29,895 (1980). Of course, this is a factual inquiry which this court would not have considered anyway. The patentee argued two contradictory definitions for the same term instead of doing what it should have done: expressly provide a clear definition in the specification for a crucial term in its claims. In some patients, the medications were released more slowly than extended-release Concerta If my memory serves, this issue (MW measurement techniques) has been litigated already in Europe, in Germany and up to the English Court of Appeal. is nefarious. Scientist: How do you differentiate how the law treats your own bank account or house than patents…professor? How is “substantially” determined? The FDA and Barr Laboratories, Inc. have announced a recall for generic Adderall tablets that may contain more of the active pharmaceutical ingredients than they are supposed to … victory from the already closed jaws of defeat. I’m in the process of demanding my insurance cover the brand name adderall IR as obviously the big pharmaceutical companies are watering down the product for money while they comprise people’s lives and health. That contempt order is a subject of the present appeal. However, I have not done peptide work, and for all I know people could use Mp to refer to average molecular weight in that subfield (see 227), and Dr. Grant may be correct. For, say, a good atom-transfer polymerization (ATRP), you can get a very narrow, symmetric peak. I feel like my post was extremely short. Find a patent jobWe regularly post top patent jobs from leading firms, corporations, and government and educational institutions. Cir. Amphetamine salts are available in generic and brand versions. Fig. In the Markman hearing, Sandoz argued that a claim was fatally indefinite for failing to identify which of three possible meanings a particular claim term, related to the molecular weight of a component of the drug, should be interpreted to have. Loss for words. Does “substantially” get you where you want to be? If not, where is the court in London going astray? An interaction between cephalexin and alcohol has not been proved. It must be quite a help, I imagine, in such a delicate case, also for the Federal Circuit judges to read through the English Decision, because the English patents judges are specialist patent jurists with a science degree followed by at least 20 years of intensive and continuous experience in patent litigation. While prosecution history estoppel and collateral estoppel are not the same thing, I am not sure what justifies caution in one case and not in the other case. Thanks in advance for fleshing out your thoughts. Typically robust (and enjoyable) remarks from MM. I guess the English court was more willing to presume validity until somebody actually proves that the disclosure is insufficient to put the invention into effect. Scoundrels! Sure, there may be situations in which only one should be forfeit, but just as assuredly, there are situations where both should be forfeited. Of interest, the majority strongly implies that “clear and convincing evidence” is required to hold a claim invalid for indefiniteness: We hold that claim 1 is invalid for indefiniteness by clear and convincing evidence because read in light of the specification and the prosecution history, the patentee has failed to inform with reasonable certainty those skilled in the art about the scope of the invention. Generic Adderall is covered by some Medicare and insurance plans, but pharmacy coupons or cash prices may be lower. See PatLex. Most of these correspond, roughly, to moments of the molecular weight distribution, and in theory there are an infinite number of such moments. The bill’s proponents foresaw three principal benefits. Cir. It IS a strawman, as no one but you is advancing that fake argument to be knocked down. Although ostensibly a claim-construction case, the ultimate issue here is actually whether the “molecular weight” term is unduly indefinite under the standards of 35 U.S.C. So I was wondering if the Sandoz/Eon, CorePharma, or any other version of instant release Adderall is easier to swallow and/or doesn't taste nasty. No, it depends. Do not suddenly stop your medicine. I've used Sandoz generic IR and its amazing. We have reached third world status at the Fed. Reexaminations were put forward as a way for the PTO to reexamine applications primarily as a benefit to patent owners — to shore up the validity of their patents and inspire “investor confidence.”