Source: https://www.patentdocs.org/2013/06/index.html
Timestamp: 2019-04-18 10:52:49+00:00

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Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al.
• Defendants: Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.
Infringement of U.S. Patent No. 6,149,938 ("Process for the Preparation of a Granulate Suitable to the Preparation of Rapidly Disintegrable Mouth-Soluble Tablets and Compositions Obtained Thereby," issued November 21, 2000) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Alpex's Suprenza® (phentermine hydrochloride, used to treat obesity). View the complaint here.
• Plaintiffs: Alza Corp.; Janssen Pharmaceuticals, Inc.
Alza Corporation et al. v. Osmotica Kereskedelmi es Szolgaltato Kft et al.
• Defendants: Osmotica Kereskedelmi es Szolgaltato Kft; Osmotica Pharmaceutical Corp.; Norwich Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,163,798 ("Methods and Devices for Providing Prolonged Drug Therapy," issued April 24, 2012) following a Paragraph IV certification as part of Osmotica's filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the Delaware complaint here.
Sandoz Inc. v. Amgen Inc. et al.
• Defendants: Amgen Inc.; Hoffman-La Roche Inc.
Declaratory judgment of non-infringement, invalidity, and unenforceability of U.S. Patent Nos. 8,063,182 ("Human TNF Receptor Fusion Protein," issued November 22, 2011) and 8,163,522 ("Human TNF Receptor," issued April 24, 2012) based on Sandoz's development of a biologic drug containing etanercept that would compete with Amgen's Enbrel® (etanercept, used to treat rheumatoid Arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis). View the complaint here.
Pegasus Laboratories, Inc. v. Wedgewood Village Pharmacy, Inc.
• Plaintiff: Pegasus Laboratories, Inc.
• Defendants: Wedgewood Village Pharmacy, Inc.
Infringement of U.S. Patent Nos. 5,747,476 ("Treatment of Equine Protozoal Myeloencephalitis" issued May 5, 1998), 6,255,308 (same title, issued July 3, 2001), and 6,448,252 (same title, issued September 10, 2002), licensed to Pegasus, based on Wedgewood's marketing and sale of a sulfadiazine and pyrimethamine product for treating horses with Equine Protozoal Myeloencephalitis caused by sarcocystic neurona. View the complaint here.
Janssen Products, L.P. et al. v. Lupin Ltd. et al.
Infringement of U.S. Patent Nos. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010), 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006), and 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
• Defendant: Alkem Laboratories, Ltd.
Pfizer Inc. et al. v. Alkem Laboratories Ltd.
• Defendants: Alkem Laboratories Ltd.
Pfizer Inc. et al. v. Sandoz Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Alkem's filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder). View the Delaware Alkem complaint here.
Par Pharmaceutical Inc. et al. v Breckenridge Pharmaceutical Inc.
• Plaintiffs: Par Pharmaceutical Inc.; Alkermes Pharma Ireland Ltd.
Infringement of U.S. Patent Nos. 6,592,903 ("Nanoparticulate Dispersions Comprising a Synergistic Combination of a Polymeric Surface Stabilizer and Dioctyl Sodium Sulfosuccinate," issued July 15, 2003) and 7,101,576 ("Nanoparticulate Megestrol Formulations," issued September 5, 2006) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients). View the complaint here.
Endo Pharmaceuticals Inc. v. Ranbaxy Laboratories Ltd. et al.
• Plaintiff: Endo Pharmaceuticals Inc.
• Defendants: Ranbaxy Laboratories Ltd.; Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Endo's Opana® ER CRF (oxymorphone hydrochloride, crush-resistant formulation, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here.
Kremers Urban Pharmaceuticals, Inc. v. Rea et al.
• Plaintiff: Kremers Urban Pharmaceuticals, Inc.
Reversal of the revival by the U.S. Patent and Trademark Office of the application that granted as U.S. Patent No. 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002), listed in the Orange Book for AbbVie's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia), and therefore a declaration that the patent is invalid. View the complaint here.
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The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent Supreme Court patent jurisprudence would perhaps not be amiss in thinking the adage should be adapted to "Bad analogies make bad law.") The current Court (or at least a 5-member majority) showed on Monday that it could be immune to these equities in reversing a $21 million judgment to a New Hampshire woman disfigured as a consequence of taking a generic formulation of sulindac, a non-steroidal anti-inflammatory drug (or NSAID). Once again, the Court waded into the waters of drug regulatory law and the interplay between the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and Hatch-Waxman Act and state, common law products liability sounding in tort, with the Court deciding that state law was preempted (to the detriment of the patient's recovery for the "tragic circumstances" of her disfigurement).
made by Mutual Pharmaceutical to Respondent Karen L. Bartlett. Ms. Bartlett suffered a known -- albeit rare -- side effect of sulindac administration (as well as other NSAIDs), toxic epidermal necrolysis, a skin hypersensitivity reaction. The consequences for Ms. Bartlett were "horrific" according to the Court: "[s]ixty to sixty-five percent of the surface of respondent's body deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind." Significant for the Court's decision, at the time she was administered the drug, the drug label did not contain any specific warning regarding this type of side effect (although the FDA required the package insert to contain a warning regarding the risk of developing this condition); the Agency later required this warning to be on the drug label.
