Proving Obvious with Post-Filing Evidence?: Yes

Sanofi-Aventis v. Glenmark (Fed. Cir. 2014)

In a post on the Patent Ethics site, Professor Hricik highlights this case with the following headline: CAFC Affirms Adverse Inference Instruction Due to Spoliation.

Post Filing Recognition of Synergy: For patent prosecutors, an important headline from the case would also be: “Synergy” of patented combination that was only recognized after the application filing can still be used to prove non-obviousness. Here, that principle was applied by the appellate panel in affirming the jury’s decision that Glenmark had failed to prove Sanofi’s patent obvious.

Some background: Sanofi’s patent No. 5,721,244 covers the combination of both trandolapril (an ACE inhibitor) and a calcium channel blocker, combined “in amounts effective for treating hypertension.” A licensed drug covered by the patent is distributed by Abbott under the brand name Tarka. Mumbai-based manufacturer Glenmark filed an abbreviated new drug application (ANDA) with the FDA requesting permission to begin selling its generic version of the drug prior to patent expiry. In order for a generic manufacturer asking to receive permission to sell a drug that that the branded manufacturer has listed in the Orange Book as covering the product, the generic manufacturer must also submit a “Paragraph IV Certification” indicating their allegation that the patent is either invalid or will not be infringed by the generic activities. See 21 U.S.C. §355(j)(2)(A)(vii).

Under the Hatch-Waxman rules, an FDA filing with a Paragraph IV certification is a form of patent infringement and here Sanfi sued – alleging infringement. That lawsuit then triggered a 30-month stay in FDA approval of the generic product. However, once the stay concluded Glenmark launched its generic product (all while the district court case continued). Glenmark’s defense was invalidity, but the jury sided with the patentee that Glenmark’s proof was insufficient and the resulting damages were $16 million in lost profits and price erosion damages.

Patent Validity: The patented invention is a combination of two known hypertension medications. However, there was no evidence that the combination was known. The question thus, was whether the combination was obvious. The appeal of obviousness questions is tricky because obviousness itself is a question of law that must be supported by factual conclusions drawn from the evidence. A jury’s factual conclusions must be supported by “substantial evidence” (a fairly low standard), but any legal conclusions are reviewed de novo. “When the question of obviousness is tried to a jury, on appeal we ascertain whether the jury was correctly instructed on the law, whether there was substantial evidence in support of factual findings necessary to the verdict, and whether the verdict was correct on the supported facts.” Here, the jury was apparently not asked to report its particularly factual conclusions but instead only whether the claims were obvious. In these black-box scenarios, the jury verdict is difficult to overturn on appeal because the implicit factual findings are so difficult to pin-down and therefore challenge.

At the time of the invention (1986) it was apparently already known to combine ACE inhibitors with CC-blockers and Glenmark argued that the use of trandolapril was merely a substitution of one known ACE inhibitor for another. Sanofi argued that there were thousands of potential ACE inhibitors and none of the prior art suggested that the particularly claimed drug (trandolapril) was the best. In reviewing these arguments, the court sided with the patentee.

Post-Filing Recognition of Benefits: Some of the “synergistic benefits” of the drug combination were not recognized until after the patent application was already filed. In the appeal, the Federal Circuit held that those benefits were perfectly acceptable as evidence of non-obviousness. The court writes: “patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest.”

How Many Plaintiffs to Screw in a Lightbulb? Another interesting aspect of the decision is whether the four plaintiff here had standing to sue. According to the case, Sanofi-Aventis Deutschland GmbH is the owner of the patent at issue and Aventis Pharma S.A. is the exclusive licensee of that patent. Abbott GmbH contracted with Aventis for the “irrevocable sole and exclusive right” to sell the drug product under the patent and Abbott Labs is the holder of the FDA-approved new drug application. Finally, ALI is the exclusive U.S. distributor for Abbott Labs.

Based upon this mess, Glenmark argued that only Abbott Labs held rights to sue on Hatch-Waxman claims (as holder of the FDA-filing) but that it did not have standing because it was neither owner nor exclusive licensee of the patent rights. On appeal, the Federal Circuit rejected this argument – agreeing with the district court that the relationships and agreements amongst the various plaintiffs resulted in Abbott Labs holding exclusive rights to the patent and thus having standing to sue. In addition, the court saw that it was important that “all entities in the license chain joined in the suit, such that there is no danger of multiple suits for infringement.”

