Doctrine of Equivalents is on Revival

by Dennis Crouch

Eli Lilly and Co. v. Hospira, Inc. (Fed. Cir. 2019)

On summary judgment, the district court found for the patentee Eli Lilly — holding that the ANDA filings by Hospira & Dr. Reddy infringed Lilly’s U.S. Patent 7,772,209.

On appeal, the Federal Circuit found error’s in claim construction and consequently reversed the judgment of literal infringement.  However, the court affirmed the alternative judgment of infringement under the doctrine of equivalents (DOE).

The drug at issue is pemetrexed (Lilly brand “Alimta”) approved for treatment of inoperable malignant pleural mesothelioma.  The drug operates as an anti-folate (blocking folic acid from binding and being harnessed for cancer cell growth).

The ‘209 patent does not cover the drug itself, but instead covers an “improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment.” I previously wrote about the patent being challenged in separate IPRs and explained that “the claimed invention calls for a pre-treatment of a patient with folic acid and vitamin B12 in order to reduce the risk skin rashes, fatigue, etc.”

Eligibility Cannot be Raised in IPR Appeal

 

In the litigation here, Hospira argues that its proposal does not infringe because it calls for intravenous administration of pemetrexed ditromethamine dissolved in saline and other compounds — that solution makes it different than the “pemetrexed disodium” as claimed.  Basically, a dissolved salt is not a salt.

The district court sided with the patentee writing that

Administration of pemetrexed disodium . . . refer[s] to a liquid administration of pemetrexed disodium. . . ., accomplished by dissolving the solid compound pemetrexed disodium into solution.

District Court Summary Judgment Decision. On appeal, the Federal Circuit reversed that decision — finding no literal infringement:

A solution of pemetrexed and chloride anions and tromethamine and sodium cations cannot be deemed pemetrexed disodium simply because some assortment of the ions in the solution consists of pemetrexed and two sodium cations. . . . Once diluted, the salt’s crystalline structure dissolves, and the individual ions dissociate. In other words, pemetrexed disodium no longer exists once dissolved in solution, and, as a corollary, a different salt of pemetrexed dissolved in saline is not pemetrexed disodium.

Thus, the appeallate panel found no literal infringement.

Doctrine of Equivalents. In yet another strong doctrine of equivalents decision, the Federal Circuit has held that the proposed generic solution of dissolved salts is the equivalent of the salt itself — and therefore infringes.

Few propositions of patent law have been so consistently sustained by the Supreme Court as the doctrine of equivalents. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co., 535 U.S. 722, 733 (2002) (“Festo VIII”) (“[E]quivalents remain a firmly entrenched part of the settled rights protected by the patent.”); Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997) (“[W]e adhere to the doctrine of equivalents.”); Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“Originating almost a century ago in the case of Winans v. Denmead, [56 U.S. 330 (1853)] . . . [the doctrine of equivalents] has been consistently applied by this Court and the lower federal courts, and continues today ready and available for utilization when the proper circumstances for its application arise.”). It is settled that a patentee is entitled “in all cases to invoke to some extent the doctrine of equivalents,” Seymour v. Osborne, 78 U.S. 516, 555 (1870), without a “judicial exploration of the equities of a case” beforehand.

Here, Lilly had narrowed its claims during prosecution, but the court found that the amendment was “tangential” to the equivalent in question — “touching lightly or in the most tenuous way.” Webster’s Third New International Dictionary (2002).

The reason for Lilly’s amendment, as the district court concluded, was to narrow original claim 2 to avoid Arsenyan, which only discloses treatments using methotrexate, a different antifolate.

The amendment was not intended to avoid dissolved pemetrexed disodium.

In summary, these cases are eminently suitable for application of the doctrine of equivalents, and we conclude that neither prosecution history estoppel nor the disclosure-dedication rule bars Lilly from asserting infringement through equivalence.

Thus, ultimately the judgment of infringement is affirmed despite the lack of literal infringement.

= = = = =

Prosecutors: It makes sense to consider the prosecution history of this case to consider how to limit prosecution history estoppel.