New Hampshire imposes design-defect liability only where "the design of the product created a defective condition unreasonably dangerous to the user," citing Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181 (2001); Chellman v. Saab-Scania AB, 138 N. H. 73, 7, 637 A. 2d 148, 150 (1993). To determine whether a product is "unreasonably dangerous," the New Hampshire Supreme Court employs a "risk-utility approach" under which "a product is defective as designed if the magnitude of the danger outweighs the utility of the product." Vautour, supra, at 154, 784 A. 2d, at 1182 (internal quotation marks omitted). That risk-utility approach requires a "multifaceted balancing process involving evaluation of many conflicting factors." Ibid. (internal quotation marks omitted); see also Thibault, supra, at 809, 395 A. 2d, at 847 (same).
Moreover, according to the Court this form of liability, while being "strict" product liability is not "absolute" liability; the distinction is that the former imposes a "duty of care" on manufacturers as opposed to the latter form of liability, which is a way states can "spread the risk" of injury due to design or manufacturing defects. This distinction is relevant, because the Court's determination that Mutual was under a common law-defined duty in New Hampshire implicated the three ways the company could comply with state law, and how two of the three were impossible under Federal law.
The Court's opinion, by Justice Alito joined by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas, found that Mutual could comply with its state-law imposed duty either by making chemical changes to the drug or changing the drug label (here, by including the more stringent warnings from the package insert on the label, as the FDA was later to do). The majority found that changing sulindac chemically was impossible both for reasons of "basic chemistry" (i.e., there is little that could be changed in the molecule without changing it into a different molecule) and FDA regulatory law, which required the generic compound to be a copy of the branded drug and to have certain pharmacological properties in common with the branded embodiment. 21 U. S. C. §§ 355(j)(2)(A)(ii), (iii) and (iv), 21 U. S. C. §§ 355(j)(8). The impossibility of changing the label is a direct consequence of the FDA requirement that a generic drug have the same label as the branded version. § 355(j)(2)(A)(v). And a generic drug manufacturer is barred from unilaterally changing either the drug itself, its formulation or its label. 21 CFR § 314.70(b)(2)(i). Thus, in this case there was a direct conflict between what was required to comply with the state-imposed duties under its tort law and the requirements of Federal drug regulatory law.
Under these circumstances, the Court held that Federal law prevails and preempts state tort liability, citing Maryland v. Louisiana, 451 U. S. 725, 746 (1981), for the principle that "[u]nder Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are 'without effect.'" And the Court rejected the third possibility open to Mutual, which was to stop selling generic sulindac in New Hampshire, saying that if this were the law "impossibility preemption" would be "all but meaningless," citing its recent opinion in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), a case involving state law liability on "failure to warn" grounds. The Court expressly rejected this alternative in the PLIVA case, saying that "[a]dopting the [appellate court's] stop-selling rationale would mean that not only PLIVA, but also the vast majority -- if not all -- of the cases in which the Court has found impossibility pre-emption, were wrongly decided."
[T]he Court appears to justify its revision of respondent Karen Bartlett's state-law claim through an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability. Remarkably, the Court derives this proposition from a federal law that, in order to protect consumers, prohibits manufacturers from distributing new drugs in commerce without federal regulatory approval, and specifically disavows any intent to displace state law absent a direct and positive conflict.
Congress' preservation of a role for state law generally, and common-law remedies specifically, reflects a realistic understanding of the limitations of ex ante federal regulatory review in this context. On its own, even rigorous preapproval clinical testing of drugs is "generally . . . incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in the studies," citing Kessler & Vladeck, A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 471 (2008); see National Academies, Institute of Medicine, The Future of Drug Safety: Promoting and Protecting the Health of the Public 37-38 (2007).
Her dissent also notes that "the FDA, which is tasked with monitoring thousands of drugs on the market and considering new drug applications, faces significant resource constraints that limit its ability to protect the public from dangerous drugs," citing Levine, 555 U. S., at 578-579, and n. 11, and that "[t]ort suits can help fill the gaps in federal regulation by 'serv[ing] as a catalyst' to identify previously unknown drug dangers," citing Bates v. Dow Agrosciences LLC, 544 U. S. 431, 451 (2005).
A manufacturer of a drug that is unreasonably dangerous under New Hampshire law has multiple options: It can change the drug's design or label in an effort to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business. If federal law or the drug's chemical properties take the redesign option off the table, then that does not mean the manufacturer suddenly has a legal obligation under state law to improve the drug's label. Indeed, such a view of state law makes very little sense here because even if Mutual had strengthened its label to fully account for sulindac's risks, the company might still have faced liability for having a defective design. . . . When a manufacturer cannot change the label or when doing so would not make the drug safe, the manufacturer may still choose between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product.
While these alternatives may be "unwelcome" from a manufacturer's prospective, "it is a choice that a sovereign State may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation."
