Source: http://ipbiz.blogspot.com/2017/11/
Timestamp: 2019-04-20 23:09:26+00:00

Document:
ALKS 8700 is a monomethyl fumarate (MMF) molecule that the company believes can perform better than dimethyl fumarate (Tecfidera, marketed by Biogen), a U.S. Food and Drug Administration-approved oral therapy for relapsing forms of MS.
A Phase 3 clinical trial, called EVOLVE MS (NCT02634307), is now evaluating the long-term safety and tolerability of ALKS 8700 in an estimated 800 people with relapsing MS. The study, which is recruiting patients at more than 100 sites across the U.S. and Europe, will measure safety via adverse events recorded over its 96 weeks. It is expected to end in December 2020.
The EVOLVE-MS clinical development program also includes an elective head-to-head study comparing the gastrointestinal tolerability of ALKS 8700, at 462 mg twice daily, and Tecfidera at 240 mg twice daily. This is a five-week study involving some 420 people with relapsing MS. Common gastrointestinal symptoms, including nausea, vomiting, upper and lower abdominal pain and diarrhea, will be evaluated using two patient-reported symptom rating scales: the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and the Global Gastrointestinal Symptom and Impact Scale (GGISIS).
Fumaderm®, an enteric coated tablet containing a salt mixture of monoethyl fumarate and dimethyl fumarate (DMF) which is rapidly hydrolyzed to monomethyl fumarate, regarded as the main bioactive metabolite, was approved in Germany in 1994 for the treatment of psoriasis. Fumaderm® is dosed TID with 1-2 grams/day administered for the treatment of psoriasis. Fumaderm® exhibits a high degree of interpatient variability with respect to drug absorption and food strongly reduces bioavailability. Absorption is thought to occur in the small intestine with peak levels achieved 5-6 hours after oral administration. Significant side effects occur in 70-90% of patients (Brewer and Rogers, Clin Expt'l Dermatology 2007, 32, 246-49; and Hoefnagel et al., Br J Dermatology 2003, 149, 363-369). Side effects of current FAE therapy include gastrointestinal upset including nausea, vomiting, diarrhea and/or transient flushing of the skin.
Because of the disadvantages of dimethyl fumarate described above, there continues to be a need to decrease the dosing frequency, reduce side-effects and/or improve the physicochemical properties associated with DMF. There remains, therefore, a real need in the treatment of neurological diseases, such as MS, for a product which retains the pharmacological advantages of DMF but overcomes its flaws in formulation and/or adverse effects upon administration. The present invention addresses these needs.
On page 12 of the Office Action of October 2015, the examiner notes the specification discloses that the claimed compounds are prodrugs of monomethyl fumarate. Citing Genentech, 108 F.3d at 1366, at page 15 of the OA, the examiner initially rejected the claims on written description and enablement grounds.
Following amendment and argument, the claims were allowed, all with the understanding that the claimed compounds were prodrugs of monomethyl fumarate.
If the generic company's application implicates a brand-name drug covered by a patent, the generic company must also certify in its 505(b)(2) application or ANDA that "such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." Id. §§ 355(b)(2)(A)(iv); (j)(2)(A)(vii)(IV). This is known as a "Paragraph IV certification."
In addition to the obligation to reference the drug upon which the 505(b)(2) application relies and certify to its patents, a 505(b)(2) applicant must also provide notice of any Paragraph IV certification to owner of the RLD and each patent owner, explaining the factual and legal basis for the applicant's opinion that the patent is invalid or not infringed. See 21 U.S.C. § 355(b)(3)(C)-(D). This notice enables the owners of the RLD and its related patents to litigate the patent issue before FDA approves the 505(b)(2) NDA applicant's new drug product.7 To this end, upon the filing of a Paragraph IV certification, FDA is required to stay any approval for at least 45 days, and up to 30 months, in order to permit any potential patent litigation to proceed. See 21 U.S.C. § 355(c)(3)(C), (j)(5)(B)(iii).
