About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
Juristat_165
Juristat #8 Overall Rank

E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.

Pharma-50-transparent_216px_red

Become a Fan

« Zeroclick, LLC v. Apple Inc. (Fed. Cir. 2018) | Main | GW Pharmaceuticals Wins FDA Approval of First CBD Drug »

June 26, 2018

Comments

I find this comment both interesting and in need of more support:

"The Federal Circuit found the District Court erred by applying the FDA standard rather than the proper patent standard in making its (erroneous) determination that the invention was not "ready for patenting" before the critical date."

If the utility of the claim is such that without meeting the FDA standard, there is NO utility, then the FDA standard IS the proper patent standard.

I "get" the GENERAL view of "Specifically, the standard is that the invention "works for its intended purpose 'beyond a probability of failure' but not 'beyond a possibility of failure.'" - but that GENERAL view is not tied to what Pharma wants to patent - especially in the manner of possession (35 USC 112) combined with utility (35 USC 101), or perhaps more precisely, possession OF the utility.

Be that as it may - such simply is NOT the question before the Court, so anything advanced along this line amounts to - at BEST - dicta, and at worse, misleading argument posing as substantive law.

Likewise not before the Court - "The contingent nature of FDA approval did not refute this conclusion," is the dirty little Pharma secret that MANY items applied for patent actually FAIL that contingency (of the FDA) and do NOT possess the utility as reflected in claims at the time of filing.

This is MUCH like the attempted patenting of a "study plan," that the Court has rejected as not possessing utility at time of filing.

For some reason, Pharma appears to get a "pass" on actual possession (not withstanding the difference noted above of the patent standard of the GENERAL view). The "rule" for Pharma appears to be to start the patent process at a time when what is possessed is merely the "study plan," and HOPE that the FDA trials bear fruit (on the level of utility for that which is claimed).

By the way, I would posit that the notion of "The opinion also cited the Court's own precedent regarding the existence of a sale despite the presence of conditions precedent to commercial transfer of goods" is inapposite to the legal question here. Conditions precedent to COMMERCIAL transfer does not bear on patent timing, due at least in part to the fact that "sale" is complimented in the patent sense by "offer for sale."

Separately we can explore the error of "the panel identified Supreme Court precedent directly contrary to their position, i.e., Pennock v. Dialogue, 27 U.S. (2 Pet.) 1, 19 (1829)." Sadly, Pennock is often misunderstood as some magic "Constitutional" writing when what happened in Pennock was directly tied to the statute of the time.

By the way, the linked case of Medicines Co. v. Hosperia includes the now-no-longer-valid ability to "swear back" in relation to "experimental use" for validity testing (as opposed to outright commercial sales).

An interesting wrinkle then is that now that one CANNOT swear back, any such "validity testing" is an indicator that the item is NOT "ready for patenting," and for which augments the position I noted above in regards to the combined 112 possession of the 101 utility AT the time of filing.

Perhaps it may be argued that the seeming "collapse" away from the GENERAL standard for Pharma is "unfair" because other innovation art fields do not have such a FDA standard to show (possession of actual utility) merit for being allowed to be on the market.

But whether fair or not, the bottom line is that prior to those very FDA trials, Pharma DOES NOT KNOW whether it actually possesses that which is claimed when they DO file.

If - as the Hospira case seems to advance - that the validity trials are necessary FIRST to show possession of utility, THEN the argument switches to whether or not the time of filing is "fair or unfair" given that those trials to show actual possession involve public disclosure and may take longer than the year allotted all art units between public disclosure and filing.

But THAT is a different argument, and whatever unfolds from that argument should NOT mask whether or not possession of utility - of actual utility and not a study plan for utility - is there AT time of filing.

Anon, you complain here that pharma patent are treated differently than patents in other fields (as you did not long ago on PatentlyO in the discussion about Senator Hatch's proposed revision of the statute).

And if pharma patents are treated differently, so what? Drugs are different from computers, automobiles, software, drilling equipment and pet enclosures. I see no problem with different standards for patentability for different types of things...and in point of fact, neither have the courts or the PTO. (Think of the distinction the courts have drawn between "predictable arts" and "unpredictable arts", for one example.) The point of the patent system is to promote the progress of useful sciences. You seem to be angling for stifling such progress in the name of doctrinal purity.

