existed.

But in the end, this case was won 3x over by Pfizer, and only lost because the CAFC decided they needed to save face. The testimony/evidence had little to do with it. As many judges do, they cherry-picked evidence to support their decision, rather than taking the evidence as a whole and providing some deference to the numerous lower decisionmakers.

@ Sean

There is much case law in Europe that a court or the EPO can disregard inventor testimony where the inventor is not representative of a person skilled in the art. But I know of no authority that a court must disbelieve an inventor's testimony on inventive step where that testimony is credible and considered to be representative of the prior art. The mere fact that Dr Stern was not considered to be typical in Unigene is no reason for saying that the court was wrong for believing Dr Wells in Pfizer. It is all down to the individuals and the trial transcript.

Furthermore, this is surely an area where there is some flexibility available to the judges. If there is no rigid rule, there can be no "trap".

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