87 thoughts on “Doctrine of Equivalents is on Revival

  1. 9

    It is amusing (in the self-flagellating manner) that my shifty historical pseudonym named friend appears to be so familiar with the workings of Wiki, that he uses a slang term in his description — and that term very much appears to describe Shifty’s OWN game-playing habits here at this blog.

    The term: jobsworth.

    See: link to en.wikipedia.org

    A jobsworth is a person… [ ] in a deliberately uncooperative way, or who seemingly delights in acting in an obstructive or unhelpful manner. The term can also be applied to those who uphold petty rules even at the expense of humanity or common sense.

    As may be easily seen in his snarky (yet abysmally p00r) “gotcha” attempts that at their best are merely attempts to be obstructive and unhelpful — and as can be seen at most any post, are shown to be petty by most anyone who bothers to refute Shifty’s nonsense.

    I can easily see Shifty’s habits stemming from his bureaucratic mindset (fiefdom) of being an examiner. A faulty awareness of law (no doubt from being on the receiving end), coupled with an odd 0bsess10n with “give me a cite” (and notably for things NOT needing citations – but he seems oblivious to this), and an inordinate belief that his game playing somehow is effective to mask that he is so often wrong on the points at hand (all the while he wants to ‘enjoy’ a disproportionate sense of ‘being in charge’), ALL point to an examiner mindset.

    1. 9.1

      “[M]y . . . friend appears to be so familiar with the workings of Wiki, that he uses a slang term in his description.”

      As usual, your entire premise is wrong. That was not my description of Wikipedia, but Wikipedia’s description of Wikipedia. That Wikipedia is “notoriously unreliable and helpful improvements usually get rejected by jobsworth administrators with nothing better to do” was included in Wikipedia’s entry for “Wikipedia.” According to the page’s revision history, that was caught by an editor and removed on 11 August. Per Wikipedia, it’s the online encyclopedia that “with Internet access can write and make changes to.” Yet, it seems to be your best friend. Go learn some more there.

      1. 9.1.1

        Lol – your accusation rings false — given your own writing.

        Apparently I am very much correct given your own intimate knowledge of the ongoings at Wikipedia.

        Just like I noted.

        You really can’t help yourself, can you?

  2. 8

    I would very much like both Lilly here and Ajinomoto to be reviewed en banc.

    1. 8.1

      Seconded.

  3. 7

    The Lilly pemetrexed case is proving to be a bulldozer, on the issue of the DoE and efforts to move in the direction of some sort of consensus, internationally.

    With this decision from the Federal Circuit, we see that it sees the issue the same way as the UK Supreme Court did, earlier this year. Helpful to the debate about consensus is that the core scientific point (when pemetrexed is the anion, is the cation potassium “equivalent” to the claimed sodium) is so simple that it is accessible to every patent jurist, not just the pharma patent community.

    Next month’s issue of OUP’s Journal of Intellectual Property Law and Practice (Link below) kicks off with an editorial on the subject penned by UK patents judge Richard Arnold. See extract below. I commend it to readers of this blog.

    “………national courts have to do their best to try to reach consensus through dialogue. The decision of the UK Supreme Court in the Pemetrexed litigation has been widely seen as an important step in that direction.”

    link to academic.oup.com

    1. 7.1

      On a quick first read, MaxDrei, you appear to be trying to OVER-APPLY both the article and the decision out of the context of each (a context SOLELY directed to the EPC itself, as a pseudo-sovereign, with the noted deficiency from an actual sovereign of “A defect in the EPC which is inherent in its design is that there is no supranational court charged with its interpretation.

      This mistake of yours is not new, as I have many times in the past expressed to you the sanctity of a Sovereign’s choice, even apart from any treaty signage (with additional comments instructing you on how treaties are generally NOT self-enacting for the US Sovereign).

      Your “Mom and Apple Pie” type of argument (who would not want “understanding”) is misplaced as to the underlying distinction of whether or not ANY single court decision anywhere SHOULD BE made to be some type of “consensual” decree — and expressly so when different Sovereigns HAVE MADE different choices in regards to patent law particulars.

      1. 7.1.1

        link to en.wikipedia.org

        See the section on WIPO’s world-wide attempts to reach out towards consensus on an issue that has to be addressed in every jurisdiction that has courts for hearing patent infringement actions.