. One can see that NONE of the congressional purposes and objectives are being currently met by today’s process abusers. Even accepting as correct the district court’s factual determinations about .. the transfer of chromatogram data to create Figure 1, these facts do not resolve the ambiguity in the Group I claim about the intended molecular weight measure. There is no question that congress intended reexaminations to benefit patent owners. Teva v. Sandoz: On remand, Still No Deference and Claim is Indefinite – The patentee’s expert testified that one of skill in the art would understand that the the calculation should be peak-average molecular weight because it would be more straightforward to calculate peak-average based upon the data presented in Example 1 … In fact, it’s a really old one. In addressing the details of this case on remand, the Federal Circuit first noted that there is no express definition of the molecular weight term and that the patentee’s expert had admitted that the term has no “default” meaning even to a person of skill in the art. Yes it will take more than a noble prize to distinguish them because they are same. I was making an uncontroversial statement about the prosecution histories of many cases where indefiniteness becomes a serious problem during litigation. There are lots of ways you can treat the data to find Mn and Mw. construction construct—broadest reasonable interpretation—that But 500 or so US patent that use the term kilodalton in the claims. PTO review proceedings given that there exists a lower Also, Fig. He used different methods than I did (of course, I mistakenly found the median instead of the mean), but we ended up with similar results, except for Mn of the 7.7kDa sample, but the median would be an underestimate of the mean when you have a long tail. There’s no reason why a patent should not be subject to the same issues. Congress had an important public purpose in mind when it enacted the reexamination statute. And Mw is usually called “weight average molecular weight.” If they argued it was Mn, they could have said yes, there is some variation (the 16% quoted above), but it’s clearly not Mp because the variation in Fig. Result here is that a host of claims are now invalid as indefinite. On re-examination the PTO held claim 26 invalid. It’s unclear what happened in this case, at least by reading the current decision. Teva v. Sandoz: On remand, Still No Deference and Claim is Indefinite, having a molecular weight of about 5 to 9 kilodaltons, CAFC Opinions Available on Pacer Hours before Court’s Website, How To Calculate Average Molecular Weight Of Mixture | Adsense, Federal Circuit: User Experience is not Computer Functionality, Request for Comments on the National Strategy for Expanding American Innovation, Government Contracts and Ownership of Technical Data, Pre-AIA 102: Meaning of On Sale “in This Country”, Doctrine of Equivalents in Lilly v. Apotex. 112(b). “This doctrine should be applied in a carefree manner”? Careful practicioners who use such standards in their claims — or who see any chance of that happening — are careful to define the measurement techniques in question. He and I had long discussions on this. Congressman Kastenmeier, who introduced the legislation in the House, described 602*602 the bill as “an effort to reverse the current decline in U.S. productivity by strengthening the patent and copyright systems to improve investor confidence in new technology”. The majority (led by Judge Moore and joined by Judge Wallach) did give deference to the lower court’s particular fact-finding, but found that the lower court had drawn incorrect conclusions-of-law from the factual bases. ), so then you know how weight relates to elution time. 6, and yes, there was a split in the circuit about whether the use of collateral attacks was an abuse of process. Thanks for your effort. MD MM, you think it a foregone conclusion that a change of horse activates the gong that sounds “INVALID”. Over reach of a panel in justifying why they are not respecting a previous panel is what is going on**. These de novo issues include ultimate claim construction outcome, findings regarding intrinsic evidence, and (according to this opinion) the decision on how to apply any subsidiary factual findings in the analysis. When I wrote “delicate”, MM, I was thinking of the delicacy of the operation of changing horses in mid-stream. PatentBob, I had a case where the patent attorney, at least initially, and the perhaps even the inventor did not know the difference between peak-to-valley and average roughness. Evidently, you know a lot about the science. The best generic is sandoz which is extremely hard to find. Also, I thought you took Mp from the mole fraction trace (Fig. I just realized I found the median values above, not the mean/average. Follow the directions on the prescription label. I do not agree with the majority that the injunction in The statute was part of a larger effort to revive United States industry’s competitive vitality by restoring confidence in the validity of patents issued by the PTO. Do not take your medicine more often than directed. whether perceived or real. To be clear, the context here is what is being said to obtain the patent right by a single party. Two Generic ADHD Drugs Not as Effective: FDA. Id. Knowing that it is from Fig. In commenting on the denial of rehearing en banc, Judge Moore, with Wallach, O’Malley and Newman, made this observation. Except you usually get a nice little printout from the software that does it all for you, I’m betting people just copied the numbers from the prinout; usually peaks are labeled, and Mw, Mn, and PDI. The applicant distinguished prior art because of the order of magnitude difference between the prior art and the claimed “roughness factor” range. . case for consideration of this standard. The “over” politeness rings hollow, a fake mask that should be avoided as the “front” that it is. You really need to take off your “align-with-me-must-be-an-Einstein” googles and realize that Malcolm is “for” any and every position that weakens patent rights – without fail. Hey the Federal Circuit got one right for a change, good job. So you would think. I have tried every single brand and strength of adderall generics. 