77 thoughts on “Proving Obvious with Post-Filing Evidence?: Yes

  1. I imagine that not just Dennis but also some readers have knowledge of the way the EPO assesses post-generated evidence of an effect, that is to say, always giving it weight, except in those cases where the application as filed contains no indication that the subject matter of the claim under consideration is capable of delivering such an effect .

    In other words, in the First to File environment of Europe, you have to have made the invention before you file on it.

    Is there anything in this CAFC Decision that might suggest to readers of this blog that the outcome is dependent on its First to Invent environment (in other words, that the outcome might have been different under the AIA)?

    1. you have to have made the invention before you file on it.

      Once again MaxDrei seems to struggle with basic patent concepts when he takes a look at US patent law.

      In both pre-AIA and AIA you need to have the invention for which you file. As has been indicated in the past, the US really does have a ‘no new matter’ added rule. That rule was not affected by the AIA.

      1. I accept that the invention be made by the filing date, also in the USA, both before and with the AIA. I’m just chewing away at what that platitude means, in practice.

        So let us take here a common situation where post-filed evidence can make a decisive difference.

        One starts with a claim to the set of molecules A through Z, and asserts that each is effective to mitigate the symptoms of a specific disease.

        The Examiner calls attention to a prior publication which asserts the same thing, for the same disease, and suggests that the claim is not patentable.

        Applicant responds with a claim limited to molecule M, says that his invention is now the new and not obvious singling out of M from the set A-Z. Applicant adduces in support of his assertions some evidence that M works better than any of A-L and N-Z.

        I wonder, is M an invention that had already been made patentable at the filing date of the application?

        1. I’m just chewing away at what that platitude means, in practice.

          Um, sure, ok,… chew away – but can you chew with your mouth closed?

        2. MD: I wonder, is M an invention that had already been made patentable at the filing date of the application?

          I would say “certainly not.” This is a written description problem, really, and post-filing data should not be able to correct that problem (at least not where the facts are as you presented them, MD).

          A different result would possibly follow where the applicant has identified the preferred species and indicated that it is, in fact, the preferred species. In that case, a post-filing submission providing the data and a declaration that the data was obtained prior to the filing of the application should be permitted if there is a question about, e.g., the obviousness of the species.

    2. MaxDrei Is there anything in this CAFC Decision that might suggest to readers of this blog that the outcome is dependent on its First to Invent environment (in other words, that the outcome might have been different under the AIA)?

      I didn’t see any suggestion of that sort.

      some readers have knowledge of the way the EPO assesses post-generated evidence of an effect, that is to say, always giving it weight, except in those cases where the application as filed contains no indication that the subject matter of the claim under consideration is capable of delivering such an effect

      Is there an EPO decision explaining how precatory such an “indication” can be? What about a boilerplate listing of a variety of desired effects?

      In my opinion, post-filing data should be permitted only to rebut an assertion by an Examiner that a claimed invention does not work (e.g., is not effective) or that something in the prior art works as well as the claimed invention. But even in this sitution, there should already be similar supporting data or a description of that data in the application as filed. Otherwise applicants can simply file on research plans, without any data at all.

      There’s nothing speculative about this practice, by the way. It’s not unusual for chem/bio applicants to “poison the well” with applications listing thousands or tens of thousands of target species without data showing the efficacy of any species. Applicants can then subsequently ride on the work of their competitors and, in a continuation, claim the species of greatest value (i.e., the species that the competitor appears likely to commercialize, based on data appearing in a competitor’s patent application or elsewhere).

      1. There’s nothing speculative about this practice, by the way. It’s not unusual for chem/bio applicants to “poison the well” with applications listing thousands or tens of thousands of target species without data showing the efficacy of any species

        LOL – because poisoning the well without actaully having any data to indicate that you actually possess the invention as described (per the Oath) is not “speculative”…..

        …specious perhaps….

        1. because poisoning the well without actaully having any data to indicate that you actually possess the invention as described (per the Oath) is not “speculative”…..

          Good grief. Do you even try to understand what people are talking about before you launch your drivel?

          My point was that I was not “speculating” about the behavior I described. It has happened. It continues to happen.

      2. OK Malcolm, thanks for those thoughts. To continue our conversation, how do you react to this:

        At the EPO the exploration of patentability toggles between the technical “features” recited in the claim and the technical “effects” the claimed combination of features produces. For novelty we compare the enabled feature combinations in the art with the one in the claim.

        But for utility and non-obviousness, we consider the effects. For such an effect to “count” you need in the application as filed to have already rendered it “plausible”.

        At AIPLA 2008, Chris Mercer of C&R, London, gave a nice Paper on post-filed results. One of his slides is entitled: The Good, the Bad and the Ugly. Good cases are those where you made it plausible but the art didn’t.