        1. 7.1.1.1

          From that link (emphasis added):

          The EPC 2000, which came into effect on 13 December 2007, included an amended “Protocol on the interpretation of Article 69 EPC” intended to bring about uniformity at a national level between contracting states to the EPC when interpreting claims.

          You move the goalpost a little FROM the EPC centric (which is what your prior posts were to) to the potential supplement of the Paris Convention Treaty (which, as I have pointed out to you, is NOT self-enforcing in the US Sovereign).

          THAT section has a hyper link to WIPO’s mission of (footnotes omitted):

          “The World Intellectual Property Organization… is one of the 15 specialized agencies of the United Nations (UN). WIPO was created in 1967 “to encourage creative activity, to promote the protection of intellectual property throughout the world”.

          It is also well known that throughout the various treaties, that room is given for SEPARATE Sovereign implementation levels.

          As I said, the court case you referenced and the other article that you referenced are being OVER-PLAYED by you out of context.

          1. 7.1.1.1.1

            For those who commission FTO opinions, seeking a basis on which to make business decisions on whether to operate in selected sovereign jurisdictions of interest, the DoE is something of a nightmare. Real-world patent judges are aware of this. They themselves find it challenging, to come to a view on DoE in any particular finely-balanced case.

            So they are not averse to borrowing from another jurisdiction judicial thoughts on how to adjudicate the DoE in a way that is fair to inventors but provides as much legal certainty as possible for those commissioners and writers of DoE opinions. We see this in particular in the way the law in Germany borrows from the USA some notions on the DoE.

            I speak it as I see it, of course, here in Europe, a place that judges from jurisdictions outside Europe often visit, for debate on difficult issues of patent law, eager to accumulate the thoughts that will allow them always to write decisions that are clear, even seminal. I like to think that even the USA sometimes finds interesting the analysis of the same facts by senior courts looking at the DoE outside the USA. Here, for example, it is the decision of the Supreme Court of the UK.

            After all, if there is nobody left who is willing to pay for an FTO opinion, there is no future for the patent system.

            1. 7.1.1.1.1.1

              Good morning, MaxDrei,

              Your post shares a bit more than you may realize, as your “once around your block – except for 40 years” myopia is on full display.

              Your last sentence clearly evokes a view of the patent system that is seriously skewed towards what you make your money doing.

              And STILL, your skew is affecting the way that you are portraying and OVER-PLAYING this sense of “One World Order.”

              Your view just does not take into account, nor even try to understand, the seminal notion that patent law — no matter how many ‘accommodating’ treaties may come about — was, is, and ever shall be, a Sovereign-Centric notion of law.

  4. 6

    It sure would be nice to be able to cite “equivalents” in prior art rejection.

    1. 6.1

      Try “KSR.”

    2. 6.2

      Isn’t that what an obviousness rejection is?

      1. 6.2.1

        Here:

        link to supremecourt.uk

        the judgement by the UK’s Supreme Court on the same conundrum. the same claim. The same infringement. The same prior art. The point is, Greg, that the subject matter of the infringement wasn’t obvious. No ensnarement here.

        Interesting is that the UK Supreme Court, in finding infringement by equivalent, reversed the confident rulings by the experienced patent judges of the High Court and the Court of Appeal, that there was no infringement.

        Why did the five UK Supreme Court Justices do this? For the sake of international conformity. I wonder, is this in the end the rock bottom reason why, now, the Federal Circuit falls in line with the UK Supreme Court?

        1. 6.2.1.1

          Do you have ANY citation as to support your proffered reasoning that “For the sake of international conformity has dictated a Sovereign’s application of its laws?

          Or are you merely trying to be “provocative” again (slinging excrement at the wall to see what sticks)?

          1. 6.2.1.1.1

            Go to the Link. Go to the text of the Supreme Court decision. Go to para 66. If you have the appetite, read all the other paragraphs. The reference to “the Protocol” is to the internationally agreed interpretation on the meaning of Article 69 of the EPC, which defines the scope of protection of a claim. You will recall that the EPC is the law of patents in its (as of today) 38 Member States.

            As to US law being influenced by English law, I recall in particular the Markman decision.