Rather than conducting its own clinical studies, Reliant depended on the data of another, already approved, fenofibrate drug called TriCor®, which was developed by a French company named Laboratories Fournier ("Fournier") and distributed by Abbott in the United States.5 Antara received FDA approval in November 2004, and Reliant began marketing the drug in February 2005. Reliant chose not to make a certification under § 505(b)(2)(A)(iv) that Antara did not infringe any patents in the Orange Book or that those patents were invalid, but elected to market Antara immediately [*228] after gaining FDA approval.6 That marketing exposed Reliant to a possible infringement suit from Abbott, making Reliant's launch of Antara "at risk."7 In a prophylactic maneuver, Reliant filed a declaratory judgment action in the United States District Court for the District of Delaware in June 2004, seeking a declaration of non-infringement with respect to four of Abbott's [**9] fenofibrate patents, U.S. Patent Nos. 6,074,670 (the "'670 patent"), 6,277,405 (the "'405 patent"), 6,589,552 (the "'552 patent"), and 6,652,881 (the "'881 patent"). Reliant also argued that the patents were unenforceable due to inequitable conduct. Abbott counterclaimed for infringement of two of the four patents. Despite that lawsuit, Antara's net sales in 2005 were $23.5 million, and for the first half of 2006 they were $18.9 million.
In its initial formulation, tenofovir needed to be injected intravenously. In 1997, defendant Gilead Sciences, Inc., obtained a patent on a "prodrug" of tenofovir, which could be administered orally and converted into its active ingredient once metabolized in the human body. That prodrug was called tenofovir disoproxil fumarate ("TDF").
TDF had side effects involving bone and kidney toxicity. In 2002, Gilead hired physicians to conduct safety and efficacy research into an alternative formulation of a tenofovir prodrug, called tenofovir alafenamide fumarate ("TAF"). Meanwhile, in 2004, Gilead publicly announced that it had abandoned development of TAF, although it filed seven patent applications relating to the use of TAF between 2004 and 2005. Gilead then resumed its clinical trials in 2011. In 2014, it published a study concluding that TAF had a higher absorption rate than TDF, thereby reducing the bone and kidney toxicity side effects.
The Adams patent discloses and claims the use of "prodrugs." Tr. 876-77. A "prodrug"—like the claimed mannitol ester of bortezomib—is a drug compound "that . . . upon administration rapidly releases the active agent." [*15] Tr. 256 (Repta); see also Tr. 256 (Repta); Tr. 766 (Anderson).
Andrew W. Torrance, Physiological Steps Doctrine, 23 Berkeley Tech. L.J. 1471, 1472-1505 (2008). On nearly a dozen sete occasions federal courts have considered whether human products of "in vivo conversion" (that is, the conversion of a first chemical species into a distinctly different second chemical species by the body's own physiological processes) constitute patentable subject matter that can be protected from infringement by valid and enforceable patent claims. These cases all consider whether human administration of an unpatented "prodrug" (or drug precursor) that is subsequently converted within the human body into a different, therapeutically active, and patented, drug can trigger patent infringement. Although well-settled principles of patent law mandate that infringers are strictly liable for making or using a claimed invention, remarkably no court has finally found infringement for the in vivo production of a patented drug within the human body. Id.
Patent law . . . establishes that a prior art reference which expressly or inherently contains each and every limitation of the claimed subject matter anticipates and invalidates . . . In . . . prior cases, however, inherency was only necessary to supply a single missing limitation that was not expressly disclosed in the prior art. This case, as explained before, asks this court to find anticipation when the entire structure of the claimed subject matter is inherent in the prior art.
Because inherency places subject matter in the public domain as well as an express disclosure, the inherent disclosure of the entire claimed subject matter anticipates as well as inherent disclosure of a single feature of the claimed subject matter. The extent of the inherent disclosure does not limit its anticipatory effect. In general, a limitation or the entire invention is inherent and in the public domain if it is the "natural result flowing from" the explicit disclosure of the prior art.
summary judgment de novo. Ariz. Dream Act Coalition v.
favorable to the opposing party. Matsushita Elec. Indus.
excluded from the scope of the claims.” Dolly, Inc. v.
Spalding & Evenflo Cos., 16 F.3d 394, 400 (Fed. Cir.
Warner-Jenkinson, 520 U.S. at 39 n.8.
beyond these conclusory statements.” (citation omitted)).
material fact for trial regarding infringement by equivalents.