        Bad cases are of course the opposite. You want a patent but the art already made “it” plausible and you, in your app as filed, haven’t really done that.

        The Ugly cases are (needless to say) where you have plausibly made it “plausible”, but so has the art.

        I guess it is largely in support of Ugly cases, that Applicants file more data at the EPO.

        There is a very recent case in the English patents court concerning the use of experimental evidence generated post-filing. It muses on what are the purposes for which such evidence is admissible (in post-issue trials of validity) and which not. Paul Cole could tutor us on that one.

        Every jurisdiction grapples with these issues, and seeks the way forward that best approximates to the over-riding objective of advancing the interests of justice.

  2. I think it is long past the time that the law recognize that synergy is an expected result for drug combinations. It is not at all surprising that some obvious combinations provide surprising results. That is like being surprised by finding a pearl in an oyster: they may be rare but it is obvious where to find them.
    The logic goes something like this: If it is obvious to try, and you get the expected results, then looking forward, before you could have known the results, it is obvious, but if it is obvious to try and you get the expected results and a little more, then looking forward, before you could have known the result, it is not obvious. That is nonsense.
    If you read the opinion, the plaintiff’s expert explained that it was obvious to try the claimed combination, but its unexpected results were not expected. He said artisans knew the combination was effective, but not more effective than other combinations, and that combination therapy was not favored (which means, it was known enough to be disfavored). To me, this dictates that the claimed combination was obvious. Why wouldn’t you do it if you expected it to be effective?
    If we want to reward some company for sifting through all the obvious combinations, we don’t need to pretend they invented something. Just hand them an outright monopoly without the legal coating that makes it easier to swallow.

    1. KDC – agreed.

      In addition to the weird scenario I outlined in Comment 3, the current law permits the following absurdity:

      Prior art teaches class A (1000 species) and class B (1000 species).

      Prior art teaches generally that a member of class A could be combined with a member of class B to treat disease X. A few specific examples are shown to work.

      On year 2000, I file a patent application describing the same generic combination of members of class A and B for treating disease X and, in addition, list 10,000 specific combinations.

      On year 2010, I notice a potential infringer. I file a continuation to specifically identify the infringer’s combination. All my previous attempts to obtain broad claims were denied but now I’ve got a hook: the defendant published some work showing some previously unknown property of one of the specific agents used in the combination (or some “synergy” — either works). So now I’ve got my post-filing “unexpected results”. Zing! Thank you, defendant!

      Alternatively, I could hire a lab or do my own experiments to show some kind of “synergy” for the specific combination and use that data as my “unexpected results.” After all, according to the Federal Circuit, who cares if I had no idea that this particular combo would have such synergy ten years earlier when I filed my application? None of that matters. According to the Federal Circuit, the “non-obviousness is inherent.” That is the most accurate summation of the Federal Circuit’s reasoning. It’s that st00pit.

      We have a broken patent system, folks. Thankfully, this is a pretty easy fix since the Fed Cir pulled it out of its behind just a few years ago and it’ll be easy to shove it back where it belongs.

      1. Adding: I also note that claim 1 in this particular patent contains a “proviso” that disclaims a particular combination.

        Anybody want to take a guess as to whether that proviso has written description support in the specification? I’ll save you the time: of course there’s no support for it.

        1. Talk about lame-axx, Malcolm creates a strawman scenario and then invites people to take a look at his phantom specification to try to find written description support for a strawman-within-a-strawman provisio added by Malcolm.

          Gee, the wonders one can create playing in Malcolm’s alternate reality – no end to the QQ there.

          Thank you so much for saving us time of looking into your strawman of a strawman – whew, you saved all of us that extensive trouble of chasing your very own AOOTWMD: “Excuse me for not being able to read your mind, dipshirt. God, what a t 0 0 l.

          1. his phantom specification

            What? My comment about the proviso is not referring to a hypothetical patent. It refers to the 5,721,244 patent at issue in this case.

            It’s rather remarkable that the applicant was somehow able to proviso out of its claimed genus apparently anticipatory art* without written description support, and simultaneously rely on post-filing data to prove the non-obviousness of a selected member of that genus.

            *alternatively, an issue might have come up regarding the enablement/toxicity/unmixability of that particular combo — who knows?

            1. What? My comment about the proviso is not referring to a hypothetical patent. It refers to the 5,721,244 patent at issue in this case.

              LOL – and that was indicated,… how?