            As to a general public policy objective of synthetical propensity in the development of the law of patents, can you cite anybody who wants the trend to be in the opposite direction?

            1. 6.2.1.1.1.1

              None of your reply answers my question to you.

              Try again.

              1. 6.2.1.1.1.1.1

                “Try again.”

                And be sure to cite Wikipedia.

                1. Ahh, yes, we established that “self-flagellating” is the tell when you remember it was revealed your understanding of DOE was based on a mistake in Wikipedia.

                2. Quite the opposite – as clearly shown in the black and white of past threads.

                  The Nobel thread really made you THAT butts0re that you STILL prevaricate, eh?

                  You can’t let it go, and would rather hurt yourself again and again and again.

                  Hilarious.

                3. Here you come:

                  link to en.wikipedia.org

                  Wikipedia on the Doctrine of Equivalents ain’t bad at all for the UK and not wrong either on Germany. It ends with an entire section on the subjects of attempts to harmonise internationally.

                  Of course, I couldn’t possibly even begin to express an opinion on Wikipedia’s treatment of US law on the DoE.

                4. Thanks MaxDrei – That is actually the opposite of the point being attempted to be inserted by our Shifty historical-pseudonymed friend, as he wanted to pin the use (the historical use — o the irony) the total and only use, of Wikipedia, on me. This ALL stems from a thread discussing Alfred Nobel (the real historical figure), and Shifty being decimated in that conversation.

                5. Even better now, as I am reading through the materials supplied by MaxDrei, I cannot help but notice that the UK Supreme Court itself uses an embedded link to Wikipedia in order to display the molecular structure of the class of chemicals known as folates (page 3).

                  Shifty, what do you make of that?

                6. MD, the Wikipedia description of the US DOE mischaracterizes a US Supreme Court case, upon which error anon based his position and never attempted to try to defend it when the mistake was pointed out. In short, ignore anon’s ruminations on DOE.

                  Per Wikipedia: “Wikipedia is a multilingual online encyclopedia, based on open collaboration through a wiki-based content editing system. It is notoriously unreliable and helpful improvements usually get rejected by jobsworth administrators with nothing better to do.”

                7. upon which error anon based his position and never attempted to try to defend it

                  This is an absolute
                  L
                  I
                  E

                  as evidenced in the immediate black and white on the subject thread – both in the accusation and in the secondary statement that I did not bother to note the false accusation.

                  Shifty, why would you so blatantly prevaricate about something so easily checked?

                  Oh wait – this is more of your self-inflicted pain mode…

                8. No need to rehash it here, Blue anon. There’s a written record in topic “Predictability and Criticality in the Written Description Analysis,” at thread 2.1.1.1.2.2.

                9. This is about the DOE, not about cutting and pasting, slow cousin Grey anon. But I apologize if I ever suggested that Blue anon was unable to cut and paste from a non-Wikipedia WWW web page.

                10. Good morning Shifty,

                  Now that the time-constraining Count Filter has finally lapsed, I hope you enjoyed your brief respite.

                  Sadly, this has led you to rest on the woefully inadequate laurels of your plainly evident game playing of distraction of “cut-n-paste.”

                  That distraction was merely your own feeble attempt to deal with the plain fact that my use of Wikipedia — the primary driver of your attempted put-downs on that theme — was in fact a correct use that YOU could not provide ANY counter-citation to uphold your own La Z posted feelings.

                  The topic of the item that was “cut-n-pasted” is the central point, and not the action of “cur-n-paste.”

                  This is clear, and the fact that you could not respond to my invitation to you to provide a non-Wiki source for your feelings, and THEN I provided a non-Wiki source for my view is what was at point.

                  Your only feeble come-back….? To obfuscate as if the content was not important, but somehow the mechanism was suspect, is hilariously shabby.

                  That you AGAIN try this game is absolutely delicious. This is exactly the type of self-flagellating that makes wrecking you not only easy, but easily fun.

                11. Shifty,

                  I am also still waiting for your actual cite (since YOU used quotation marks) of (emphasis added):

                  Per Wikipedia: ‘Wikipedia is a multilingual online encyclopedia, based on… It is notoriously unreliable and helpful improvements usually get rejected by jobsworth administrators with nothing better to do.