Ironically, the majority, usually so quick to rely upon Federalism (or "states' rights") principles in other contexts finds state tort law liability to be preempted while the traditionally "liberal" members of the Court would hew to basic Federalism principles in permitting states to protect their citizens under common law tort law. While the majority "saves for another day the question whether a true absolute-liability state-law system could give rise to impossibility pre-emption," it seems that states adopting an "absolute liability" regime that imposes no affirmative duties contrary to Federal law but merely "spreads the risk" might be one way for the states to regain their traditional right to employ the sovereign police powers to impose tort liability that would escape the wide latitude of preemption embodied in the Court majority's decision.
It has been just over a month since the Federal Circuit's fractured en banc ruling in CLS Bank Int'l v. Alice Corp. regarding patent-eligibility of computer-implemented inventions under 35 U.S.C. § 101. Last week, the Court decided another § 101 case, Ultramercial, Inc. v. Hulu, LLC. Of interest is that the panel for the latter included the authors of the two main opposing opinions in CLS Bank -- Judge Lourie and Chief Judge Rader. However, instead of throwing down, the judges agreed that the claims at issue met the requirements of § 101, even if they disagreed on the rationale for this conclusion.
This action began when Ultramercial sued Hulu, YouTube, and WildTangent for infringement of U.S. Patent No. 7,346,545. Hulu and YouTube were eventually dismissed from the case. On a 12(b)(6) motion, the District Court held that the '545 patent does not claim patent-eligible subject matter. On appeal, the Federal Circuit reversed and remanded. However, that decision was vacated by the Supreme Court. Back in the Federal Circuit again, Chief Judge Rader authored the majority opinion, joined by Judge O'Malley, once again reversing the District Court. Judge Lourie concurred in the outcome.
First, Chief Judge Rader noted that it is rare for a patent to be dismissed in the pleading stage, because issued patents enjoy a presumption of validity. Thus, factual allegations of patent-ineligibility must be viewed in the most favorable light for the patentee. Indeed, there must be "clear and convincing evidence of ineligibility," and consequently, "12(b)(6) dismissal for lack of eligible subject matter will be the exception, not the rule." Chief Judge Rader also noted that the various § 101 analyses propounded by the judges of the Federal Circuit generally require some degree of factual inquiry. As a result, the presence of these factual issues would normally "render dismissal under Rule 12(b)(6) improper."
Turning to the history of title 35, Chief Judge Rader emphasized, like he did in CLS Bank, that Congress intended § 101 to be read expansively. Congress made no exceptions to patentable subject matter -- those were introduced by the courts. Particularly, the well-known exceptions of abstract ideas, laws of nature, and natural phenomena were introduced to "prevent the monopolization of the basic tools of scientific and technological work."
Following his 'broad statute with narrow exceptions' interpretation of § 101, Chief Judge Rader addressed the patentability of abstract ideas with respect to software and business method claims. He noted that "a process need not use a computer, or some machine, in order to avoid abstractness." In rejecting the machine-or-transformation test for § 101 eligibility in Bilski v. Kappos, Chief Judge Rader believes that the Supreme Court was attempting to allow the patent laws to accommodate new and future technologies of the information age.
Chief Judge Rader further indicated that, in doing so, the Supreme Court has set forth a number of guidelines. These include the principles that (i) a claim that recites an abstract idea can be valid as long as the claim is directed to an application of the idea, and (ii) determining if this is the case requires consideration of the claim as a whole to ascertain whether the claim includes meaningful limitations restricting it to such an application. Factors determining whether a limitation is meaningful were spelled out by Chief Judge Rader's concurrence-in-part and dissent-in-part in CLS Bank, and he revisits them here.
One of Chief Judge Rader's challenges in both CLS Bank and this case was to synthesize two opposing notions originally set forth by the Supreme Court in Parker v. Flook and Diamond v. Diehr, respectfully. On one hand, Flook indicated that the § 101 inquiry should treat claimed abstract ideas as "a familiar part of the prior art." On the other hand, Diehr held that "[t]he question therefore of whether a particular invention is novel is wholly apart from whether the invention falls into a category of statutory subject matter." The Supreme Court's most recent ruling on patent-eligible subject matter, Mayo v. Prometheus, seems to defer more to Flook than Diehr in this regard. For example, in Prometheus, the Justices stated that "in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap."
[T]he Supreme Court's reference to "inventiveness" in Prometheus can be read as shorthand for its inquiry into whether implementing the abstract idea in the context of the claimed invention inherently requires the recited steps. Thus, in Prometheus, the Supreme Court recognized that the additional steps were those that anyone wanting to use the natural law would necessarily use. If, to implement the abstract concept, one must perform the additional step, or the step is a routine and conventional aspect of the abstract idea, then the step merely separately restates an element of the abstract idea, and thus does not further limit the abstract concept to a practical application.
Thus, Chief Judge Rader seems to be advocating that the "inventive concept" and "meaningful limitations" tests involve limited consideration of prior art. This consideration would determine whether the non-abstract-idea features of a claim are essential, routine, or conventional facets of a recited abstract idea.
Applying this notion to computer-implemented inventions, he notes that mere reference to a general purpose computer in the claims falls into the essential, routine, or conventional category. On the other hand, Chief Judge Rader suggests that if "the claims tie the otherwise abstract idea to a specific way of doing something with a computer, or a specific computer for doing something . . . they likely will be patent eligible." He also notes that "meaningful limitations may include the computer being part of the solution, being integral to the performance of the method, or containing an improvement in computer technology." Such limitations would avoid pre-emption of a claimed abstract idea.