Cf. Perkin–Elmer Corp. v. Westinghouse Elec.
claim of acquired distinctiveness. 37 C.F.R. § 2.41; see La.
read B & B Hardware as disrupting our well-settled law.
acquired distinctiveness. La. Fish Fry, 797 F.3d at 1336.
varies on case-specific facts and the nature of the mark.
that the term is merely descriptive. Yamaha Int’l Corp. v.
Blast from the plagiarism past, "Mind Over Mayhem"
The Colombo episode, Mind over Mayhem," first aired in February 1974, and had an interesting plot involving plagiarism, which copying was uncovered by a chemistry professor, Dr. Howard Nicholson (played by Lew Ayres).
The plagiarism victim was a physicist type and already dead by the time of the opening scene. The plagiarism culprit, Neil Cahill, was a computer type who had obtained the notes of the physicist, and had published the theory under his own name. He was to receive an award. The chemist, figuring the computer type unlikely to have developed the theory (an issue not contemplated by the award givers, who are known to be sometimes oblivious to possible plagiarism), found evidence of the copying and asked Cahill's father (Dr. Marshall Cahill played by Jose Ferrer) to intervene.
Cahill's (Ferrer's) first response was of interest: that a chemist would be incapable of understanding the theory.
Nicholson persisted and was murdered for his trouble. Uncoverers of plagiarism typically do not fare well.
Of interest in the episode was an appearance by Robby the Robot, an appearance by a character named Steve Spelberg (yes, the naming was intentional), and an oblique reference to colchicine.
"This unprecedented action is taken with the utmost seriousness and deliberation," said a statement from Christopher Callahan, Dean of the Walter Cronkite School of Journalism and Mass Communication at Arizona State University. "The idea of 'taking back' a Cronkite Award is so foreign that the possibility was never even considered when the award was first created."
"We give the award each year based on the knowledge we have of a recipient at that time," Callahan's statement continued. "When new information about a recipient surfaces, the question we ask is not whether the award would be given again with a new set of facts, but whether the transgressions are so egregious that they demand nothing less than a reversal of history."
**Separately, in the "alternate history" vein, recall MacKinlay Kantor's If the South Had Won the Civil War.
damages due to intervening rights.
petition for rehearing en banc) (citing Wellman, Inc. v.
Eastman Chem. Co., 642 F.3d 1355, 1367 (Fed. Cir.
a clamping pressure within a specified range.
was within the knowledge of someone skilled in the art.
skilled artisan based on an established method.
sale of ATC’s infringing 550 line of capacitors.
made by the infringer.” Crystal Seminconductor Corp. v.
TriTech Microelecs. Int’l, Inc., 246 F.3d 1336, 1353 (Fed.
can be proven using the test given in Panduit Corp. v.
Stahlin Bros. Fibre Works, Inc., 575 F.2d 1156 (6th Cir.
Irving Naxon's electric bean cooker, the Beanery, was inspired by his Lithuanian Jewish mother's stories of her childhood. "On Friday afternoons, as the ovens were being turned off for the Sabbath, they would put the crock in the ovens," recalled Irving Naxon's daughter, Lenore. "And then, when shabbat was over Saturday night, they would have their Saturday evening dinner."
The Beanery was one of over 200 inventions Naxon patented before eventually selling his company to Rival.
McCormick started the magic back in 1934. Jill Pratt, VP of marketing at McCormick: "Pumpkin pie spice was originally created to make great-tasting pumpkin pies."
The shift to “wisdom of the crowd” was seen in the story on the Black Swan restaurant, owing its fame to ranking on Trip Advisor. The Black Swan was named the Best Restaurant in the World by Trip Advisor.
"In terms of business, it's just a game-changer," chef Tommy Banks said. "We're fully booked. We release bookings three months in advance. And people sit online at midnight and snap them bookings up. So it's amazing. You don't even have to answer the phone. Because by the time you wake up in the morning, all the bookings have gone!"
What's the attraction? Innovative cooking using local products. Really innovative.
The Black Swan's signature dish, based on the previously humble beet root, treated more like a steak, with exotic toppings.