              Oh, that’s right – it wasn’t. Thus my throwing your AOOTWMD right back in your face….

              Learn to read Bud (and write – especially as you are the one who likes to throw out there that “English as a first language quip).

            2. that was indicated,… how

              Several ways, dipshirt: (1) by default, it’s pretty safe to assume that when someone refers to “this patent”, they are discussing the same patent that is the subject of Dennis post. (2) my comment was part of a subthread discussing issues directly related to the subject of Dennis’ post; (3) the patent claim in this patent (which I reproduced earlier for evveryone ) includes a proviso — a really huge clue.

              You really do need to get your meds adjusted, Tr0llb0y. Lately you’re even more of a desperate and pathetic creep than usual, which is saying a lot. The fact is you got your subthreads mixed up and instead of apologizing for your dipshirt insults based on that mix-up, you pretend that it’s my fault. Just go see a shrink already.

            3. LOL – You are wrong in even being wrong.

              1) “ by default, it’s pretty safe to assume” – check again Malcolm, your post was at 4.1.1 – in response to your post at 4.1 that had the hypothetical. – If you meant to place the comment somewhere else, then THAT IS your fault.

              Tell me again what is normal to assume from that.

              2) “my comment was part of a subthread” – ditto.

              3) “the patent claim in this patent (which I reproduced earlier for evveryone ) includes a proviso – you did not produce and label it clearly “earlier” – the first time you used the word provisio was in 4.1.1 – See 1) above.

              lately you’re even more of a desperate and pathetic creep than usual” – and your AOOTWMD is more virulent than usual.

            4. LOL – this is comment string starting with “4″ – are you talking about the DIFFERENT subthread starting with “1″?

              Was I supposed to read your mind when you cannot place your comment in the right place?

    2. Crocket: He said artisans knew the combination was effective, but not more effective than other combinations, and that combination therapy was not favored (which means, it was known enough to be disfavored).

      Indeed. “Not favored” is hardly “teaching away.” Here’s the quote from the case: combination therapy was not favored in 1986 as compared to “stepped care,” in which physicians were instructed to use one drug
      at a time.

      The prior art wasn’t teaching “The combination won’t work”. Nobody on earth was saying that. Everyone expected the combination to work.

      “Stepped care” is nothing more than a treatment model where inexpensive, generally effective, low side effect drugs are used first, and only after they are shown to be ineffective are less well-studied but potentially more powerful “combination” therapies used. It’s the furthest thing in the world from teaching that combination drugs don’t work.

    3. K David,

      Where do you draw the line on what “obviousness” means? at what level does the common sense of PHOSITA expand a sense of ‘common sense’ to ‘ordinary level of intelligence’ to ‘ordinary level of inventiveness?’

      I see a slippery slope, sliding you right to the (discredited) Flash of Genius.

      1. Instead of playing your usual games, Tr0llb0y, how about you just tell everyone your opinion about the law that was applied in this case and similar cases? i.e., cases where combining the classes were taught in the prior art for a particular purpose, the applicant claims a particular combination for the same purpose contemplated in the prior art (no other details as to ratios, dosages etc recited in the claim), and cites some “unexpected” (i.e., previously undisclosed) inherent property of the combination to get the patent allowed.

        Let us know your thoughts. After all, you’re an expert on patent law, right? You surely have thoughts on this subject.

        And then let us know what you think about applicants/patentees relying on post-filing data that is not presented or discussed in the application as filed to overcome the prior art.

        And then let us know what you think about the situation where that post-filing data is produced by a third party, e.g., the defendant.

        We all want to know what really smart people like you think. That’s why you’re here, isn’t it?

        1. Instead of playing your usual games

          For some reason, Malcolm does not want a conversation here…

          Hush Malcolm, let K David speak.

          1. For some reason, Malcolm does not want a conversation here…

            Everyone with half a brain understands that a “conversation” with you is impossible, dipshirt, especially when the conversation begins with a lame-axx question like “Where do you draw the line on obviousness”? Go and play at Gene’s place where pathetic m0r0n’s like you are coddled and loved.