Turning finally to Ultramercial's claim, Chief Judge Rader held that the District Court erred in "requiring the patentee to come forward with a construction that would show the claims were eligible." Instead, he indicated that, given the procedural posture of the case, the District Court "should either have construed the claims in accordance with Markman, required the defendant to establish that the only plausible construction was one that, by clear and convincing evidence rendered the subject matter ineligible (with no factual inquiries), or adopted a construction most favorable to the patentee." In analyzing the claims, Chief Judge Rader opted for the latter approach.
In determining whether the claim encompassed an abstract idea, the parties agreed the claimed idea that "advertising can be used as a form of currency" is abstract, and focused their dispute on whether the claims include meaningful limitations to overcome this abstractness. Chief Judge Rader answered this question in the positive, observing that some steps of claim 1 "plainly require that the method be performed through computers, on the internet, and in a cyber-market environment." As a result, he found that the complexity of such a computer implementation involved "no risk of preempting all forms of advertising, let alone advertising on the Internet" and met the requirements of § 101.
Thus, despite a recitation of "the Internet" being the only concrete structure in the claim, a combination of the claim's many specific limitations, and the procedural requirement of construction most favorable to the patentee, led to the conclusion that the claim was patent-eligible. Notably, Chief Judge Rader posited that the claim requires "controlled interaction with a consumer over an Internet website, something far removed from purely mental steps."
In concurring, Judge Lourie wrote separately to advocate "faithfully follow[ing] the Supreme Court's most recent guidance regarding patent eligibility in [Prometheus] and . . . the plurality opinion of five judges from this court in CLS Bank." Judge Lourie agreed that the claims included the abstract idea of "using advertising as an exchange or currency."
However, he disagreed with Chief Judge Rader's focus on the complexity of the computer implementation of the claimed method, since a specific implementation is not recited. Instead, Judge Lourie found that "the added limitations in these claims represent significantly more than the underlying abstract idea of using advertising as an exchange or currency and, as a consequence, do not preempt the use of that idea in all fields." And he left it at that, with no further substantive analysis or discussion.
So . . . now what? In a sense, this case is a valuable data point. It demonstrates how a claim that encompasses an abstract idea can include sufficient "inventive concept" and "meaningful limitations" to satisfy the judges who disagreed so fiercely in CLS Bank. But what analytical technique should be used to evaluate such a claim? Do we turn to Chief Judge Rader's approach, which seems limited to the facts of this case, or to Judge Lourie's approach, which is conclusory at best?
One point seems clear, however. The Federal Circuit is not going to abandon the "inventive concept" and "meaningful limitations" tests -- the progeny of Prometheus -- any time soon.
When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed functional activity (and it can be routinely performed by one skilled in the art)? The Federal Circuit tackled this problem on Wednesday in the Wyeth v. Abbott Laboratories case, in which the Court affirmed a lower court's grant of summary judgment of non-enablement. It was unclear from the decision how many compounds were encompassed by this genus, but Abbott alleged that there were tens of thousands, and Wyeth's expert appeared to acknowledge that the number would be "significantly smaller" than "millions of compounds." Nevertheless, it was decisive to the Court that there were no suggestions in the patents at issue as to which substitutions in the compound would be preferable, that there was no guidance or predictions about any particular substitutions, and that the unpredictability in the art would have required the testing of each compound to see if it fell within the functional limitations of the claim. And, even though the Court acknowledged that undue experimentation is a matter of degree, synthesizing and screening tens of thousands of compounds qualified as "excessive" and therefore was found to be undue. The only other hint as to what amount of effort might or might not also qualify as "excessive" was that the Court noted that "it would take technicians weeks to complete each of these assays." Nevertheless, to affirm a grant of summary judgment with so many factual issues to consider, not the least of which was whether one skilled in the art would consider such experimentation to be undue, this was apparently not a close case for the Court.
This compound was known in the art, so the patents do not even contain this structure, instead referring to a patent that discloses and claims rapamycin (although again only the sirolimus compound). Nevertheless, even though the patents only refer to this one compound, the District Court adopted Wyeth's broad construction of "a compound containing a macrocyclic triene ring structure produced by Streptomyces hygroscopicus, having immunosuppressive and anti-restenotic effects." Therefore, any substituent beyond the C-37 position (the dashed circle) can be used to modify the structure and still fall within the scope of this definition. Wyeth likely sought such a construction because the defendants separately market stent products that elute everolimus and zotarolimus, which have the same macrocyclic ring, but different constituents at the C-42 position. The likely real problem that the Court had with this case, therefore, was that it appeared as if Wyeth was trying to assert its patents against currently used compounds that were not specifically taught in the patent disclosure (which itself only mentioned one species).
