Enjoying your posts and your suffering. :)
Without going into them, there are a variety of reasons running the gamut right now that rob me of the time and stamina required to read, write and obsess about biotechnology patents. You're doing enough for both of us. LOL!
I can't wait for the time in the not too distant future when the Calgene court has to choke on a couple of its prokaryotics, eukaryotes and viruses comments as Enzo's genetic antisense does indeed appear to work in all.
What was that about the law is the law??? That's why we have appeals and why others have mused that sometimes the law is an arse/ass!
Did you pick up whoisajohngalt's url (PDF)at: http://www.kslaw.com/library/pdf/pharmaknowles.pdf
The article by Sherry M. Knowles appears an easy read, but as the print-out is undated (and although I see at least one citation to a year 2000 decision), it may be that later decisions may have altered prior cases.
Talking of "the law is the law" -- please do note the last two sentences (see below) of the author's commentary in Ajinomoto Co. v. Archer-Daniels-Midland Co., a CAFC 2000 decision discussed at the end of p. 33 thru' p. 34. Compare it to the same Federal Circuit Court of Appeals' very recent statement in Enzo v. Gen-Probe, et al.
The author notes: "Additionally, the Federal Circuit agreed with the district court that the patentee had satisfied the enablement requirement by depositing the bacterial products in accordance with 35 U.S.C. Sec. 122. Specifically the court held, "the deposit of biological organisms for public availability satisfies the enablement requirement for materials that are not amenable to written description or that constitute unique biological materials which cannot be duplicated."...<<
BTW, whether one or both of the elements of the enabling requirements existed in the Gen-Probe case are issues of FACT. As the defendants' apparently neither claimed and/or showed either or both elements did not exist at the time Enzo's biologic deposit was made, summary judgment should have been granted to Enzo not Gen-Probe.
Had Gen-Probe, et al., alleged the lack thereof, then summary judgment would also have been inappropriate as determination of the existence of either requirement would have been a disputed issue of FACT requiring a trial and expert testimony of one or more relevantly qualified scientists.
IMO, the trial court's grant of summary judgment in Gen-Probe, et al.'s favor was erroneous on this additional ground. Consequently, also IMO, the CAFC's 2 to 1 decision affirming the lower court and totally rejecting the relevance of the biologic deposit by Enzo were also erroneous rulings.
It will be interesting to see what the CAFC en banc decision will hold and whether it will go on to the U.S. Supreme Court, unless certain factual issues are remanded below.
In the interim, do keep on having fun -- i.e., in a masochistic way -- by reading tomes of patents and other grueling tasks. :)
i found it startling that in the enzo v. genprobe ruling ajinomoto v. ADM wasn't even cited since it seems quite relevant; after a cursory look, though, it seems to me they are about different issues...in ajinomoto it's about enablement, in enzo v genprobe it's about defintion...trying to define something by it's function rather than it's structure..in ajinomoto they used the words ". . .satisfies the enablement requirement for materials that are not amenable to written description or that constitute unique biological materials that cannot be duplicated." The point in the enzo case was that the function of the materials deposited might be able to be duplicated by other similar materials, i.e. other sequences complementary to n. gonorrhea but not n. meningitidis. There was no proof that the deposited materials were unique....if ajinomoto were germane, it's hard to believe it wouldn't have been cited, dealing as it does with deposited materials
As for calgene, whether or not it works in prokayotes or viruses or eukaryotes now is irrelevant; that which is known now has no bearing on what they claimed then. The enzo claims were held invalid because undue experimentation was required, they didn't claim it worked in tomatoes, not because it would have worked had they claimed and/or described it.
But stepping back for a minute (and remembering my bias :) what exactly is enzo trying to do here? HC as a commercial product has existed for well over a decade, going back to the original HCT (tube) test as opposed to the HC2 microtiter plate assays; therefore they have been "infringing" for well over a decade. Yet in all that time, enzo has pursued an entirely different method, focusing on using polynucleotide probes for "capturing". If digene was already infringing the parent engelhard patent from which '581 continues, why now, many many years later? Because they weren't, until '581 attempted to expand the parent.
It is quite clear reading all of the "descriptions of inventions" going back to parent applications, that enzo never really envisioned that monoclonal antibodies alone be used as a capture affixed to a solid matrix. They spent literally hundreds of pages describing inventions unlike hybrid capture.
Yet now, based on additions to claims from parent applications, yet filed years after HC1 was on the market and 18 months after digene's HC patent was filed, they want to say that it's their idea. Maybe, but as enzoobserver aptly stated, they never pursued that avenue. They have nothing resembling HC in their product portfolio. Digene has spent almost 15 years and millions of dollars bringing this through clinical trials involving over 100,000 patients worldwide, innumerable FDA approvals for their technique, not just for hpv but for ct, gc, cmv, have sold hbv and hiv assays based on the platform as RUO for years, and suddenly enzo thinks they are infringing? (Granted it was provoked by the digene suit, but the principle remains the same).
