At least 84 percent of patents reaching a final written decision in a PTAB validity challenge are adjudicated to have at least one invalid claim (usually many more than one claim), with 69 percent having all claims invalid. Add settlements, which are v…Continue Reading ...
Stephan Wenzel has published an article in the November 2016 issue of Mitteilungen der deutschen Patentanwälten (pp. 481-85) titled Olanzapin macht aus dem Patent ein Gebrauchsmuster: Ein Kommentar zue aktuellen Rechtslage bei einstweiligen Verfügungen aus einem erteilten Patent (“Olanzapin turns patents into utility models: A commentary on the current state of the law concerning preliminary injunctions for issued patents”). Here is the abstract (my translation):Since the Olanzapin and Harnkatheterset decisions of the Düsseldorf Court of Appeals, there has been an increase in denials of motions for preliminary injunctions on the ground that the validity of the patent in suit is uncertain. Not all infringement courts follow this opinion, however. An analysis.To put the title in perspective, “utility model” (or sometimes “petty patent”) is the term most commonly used in English for an intellectual property right in an invention that may not qualify for a patent (perhaps because it wouldn’t satisfy patent law’s nonobviousness criterion). What I just said can be a bit misleading, though, because the law of utility models (in countries, unlike the U.S., that recognize them at all) can vary quite a bit from one place to another. Indeed, since 2006 under German law utility models (Gebrauchsmuster) must satisfy the same “inventive step” criterion that applies to patents. They are generally easier to obtain, however, because there is only a cursory examination up front, and once obtained a German utility model can be converted into a patent (and thus provides a measure of temporary protection). Another difference between patents and utility models is that in Germany patent validity and infringement decisions are bifurcated. The German Patent Office’s Bundespatentgericht, not the courts hearing infringement matters, resolve patent validity challenges, although in the end the Patent Office’s determination can be appealed to the Federal Supreme Court. With regard to utility models, on the other hand, validity is resolved in the context of infringement litigation, not in a proceeding before the Bundespatengericht. For fuller discussion, see my book pp. 237-38.Anyway, this brief introduction to utility models illuminates the author’s meaning above, where he suggests that, in deciding whether or not to grant a preliminary injunction in a patent infringement case, the Düsseldorf courts are too willing to substitute their own opinions on patent validity, and do not give sufficient weight to fact that the German or European Patent Office has granted a patent in the first place. To be sure, this lack of deference can work in both directions. In the Olanzapin case the author refers to, the court reversed a denial of a preliminary injunction, despite the fact that the patent had been found invalid by the Patent Office, on the ground that that decision was clearly erroneous (evident unrichtig). (For discussion of Olanzapin, see my book pp. 243-44.) But both Olanzapin and the subsequent decision in Harnkatheterset contain language suggesting that validity can be adequately ascertained only if the patent has already withstood a validity challenge, and it’s this part that Dr. Wenzel finds most troubling. (For a previous blog post on Harnkatheterset, see here.) Dr. Wenzel cites work by other scholars and decisions from other courts in Germany that do not appear to make it quite so difficult for patent owners to obtain preliminary injunctions, though they differ somewhat in their verbal formulations. (They may require a high probability of validity, for example, but not necessarily a Bundespatentgericht decision upholding validity.) He concludes by suggesting that courts are more willing to grant preliminary injunctions in favor of drug companies against generic drug makers, and that this favoritism violates the principle of equality.Continue Reading ...
Some analysts have concluded that the Supreme Court’s recent decision in TC Heartland will make it more difficult for patent owners to enforce their patents. Generally, they assert that patent infringement litigation will become more costly for patent owners because they may have to assert their rights in multiple jurisdictions throughout the country. They also contend that concurrent litigation in multiple courts will lead to inconsistent outcomes. One response to these concerns is…
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There is “no question” that there is a link between the infrastructure of the internet and human rights, Nicolas Seidler, senior policy advisor at the Internet Society, said at an information society event this week. Human rights are becoming “increasingly part of the design of the internet,” Niels ten Oever, head of digital at ARTICLE 19, said at the same event.Continue Reading ...