      2. I think this is really far from the slippery slope to the flash of genius, and more like a skid-proof path to the brain-fart of common sense.
        In this particular context, I draw the line well above synergy and unexpected results “discovered” in obvious combinations. That is, if a combination is obvious to try, it is obvious, even if you can honestly demonstrate some unexpected beneficial effect.
        In this case, according to the testimony of both parties, combining double-ring ACE inhibitors with CC blockers was known. Effectiveness of any combination was expected (according to the plaintiff’s expert, they just did not think it would be more effective).
        More generally, it seems that everyone in the art knows that combination therapy often results in improved results, so it is obvious to play around with known compounds and see if one combination works better: Pharmacologists or other PHOSITA’s expect to find unexpected results. Even lay people expect potentiation (aspirin and ibuprofen, cocaine and decongestants). Sifting through known ACE inhibitors and CC blockers is a task that should naturally occur to any PHOSITA.
        So just applying John Deere factors, it is straight path to obviousness: Elements disclosed in the prior art and a well-established motivation to combine them.

        1. I think this is really far from the slippery slope to the flash of genius, and more like a skid-proof path to the brain-fart of common sense.

          I’d like to subscribe to your newsletter.

        2. Thanks DC,

          In this particular context, I draw the line well above synergy and unexpected results “discovered” in obvious combinations

          OK

          Obvious to try back in full force. Not where I would go (as it begs the question and creates a bit of circularity), but, I can see the allure of having a brightline like that.

          Pharmacologists or other PHOSITA’s expect to find unexpected results

          We probably want to use different words then. One cannot expect unexpected. You have a bit of a “defining black is white” problem there.

          Even lay people expect potentiation (aspirin and ibuprofen, cocaine and decongestants).

          Not sure this can be universally agreed to – again, probably just a nit as to the expecting the unexpected issue you need to fix.

          Sifting through known ACE inhibitors and CC blockers is a task that should naturally occur to any PHOSITA.

          We might want to visit that last paragraph of 103 again – you know the one, right?

          Elements disclosed in the prior art and a well-established motivation to combine them.

          That’s pretty good. You also have some potential issues with ‘motivation,’ as that last sentence in 103 is a bit entangled there, but if I get what you are saying, you are talking about well within a single art field, the elements are all known AND it is known both that one might want to combine them and that synergetic benefits are expected from such combinations (synergetism is NOT unexpected, but rather, with the specific facts, very much expected).

          1. Tr0llb0y, doing his best to “not understand”:

            One cannot expect unexpected. You have a bit of a “defining black is white” problem there.

            DC wrote “pharmacologists or other PHOSITA’s expect to find unexpected results”. The specific nature of those unexpected results may not be predictable, but the likelihood of being able to identify a previously undescribed and unexpected “result” of, e.g., administering a new pharmaceutical is not terribly low, especially if you have a few years to look for it.

            This is what attracts people to biological research, after all.

            Anyway, nothing controversial about DC’s point and there’s no “problem” unless you’re just being a troll.

            1. Malcolm, there is exactly the ‘problem’ as I describe it in my post.

              If you do not like my post, you are more than welcome to point out something substantive that you do not like rather than merely put up yet another of your vapid and vacuous ad hominem posts.

              Your AOOTWMD Trolling is bit tedious.

              This is what attracts people to biological research, after all.” – and this has exactly what to do with the last sentence of 103…? (I am trying to see if you had a point after all…)

  3. Dennis: For patent prosecutors, an important headline from the case would also be: “Synergy” of patented combination that was only recognized after the application filing can still be used to prove non-obviousness. Here, that principle was applied by the appellate panel in affirming the jury’s decision that Glenmark had failed to prove Sanofi’s patent obvious.

    Ignoring for the moment the Fed Cir’s temporary insanity on the issue of post-filing data to support non-obviousness, are you sure the principle of “synergy” was applied here, Dennis? I ask because I don’t see the term “synergy” used in the Opinion.

    Glenmark’s argument seems to have been more subtle: Glenmark argues
    that it is irrelevant that the combination is ultimately found to have unpredicted or superior properties if those properties, though unknown in the prior art, could be attributed to one of the prior art components of the combination.

    This appears to be more of a inherency argument. For example, let’s say I claim “A composition for treating headaches, comprising A and B.” A was taught in the prior art for treating headaches. B was taught in the prior art for treating headaches. I combine them because “it reduces side effects of A and B”. Due to PTO incompetence and my awesome lawyerly skills, my claim is granted. Now I start sueing people. While getting ready for the court case, I notice that a paper was just published saying that B reduces cholesterol. Now I have my unexpected result: a headache medicine that also reduces cholesterol! The overweight unhealthy jury loves me and my headache medicine and I draw Judge Newman on my panel. Yay! I’m rich as a king.

    Glenmark appears to be arguing (correctly, in my opinion) that this is an absurd result. The patentee is being rewarded for a discovery of an inherent property made not only *after* the patentee filed its application, but for a discovery made by someone else! Indeed, the defendant could have made this discovery and published it, thereby shooting itself in the face.