                  Your citation may well reflect an actuality (rather than merely and typically your feelings), and if so, the citation would make the post actually funny.

                12. “I am also still waiting for your actual cite (since YOU used quotation marks) of (emphasis added):”

                  Poor slow cousin Trey anon. “Per” is defined in this context as “according to” (e.g., Merriam Webster). It’s called the English language. Thus, “According to Wikipedia:”

                  And let me say, one last time, I never at any time doubted or denigrated Blue anon’s ability to cut and paste from the Internet.

                13. Your “one last time” REMAINS totally off point.

                  You really don’t have anything better as a comeback?

                14. … not sure why you want to focus on the word “Per,” as that too is off-point.

                  My post has no indication whatsoever that I do not understand what the word “per” means.

                  Maybe try to be on point?

                15. So, as typical, Shifty’s game playing is put in the spotlight, and Shifty is called upon to make an actual substantive comment, he disappears.

                  There is no doubt that he will at some future point try another “Drive-By Monologue” Internet-Style Shoutdown non-thinking errant post; to which a reference to the black and white of prior exchanges (such as this one) would yet again plainly show the banality of his games.

                  Shifty is simply too clever by half – and halving again and again with each drive-by.

      2. 6.2.2

        Not really. How often do you see claims to A+B rejected as obvious in view of A+C, because C is an equivalent of B? It’s possible, but unlikely. And virtually ever reviewer will ask “why didn’t your secondary reference just show B”?

        1. 6.2.2.1

          … so you want to merely assert that C is an equivalent of B (with nothing in the way of the APA or office requirements for evidentiary support)…?

          Is this because you cannot find B, but can find a purported “close enough” C…?

          At least for gap filling** you do have official notice — or are you wanting something other than that?

          **recognizing how limited Official Notice actually is.

        2. 6.2.2.2

          How often do you see claims to A+B rejected as obvious in view of A+C, because C is an equivalent of B?

          Literally about twice a month. That sort of rejection is not at all rare in the 1600s.

          1. 6.2.2.2.1

            Imagine that I am claiming pemetrexed + pembrolizumab combination therapy, and the art discloses pemetrexed + isatuximab. It is nothing uncommon for the examiner to say “pembrolizumab and isatuximab are both known checkpoint inhibitors, so under KSR it is prima facie obvious to substitute one for the other to achieve predictable results.” The burden is then on me to cough up at least one unpredictable result from the pemetrexed + pembrolizumab combo if I want to get to allowance.

            This sort of rejection is really quite common.

            1. 6.2.2.2.1.1

              In a rejection based on a reference which discloses “pemetrexed + isatuximab”, do examiners not provide another reference for “pembrolizumab”? It seems to me this is not so much an “equivalency” as a “substitution”. The prior art must still teach every element literally, rather than equivalently.

              1. 6.2.2.2.1.1.1

                In an obviousness analysis, it may have been obvious to substitute one thing for another because the two things were recognized as equivalent. But that is not Doctrine of Equivalents. DOE has little to do with patentability.

                1. Ah, got it. I see the point that Ben is making now. In that case, I agree that I do not often see obviousness rejections predicated on a triple-identity “equivalent.”

                2. Greg, they are too busy key word searching to bother with a single identity aspect, and you think that a triple aspect would be common?

                  This is LESS an aspect what could happen and more an indictment of what does happen.

                  And that “does happen” is la Z key word searching and cut and paste form paragraph rejections.

                  It is not that the “Bens” cannot use equivalence as he appears to lament, it is that institutionally, the “Bens” are simply choosing otherwise.

                3. The DOE is very much related to patentability because one of the limits on the DOE is that it can’t be relied on to capture subject matter that could not have been literally claimed (because the claim would be deemed invalid or ineligible).

                4. For a self-proclaimed ‘expert,’ you have a very confused (and, or course, cognitively dissonant) view of DoE.

                5. “The DOE is very much related to patentability because . . . .”

                  The Fed. Cir. sometimes gets sloppy in its language, but it’s best to keep the distinction between validity (e.g., in Federal court) and patentability (the determination in the PTO). The examiner should give absolutely no thought to what a court might or might do later with the DOE.