The reality of drug development is that you have file your patent applications at the outset of the process, before you begin clinical trials, and many years before the safety and efficacy of a drug candidate is proven. So if "ready for patenting" for pharma means up to FDA approval standards, then there will be no new drugs.

Maybe that's the kind of world you want to live in.

Personally, I'd rather see new drugs reach the market, especially for diseases and conditions for which there presently are no treatments. If that means that the standard for showing utility in a pharma patent application is merely showing binding of a class of molecules to a particular receptor, or inducing some activity in cells in vitro, I can live with that. If it your top one or two drug candidates eventually fail in FDA trials, no one's going to infringe the patent anyway, and you're probably just going to let it lapse.

Thanks Dan. Mostly, I agree. But I baulk at the notion of different rules for different art fields. There is no need for that, at least under a First to File system.

One way to regulate patentability is to punish filings that are too early and too speculative. Find their claims bad for insufficiency or inutility. Filing on pure speculation must be deterred, if the patent system is not to be harmed. In a properly functioning FtF jurisdiction, that deterrent is extremely potent (you disclose to your competitors, but end up with no patent rights of your own).

Of course, it is counter-productive (as you say) to punish pharma for filing at the earliest appropriate date. We want all those useful contributions to the art to be revealed to the public, as soon as possible.

What is the earliest safe date on which to file? As early as possible but not too early? Why, when you can write a specification that contains evidence enough to render it "plausible" that the medicament has the effect boasted of, in the application, on the filing date.

This is not rocket surgery or brain science, to name but two specific art fields, just common sense.

Mr. Feigelson,

I take your position as an admission that my legal views are correct.

Thank you.

Skeptical:

First, thanks for confirming that you are "anon".

Second, you're wrong on the law: as I noted, as a descriptive matter, the courts already treat different technologies differently; and prescriptively, that's as it should be.

Third, this is my last entry in this discussion, because I'm not going to continue using my real name while your identity remains veiled.

The Pennock v Dialogue concern that the Helsinn Federal Circuit opinion raises at its footnote 10 is better addressed by the forfeiture doctrine announced in D.L. Auld v. Chroma Graphics, 714 F2d 1144 (Fed. Cir. 1983). Attempting to deal with it using the statutory on sale bar creates the problem of how to treat secret sales by third parties unrelated to the patentee. W.L Gore v. Garlock, 721 F2d 1540 (Fed. Cir. 1983) held that such sales were not prior art, but other cases have struggled with this problem, often reverting to the fact that the sale made product embodying the invent available to the public. If the express language of DL Auld is accorded proper weight the AIA changes to 102 did not impact this judicial doctrine which was not an interpretation of 102but an independent doctrine like inequitable conduct or obviousness double patenting.

evidence enough, you say?


Sure, who can argue with that.

But what exactly does that mean? Does that mean that a study plan is enough? Does that mean that a claim (as filed) need be to non-human efficacy? Or does it mean that the claim as filed must be commensurate with the results actually possessed?

Keep in mind here that the fact remains that MANY "hopeful" drugs wash out during FDA trials and simply do NOT have (as in do not have the possessed utility) what is claimed in the as-filed application. Common sense dictates that such a consistent failure demands more - at the time of filing - than a mere "hope and study plan."

As to Mr. Feigelson's weak argument about "rather see new drugs reach the market" and "maybe that's the kind of world you want to live in" - you ASSume your own conclusion that Pharma "MUST" be treated differently. You also directly indicate that treating Pharma differently is "ok" with you.

It is not "ok" with me - at least, not on the basics of a functioning patent system which includes possession at time of filing.

The problem that you run into with the mindset of "treat pharma differently" is the "divide and conquer" approach that you see right now. You mention Sen. Hatch - but what you don't mention is just why the exemption proposed is so bad, or why it is a fallacy to want to treat Pharma different directly in relation to why the original IPR scheme was sold (to take care of patents that should never have been issued). If such "ends" are "good enough" for all other art fields, there has been NO cogent reason provided as to why such "ends" are also not "good enough" for Pharma.

Put aside your assumptions that Pharma "MUST" be treated differently. By treating Pharma the same (especially in the basics), the competitive field applies to all, so there is NO "calamity" that drug development will not happen.

Mr. pope,

You say " If the express language of DL Auld is accorded proper weight" - and I agree.