    It makes no sense and eventually this “post-filing” madness is going to end up in the trash. All we’re waiting for is the right case, with the right defendant willing and able to make the argument forcefully, and the right to panel to introduce the split necessary to take the case en banc.

  4. Abbott/Sanofi-Aventis should be grateful that the panel included Newman and Wallach (who thus far has demonstrated a fair amount of sense in his decisions). What are the odds that if any two of the judges on this panel were replaced by Bryson and Lourie, the decision would have gone the other way?

  5. Nicely written synopsis of the opinion.
    In passing, I remain unconvinced that “in amounts effective for treating …” puts the public on notice on what does not infringe.

    1. “In amounts effective for treating” is real sooper dooper patent invention language. Don’t dare call it “j*nk”.

      1. Oh lookie! Our patent teabaggers think they found a claim that is “just like” the functionally-claimed computer-implemented junk that they love so much! Therefore … what? They don’t say. Looks like they’re just throwing some kind of “nyah nyah everybody does it!” tantrum. Anyone surprised?

        Here’s the full text of claim 1:

        1. A pharmaceutical composition comprising:

        (a) an angiotensin-converting enzyme inhibitor (ACE inhibitor) of the formula I ##STR14## in which n=1 or 2,
        R=hydrogen,
        an aliphatic radical with 1-8 carbon atoms,
        an alicyclic radical with 3-9 carbon atoms, or
        an aromatic radical with 6-12 carbon atoms,
        an araliphatic radical with 7-14 carbon atoms,
        an alicyclic-aliphatic radical with 7-14 carbon atoms,
        a radical OR.sup.a or SR.sup.a, wherein
        R.sup.a represents an aliphatic radical with 1-4 carbon atoms or an aromatic radical with 6-12 carbon atoms,
        R.sup.1 is hydrogen,
        an aliphatic radical with 1-6 carbon atoms,
        an alicyclic radical with 3-9 carbon atoms,
        an alicyclic-aliphatic radical with 4-12 carbon atoms,
        an aromatic radical with 6-12 carbon atoms,
        an araliphatic radical with 7-16 carbon atoms or
        the side chain, protected if necessary, of a naturally occurring α-amino acid,
        R.sup.2 and R.sup.3 are the same or different and are
        hydrogen,
        an aliphatic radical with 1-6 carbon atoms,
        an alicyclic radical with 3-9 carbon atoms,
        an aromatic radical with 6-12 carbon atoms,
        an araliphatic radical with 7-16 carbon atoms and
        R.sup.4 and R.sup.5 together with the atoms carrying them form a heterocyclic bicyclic or tricyclic ring system selected from tetrahydroisoquinoline, decahydroisoquinoline, octahydroindole, 2-azaspiro 4,5!decane, 2-azaspiro 4,4!nonane, spiro (bicyclo 2,2,1!heptane)-2,3′-pyrrolidine!, spiro (bicyclo 2,2,2!octane)-2,3′-pyrrolidine!, 2-azatricyclo 4,3,0,1.sup.6.9 !decane, decahydrocyclophepta b!pyrrole, octahydroisoindole, octahydrocyclocopenta c!pyrrole, 2,2,3a,4,5,7a-hexahydroindole, 2-azabicyclo 3,1,0!-hexane, hexahydrocyclopenta b!pyrrole,
        or a physiologically acceptable salt thereof, and

        (b) a calcium antagonist or a physiologically acceptable salt thereof;
        wherein said ACE inhibitor and said calcium antagonist are present in said composition in amounts effective for treating hypertension;

        and with the proviso that when said calcium antagonist is 4-(2,3-dichlorophenyl)-2,6-dimethyl-3-methoxycarbonyl-5-ethoxycarbonyl-1,4-dihydropyridine (felodipine), said angiotensin-converting enzyme inhibitor is not 1-(2S,3aR,7aS)-octahydro 1H!indole-2-S-carboxylic acid (trandolapril).

        Looks pretty structural to me (“calcium antagonists” are defined in structural terms in the specification). Then again, we’ve seen the patent teabaggers scraping the bottom and asserting that all structural descriptions are “functional” so who knows what they’re thinking.

        That said, if it were up to me, all such claims would be amended to recite a range of amounts and ratios (as disclosed in the instant specification) before they are granted. Those values (which are part of the structural description of the composition) were typically deemed by Examiners to be understood by the skilled artisan (or even the unskilled artisan — check your pain reliever bottles for the phrase “as needed”). This isn’t homeopathy, after all.