Conservative projections say that China will surpass the United States as the number one economy in the world by 2030, but the shift could happen as soon as next year. Either way, there’s no doubt that China has emerged as one of the most important commercial economies in the world, and businesses everywhere are vying to enter its market. However, there is a serious hurdle when foreign companies decide to take their products to China – intellectual property rights (IPR), or more accurately, the country’s lack of adequate IP protection. History shows that bringing business to China, while extremely lucrative, has also been extremely risky – but it’s a market that cannot be ignored. Here is a look at the past, present and future of IPR in China.Continue Reading ...
Designing a world where humans have to share space with robots is not an easy task. Several initiatives are looking at ways to address issues linked to the main fuel of artificial intelligence: data. Such issues include privacy, data ownership and shar…Continue Reading ...
The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably…
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It has been six weeks or since you last heard from us on the predicament of the ASA in South Africa. Recently, their new acting CEO – Gail Schimmel* – took time out to speak with Afro-IP on developments.Upbeat and positive, Gail is addressing the main issues raised in the Business Rescue Report as follows:Short Term FundingThe ASA is calling on every single player in this industry – every agency, every marketer, every advertiser, every media owner and the lawyers – to pre-pay ONE ASA filing fee (R24 396 including VAT).Their call to action is based on the simple premise that advertising disputes need a place of self-regulation away from the courts and the government, that is both speedy and accessible (an attribute of a well-functioning ASA).In exchange for that filing fee, funders will get:· Full credit to file a complaint using this fee at any point in the future;· A year’s access to the ASA Rulings Library, valued at R3300;· The right to carry the ASA logo, adapted to reflect that you are a supporter of self regulation, on your marketing material;· A responsible marketer MAC certificate (providing the funder qualifies) which in turn earns BEE points;· Access to training and support in how to leverage the ASA process.Jurisdictional ConcernsTo address concerns over jurisdiction highlighted in the Herbex case (which the ASA currently appealing) Gail aims to address these in its memberships contracts which is consistent with the recommendation in the Business Rescue Report. This means that where mainstream associations are involved, it could address the problem if contractual obligations are adopted and enforced by them as part of their membership with the ASA.SustainabilityGail informed us that the ASA has reduced staff from 22 to 7 and consequently decreased its overheads significantly. It has also received several substantial pledges for funding going forward. Gail hopes to further streamline the ASA process and reduce the cost of appeal to make the system more user friendly. Gail also plans to halt the ASA’s application to become an ombudsman under the Consumer Protection Act, focusing instead on renewing public confidence in the ASA as a forum of choice for advertising disputes.TeaVisiting the ASA, it is clear that it is already different from the forum just a year ago. Tea is served with the teabag in the cup, leaving nothing to chance, and although this is something Gail also promised to fix it’s indicative of an already more austere, purposeful and pragmatic ASA. In a sense (cents) – it is up to the advertising industry and related stakeholders now.*Who is Gail Schimmel?Bright and affable, Gail is armed with more than sufficient nous and experience to understand the dilemma faced by the ASA and to turn the organisation around. She needs support though. Gail’s online profile, twitterand blogcan be viewed through the links.How to pledge?Follow the information here.
It was reported yesterday that the German Constitutional Court has asked the German Federal President not to ratify the Unified Patent Court Agreement (UPCA) for the time being. The request is the result of a complaint (Az.:2BvR 739/17) made to the Con…Continue Reading ...
BE BETWEEN A AND B
$$ The typical thickness of the gate dielectric layer is between 150-1000 nm. (USP7629261…Continue Reading ...
McCann Worldgroup Philippines did an ad for the Philippines Department of Tourism (DOT) involving many images and then revealing the person “viewing” was blind. There are allegations of copying from an earlier Meet South Africa ad, because both featur…Continue Reading ...