Unfortunately for your position, the proper wight for the express language is non-controlling dicta, at best.

Take note of what a holding in that case would need to deal with:

"ISSUES

(1) Whether issues of material fact were present, rendering issuance of summary judgment improper.

(2) Whether absence of an oral hearing before issuance of the original order rendered that order invalid in this case."

Your ascribed position is not necessary to resolve the issues before that court.

anon (Skeptical) asks me, what does "enough evidence" mean, when the criterion is "made plausible? Answer: read the White Book of The Established Caselaw of the Boards of Appeal of the EPO. By now there are plenty of Decisions on the point. They come from oppositions, which are full-blown disputed inter Partes proceedings at the EPO, in which the patentee averred that the application as filed did succeed in making "plausible" the technical effect relied upon for patentability. And the Opponent argued the contrary.

You might be surprised, how easy it is for a highly specialised Technical Board of Appeal to rule on that issue, after hearing all the evidence.

Mind you, the EPO isn't constrained by any complex Rules of Evidence. It decides the technical issue on a "free evaluation" of the merits of the cases advanced by the opposing sides of the argument.

In D.L. Auld, once one decides that there are no issues of material fact and that a hearing was not required, one still has to apply some rule to find the patent invalid. The announcement of the rule which will be applied is not dicta. The Federal Circuit affirmed a finding that the evidence of record clearly established that D.L. Auld had commercially exploited its secret process for more than a year before the critical date and that there was not sufficient evidence to the contrary to merit a trial. The Court then had to decide what was the legal consequence of that factual finding. It found that it worked a forfeiture of the right. That legal finding is assuredly not dicta.

So, MaxDrei, to arrive at an answer, one must read the White Book, and if one does not find a spot on case, then one must litigate to arrive at an answer?

Since you place so much faith in the answer having arrived from "They come from oppositions, which are full-blown disputed inter Partes proceedings" - how does one get there from here (without oppositions)?

And clearly, there being so many (as you proudly state), any one in particular is likely not to do (elsewise, you would not have so many).

It does not sound like your answer is a very good one (a priori, and without litigation/opposition).

Mr. Pope,

Anything not addressing the stated issue of the case is dicta (at best).

My position stands.

No, anon, it is not necessary to litigate to arrive at an answer.

What is important (in any jurisdiction) is the degree of confidence with which a competent patent attorney can assess the outcome, if it ever were to come to litigation.

Ask around. You will find that European patent attorneys have a lot of confidence in their predictions.

And observe the changes in each successive edition of the EPO White Book, of the Established caselaw of the EPO. In successive early editions, when the EPC was new, there was a lot new, in each succeeding edition, on the substantive provisions of the law of patentability. By now though, there is very little of that in the Book. It is in the details of procedure that, these days, each new Edition distinguishes itself from the one immediately preceding.

Do you not learn at Law School how the law develops in a civil law jurisdiction?

Of course, when opposition at the EPO is so cheap, you can't stop parties opposing, thinking they might "get lucky".

But every decision on an opposition is another data point. The more such data points, more than a thousand every year, the more the members of the Boards learn how to express themselves precisely. This learning process, this evolution, informs each new decision that an EPO Board hands down.

Thank you, MaxDrei

Your comment though about civil law jurisdiction flies in the face of your aversion to res judicata (as discussed elsewhere).

And again - if you are adding "more than a thousand every year," then you cannot have your "By now though, there is very little of that in the Book."

Which is it?

And how much "informing" can you have when you keep on adding data points instead of using the results of prior data points? It almost sounds as if you want our system of courts hewing to their past decisions unless a court with more import expressly overrules.

The Summary Judgement which was affirmed by the Federal Circuit in D.L. Auld v. Chroma Graphics was "that Patent No. 4,100,010 was, therefore, invalid".

To reach that ultimate holding the Federal Circuit did need to make some intermediate findings: "(1) that no genuine material issue of fact was present; (2) that the contradicted facts of record establish that the claimed method invention had been commercially exploited more than a year before the crucial date; (3) that no possibility of proving an experimental purpose was present".

The mere fact that the Court listed two issues on which is chose to focus, can not change the fact that it ruled on the validity of the D.L. Auld Patent. The rationale of a court which provides the basis for its holding is simply not dicta.