"Kind of a braised meat," Banks said, "on top of it you got horseradish and the goat's curd. And beef and horseradish is, like, the most classic English [dish]."
"So, where did that idea come from? How did you decide, 'Hmm, beet root'?"
"Well, when you got about 10,000 beet root in a field, you have to come up with a pretty original idea of something to do with it!"
BASF appeals. We have jurisdiction under 28 U.S.C.
We review a determination of indefiniteness de novo.
135 S. Ct. 831, 841–42 (2015); UltimatePointer, L.L.C. v.
composition B’ limitation, and which are not.” J.A. 5.
633–35 (Fed. Cir.), rehr’g denied, 809 F.3d 1223 (Fed. Cir.
Services, Inc. v. M-I LLC, 514 F.3d 1244, 1252–54 (Fed.
Trade Commission, 341 F.3d 1332, 1340–42 (Fed.
information than the patent here provides.
ammonia and improved nitrogen selectivity, see id., cols.
effective to reduce NOx or to oxidize ammonia.” J.A.
the existence of just that understanding.
See also 15 N.C. J.L. & Tech. 463: Google describes some specific requests related to YouTube and Google Groups.
Small Justice v. XCentric, 873 F.3d 313 (CA1 2017) explores an interesting attempted use of copyright law.
The beginning of the decision describes the features of "Ripoff Report."
Xcentric operates a website called the Ripoff Report. The website's purpose is to permit consumers "to post free complaints, called 'reports,' about companies and individuals whom [sic] they feel have wronged them in some manner." The website works as follows for one who wishes to post a report on it.
Before submitting a report to be posted on the website, the would-be poster must click through a series of screens. Those screens ask the user to describe and to categorize the nature of the complaint that the user wishes to post as a report.
Ultimately, a user attempting to post a report encounters a final screen that is captioned, "Submit your Report." Below that caption is a text box. That text box is separately captioned, "Terms and Conditions," and contains a vertical scroll bar on the right side. Without employing the vertical scroll bar, a user who encounters this screen can see the very beginning -- but only the very beginning -- of what is a longer list of terms and conditions.
One of the "Terms and Conditions" -- which, according to the District Court, is "not visible unless a user employs the scroll bar" -- provides: "[b]y posting information or content [*4] to any public area of [the Ripoff Report], you automatically grant, and you represent and warrant that you have the right to grant, to Xcentric an irrevocable, perpetual, fully-paid, worldwide exclusive license to use, copy, perform, display and distribute such information and content . . . ." As the District Court noted, in order to post a report, a user is not required to click on a box indicating that the user has read and agreed to the text set forth in the text box captioned, "Terms and Conditions."
By posting this report/rebuttal, I attest this report is valid. I am giving Rip-off Report irrevocable rights to post it on the website. I acknowledge that once I post my report, it will not be removed, even at my request. Of course, I can always update my report to reflect new developments by clicking on UPDATE.
Adjacent to this text is a check box. The parties agree that, to submit a report to be posted on the website, a user of the Ripoff Report must click on this check box. The user must then click [*5] on the "continue" button at the bottom of the same screen.
Several years ago, Goren was the subject of two negative reports that had been posted on the Ripoff Report. The person who posted the two reports, DuPont, had been the defendant in a lawsuit in which Goren was representing a party suing DuPont. In the two postings, DuPont leveled a number of criticisms regarding Goren's character and conduct.
In response, Goren filed suit in Massachusetts state court, under Massachusetts state law, for libel and intentional interference with prospective contractual relations. Goren sought both money damages and injunctive relief in the form of an order "enjoining [DuPont] from continuing to publish" the reports that DuPont had posted.
DuPont did not defend the lawsuit, and Goren, after first voluntarily dismissing those counts of the state court complaint that sought money damages, successfully obtained a default judgment. The state court granted Goren certain equitable relief in connection with that [**1309] default judgment. Specifically, the state court enjoined DuPont from "continuing to publish or republish" the two reports that DuPont had posted. The state court also transferred to Goren "all rights [*6] in and to ownership of the copyright" for each of the two reports that DuPont had posted. Finally, the state court appointed Goren as DuPont's attorney-in-fact in order to "execute and deliver a conveyance, transfer, and assignment of all rights in and to ownership" of DuPont's copyright in each posting to Goren. Thereafter, Goren assigned to himself the copyright in the reports that DuPont had posted, which Goren then assigned to Small Justice.