1 (1979) (Senate Hearings.) The intrinsic evidence seen by the Federal Circuit here actually came from the prosecution history of a continuation application related to the patent-in-suit. In my view, it is really this late-stage change-in-definition that led to the Federal Circuit’s indefiniteness holding. The district court relied upon that conclusion in its analysis. Teva and Sandoz are by far the best two generic Adderall Available. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. ___ (2015),[1] is a landmark patent Supreme Court case disputing over the Copaxone patent. When the patents themselves are simply variations of “do this type of commerce on a computer” or “do this routine ancient information processing activity in this specific context on a computer”, the cost of “innovation” is close to zero. When they accused my client of infringement, the patent attorney who had prosecuted the application and now representing his client in litigation asserted the claims against our products measuring our roughness using average roughness. through its precedent on finality or through Congress, And, equally, that if the state makes a mistake on property tax records and sells you property at auction, you should be allowed to keep it despite not really legally being able to buy it. Of course, the histogram method used by Hunter (see 232) is prone to errors, but I think it should be a good enough approximation. This is the legal question—and on this question—we reverse the district court. Why not both? Lastly, was not the calling of experts in fact an attempt to consider the particular factual inquiry? And it is not surprising that defendants pursue This is what the Teva/Barr version looks like: This is the Sandoz/Eon version: I was thinking to myself, perhaps if they didn’t regard it as a game then we wouldn’t be in this mess. The internal coherence and context assessment of the patent, and whether it conveys claim meaning with reasonable certainty, are questions of law. I was thinking that if Mp, Mn and Mw measurements substantially (=/- 20% ?) overlap, then the claim would be definite enough. It therefore concluded that the fact that the peaks do not match the listed molecular weights does not dissuade the conclusion that “molecular weight” means Mp. Also, what is meant by “definite enough?” Enough for what? Except this doesn’t match with the legend of the Figures, as I noted above, and which the appellants also noted. It reminds me of the doctrines whose applications should (allegedly) be “rare.” The frequency at which the doctrine is applied depends on how frequently the appropriate circumstances for applying the doctrine present themselves to the court. 29,895 (1980) (statement of Rep. Kastenmeier). The majority and the minority dispute whether an injunction was final when the PTO held the claim which was the subject of the injunction invalid. For whom? Ritalin is the brand name for a stimulant called methylphenidate . I got a new script from my psychiatrist who fortunately appreciates the variances in genetics and on Dec 26 went to a Walgreens that carries Teva and I … But when Patent A is obtained by arguing that “X is white” and continuation Patent B is obtained by arguing that “X is black”, then one of those two patents is almost certainly invalid. That decision was affirmed by the Federal Circuit in 2013. MM, you think it a foregone conclusion that a change of horse activates the gong that sounds “INVALID”. created, but for at least a subset of cases, defendants are Amphetamine salt combo (Adderall) is a moderately priced drug used to treat attention-deficit hyperactivity disorder and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep). In 1979 President Carter in his Industrial Innovation Initiative Message to Congress announced his intention to seek reexamination legislation, stating that “Patents can provide a vital incentive for innovation, but the patent process has become expensive, time-consuming, and unreliable.” 