I've seen enough patent law to recognize that digene could lose, but then what? Because enzo MAY have enabled HC (and i think that 15 years of millions of $$ on R&D efforts might actually be construed as undue experimentation and not enablement) digene's novel platform, NEVER even attempted by enzo, goes to the junkyard? I guess that would be justice, but what kind of justice i'm not sure.
Do try to step back and look at the common sense picture...enzo has never ever given passing thought to "inventing" a method based on monoclonal antibody capture of hybrids, and now, on the eve of potential success they claim infringement? And if they win, they gain no tangible benefit, and if they lose, they are not "harmed" (because they have no products based on the alleged infringing method).
Seems screwy to me, but i'll say it again, i'm biased. I asked it before...why now, after over a decade of an allegedly infringing product? The answer to me
In part you demonstrate by your statement: �There was no proof that the deposited material were unique,� that you are busy defending your Digene preferred position based on inadequate knowledge and/or understanding of relevant real facts and principles of law. Proof was neither offered nor adduced because theGen-Probe trial court denied Enzo an opportunity to have a trial and to present expert scientific testimony concerning the sufficiency of its written description to a scientist skilled in that art, etc. Instead, the trial judge erroneously decided issues of fact the governing statute mandated be addressed by a particular level of scientific expert and not by a law person.
Let�s face it, a trial judge doesn�t have an obligation to provide proof of fact . Nor is s/he subject to direct and/or cross-examination as to the accuracy of his/her scientific determination or his/her qualifications to render expert scientific opinion, especially on issues of fact previously reserved to another by the governing statute. Yet it is these factual issues the parties are required to prove or refute. Thus, it�s easy to see why summary judgment is deemed a �drastic remedy� that may not be granted where there remains disputable issues of fact requiring resolution at trial and/or with input from another type of expert. IMO, CAFC should have reversed and remanded for a trial of the many issues of fact still in dispute. We�ll wait on the decision of CAFC�s En Banc panel.
As the Gen-Probe dissent notes, there remain many disputed issues of fact requiring trial. By way of example and not of limitation, one such unresolved issue of fact include (a) whether Enzo�s patent document, taken as a whole, contained a written description sufficient in form and substance (i.e., drawings, schematics, words, formulaic expressions, etc., or a combination thereof) to enable a scientist skilled in the relevant art to understand how to make (i.e., enable) what the applicant sought to patent; (b) whether at the time Enzo�s biologic material was deposited and made publicly available in accordance with the statute it constituted an acceptable alternative (if such was necessary) to the written description in Enzo�s patent. Subsumed therein are factual issues of whether, AT TIME OF DEPOSIT, Enzo�s biologic met either or both of the statutory requirements for its use as a substitute for (a) a sufficient written description, (b) an enablement of the patent; and (c) evidence of the existence and possession of the result claimed in the patent application. That is: (i) was the filed biological organisms NOT AMENABLE TO WRITTEN DESCRIPTION; OR (ii) were the filed biological organisms UNIQUE biological MATERIALS that CANNOT be duplicated .Testimony ofa scientific expert(s) is required on these issues.
Denial to Enzo of an opportunity try these and other issues of fact on the record and to submit and obtain the statutorily mandated expert testimony in opposition to defendants� claims that Enzo�s patent was invalid amounts to a prohibited denial of due process. Yet you keep approaching this matter as though there had been a full trial where all issues of fact relevant to a correct decision were addressed by the parties and their experts. It didn't happen. IMO, it�s just silly to try to apply law when the full facts are not known and tested by trial. My statement is not an assertion a trial will or will not alter the status quo in Gen-Probe or Digene. Frankly, I don�t have the time or energy to waste on hypothetical nonsense. Neither you nor I know what the true facts or claims are in either case. Anyone can claim anything. Proving and/or refuting such claims is for the trial. All parties must be afforded due process and the opportunity to protect a constitutionally protected fundamental right to control and dispose of their property as they deem fit.
Something from a case in language i can understand, and that expresses in far more pithy form what i tried to set out in my previous post:
From Brenner v. Manson, 383 U.S. 519, 536 (1966)
". . . a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion."
I rest my case. Let the games begin!
i'm a sucker for steep learning curves
right now my fondest hope is to casually use use 'estoppel' in a conversation! it's my favorite lawyer word so far :)
yes i printed out the whoisjg link and will read it and did notice it is undated
we are all biased by our desired outcomes, to some degree, although judges are supposed to be above that and my naive assumption is that they are most of the time...they are human and that shows through in their testiness in their printed decisions...everyone, it seems, wants to be right!
i need to digest a lot of what i've taken in but i am finding it quite fun in my own bizarre way