The plaintiffs next proceeded to file this lawsuit in federal court in Massachusetts against Xcentric, the owner of the Ripoff Report. As amended, the plaintiffs' complaint claimed, with respect to copyright law, a right to a declaration of Small Justice's ownership of the copyright to the two reports that DuPont had posted, and copyright infringement. The amended complaint also made claims under Massachusetts state law for libel, intentional interference with prospective contractual relations, and violations of chapter 93A.
The plaintiffs appear to concede that the Ripoff Report qualifies as an ICS under § 230 and, thus, that Xcentric enjoys immunity under that section from claims that would treat it "as the publisher [*17] or speaker of any information provided by another [ICP]," 47 U.S.C. § 230(c)(1). See Klayman v. Zuckerberg, 753 F.3d 1354, 1358, 410 U.S. App. D.C. 187 (D.C. Cir. 2014) "[A] website does not create or develop content when it merely provides a neutral means by which third parties can post information of their own independent choosing online."). However, the plaintiffs contend that Xcentric may not claim CDA immunity under § 230 because the plaintiffs contend that those postings do not constitute "information provided by another [ICP]." 47 U.S.C. § 230(c)(1).
As we explained in Lycos, immunity [*18] under § 230 should be "broadly construed." 478 F.3d at 418-19. In fact, we noted there that Congress has expressed a "policy choice . . . not to deter harmful online speech through the . . . route of imposing tort liability on companies that serve as intermediaries for other parties' potentially injurious messages." Id. at 418(quoting Zeran v. Am. Online, Inc., 129 F.3d 327, 330-31 (4th Cir. 1997))(omissions in original). Given that legislative policy choice, we do not see how we can construe the CDA's definition of an ICP -- which provides that an ICP is a "person or entity that is responsible . . . for the creation or development of information[,]" 47 U.S.C. § 230(f)(3) -- to encompass Xcentric in this case.
Such a construction of this statutory definition of an ICP would flout Congress's intent by wrongly preventing an ICS like Xcentric from claiming immunity. Lycos, 478 F.3d at 418. As the plaintiffs recognize, Xcentric did not alter the content of the information DuPont posted such that Xcentric could be said to have been "responsible for . . . creat[ing] or develop[ing]" that content by reason of having actually authored it, whether in whole or in part. In addition, as the District Court found, nothing in the amended complaint indicates that Xcentric, simply by holding itself out as the copyright holder of the postings or by directing [*19] search engines to cache DuPont's postings on their websites, "specifically encourage[d]" the content set forth in DuPont's postings.
In fact, a sister circuit has rejected the view that an ICS, by merely providing such direction to search engines with respect to information the ICS has not altered, becomes an ICP of that information. See Kimzey v. Yelp! Inc., 836 F.3d 1263, 1270-71 (9th Cir. 2016) ("Yelp is not liable for disseminating . . . [user-generated] content in essentially the same format to a search engine, as this action does not change the origin of the third-party content." (citing Ascentive, LLC v. Op. Corp., 842 F. Supp. 2d 450, 476 (E.D.N.Y. 2011))); see also Ayyadurai v. Floor64, Inc., No. 17-10011-FDS, 2017 U.S. Dist. LEXIS 144030, 2017 WL 3896668, *17 (D. Mass. Sept. 6, 2017) (analyzing cases from other circuits which determined that "republishing and commenting upon user generated content, does not constitute 'creation or development.'" (citation omitted)). And we do not see why that conclusion should differ if the ICS also represents that it holds the copyright. Nor are we aware of any precedent that requires a contrary conclusion. Accordingly, we affirm the District Court's ruling on the motion to dismiss.
The District Court concluded that "DuPont conveyed a nonexclusive, irrevocable license to Xcentric to display the [two postings]" when DuPont clicked the check box next to the accompanying text stating that a user who posts on the Ripoff Report agrees to give an "irrevocable right" to Xcentric to display his postings on the Ripoff Report website. As a result, the District Court held, even if Xcentric was not "the owner of the copyright to [DuPont's postings]," Xcentric could nevertheless "display them in perpetuity" without infringing DuPont's copyright.