The enablement question turned on the fact that not all species of the rapamycin genus were immunosuppressive and anti-restenotic. Wyeth's expert did point out, however, that one skilled in the art would know that you could not just add anything to ring. If so, the number of possible species would be in the millions, and might approach infinite. However, to have the claimed functional effects, the compound would need to be permeable across cell membranes. This limits the practical size of compounds to below 1,000-1,200 Daltons (for comparison, sirolimus is approximately 914 Daltons). Even though there was some confusion at the oral hearing, the Court understood that this would limit the number of compounds to the tens of thousands. More importantly, because the patents in suit did not disclose any other species of this genus, there was no disclosure of which substituents would be preferable, or any predictions as to which substituents would be active. The only teaching along these lines was the inclusion of assays to determine immunosuppressive and anti-restenotic activity, which the Court accepted would be routine for one skilled in the art. Nevertheless, even though routine, testing tens of thousands of compounds would be excessive, and therefore the amount of experimentation was found to be undue.
The opinion was straightforward, and provides some guidance as to how many species of a generic compound could cause undue experimentation if the disclosure provides no guidance as to which substituents would fit the functional limitation. However, what was not clear from the opinion or the oral argument was whether one skilled in the art would have considered such testing to be undue, or at least whether this question should have been decided at trial. Also, it was unclear just how many species of the tens of thousands were, in fact, inoperative. It was suggested that only around seven had been identified as active, but no mention was made of the species that were found to be inactive. This could be because the Court believed this fact was irrelevant, especially in view of the unpredictability in the art. However, it would be interesting to know whether the decision would have been different if all known species were active. And, if so, what if only half of the species were active? The take home lesson is if you are drafting and prosecuting such claims, provide as much detail about the substituents as possible, and claim varying scopes of generic structures. Of course, Wyeth was stuck with its disclosure from 1992, and so they were between a rock and a hard place (because the defendants were not selling the species that they disclosed).
The really troubling aspect of this case came during oral argument, but did not make it into the opinion. This issue related to grant of summary judgment for lack of written description with regard to two routes of administration, specifically transdermally and rectally. Apparently, the inventors testified that they did not know how to administer the compound via these routes, and it was unclear whether anyone else in the art knew at the time. Judge Moore, who wrote the opinion, questioned from the bench whether the point of the written description requirement was to demonstrate that the inventor possessed the invention. And, if the inventor admits to not possessing a particular aspect of the invention, Judge Moore asked, can the specification truly be described? She then carried this line of thought to its logical, if not absurd, conclusion, that if a synthetic chemist does not know how to administer drugs to patients, how can they ever be entitled to method of treatment claims? She wondered if a formulator should also be included in the inventive entity, especially considering the fact that in this case both parties agreed that the definition of a person skilled in the art would also include a formulator. Of course, Wyeth's counsel cautioned against such draconian approach to pharmaceutical patent claims. Nevertheless, because the Court did not comment on the written description found in the specification, it is unclear whether Judge Moore was simply musing, or whether we can expect to see closer scrutiny of pharmaceutical method-of-treatment claims from her (or the Court in general), especially if such claims contain specific administration routes as limitations.
The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat osteoporosis. This product was covered by a supplementary protection certificate (an SPC), as well as two use patents. Hospira, a generics company, started revocation actions against these two patents and obtained a marketing authorisation for zoledronic acid to treat a number of conditions, including osteoporosis.
Soon after becoming aware of the marketing authorisation, Novartis wrote to Hospira requesting an undertaking that no product would be sold before the expiry of the SPC, which was duly given by Hospira. A subsequent letter requested confirmation that if the claims were found to be valid in revocation proceedings, the product would not be launched even after the lapse of the SPC. This confirmation was not given. Instead, as both patents were found to be invalid in the revocation action, Hospira indicated their intention to launch the product after the lapse of the SPC.
Novartis appealed the revocation decision and started infringement proceedings concerning the two use patents and applied for an interim injunction to prevent Hospira's launch. In response to this application, Hospira argued that once a decision on the merits had been given, a party needs an arguable case on appeal for an injunction to be granted and that it would not be right to equate such a case with a good arguable case on the merits at the start of proceedings. It was argued that different considerations applied once trial had taken place. The court of first instance held that the case was plainly arguable and that Novartis was more at risk of suffering larger losses. However, the appeal on the revocation was not nugatory and did not have a strong prospect of success. Instead, the appeal was arguable and could inflict uncompensatable harm on either side. Further, it was said that Novartis should have started infringement proceedings earlier to allow a conclusion to be reached in good time. An injunction was therefore not granted. Novartis subsequently appealed against the decision on the granting of the injunction.
The Court of Appeal held that there was not a clear view on the merits, as the appeal had a realistic prospect of success. The exercise of discretion should therefore not be approached on the basis that the merits are clear in favour of one side or the other. It was further held that the previous decision on the merits should not affect the balance of hardships considered when granting an injunction. This balance fell in Novartis' favour, based on the damage that would be suffered by Novartis if an injunction was not granted being more certain and greater in magnitude than the damage to Hospira if an injunction was granted.
The facts that Hospira was also selling zoledronic acid for other, less profitable diseases and that the public would be disadvantaged by an injunction were deemed to be irrelevant. It was held that an appeal in cases such as this should be expected and that generic companies should have to disclose their intentions to the innovator in time for an appeal to take place, or expedite proceedings accordingly. The decision at first instance could not be expected to determine Hospira's freedom to sell the product. The Court of Appeal therefore found in Novartis' favour and granted an interim injunction.