Purdue lost in the interference for lack of written description:
Purdue Pharma L.P. (“Purdue”), the senior party in
an interference proceeding, appeals from a judgment of
the Patent Trial and Appeal Board (“Board”) refusing
claims in Purdue’s Applications 13/833,263 (“’263 Application)
and 14/094,968 (’968 Application) (collectively, the
“Applications”). The Board granted junior party Recro
Technology, LLC’s (“Recro”) motion for judgment that
Purdue’s claims lack written description, concluding that
claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55
of the ’968 Application and claims 63–67 and 70–71 of the
’263 Application (collectively, the “involved claims”) are
unpatentable for lack of written description support under
35 U.S.C. § 112. We affirm.
Having concluded that the involved claims are unpatentable,
the Board issued a judgment terminating the
interference. Purdue appeals the Board’s written description
decision with respect to Purdue’s involved claims.
The test for written description “is whether the disclosure
of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of
the claimed subject matter as of the filing date.” Ariad,
598 F.3d at 1351. “Based on that inquiry, the specification
must describe an invention understandable to that
skilled artisan and show that the inventor actually invented
the invention claimed.” Id. “[W]hile the description
requirement does not demand any particular form of
disclosure, or that the specification recite the claimed
invention in haec verba, a description that merely renders
the invention obvious does not satisfy the requirement.”
Id. (citations omitted).
The issue here is whether the specifications adequately
disclose the claimed separate populations of IR and CR
multiparticulates, which each comprise inert beads coated
with hydrocodone, combined in a single dosage form.
Both parties submitted expert testimony to the Board on
this issue. The Board found that the claimed formulation
is not disclosed. We conclude that substantial evidence
supports the Board’s finding.
Although the written description generally discloses
that a single dosage form may include both IR and CR
hydrocodone components, it does not disclose a formulation
wherein the IR and CR components exist as separate
multiparticulates each containing an inert bead core.
There was an “incorporation by reference” issue:
Purdue finally urges that the claimed formulations
are supported by U.S. Patent No. 5,472,712, (“the ’712
Patent”), which was incorporated by reference into the
Purdue applications. The Board was “not persuaded that
the ’712 [P]atent sufficiently describes the specific dosage
forms Purdue claims. The descriptions do not recite the
actual elements of Purdue’s claims, most notably inert
beads coated with hydrocodone. Instead, the examples of
. . . [the] ’712 [P]atent describe formulations of [a] different
drug: . . . hydromorphone . . . .” J.A. 39 (emphasis
added). Recro’s expert, Dr. Palmieri, stated at deposition
that “the examples . . . in the [’712 Patent] are to a different
active pharmaceutical ingredient than the applications.”
Of this portion of Purdue’s argument:
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“[A] description that merely renders the
invention obvious does not satisfy the [written description]
requirement.” Ariad, 598 F.3d at 1352; see also
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723
F.3d 1336, 1349 (Fed. Cir. 2013) (explaining that the
written description analysis requires “[t]aking each claim
. . . as an integrated whole rather than as a collection of
independent limitations”). Substantial evidence supports
the Board’s findings in this regard.
Artificial intelligence can solve many challenges facing humanity and it is seen playing a contributing role to the achieving of the United Nations Sustainable Development Goals (SDGs), but being data-driven, the inevitable question that arises is who …Continue Reading ...