In arguing otherwise, the plaintiffs do not dispute that in the case. "[u]ses of the copyrighted work that stay within the scope of a nonexclusive license are [*21] immunized from infringement suits." John G. Danielson, Inc. v. Winchester-Conant Props., Inc., 322 F.3d 26, 40 (1st Cir. 2003) (citing Graham v. James, 144 F.3d 229, 236 (2d Cir. 1998)). The plaintiffs also do not contend, at least in their opening brief, that Xcentric exceeded the scope of the nonexclusive license, insofar as Xcentric had that license.11 Instead, the plaintiffs contend that Xcentric did not obtain a valid nonexclusive license to display DuPont's postings for two reasons.
11 In their reply brief, for the first time, the plaintiffs argue the scope of the nonexclusive license was only "to post [the defamatory report] on the website" and that Xcentric exceeded that scope of the license by "add[ing] its notice of copyright ownership to each report, tag[ging] the report with codes and instructions to allow Google and other third-party search engines to index and also to display copies of it extrinsic to the website." But, .arguments developed for the first time in a reply brief are waived. See Braintree Labs., Inc. v. Citigroup Glob. Markets Inc., 622 F.3d 36, 44 (1st Cir. 2010) (finding waived an argument cursorily mentioned in appellant's opening brief, as even "[t]he slight development in the reply brief does nothing to help matters, as arguments raised there for the first time come too late to be preserved on appeal").
First, the plaintiffs argue that Xcentric offered no consideration for the irrevocable nonexclusive license that the District Court ruled Xcentric had been given by DuPont. The plaintiffs thus argue that, in consequence, no valid contract existed that could have conveyed the license to Xcentric. In support of this contention, the plaintiffs point to the website's terms and conditions, which the plaintiffs contend were "subject to change by Xcentric, at any time" and without notice to DuPont, and that "it is undisputed that Xcentric [has redacted information] from posted reports and has removed reports upon the request of the author." The plaintiffs thus argue that the only possible promises that Xcentric made to give something in consideration for the license were "illusory" and, thus, in fact "Xcentric promised nothing" [*22] and, therefore, "gave no consideration."
The problem with this argument, however, is that, even if consideration is necessary in order for a party to grant an irrevocable nonexclusive license, see 3 Nimmer on Copyright § 10.03 (Rev. ed. 2017)(explaining that "consideration is necessary to render a nonexclusive license irrevocable"), performance can itself constitute consideration sufficient to establish a binding contract. And, in this case, the plaintiffs concede that Xcentric did actually post the reports at issue. Thus, given that performance, the plaintiffs offer no authority or persuasive argument as to why there is insufficient consideration for the conveyance of the irrevocable nonexclusive license in this case. See 3 Williston on Contracts § 7:15 (4th ed. 2008) ("[T]hat the purported consideration is invalid will not cause a subsequent performance to be likewise invalid . . . . [A] performance which has been rendered needs no consideration though the promise to give it originally did. Since the performance has been rendered . . . and . . . received as the consideration for the promise, the promise thereby becomes binding.").
Second, the plaintiffs contend that the irrevocable nonexclusive license is unenforceable on public policy grounds. The plaintiffs' argument here is that Xcentric's promise not to remove any postings -- even if the postings are libelous -- is contrary to the public policy "against per se libel." But, while the plaintiffs contend that there is a "strong public policy against per se libel[,]" the plaintiffs offer no basis for concluding that this public policy provides a reason to hold the nonexclusive license itself invalid. The fact that one holds such a license does not in and of itself protect one from liability for libeling another. Furthermore, even assuming that DuPont's postings were per se libelous, no aspect of copyright law protects the holder of such a license from liability for libel, and nothing in the District Court's opinion suggests otherwise. Thus, the plaintiffs' assertion that there is a public policy against per se libel fails to show that this nonexclusive license may not be enforced.