This decision therefore sets a precedent for interim injunctions pending appeal to be granted even if the relevant patents were found invalid at first instance.
This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK. Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.
The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the "safe harbor" provisions on 35 U.S.C. § 271(e)(1). Specifically, two panels of the Court, both consisting of Chief Judge Rader and Judge Moore, have come to different interpretations of the statute with regard to post-approval activities. In Classen Immunotherapies, Inc. v. Biogen IDEC, (where the Court earlier refused to grant certiorari in a case styled Glaxo Smith Kline v. Classen Immunotherapeutics), a majority of the merits panel (Chief Judge Rader joined by Judge Newman) held that post-approval activity did not fall within the safe harbor (over a vigorous dissent by Judge Moore). In contrast, in the Momenta case, the panel majority (Judge Moore joined by Judge Dyk) found that such activity does fall within the scope of the statute (over an equally vigorous dissent by Chief Judge Rader), giving the statutory language a broad reading compelled, according to Judge Moore, by the Supreme Court's decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).
To briefly recap, the Momenta decision arose in the context of a District Court grant of a preliminary injunction to Momenta in litigation between two ANDA filers. Momenta entered the marketplace after ANDA litigation with the patent holder, Aventis, over Lovenox (enoxaparin), a specific formulation of heparin. As explained in the opinion, heparin (unlike most drugs) is not "a single defined molecule" but rather a heterogeneous mixture of molecules that differ in "the length of the polysaccharide chain" and the "component disaccharide units and the corresponding distribution of disaccharide unit sequences in the polysaccharide chains." This affects its molecular weight distribution as well as the distribution of uronic acid moieties. Enoxaparin is the result of fragmentation of native heparin into a "diverse set" of oligosaccharides. Accordingly, FDA approval for ANDA filers required five "criteria" or "standards of identity" to be met, including "[e]quivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species" identified by specific enzymatic treatment and physical/chemical analyses of the drug product, including separation and spectroscopy.
Being the only generic version of enoxaparin has it benefits: its sales generated revenues of $260 million per quarter. . . . The approval of Amphastar's version of enoxaparin, and the resultant ruinous competition of another generic version of the drug, threatened this unique market position. Understandably unwilling to give up a billion dollars in yearly revenue, Momenta initiated the present litigation two days after Amphastar received final FDA approval to market its generic enoxaparin.
6. A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising: providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that includes .beta.-eliminative cleavage with a benzyl ester and depolymerization; and making a determination about the enoxaparin sample based upon a comparison of the determination of the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 to a reference standard for enoxaparin, wherein the determination based upon the comparison to the reference standard regards the quality of the sample, to thereby analyze the enoxaparin sample.
15. A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising: providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that includes .beta.-eliminative cleavage with a benzyl ester and depolymerization; and making a determination about the enoxaparin sample based upon a comparison of the determination of the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 to a reference standard for enoxaparin, wherein the level of one or more structural signatures associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 is determined, to thereby analyze the enoxaparin sample.
The Federal Circuit characterized Momenta's complaint as alleging that Amphastar infringed the '886 patent by complying with FDA requirements for testing its enoxaparin product as part of the quality control necessary for making this drug. Judge Moore's opinion vacated the preliminary injunction and remanded using language that made it very unlikely that the District Court would be able to grant the injunction (see Patent Docs post). Chief Judge Rader's dissent directed his contrary analysis not only to the specific matter before the Court but also opined more broadly (see "Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals, Inc.: 'The Rest of the Story'").
The District Court rejected this contention because the infringing activity occurred after Amphastar received regulatory approval, the Court interpreting the statute to be limited to otherwise infringing acts that were performed in order to obtain approval (while acknowledging that the information was, ultimately, submitted to the FDA). According to Judge Moore's opinion, the District Court interpreted the meaning of the statute with reference to its legislative history. This was the source of the District Court's error, according to Judge Moore.
When the intent of Congress is expressed so clearly and consistently throughout the statute, there is neither the need nor the occasion to refer to the legislative history. Id. The scope of the Hatch-Waxman safe harbor does not stop at activities reasonably related to development of information submitted in an ANDA. Instead, the safe harbor applies "to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." As long as the allegedly infringing use is "for uses reasonably related" to the development and submission of that information it is not an act of infringement, regardless of where that requirement resides in the law.
The panel majority cited two specific instances where the Supreme Court ruled on the meaning of § 271(e)(1) in a manner consistent with its interpretation: Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 666 (1990), and Merck KGaA v. Integra Lifesciences I, Ltd. In the Lilly case, the Court interpreted the safe harbor to include testing of medical devices because (despite the "clear and unambiguous language of the statute" that the safe harbor was limited to drugs) in the Court's view, regulation of medical devices fell within the ambit of the FDCA. And in Merck, the Supreme Court "reaffirmed this expansive view" of the safe harbor, holding that infringement of patent claims directed towards activities that were not directly related to obtaining data for submission to the FDA, i.e., clinical trials, but extended to basis compound discovery activities, on the grounds that Congress had used the word "any" in reciting the activities within the scope of the safe harbor. And the panel majority also provided a reminder that Merck held that the phrase "reasonably related to the development and submission of information" relating to regulatory approval did not require that the activities actually resulted in information that was submitted for regulatory approval. Accordingly, the panel majority concluded that the Court's Merck decision "explicitly rejected the notion that § 271(e)(1) was limited 'to the activities necessary to seek approval of a generic drug'" so long as "the accused infringer 'has a reasonable basis for believing' that the use of the patented invention might yield information that 'would be appropriate to include in a submission to the FDA.'"