          1. Even worse for the “nyah nyah” wankers, I see now that claim 1 wasn’t even at issue here (no doubt because it was invalid).

            Claim 3, which was at issue, is limited to a composition comprising two specific chemicals described in unambiguous structural terms.

    2. John: I remain unconvinced that “in amounts effective for treating …” puts the public on notice on what does not infringe.

      There’s definitely some fuzziness around the lower margins (and possibly the upper margin as well) because each patient is different. Applicants should put as much support as possible in the specification for specific ranges, including ranges that are keyed to the age/weight of the patient (at least where those parameters are deemed to be relevant, or potentially relevant).

      As a practical matter, it’s unlikely that any defendant is going to sell a combination that isn’t effective so it ends up being a moot issue. The risk for patentees is (1) prior art compositions sold for another use (including a non-therapeutic use) that happens to include both of the components, thereby putting the “effective” language into the spotlight; and (2) prior art suggesting that the combination was obvious for some other use, again putting the “effective” language into the spotlight.

      As already noted by others, this specific claim could (and probably should) have been tanked as obvious garbage. The patentee lucked out in a number of ways, including the “spoilation” business which probably soured the jury on the defendant generally.

      1. There’s definitely some fuzziness around the lower margins (and possibly the upper margin as well) because each patient is different

        Are you claiming patients as part of your ‘structure’…?

          1. ..so why are you talking about fuzziness and tying this to “each patient is different.

            You have structure or you do not. If you have a term that depends on something outside of the claim – then you do not have structure, right? You seem to have a functional thing in the claim completely unrelated to any physical thing in the claim, and that thing directly tied to the very utility of what is being claimed.

            (I am just trying to see how you think and how consistent you are in what you are saying in this art field)

            1. You seem to have a functional thing in the claim completely unrelated to any physical thing in the claim

              Mass is “completely unrelated” to chemical compositions?

              That’s a new one.

              I am just trying to see how you think

              Get a life.

            2. Mass is “completely unrelated” to chemical compositions?

              That’s a new one.

              – you just got done saying that the patient is not part of the structure – not part of the claim and now you want to put back in the mass of the patient….

              Never mind consistency across art fields, let’s aim for consistency in a single claim.

              Try again.

            3. you just got done saying that the patient is not part of the structure

              Right. The patient is not part of the structure.

              now you want to put back in the mass of the patient….

              The mass I referred to is the mass of the composition. That mass is determined by reference to the well-known weight of human beings.

              Similarly, if one claims a “mechanical arm bearing a weight, where the weight weighs less than the earth”, that doesn’t mean that the earth is “part of the structure.”

              Given that you are having difficult following along at this stage, maybe you should consider just giving up. Or just keep digging, like the sad pathetic wanker that you are.

            4. That mass is determined by reference to the well-known weight of human beings.

              You might want to read the case – that is not something that is cut and dried here.

            5. Similarly, if one claims a “mechanical arm bearing a weight, where the weight weighs less than the earth”, that doesn’t mean that the earth is “part of the structure.

              LOL – that’s a pretty sad strawman.

            6. You might want to read the case

              I did read the case, Tr0llb0y. Do you have a point to make with some evidence/logic backing up that point? If so, spit it out.

              If not, well, I suppose you can just keep tr0lling. And Dennis and Jason can ignore your dumaxx tr0lling. And then you can shame Dennis and take a giant shirt on academia. Fun times!

              that’s a pretty sad strawman.

              It’s not a strawman at all. It’s just a very simple example to show everyone why reference to an “effective amount” does not make the patient a “part” of the claimed structure, as you erroneously suggested. Try harder not to troll, Tr0llb0y. We all know it’s really hard for you … but just try a bit harder. Do it for Gene.

            7. I did read the case, Tr0llb0y

              LOL – did you read the case before or after I suggested that you read the case?

              Do you have a point to make with some evidence/logic backing up that point? If so, spit it out.

              Yes – my point was made at 1.2.1.1.1.4. If you had read the case, then the point is clear: your statement at 1.2.1.1.1.3 is problematic. Hint: read the dissent.

            1. LOL – and in the subthread starting with “4″ Malcolm attempts a typical AOOTWMD and BLOWS IT.

              Pay attention Malcolm: sub threads start with the same number.

              Ahhh, what were Malcolm’s own choice words for bot being able to follow a simple number? Oh yeah, “You really do need to get your meds adjusted, Tr0llb0y. Lately you’re even more of a desperate and pathetic creep than usual, which is saying a lot. The fact is you got your subthreads mixed up and instead of apologizing for your dipshirt insults based on that mix-up, you pretend that it’s my fault. Just go see a shrink already.