15 Weekly Comp. At Sandoz, we discover new ways to improve and extend people’s lives. Cir. But then somebody might figure out how to design around our invention! Property can also be removed as part of Imminent Domain (Which, if we applied it to Patents, I think would cause a gigantic howling). This can happen through Fraud or Mistake. You are absolutely correct about this. Does anyone know what the variation in molecular weight would be for Mp, Mw, or Mn? It looks like they used GPC for separation (see Ex. **granted here there may be intervening “law” written from above that justifies a panel not following an earlier panel, but such an action must be explicitly made clear. You wrote “20%” as some type of gauge, and I note the question mark, but what would be the appropriate gauge – and perhaps more importantly, why? he Federal Circuit position in e.digital v. futurewei was that collateral estoppel should be applied with caution when patent claims, even claims from related patents, use the same wording. The link above is to the English judgement and in it para 223 to 257 treat the “average MW” issue. I literally just heard a advertisement on my pandora where an ‘innovator” or their attorney was qqin about too many “innovators” being forced “out of the game” by the new proposed bill in congress. #$%! MM, in 1980, POs were using no-defect reissues to reexamine applications in face of new prior art because of Rene Tegtmeyer (former deputy commisioner). This is fact and I’ve been on this medication for 9 years due to severe adhd. 2), but you take it from the mass fraction trace (Fig. After losing on the merits, the district court in 2011 entered a final injunction with respect to claim 26. Professional scientists and skilled researchers with a couple ounces of integrity are used to providing that information in clear terms so others can reproduce their results. Here, the patent claims include a copolymer “having a molecular weight of about 5 to 9 kilodaltons.” The problem is that polymer chemists have three different ways that molecular weight could be calculated in this context (peak average; number average; and weight average). Or better yet: a patent. Typically, it’s about 1.5ish, unless you’re doing controlled polymerizations, which are tricky/difficult to do (although they do it all the time in peptide chemistry, but that’s an entirely different story). Legally we provide different types of property different levels of legal protection. What are the ingredients in Adderall®? >The district court, however, accepted Dr. Grant’s opinion that a person of ordinary skill would understand that the process of transferring data from a chromatogram could cause a shift in the peak of the curves. Time and time again, inventors are so perplexed by what the patent attorney describes as their invention, in the patent application to be filed forthwith at the PTO, that they don’t give serious enough attention to the precise text of the patent application. For more information about Adderall®, please contact Teva Pharmaceuticals at 1-888-838-2872. Sure, there may be situations in which only one should be forfeit, but just as assuredly, there are situations where both should be forfeited. Of course, the clear-and-convincing standard is associated with factual conclusions not questions of law and the Federal Circuit here does not appear to have relied upon any factual conclusions for its decision. 126 Cong.Rec. Also, I’d be careful about demanding Patents and Personal Property be treated the same. 2069, 2070 (Oct. 31, 1979). Mw can be less than Mp if you have a broad tail at molecular lower than Mp, with a narrow tail at molecular weights higher than Mp. For most, the effects of 10mg Adderall IR will usually last around 4 to 6 hours. [4] In doing so, the judge relied in part on expert witness testimony. If you fail to properly disclose something (fraud) and it get’s invalidated, you lose it. Second, the procedure would allow courts to refer patent validity questions to the expertise of the Patent Office. Hi everyone, I filled my first Adderall generic prescription back in late November and got the Aurobindo generic which was absolutely awful. Likewise, 8,969,519 specifies “as determined by gel electrophoresis under deglycosylated, reduced, and denatured conditions” but does not specify Mp, Mw, or Mn. My comments are not a “strawman”. Submit a patent jobFind a patent professional among the 15,000+ monthly visitors of the job board, many of whom are patent professionals at large firms and corporations. Teva's IR and XR is okay. The Court held that, when reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review. Corepharma, Teva, Sandoz Generic IR Adderall differences? The law states that patents are personal property. Other pharmaceutical companies that make generic versions of Adderall -- including Teva, Barr, Impax Labs, Sandoz, and CorePharma -- will also benefit if the DEA raises its annual quota on industrial amphetamine production. Subscribe to the blogAbout 25,000 individuals now receive Patently-O via e-mail each morning. 2009-2010, Shire’s XR, 2010-2011, Global XR (generic), 2011-current, Barr/Teva IR, Sandoz… So not very close at all. no problem with the dual track system Congress has collateral estoppel should be applied with caution. DC: the majority strongly implies that “clear and convincing evidence” is required to hold a claim invalid for indefiniteness: I suppose the alternate interpretation of the passage you cited is that the Federal Circuit simply believes that the claim is clearly and convincingly indefinite and should be held invalid whatever standard is applied. Do you really want government to take away your house, car, bank account at anything else than with clear and convincing evidence? patent owners who must defend on two fronts. There are more than three molecular weight averages that can be talked about in polymer science. In Nautilus, the court  lowered-the-bar by making it much easier to find a patent indefinite whenever a claim’s scope lacks “reasonable certainty.”