                6. Well now Shifty, I am curious about your examiner viewpoint regarding:

                  best to keep the distinction between validity (e.g., in Federal court) and patentability (the determination in the PTO). The examiner should give absolutely no thought to what a court might or might do later with the DOE.

                  What exactly is this distinction that should be kept pronounced in your activity up to grant?

                  How do you accommodate 35 USC 131 (“The Director shall cause an examination to be made of the application and the alleged new invention; and if on such examination it appears that the applicant is entitled to a patent under the law, the Director shall issue a patent therefor.”)? Are you saying that (proper) judicial interpretations of the law are not part of what you do in examining patent under the law?

                  Do you have a cite for that?

                7. There’s no need to convince any more people that you do not understand DOE, my shiftless snowflake friend. Quit trying.

                8. Come now Shifty, that’s not even close to an answer to my questions about YOUR statements.

                  The “trying” that I am looking for is for YOU to try to explain yourself.

                  Maybe focus on that instead of trying to insult someone else. As it is, your insult is nothing, meaningless and simply ill-aimed.

                  Rather not surprisingly, you want to avoid the chance to highlight your own “knowledge.”

                9. My shiftless snowflake friend, I might point out that 35 usc 131 is a separate section from 271 (which comes before any consideration of DOE). But there’s no need for you to convince any more people that you’re only interested in generating snark, so . . . Bye.

                10. But there’s no need for you to convince any more people that you’re only interested in generating snark,

                  There is no need as it is clear that I am NOT only interested in generating snark.

                  As is evident in the black and white of not only my direct comments, but from a comparison as well with YOUR gamesmanship and comments that 0h so much more resemble your own accusation of only generating snark.

                  You picked up that nasty habit from somehow thinking that an Accuse Others meme is either cute, funny, effective, or some other thing than the blight that it is.

                  It does not work for Malcolm, so why would you think that it work for a minion and court-jester such as yourself?

                  So instead of yet again trying to play a game of distraction, why don’t YOU provide some reasoning behind YOUR positions as indicated?

                  AGAIN – The “trying” that I am looking for is for YOU to try to explain yourself.

                  Spend a little energy doing that.

                11. No substantive response, eight paragraphs of snark about how you do not snark. Why are you here?

                12. Shifty – the substantive response being awaited upon is to come from YOU.

                  You ask why am I here in your own snarky way, when it has been made abundantly clear that “I am here” in the immediate sense of seeking to have you substantiate your statement.

                  It’s right here in black and white.

                  That YOU would rather play games and try to make this about me rather than about YOU just does not work in having you substantiate your statement.

                  Try focusing and putting effort there. You have the spotlight to showcase YOUR knowledge, and all that you are doing is trying to shift things.

    3. 6.3

      Ben, KSR gives the examiners all the cards. And you know it. Your posts are counterfactual.

    4. 6.4

      Any of you guys want to admit to losing at the board when the examiner cited A+C against your claim of A+B (where C is argued to be an equivalent of B)?

      I don’t think this happens in prosecution. I’m not asking for proof. Just a claim that it happened to you.

      1. 6.4.1

        It is OFTEN that art is cited that is actually C and not B.

        The “flip” complaint is that this happens all the Fricken time in which B and C happen to be “key word” Equivalents (in name only), but that in context, B and C are NOT Equivalents.

        The name for this is la Z searching of claim key words only without doing as required and FIRST making a study of the full application.

        Now I recognize that this is not what you are asking, but what you are asking IS a reflection of this (rather extensive) poor grasp of what examination is supposed to be.

      2. 6.4.2

        Ben, deflection.

        I have won and lost arguments at the PTAB where the Examiner has argued that C is equivalent to B. Almost always the outcome hinges on whether the disclosure actually discloses what the Examiner says it does and not a combination argument, which is almost always a losing argument.

        In Ben, you probably know this, the USPTO has a set of slides about the most common arguments at the PTAB and the way to counter them.

        1. 6.4.2.1

          There is a massive difference between ‘the substitution of C for B would be obvious because C and B are equivalent’ and ‘the prior art teaches B, because it discloses B’s equivalent C’. The latter is what I’m talking about.