              So he gets the subthread starting with 1 wrong (ouch). And then compounds it by getting his Accuse Others Of That Which Malcolm Does at the subthread starting with 4 wrong as well.

              Malcolm, here’s a novel idea (novel that is for you): try posting only using law and unspun facts.

              Try it.

      2. There’s definitely some fuzziness around the lower margins (and possibly the upper margin as well) because each patient is different.

        Just as each automobile is different. From the MPEP:

        In ]Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1 USPQ2d 1081 (Fed. Cir. 1986)], a claim directed to a wheel chair included the phrase “so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats thereof.” 806 F.2d at 1568, 1 USPQ2d at 1082. The court found the phrase to be as accurate as the subject matter permits, since automobiles are of various sizes. Id., at 1576, 1 USPQ2d at 1088. “As long as those of ordinary skill in the art realized the dimensions could be easily obtained, § 112, 2d para. requires nothing more.” Id.

        1. The court found the phrase to be as accurate as the subject matter permits,

          LOL – yep, that’s a phrase (and a case I have shared in the past) that is in the back of my mind on this topic – let’s see how Malcolm responds to the concept.

          Then let’s see just how consistent the notion is for him. Does he ‘forget’ the concept when talking about a different art field (much like during the Myriad discussions, Malcolm often could not remember what the word ‘effectively’ meant).

          1. Tr0llb0y, I’ve already expressed my views upthread:

            if it were up to me, all such claims would be amended to recite a range of amounts and ratios (as disclosed in the instant specification) before they are granted. Those values (which are part of the structural description of the composition) were typically deemed by Examiners to be understood by the skilled artisan (or even the unskilled artisan — check your pain reliever bottles for the phrase “as needed”). This isn’t homeopathy, after all.

            We all know you’ve labored before under the false impression that I am somehow very forgiving of other arts but unfairly strict when it comes to the patenting of computer-implemented junk.

            Where you got that impression is anybody’s guess, of course, since I showed no love for Prometheus or Myriad. I’m glad their claims got tanked. They were junk. I’ve never stopped saying that. Indeed, with respect to Myriad, I’m happy to see they are struggling with their “leftovers” because, as I’ve noted many times, they are one of the worst companies in the world.

            1. since I showed no love for… Myriad

              LOL – sure. That was a case “you really did not care about” yet wrote 30,000 plus mewling words of QQ directly after the case instead of three very simple ones: anon was right.

              Gee, I wonder where that “impression” came from….

            2. That was a case “you really did not care about” yet wrote 30,000

              I never said I didn’t care about Myriad. Pretty sure the opposite is more likely true as I strongly advocated for the tanking of Myriad’s junk claims from the first time I saw them.

              Who are you quoting?

            3. I never said I didn’t care about Myriad

              LOL – you spend so much time spinning that you no longer can even recall what you said.

              Hilarious.

            4. you spend so much time spinning that you no longer can even recall what you said.

              Or maybe — just maybe — I said something in one context at one time that really doesn’t apply in the context of your present pathetic attempt to identify some “problematic inconsistency” in my position towards functional claiming, you sad sick psycho.

            5. Or maybe — just maybe

              Hmm, let’s give this its due consideration – OK (that was quick), but sorry Malcolm, your maybe is denied. 1.2.2.1.1.3 is simply much more likely to hold.

    3. Check out today’s Braintree decision in which the district court got reversed for not knowing how to construe “clinically significant”.

      Just Sooper Dooper stuff.

      1. Claim 15, which the parties agree is representative, recites:

        A composition for inducing purgation of the colon of a patient, the composition comprising from

        about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

        Nice structure.

        1. A composition for inducing purgation of the colon of a patient, the composition comprising from

          about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

          Nice structure.

          Man, the patent teabaggers really do like the taste of the barrel bottom. First, there’s all kinds of structure in the claim. Second, congrats on finding a junky invalid patent claim! It’s weird that you only seem to be able to identify such claims and get excited about them when they are in the chem/bio arts, but hey it’s perfectly consistent with your habitual hypocricy and kindergarten-level behavior.

          You and Turdbillion should make a tent out a blanket and play all day with your new junky chem/bio claim. Whatever turns your cranks, boys.

          1. …or even claims to software which is a manufacture of man and a machine component,. known by the person having ordinary skill in the art to which the invention pertains to NOT be something that is totally in the mind.

            Malcolm merely dreams of rising up someday to taste that bottom of the barrel.

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