12 In light of the District Court's subsequently appended footnote, it is not clear that the District Court actually issued a ruling as to whether Small Justice, in fact, holds the copyright to DuPont's postings. Rather, the District Court appears to have concluded only that Xcentric is not the copyright holder.
13 The plaintiffs' only request for a declaration of ownership in their amended complaint was a request for a declaration confirming Small Justice's ownership of the copyright to each of the two posts at issue. After the District Court's summary judgment ruling and appended footnote issued, DuPont moved to further amend the complaint to include a request for a declaration that DuPont owned the copyright for each of the postings or, alternatively, a declaration that the nonexclusive license DuPont allegedly granted Xcentric was unenforceable as contrary to public policy. The District Court denied DuPont's motion, as judgment had already entered and DuPont failed to provide an adequate reason for his delay in seeking the amendment, which was prejudicial to Xcentric, "given that the Plaintiffs were aware of the facts underlying their claim when they filed their first two complaints." The plaintiffs did not appeal the denial of the motion to amend.
14 We thus need not address the question of whether the Massachusetts state court decision violated Rule 54(c) of the Massachusetts Rules of Civil Procedure, which requires that "[a] judgment by default shall not be different in kind from . . . that prayed from in the demand for judgment," nor whether that court's judgment transferring DuPont's copyright to Goren pursuant to a default judgment is a valid transfer of copyright under 17 U.S.C. § 201(e). We likewise need not address whether a browsewrap agreement may satisfy the writing requirement in 17 U.S.C. § 204.
In 76 Minn. L. Rev. 507 (1992), Myrna S. Raeder wrote "we should not be surprised that courts often do not distinguish the nature of review for Confrontation Clause challenges or evidentiary issues which raise questions of law from that of discretionary evidentiary rulings."
De novo review of legal issues requires an independent analysis.
Thus, the abuse of discretion standard of review, which accords considerable deference to the decision made at the trial level, leaves the primary responsibility for resolving that matter to the trial court. n134 In contrast, the de novo standard of review, which accords non-deferential, independent review by the appellate court, places primary decision-making authority in the appellate court.
applying pure de novo review as a function of the appellate court seems certain to have different results than holding that the legal interpretation by the court below is so egregiously erroneous as to constitute abuse. Obviously, pure de novo review will be the more rigorous and intrusive.
See also Judge Cabranes text in ZERVOS, 252 F.3d 163; 2001 U.S. App. LEXIS 11732.
of forfeiture under that framework.
transfer for lack of venue.
thus allow the court to do a reasonably complete job.”).
v. Hallco Mfg. Co., Inc., 947 F.2d 469, 475 (Fed. Cir.
disapprove that precedent. See Eulitt ex rel. Eulitt v.
Maine, Dep’t of Educ., 386 F.3d 344, 349 (1st Cir. 2004).
The issue in this case is whether [the amendment to the statutes] supplants the definition announced in Fourco and allows a plaintiff to bring a patent infringement lawsuit against a corporation in any district in which the corporation is subject to personal jurisdiction. We conclude that the amendments to §1391 did not modify the meaning of §1400(b) as interpreted by Fourco.
is related to what Dennis is saying.
Is a district court free to interpret Supreme Court precedent in a way that is completely negated by a holding of the regional circuit?
The court denied defendant's motion to dismiss or transfer plaintiff's consolidated patent infringement actions for improper venue because defendant waived its venue defense. "It is well settled that an improper venue defense is waived if it is not included in 'a responsive pleading or in an amendment allowed by Rule 15(a)(1) as a matter of course.' [Defendant's] Motion to Dismiss the Complaint in [the first action] did not raise a defense of improper venue. The defense was therefore waived. . . . Even if the TC Heartland decision was an intervening change in law, the 'omission of improper venue from [a party]⁠'s first 12(b) motion constitutes a "procedural misstep,"' which precludes a party from '"invok[ing] intervening Supreme Court case law" in order to "correct" it.'. . . As to [defendant's] venue challenge in [the second action], [defendant] has already admitted that venue is proper. It may not now 'take back' this admission or otherwise seek to avoid its effects."