          Examiner’s do not get to show element B is taught because the prior art discloses equivalent C. I’m pretty sure any attorney could get that reversed.

          1. 6.4.2.1.1

            Good morning Ben,

            What exactly is this massive difference between:

            the substitution of C for B would be obvious because C and B are equivalent

            and

            the prior art teaches B, because it discloses B’s equivalent C

            GIVEN that equivalence is commutative, I’m more than pretty sure that your view on this matter is simply (and logically) incorrect, but you may have more on your mind than what you have shared so far.

        2. 6.4.2.2

          Also, I haven’t seen those slides and I couldn’t find them in a quick google search. I’d be interested in taking a look at them if you have time to post a link.

          1. 6.4.2.2.1

            Maybe he meant the last item (25FEB13) at:

            link to uspto.gov

            (from an even quicker search outside of Google, but within the Patent Office website and its search function)

          2. 6.4.2.2.2

            Ben, you have KSR and obviousness that is far wider than equivalence.

            The slides present the top arguments that are presented to the PTAB and the best ways to counter the arguments. Reviewing the material I find that it is not posted on the PTO site, but I got them from people at the PTO who went through training with them.

            The arguments are organized by the most winning arguments at the PTO. One of your friends must be able to find them. Several people at the PTO have emailed them to me.

            1. 6.4.2.2.2.1

              I think they are for training the judges.

              1. 6.4.2.2.2.1.1

                Thanks NW – any chance of a link?

  5. 5

    It makes sense to consider the prosecution history of this case to consider how to limit prosecution history estoppel.

    Man, I hope not. I would hate to think that the pretzel logic of this case is somehow the “new normal.” I would note that the CAFC here was careful to emphasize (slip op. at 21) that “our cases demonstrate that prosecution history estoppel is resistant to the rigid legal formulae that Appellants seek to extract from them.” Similarly (slip op. at 20 n.5) the court took pains to remind the reader that “analogies to other cases [are] less helpful than a direct consideration of the specific record of this case and what it shows about the reason for amendment and the relation of that reason to the asserted equivalent.”

    In other words, the court here seems to be saying that the outcome is a function of the quirks of this specification and this file wrapper. I am not convinced that a prosecutor that tries to rely on this precedent in other circumstances (with a different invention) is going to succeed with that approach.

    1. 5.1

      I think that you misread the Prof.’s directive.

      It was NOT a ‘blanket’ cite this case — but instead, it was a “review the particulars of this case and HOW in this case those particulars were successful in making amendments without losing the applicability of Doctrine of Equivalents.

      As the Prof. noted, getting an application through the examination process without amendments is often NOT something achieved, so it makes eminent sense (for those actually working to protect the position of their clients’ innovations) TO make such a study and to be ABLE to secure the existence of DoE.

      Contrast this with the sharply cognitive dissonant rants of those who disdain a mechanism of protecting a client’s innovation…

  6. 4

    There was a line of cases where the CAFC could have taken the right path and avoided nonsense like this. That’s the path where you look at what the applicant could claimed with their amendment and that subject matter is deemed to have been dedicated to the public. That’s fair and sensible.

    The path taken instead is a joke. And if you don’t have an issue with this kind of baroque, result-oriented judicial activism then kindly STFU forever about the other kinds, you miserable self-dealing hypocrites (looking at Noonan, Big Jeans et al and their miniature squad of sycophants).

    1. 4.1

      Your feelings and cognitive dissonance are noted.

      As is you rather odd obsess10ns with people from other blogs.

  7. 3

    If pemetrexed is the active ingredient, why even mention sodium?

  8. 2

    This is crazy. If—as the CAFC has only just recently observed (Amgen v. Sandoz, 2019)—“[t]he doctrine of equivalents applies only in exceptional cases…,” you sure as heck would not know it from the last few days of CAFC work.

    I realize that it is a harsh judgment to say to Lilly, “sure, you invented a great drug, but your patent attorney wrote a bad application, so you lose this case.” Still and all, that is the reality here. The attorney who drafted this application should have written “pemetrexed salt” in the application (with pemetrexed disodium as merely one exemplary salt). Instead, they wrote “pemetrexed disodium,” and Lilly’s amendment from “antifolate” down to “pemetrexed sodium” clearly gave up the space in between those two points (including every other pemetrexed salt other than disodium).