The panel majority based its decision that Amphastar's activities fell within the safe harbor expressly on the Merck decision, and in the process distinguished the Federal Circuit's earlier Classen decision (as it had to in order to arrive at its contrary conclusion). Classen, the panel majority stated, involved voluntary studies "not mandated by the FDA" and that produced "'information that may be routinely reported to the FDA, long after marketing approval has been obtained'" (i.e., adverse event information that is reported as it is obtained). That was not this case according to the opinion, because the information obtained from infringing Momenta's patents was necessary for Amphastar to continue to sell enozaparin (and failure to do so could cause FDA to "suspen[d] or revo[ke] Amphastar's approval"). Accordingly, the opinion stated that "post-approval studies that are "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs" fall within the scope of the § 271(e)(1) safe harbor." And under this interpretation of the law, the majority further held that Momenta was not likely to prevail on the merits below.
The purpose of 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement. Since the Committee's Subcommittee on Health and the Environment began consideration of this bill, the Court of Appeals for the Federal Circuit held that this type of experimentation is infringement. In Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984), the Court of Appeals for the Federal Circuit held that the expiration date of a patent claiming that drug product constitutes patent infringement, even though the only purpose of the experiments is to seek FDA approval for the commercial sale of the drug after the patent expires. It is the Committee's view that experimental activity does not have any adverse economic impact on the patent owner's exclusivity during the life of a patent, but prevention of such activity would extend the patent owner's commercial exclusivity beyond the patent expiration date.
H.R. REP. NO. 98-857, pt. 1, at 45-46 (1984) (emphases added).
At that point, Amphastar stepped in and took Momenta's patented invention without permission and used it to manufacture each commercial batch it sells on the market. Indeed Amphastar continues to trespass and promises to trespass for years to come. In fact, as the court repeatedly acknowledges, Amphastar is only able to compete with Momenta by taking its patented invention. Amphastar has not developed its own method, but instead delights in trespassing and refuses to pay a reasonable royalty to make the trespass lawful.
Nowhere in the legislative history can this court find any suggestion that § 271(e)(1) would apply other than in the limited scenario of conducting de minimis experiments pre-approval (i.e., to obtain FDA approval). Nowhere in the legislative history can this court find a hint that an "infringer" could continue to use its competitor's patented method in manufacture of each commercial batch for contemporaneous sale. Nowhere in the legislative history can this court find any mention of the post-approval, continuous, commercial sales allowed by this decision. Nowhere in the legislative history can this court find any suggestion that the mere maintenance or retention of information as part of a company's records is considered a submission that would trigger § 271(e)(1). In fact, this court makes no attempt to examine the legislative history of this section at all -- a very telling silence.
This new interpretation would allow almost all activity by pharmaceutical companies to constitute "submission" and therefore justify a free license to trespass. The FDA can inspect records of any drug manufacturer and seller. See 21 U.S.C. § 374. Thus, the drug manufacturer need only make a record, which could potentially be inspected by the FDA, and then any activity could satisfy this new meaning of "submission."
While the Supreme Court does not indicate why it refused to grant certiorari, consideration must be given to the views of the Solicitor General which were expressed upon invitation by the court in the GSK v. Classen Immunotherapeutics case.
According to the Solicitor General's CVSG brief, "further review [of the Classen decision with regard to the safe harbor} was "no longer warranted" in view of the Federal Circuit's later Momenta decision. The SG expressed the view that the Classen majority erred when the opinion stated "that Section 271(e)(1)'s safe harbor encompasses only activities undertaken to obtain the FDA's pre-marketing approval of generic products" because "Congress not only con­templated that drug manufacturers would conduct post-approval scientific studies and clinical trials, but specifically authorized the FDA to require such stud­ies in a variety of circumstances." Thus, any post-approval studies that involve the use of patented inventions solely for uses reasonably related to the development and submission of information to the FDA should fall within the safe harbor by the statute's plain meaning. The basis for the SG's arguments came almost exclusively from the Court's reasoning in the Merck decision, which held that any use of a patented invention for developing information that could be submitted to the FDA or other regulatory agency to obtain marketing approval falls within the scope of the safe harbor. And, according to the SG, there is no basis in the statutory language to distinguish eligible post-approval activity from pre-approval activity. The SG maintained that the Federal Circuit corrected its error in its Momenta decision by applying the law according to the government's position, thus eliminating the need for the Supreme Court to apply correction by granting certiorari.