Yesterday, June 12, 2017, the U.S. Supreme Court surprisingly granted cert to hear the Oil States Energy Services v. Green’s Energy Group’s case (Notably, a Rule 36 affirmance by the Federal Circuit which means there is not an opinion—the Federal Circuit is just affirming without giving reasons.). The U.S. Supreme Court has limited its review to one question: “Whether inter partes review, an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents, violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.” Could this case completely wipe out inter partes review proceedings (IPRs)? That is certainly the hope of some. Notably, the U.S. Supreme Court refused cert to hear the MCM Portfolio v. HP case in 2016 which raised a very similar issue. As stated by Judge Dyk in the below Federal Circuit opinion: “On the merits, we reject MCM’s argument that inter partes review violates Article III and the Seventh Amendment, and we affirm the Board’s decision that claims 7, 11, 19, and 21 of the ’549 patent would have been obvious over the prior art.”Notably, that particular case was graced with several amicus briefs, including by 13 law professors, the Houston Inventors Association and the University of New Mexico. The conservative Heritage Foundation has a piece discussing the importance of the MCM Porfolio case and a call for congressional action on IPRs after the U.S. Supreme Court denied cert in 2016. Part of the attack on IPRs includes the argument by the University of New Mexico that it essentially devalues university patent rights. The amicus brief by 13 law professors, led by Professor Adam Mossoff, specifically confronts the question of whether patent rights are public rights or private rights:By resting its decision on the premise that “patent rights are public rights,” MCM Portfolio LLC, 812 F.3d at 1293, the Federal Circuit directly contradicts these numerous, longstanding, and binding decisions of this Court. Furthermore, the two primary administrative law cases relied on by the Federal Circuit, see id. at 1292–93, are inapplicable in determining whether the PTAB is respecting vested property rights secured under the separation of powers doctrine and under other substantive constitutional provisions, such as the Due Process Clause of the Fifth Amendment or the Seventh Amendment. These two modern cases address solely creatures of modern administrative statutes—procedural entitlements solely created in and adjudicated by modern regulatory regimes. See, e.g., Atlas Roofing Co. v. Occupational Safety & Health Review Comm’n, 430 U.S. 442, 455–56 (1977) (addressing procedural rights within the administrative regime created by the Occupational Safety and Health Act of 1970); Tull v. United States, 481 U.S. 412, 425–27 (1986) (addressing procedural rights within administrative regime created by the Clean Water Act of 1972). Decisions by this Court addressing modern regulatory procedural entitlements are distinct from the constitutionally protected private property rights in patents long recognized by this Court and by Circuit Courts for over two hundred years. This Court recently and repeatedly confirmed the principle that patents are private property rights that are secured under the Constitution. See, e.g., – 10 – Horne, 135 S. Ct. at 2427; Fla. Prepaid, 527 U.S. at 642. This Court also warned the Federal Circuit in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002), that it must respect “the legitimate expectations of inventors in their property” and not radically unseat such expectations by changing doctrines that have long existed since the nineteenth century. Moreover, Chief Justice John Roberts specifically stated in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), that nineteenth-century patent law should be accorded significant weight in modern patent law in determining the nature of the private property rights secured to patent-owners. Id. at 393–94 (Roberts, C.J., concurring).So, the question is why now? Why does the U.S. Supreme Court grant cert now (especially a Rule 36 affirmance without a written opinion below) and not in 2016? For sure, inter partes review proceedings, perhaps intended to wipe out bad software patents has been used surprisingly against biotech/pharma patents. Could it be new Associate Justice Neil Gorsuch? Assuming the timing works out, it takes four justices to take a case by writ of certiorari. (Gorsuch, Thomas, Alito and Roberts?) Would Kennedy swing? Curiously, over the years, I have heard many complain about the loss of the American jury system.
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Above all, LES recommends appointing a Director dedicated to protecting intellectual property, generally, and patents in particular, as the private property right our nation’s founders envisioned. The founders saw great value in rewarding individuals who toil to bring forth from commonly accessible resources useful products and processes by granting to those individuals an enforceable property right. They recognized that such a property right would, in the fullness of time, work a substantial…
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- News from Abroad — Mexican Antitrust Authority Study on Generic Drug Entry — On Patents and Marketing Authorizations — Part II
- CAFC in ALVARADO HOSPITAL. A dissent by Judge Newman.
- Two CAFC judges in Nidec case: we question whether the practice of expanding panels
- Nidec v. Zhongshan — Did the Federal Circuit possess jurisdiction?