New York Times mentions "pop-culture plagiarism"
In case your memory doesn’t stretch back to the 1984 “Last Starfighter,” “Future Man” stars Josh Hutcherson (himself a reference to “The Hunger Games”) as a janitor named Josh who lives with his parents and distracts himself from his millennial malaise by obsessively playing a violent, futuristic video game. When he finally unlocks the last level, two of the game’s characters, Tiger and Wolf (Eliza Coupe and Derek Wilson), appear in his bedroom and tell him that the game was a test sent back from the post-apocalyptic future to find humanity’s savior.
Apotex wins at CAFC in case related to pegfilgrastim (Neulasta®) and filgrastim (Neupogen®).
patent, either literally or under the doctrine of equivalents.
Amgen appeals. We have jurisdiction under 28 U.S.C.
letters lack probative value as a matter of law.
indicating that the information in the letters was inaccurate.
evidence to make that finding.
would infringe. Id. at 1280.
filgrastim or pegfilgrastim) specified by the applications.
in Apotex’s applications to be clearly erroneous.
in crucial respects for Sanofi. Sanofi v. Glenmark Pharm.
Inc., USA, 204 F. Supp. 3d 665, 704–705 (D. Del. 2016).
10 and 11 as well.
der 28 U.S.C. § 1295(a)(1). We affirm.
desired result, see id., at 27.
the action that he or she wishes to bring about.” Id.
atrial fibrillation.” J.A. 7609; see J.A. 7784.
tics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed. Cir.
lar hospitalization in the ATHENA patient population.
themselves.” 491 F.3d at 1361; id. at 1361–63.
A post at the Boston Globe titled State Street CEO-designate says law school plagiarism was a ‘very big mistake’ has an interesting account of plagiarism at the Vanderbilt Law School.
In 1983, O’Hanley withdrew from Vanderbilt University Law School after admitting to plagiarism as editor-in-chief of the Vanderbilt Law Review in his third year. It was a mistake O’Hanley, 60, now says he deeply regrets.
Even as O’Hanley’s career advanced, there has been little mention of the plagiarism incident, to the surprise of some classmates. A May 1983 National Law Journal story said O’Hanley plagiarized parts of an article on the legal protection known as double jeopardy written by an attorney who had attended Vanderbilt as an undergraduate.
Compromising on slavery had been part of how America stayed together, and staved off war, from the beginning. No historian disputes this. But for writers like Chait and The Atlantic’s Ta-Nehisi Coates, compromise was a bad thing because it preserved slavery. That such compromises limited slavery’s spread and put it on the path to extinction carries no weight with them.
In a widely shared thread on Twitter, Coates joined in lambasting Kelly’s remark about compromise, but managed to turn the question on its head. For Coates, each compromise that preserved the Union and prevented war prior to the Civil War was morally bankrupt. He also rails against the compromises struck after the war to restore the Union, as well as the compromises Lincoln offered during the war to bring rebellious southern states back into the fold.
Coates’ initial line of criticism—that Kelly should know about all these compromises because the relevant history is “easily accessible, not tucked away in archives somewhere”—gets to something deeper. For Coates and his ilk, the entire idea of America is indefensible.
The Almanac feature of "Sunday Morning" on November 5 celebrated the birthday of Raymond Loewy (born November 5, 1893), with much discussion of his design of the Studebaker Avanti. CBS did not mention this was a team effort, also involving John Ebstein, Bob Andrews, and Tom Kellogg. Loewy is also known for the design of the Exxon logo and the 1964 Kennedy stamp. Four years prior to the CBS show, on November 5, 2013, Loewy was the subject of a Google Doodle. Of some relevance to intellectual property, note his 1951 book Never Leave Well Enough Alone . See more at wikipedia.
The "nature" feature on 5 Nov 2017 was pelicans in Marin County, continuing a trend of generic, puff nature pieces, and away from naming of more specific destinations one might want to enjoy.
25 But Jesus knew their thoughts, and said to them: “Every kingdom divided against itself is brought to desolation, and every city or house divided against itself will not stand. 26 If Satan casts out Satan, he is divided against himself. How then will his kingdom stand? 27 And if I cast out demons by Beelzebub, by whom do your sons cast them out? Therefore they shall be your judges. 28 But if I cast out demons by the Spirit of God, surely the kingdom of God has come upon you.

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