An unfortunate consequence of the Court's refusal to grant certiorari is that whether a particular activity -- pre- or post-approval -- falls within the safe harbor will depend on how a panel is constituted. In his Momenta dissent, the Chief Judge contended that the Court had "already decided the meaning of this statute," which if correct would preclude the later panel from having come to the opposite conclusion. That the majority in the Momenta case did come to the opposite conclusion was based on Judge Moore being able to distinguish the facts and activities in Classen from those in Momenta. However, given the fact-intensive nature of the question, it is not unlikely that the next case before the next panel that considers the question would (and depending on the panel's constitution, perhaps will) make its own distinctions. Unless the entire Court takes the case en banc there will be no firm precedent (despite the SG's reassurances to the Supreme Court) upon which litigants will be able to rely. This situation is antithetical to Congress's purpose in establishing the Federal Circuit, and provides one more example of questions arising before the court that have no consistent answers. Although Supreme Court review has its own perils (KSR, Bilski, Mayo, Myriad), this question would appear to be one that will only be resolved by an unambiguous decision from the Court (which, no matter how it comes out on the merits will at least confer the benefits of certainty).
Earlier today, the Intellectual Property Owners Association (IPO) announced the release of its 30th annual list of the top 300 organizations receiving U.S. patents. Patent Docs Readers may recall that the U.S. Patent and Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."
Falling out of the Top 15 in 2012 were Hewlett-Packard Co. and AT&T Corp., which dropped to 16th and 18th, respectively.
Life sciences companies and organizations that failed to make the IPO top 300 in 2012 after making it in 2011 included Cardiac Pacemakers, Inc. (#90 on the IPO top 300 for 2011), Japan Science and Technology Agency (256), University of Illinois (274), University of South Florida (281), Advanced Cardiovascular Systems, Inc. (283), Genentech, Inc. (296), General Hospital Corp. (298), and National Institute of Advanced Industrial Science and Technology (299). Becton, Dickinson and Co. and Vertex Pharmaceuticals, Inc. returned to the Top 300 after a one year hiatus.
Please note that some of the companies and organizations listed above may be involved in work outside the life sciences sector, and therefore, a portion of the patents granted to these companies and organizations may be directed to other than life sciences-related inventions. In addition, our list is a little inclusive in that we included medical device companies.
Alza Corp. et al. v. Par Pharmaceutical Inc. et al.
• Defendants: Par Pharmaceutical Inc.; Actavis Elizabeth LLC; Actavis Inc.
Infringement of U.S. Patent No. 8,163,798 ("Methods and Devices for Providing Prolonged Drug Therapy," issued April 24, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Kissei Pharmaceutical Co. Ltd. et al. v. Hetero USA Inc., et al.
• Plaintiffs: Kissei Pharmaceutical Co. Ltd.; Watson Laboratories Inc.; Actavis Inc.
Kissei Pharmaceutical Co. Ltd. et al. v. Sandoz Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,387,603 ("1,5,7-Trisubstituted Indoline Compounds and Salts Thereof," issued February 7, 1995) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Watson's Rapaflo® (silodosin, used to treat benign prostatic hyperplasia). View the Hetero complaint here.
AbbVie Inc. v. Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,232,333 ("Pharmaceutical Composition," issued May 15, 2001), 7,141,593 ("Pharmaceutical Formulations," issued November 28, 2006), and 7,432,294 (same title, issued October 7, 2008) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.
Insite Vision Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
• Plaintiffs: Insite Vision Inc.; Merck Sharp & Dohme Corp.; Inspire Pharmaceuticals, Inc.; Pfizer Inc.
Infringement of U.S. Patent Nos. 6,861,411 ("Method of Treating Eye Infections with Azithromycin," issued March 1, 2001), 6,239,113 ("Topical Treatment or Prevention of Ocular Infections," issued May 29, 2001), 6,569,443 (same title, issued May 27, 2003), and 7,056,893 (same title, issued June 6, 2006), licensed to Inspire (now Merck), following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Merck's AzaSite® (azithromycin, used to treat bacterial conjunctivitis). View the complaint here.
Senju Pharmaceutical Co., Ltd v. Apotex Inc. et al.
• Plaintiff: Senju Pharmaceutical Co., Ltd.
• Defendants: Apotex Inc.; Apotex Corp.; Ista Pharmaceuticals, Inc; Bausch & Lomb Inc.
Infringement of U.S. Patent No. 6,335,335 ("Prolonged-Action Eye Drop," issued January 1, 2002) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Senju's Istalol® (timolol maleate ophthalmic solution, 0.5%, used treat elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma). View the complaint here.
Two pre-conference workshops will be held on July 16, 2013. The first, entitled "Industry Roundtable: Addressing the Day to Day Legal, Regulatory, and Business Challenges of Generic Manufacturers," will be offered from 10:00 am to 12:00 pm. The second, entitled "Business Development Master Class: In-House Counsel Perspectives on Selecting and Evaluating Outside Counsel," will be offered from 2:00 pm to 4:00 pm.
The agenda for the Legal and Regulatory Summit on Generic Drugs can be found here, and additional information about the post-conference workshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $2,295 (conference alone), $2,695 (conference and one workshop), or $2,895 (conference and both workshops). Those registering by June 26, 2013 will receive a $200 discount. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

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