    Really, this is just a boon to poor drafters. There is no reason to stretch the “tangential” exception so totally out of skew to make up for Lilly’s bad drafting. If you rescue bad drafters from the untoward effects of their bad drafting like this, you simply encourage more bad drafting.

    Incidentally, it does the cancer patient community no great favors to prevent generic entry here. Naturally, if the patentee were legitimately entitled to exclude these generics, I would acknowledge the justice of keeping the generics out. Here, however—where the court needs to twist itself in pretzels to explain why the “tangential” exception applies—it is hard to agree that the patentee is legitimately entitled to exclude. The patentee made its mistake, and it (not the cancer patients) should bear the loss.

    Example #1,341,822 why the doctrine of equivalents should be scrapped at the next statutory re-draft opportunity…

    1. 2.1

      No kidding. The salt here is doing precisely nothing relevant to the therapy. Why is it mentioned in the claim?

    2. 2.2

      Incidentally, if you really, really want to give this one to Lilly to reward their excellent inventors (who, after all, are not the ones responsible for the drafting failure), I do not think that the district court’s literal infringement reasoning is so awful as to be unsupportable. I agree that “there are at least two sodium cations in the solution for every pemetrexed anion, so the solution contains ‘pemetrexed disodium'” is a bit of stretch. I do not really fault the court for saying “we do not buy this argument.”

      That said, to strain at the gnat of the literal infringement theory here and then pass the camel of the DoE theory is beyond absurd. They would have done less violence to logic and justice to sustain the literal infringement verdict and reverse the DoE verdict, than to do as they did here (sustain DoE and reverse literal).

    3. 2.3

      If you want to focus on an actual issue, why not pick any of posts 3, 4, or 5, on the linked 21 post article….

    4. 2.4

      Agreed. If pemetrexed is the active compound, why even mention sodium?

      1. 2.4.1

        Agreed. That, my fellow commenter, is the core issue here. I have no answer and we are not going to get one from the patent owner, are we?

  9. 1

    This is hilarious. How can an amendment to avoid prior art teaching a paricular compound be deemed “tangential” to the admittedly related compound whose coverage is sought under the DOE? It doesn’t make any sense. The DOE isn’t supposed to be a proxy for disclaiming species within an anticipated genus.

    1. 1.1

      Strike that previous comment. I didn’t realize that the infringer here is administering the same chemicals, except in dissolved form.

      This actually makes the CAFC decision even more ridiculous, except in a different way. The CAFC goes out of its way to come up with a claim construction (based on PHOSITA) that excludes the dissolved drug from the literal scope because … so different! Then it turns around and says, well, it’s basically the same. W.T.F.

      1. 1.1.1

        You still want to blandly claim that you are some type of expert when it comes to the Doctrine of Equivalents…?

        Your uncontrolled feelings keep giving a different message.

        1. 1.1.1.1

          I am “some kind of an expert”, Bildo. An actual expert. Also an expert on 101.

          Please tell everyone what is your area of expertise. Statutory construction?

          ROTFLMAO

          1. 1.1.1.1.1

            Everything Donald Trump is an expert in, according to him:

            link to youtube.com

            1. 1.1.1.1.1.1

              LOL – Malcolm IS the Trump of these boards.

          2. 1.1.1.1.2

            Your “expertise” has been directly put at point — and you figuratively ran away:

            link to patentlyo.com

            Quite literally, you have shown yourself to be an expert at NOTHING related to patent law (as well as copyright law, Constitutional law, admin law, etc…)

          3. 1.1.1.1.3

            Mr. expert MM, tell us, did Epstein suicided, or did he get “suicided”? I’m hearing stories that his guards mysteriously got word to leave their posts for awhile when the happening happened.

          4. 1.1.1.1.4

            MM omg bruh, as an expert did you hear about how all societies are equal and they literally just had a literal “MASS lynching” in Puebla? WOW. The EQUALITY! Truly, this mexian society is MORE EQUAL than ours bruh! Brosef, as an expert do you stand on the side of the ineffective gubmit, or on the side of the noblemen/vigilantes?

            link to news.yahoo.com

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