Mr. Pope,

You have confused yourself as to which level Court was making which holding and have misapplied the words (and concepts) of “intermediate findings” and “ultimate [ruling].

A PARTICULAR court’s holding is ONLY that which is necessary to resolve the PARTICULAR issue that it sets out (and may be quite unrelated to a holding of a lower court).

This is not a new or different concept that I point out to you. An easy example is the cert question that the Supreme Court will accept - clearly, there is no holding on matters unrelated to what the Court has set out for itself (further, this is merely the epitome of what “dicta” means).

When an appellate court affirms the holding of a lower court, that holding becomes a holding of the appellate court. It is entirely proper to say the Federal Circuit held the patent invalid. An affirmance is an adoption of the holding below as contrasted to a remand which may only identify some defect in the decision of the lower court.

There is no proper analogy to a decision on a cert. petition. The US Supreme Court is uniquely privileged to decline a case or take up so much of a given case as it chooses. But is the Supreme Court were to take a case up on limited issues that were not dispositive of the case, i.e. issues whose resolution did not necessarily dictate which party "wins", it could not affirm the decision below. Instead, it would remand the case with instructions to resolve it in accordance with the direction it had provided in resolving the limited issues that it had taken up. For instance, if the jurisdiction of the court below had been challenged on grounds that no federal question was involved, the Supreme Court could find a Federal Question and remand. If the Supreme Court commented or mused on the merits in concluding there was a Federal Question, those musings would indeed be dicta.

In this regard, the Federal Circuit made no new holdings. The two issues it set for itself, the presence of disputed issues of fact and the need for a pre-decision hearing were issues already decided by the magistrate. It just found that the magistrate below had resolved those issues correctly and that therefore his conclusion of patent validity was correct. But in deciding the magistrate's holding of invalidity was correct, the Federal Circuit necessarily had to decide (hold or find) that there was a rule of law that supported the conclusion of invalidity. Had there been alternative grounds on which to find invalidity, there might have been a law school argument whether one of the grounds mentioned by the court was dicta, but that wasn't the case here.

You are still trying to elevate the dicta in the higher court into something that it is not.

That is legal error - plain and simple.

Later cases have cited the Federal Circuit decision of D.L Auld as standing for the proposition "that a sale by a patentee or an assignee of a product made by a claimed method before the critical date results in a "forfeiture" of any right to a patent to that method"(See for instance In re Kollar, 286 F3d 1326 (Fed Cir. 202)). If failing to recognize this "holding" as dicta is legal error, then the Federal Circuit has made this error numerous times in later cases.

Mr.Pope,

Courts make errors all the time.

Even courts of appeals.

Please tell me that you understand this.

(then kindly put away the fallacy of appeal to authority when the direct legal point that I provided is front and center)

I certainly understand that appellate courts make mistakes. I firmly believe that the US Supreme Court got it quite "wrong" in Mayo. But usually when a significant proportion of the legal community views a decision as erroneous there is commentary reflecting that view. I'm not aware of any such commentary dismissing the forfeiture rule announced in the Federal Circuit D.L.Auld decision as dicta. Some have argued that the AIA obviated the Metallizing decision, but that's an entirely different issue.

I'm at a loss to understand just what is "front and center" that makes an affirmance of a lower court holding dicta.

It is not as “dismissing” is the point, though. It is the attempt (by you) to take this out of the context that 102 is the statutory basis. You want to make this some “judge-made” thing outside of 102. You rely on dicta and try to elevate the dicta because the words appear to support a view that you want to rely on. Careful reading simply points otherwise.

The affirmance just does not mean what you want it to mean. Sure, the lower court was affirmed. No one is suggesting otherwise. But the appeal level court decision - in and of itself - carries its own holding as well as dicta. That appeal level court decision is clear as to which is which. Your view appears to say that there is no dicta whatsoever in an appeal court decision that affirms. That is just not how it works. As stated above, the express language is to be accorded its proper weight. The propriety is a simple matter of recognizing that dicta (even in an affirmance), exists.

D.L Auld v Chroma Graphics can not be an application of 102. The patent covered a process and the process was not "on sale". The process was not disclosed to any third party nor did any third party pay for a practice of the process. The product of the patented process was offered for sale more than one year before the filing date. This was the problem with which the magistrate and the Federal Circuit wrestled. In this regard, the case can be distinguished from Metallizing Engineering because in Metallizing the patentee was selling a reconditioning service which was a practice of the patented invention.