. 1; Mn is the integral of Fig. One group's side effects appear like taking too much Adderall side-effects: sleep less, eat less, more side-effects, less duration, jitteriness. However, the applicant tried to argue that it was Mp, but the (presumably GPC?) Sandoz Adderall is the smoothest Adderall in my opinion, meaning there aren't a lot of hills and valleys when you're taking the proper amount. Spangenberg is on the record somewhere saying, in effect, that it’s time to find a new grift. 2 would have to be much larger, like 100% (since the peaks are both around 8k). It’s been almost a decade since I’ve done polymer chemistry…. Unforturnately, after allready having ordered it, I am now reading of people on message boards saying Sandoz was far superior to Barr (search google for: barr vs sandoz adderall). I'm hoping Prasco does something great with it. It’s not clear what that’s supposed to mean. By law patents are personal property and carries with it clear and convincing evidence, facts or law aside. Why not both? Thanks Obama. Whether you call it “ownership” or “right to sue” they are one and the same. makes invalidation based on prior art easier. In addition to those mentioned in Teva, there is also, at least, z-average. It would be printed with Adderall XR 10 mg. How Long Does 10mg Adderall Last? The Fed. I think they really shot themselves in the foot by arguing that it was Mp in order to try to overcome the original indefiniteness argument. But the system IS being used by accused infringers to game the system via the PTO’s lower standard of proof and BRI. Third, reexamination would reinforce “investor confidence in the certainty of patent rights” by affording the PTO a broader opportunity to review “doubtful patents”. [According to Mr. Tegtmeyer, reissue proceeding were unavailable for government mistakes.]. Certainly assuming there’s something nefarious about this is not reasonable. certain validity issues, not duplicative of them. In Teva, the Supreme Court held that findings-of-fact subsidiary to a claim construction decision should be given deference on appeal. Where is the uproar a la Williamson v. Citrix? Just a note, if you are wrongly issued a deed of ownership, it can be taken away. During prosecution, the point of novelty was the degree of roughness. Depends on the distribution of molecular weights, which usually depends on the method of making of the polymer. With the lower standard of proof, BRI and the PTO’s acceptance of collateral attacks by infringers already in litigation, the reexamination monster set loose on the patent system is the opposite of what congress intended. In a collateral attack, Lawson petitioned for re-examination. The injunction was affirmed on appeal in 2012 with respect to claim 26 but not with respect to other claims. Under the terms of the agreement, Sandoz, the generics unit of Swiss pharma giant Novartis, will exclusively sell an authorized generic version of Adderall XR supplied by Shire as of 1 July 2016. There are also other ways of determining “molecular weight” from some physical property like modulus or viscosity. Indefiniteness is considered part of the claim construction analysis and thus is also a question of law. Pka collateral estoppel should be applied with caution. It also approved generic versions of drugs offering the combination of amphetamine and dextroamphetamine. We both know that you know that that I know that you have Zero evidence for the “willy-nilly… new definitions… new terminology” comment, which is merely an attempted spin for your usual short script attack on innovation in a particular art field. What’s the alternative? Adderall. and convincing) and given that the PTO uses a claim It is reasonable to assume that anything coming out of the Fed. Adderall ® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Even the practitioners that are careful to specify the technique used to measure molecular weight appear to disregard the possibility that Mp, Mw, and Mn might be so far apart that a single expressed range would be indefinite. Also, I thought Mp was from the mole fraction trace, but I was mistaken; it is read from the mass fraction trace. Law Professor at the University of Missouri School of Law. On remand, the district court found the defendant, Lawson, in contempt of the injunction regarding claim 26 because it’s allegedly redesign products continue to infringe. MM..you want to take a position that you won’t sue if someone lives in your house or takes off your money without your permission? applicability of the broadest reasonable construction As well as name brand. Wow. The Federal Circuit is correct that introducing an expert to testify that “I’d resolve the contradiction/ambiguity in the instrinsic evidence this way” does not change the fact that the instrinsic evidence is contradictory and the undefined claim term is ambiguous. And the inventors probably never gave it a second thought. But the mean and median are typically close enough that it doesn’t really matter. 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