Your reasoning here is circular, Mr. Pope - AND it goes against the very words that you are attempting to elevate (the decisions themselves base the item firmly as "an application of 102."

You will eventually simply have to face it that I am correct.

I'm somewhat confused on why my recitation of the facts of D.L. Auld amounts to circular reasoning. The phrase "an application of 102" does not appear in D.L. Auld.

From page 1147 of D.L Auld: "Waugh's invention is a method. The parties cite numerous cases involving "on sale" considerations in respect of product inventions under 35 U.S.C. § 102(b). The focus of inquiry here, however, is on the method. If Auld produced an emblem by the method of the invention and offered that emblem for sale before the critical date, the right to a patent on the method must be declared forfeited. Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516, 68 USPQ 54 (2nd Cir.1946). The "forfeiture" theory expressed in Metallizing parallels the statutory scheme of 35 U.S.C. § 102(b), the intent of which is to preclude attempts by the inventor or his assignee to profit from commercial use of an invention for more than a year before an application for patent is filed. The record includes testimonial and documentary evidence establishing that the claimed method was employed in preparing a number of sample emblems and that Auld attempted to profit from use of that method by offering some of those samples for sale to a number of potential buyers well before the critical date. Those facts operate to create a forfeiture of any right to the grant of a valid patent on the method to Auld."

Judge Markey undoubtedly choose the word "parallels" quite deliberately. If B parallels A, it necessarily means that B is not A, regardless of whether A and B are straight lines or A is "the statutory scheme of 35 USC 102(b)" and B is a forfeiture rule. Judge Markey would hardly analogize the forfeiture rule with which he was concerned to 35 USC 102 (b) if he was simply applying 35 USC 102 (b).

You continue to try to elevate the dicta of the case into something that it is not. You then refuse to acknowledge what the lower court did in relation to 102 (and what was affirmed by the reviewing court - which does NOT include the dicta).

You want the dicta to NOT be dicta, when that is simply not the case.

Your answer to my pointing this out is merely to circle back and want that dicta to not be dicta (again).

Dear Skeptical, could you point me to the language in the Federal Circuit D. L. Auld decision which explicitly states that the Court is applying 102 and could you explain why Judge Markey's statement as to why the Waugh patent was not valid is dicta?

It is basic appellate law that a reviewing court affirms the result reached by the lower court and not necessarily the rationale employed by the lower court to reach that result. In this case, the magistrate held the Waugh patent invalid and the Federal Circuit affirmed, while supplying its own rationale for reaching that result, which I've quoted in my last post. Labeling this rationale "dicta" does not make it "dicta". Dicta is a discussion of a hypothetical that the Court is not taking as established and often has the language "even if" or in the view of some legal scholars it is an alternative rationale for reaching the result. The quote I supplied in my last post mights neither of these criteria.

I have already explained why it is dicta, Mr. Pope.

The court of which you wish to elevate comments from was explicit as to what issues it was addressing.

You continue to attempt to elevate past that critical point.

I need do no more than remind you of that which makes the comments you wish to elevate to be dicta. This is NOT some mere "labeling." This is the essence of what dicta means. Dicta is NOT limited to being "discussion of a hypothetical that the Court is not taking as established." I do not know where you get such a crabbed view. Also, there is NO such "language requirement of "even if" - again, you appear to want to force "dicta" into crabbed channels just because you do not like the plain fact that your desired quotes are simply not necessary for the holding on the issues that the reviewing court itself set out as what it was talking about and adjudicating upon.

You simply do not get to elevate the item just because you like it and wish it were more than what it is. As I stated in my initial reply, "You say " If the express language of DL Auld is accorded proper weight" - and I agree."

After that point, you seem to not understand what that proper weight is. I am not the one that decides what that proper weight is, but I have plainly explained to you why that proper weight is as dicta (at best). That's not "labeling."

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Working...
Your comment could not be posted. Error type:
Your comment has been saved. Comments are moderated and will not appear until approved by the author. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.

Working...

Post a comment

Comments are moderated, and will not appear until the author has approved them.

Your Information

(Name is required. Email address will not be displayed with the comment.)

September 2018

Sun Mon Tue Wed Thu Fri Sat
            1
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24 25 26 27 28 29
30