A few days after a Leonardo da Vinci painting shattered the record for the most expensive artwork ever sold at Christie’s auction house in New York, the question of resale right for visual artists was discussed at the World Intellectual Property Organization. According to researchers, the establishment of a resale right in a particular country, which benefits the artist when her work is resold at a much higher value, is likely to have no negative effects on the country’s art market. The United States and China, the two largest global art markets, have not implemented the resale right yet.Continue Reading ...
The World Intellectual Property Organization copyright committee last week sent back to the drawing board draft action plans provided by the secretariat on exceptions and limitations to copyright for specific actors such as educational institutions and…Continue Reading ...
Celgene faces a new gang of generics moving in on its blockbuster Revlimid®. Over the past year, a number of generics have filed ANDAs against Revlimid®, including Dr. Reddy’s, Zydus, Cipla, and Lotus Pharmaceutical. Those ANDAs have triggered corresponding Hatch-Waxman lawsuits from Celgene. Among the asserted patents, most of them expire by 2022, with the exception of two polymorph patents that could extend Revlimid® monopoly until 2027. The lawsuits are in their early stages, but an…
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[USTR NAFTA Objectives] Obtain commitments to ratify or accede to international treaties reflecting best practices in intellectual property protection and enforcement. Provide a framework for effective cooperation between Parties on matters related to the adequate and effective protection and enforcement of intellectual property rights. Promote transparency and efficiency in the procedures and systems that establish […]Continue Reading ...
As a consequence of the decision of the United Kingdom to go its separate way, the remaining European Union member states decided yesterday that the European Medicines Agency should move to Amsterdam by the end of March 2019.Continue Reading ...
Pharmaceutical companies would like their blockbuster drug exclusivity to last forever. But patents expire and generics enter the marketplace. This ecosystem has led to a battleground, with opposing claims about unfair competition, evergreening, patent misuse, etc. There’s a fair amount of data out there, but with respect to evergreening there has been more heat than light. A recent paper by Robin Feldman (Hastings) and Connie Wang (Hastings – student) attempts to change this by gathering data on 16,000 Orange Book entries between 2005 and 2015.
For the unaware (and I’ll admit that I’m mildly aware), the Orange Book is an FDA listing of all the “exclusivities” that companies claim related to their New Drug Applications (i.e., their drugs). These exclusivities might relate to patents associated with the drug, research related to the drug, approval to use the drug on new populations or for “orphan” (low incident) diseases.
Feldman and Wang argue that the Orange Book has been used by companies to “evergreen” their drugs – that is, to extend exclusivity beyond patent expiration. The paper is on SSRN and the abstract is here:
Why do drug prices remain so high? Even in sub-optimally competitive markets such as health care, one might expect to see some measure of competition, at least in certain circumstances. Although anecdotal evidence has identified instances of evergreening, which can be defined as artificially extending the protection cliff, just how pervasive is such behavior? Is it simply a matter of certain bad actors, to whom everyone points repeatedly, or is the problem endemic to the industry?
This study examines all drugs on the market between 2005 and 2015, identifying and analyzing every instance in which the company added new patents or exclusivities. The results show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. Key results include: 1) Rather than creating new medicines, pharmaceutical companies are recycling and repurposing old ones. Every year, at least 74% of the drugs associated with new patents in the FDA’s records were not new drugs coming on the market, but existing drugs; 2) Adding new patents and exclusivities to extend the protection cliff is particularly pronounced among blockbuster drugs. Of the roughly 100 best-selling drugs, almost 80% extended their protection at least once, with almost 50% extending the protection cliff more than once; 3) Once a company starts down this road, there is a tendency to keep returning to the well. Looking at the full group, 80% of those who added protections added more than one, with some becoming serial offenders; 4) The problem is growing across time.
I think the data the authors have gathered is extremely important, and I think that their study sheds important light on what happens in the pharmaceutical industry. That said, as I explain below, my takeaways from this paper are much different from theirs.
My concerns are fourfold. First, even assuming that every one of the efforts listed by the the study were an attempt to evergreen, I have no sense for whether evergreening actually happened. This study doesn’t provide any data about generic entry or pricing. For example, the study describes 13 listings for OxyContin, but I’d bet dollars to donuts that there was plenty of generic oxycodone available. Similarly, many of the new listings are changes from Drug 1.0 to “new and improved!” Drug 2.0. This, of course, has been criticized as anti-competitive (since generics rely on auto-substitution laws), but the study presents no data about whether insurers refuse to pay for Drug 2.0 and instead require the generic, nor does it explain why generics can’t do their own advertisements to get doctors to prescribe Drug 1.0.
Second, many of these listings and the new patents that go with them are for advances, like extended release and dissolvables. These can be critically important advances, and they are preferred by consumers. Thus, one person’s “evergreening” is another person’s innovation. I take extended release drugs (and expensive generic) to avoid side effects and I gave my son dissolvable Prevacid when he wouldn’t stop crying with GERD (and was glad for it). Without consumer data or patent data, it is impossible to tell just how much evergreening is going on (or how harmful it is). Now, if these patents are obvious because making them dissolvable or extended is easy, I’m all for stripping protection – but that’s a different issue.
Third, the article speaks of orphan drug approvals as if they are a bad thing. This made me bristle, quite frankly. My mother has an extremely rare autoimmune disease that is very painful. I often wondered, isn’t there some incentive to develop drugs to treat it? Turns out there is, and though she got no relief, apparently a bunch of other rare diseases did, and that’s the whole point behind orphan drug exclusivity. Concern about this exclusivity seems misguided anyway. If it turns out that drug companies are gaming it and nobody actually needs the drug, then the the loss is not too large, because it’s a small population and nobody needs the generic anyway. And if it turns out that they do need it, the Orange Book only limits labeling, and doctors are free to prescribe a generic for off-label use. Without evidence that doctors refuse to do so, there’s no real evidence that Orphan exclusivity does much harm. In another personal story, my wife was prescribed a generic drug in a different formulation than the patented tablet for off-label use.
Fourth, and most generally, the article speaks of new patents as if there is no innovation. New use discoveries are important. Many of our most important drugs are not for their original uses. As far as I know, generics are not barred from finding new uses and patenting them, either, though admittedly their hands are tied for patient use. So, where the authors see evergreening, I see innovation. Maybe. Maybe it’s obvious. But we can’t tell that from this high level, and I’m not ready to write it all off as evergreening. It is telling that I was able to provide four personal stories about how supposed evergreening efforts benefited, would have benefited, or did not increase costs for my family or me (and thankfully none of them involved oxycodone).
With these concerns stated, I will note one area of agreement – the very narrow range of new drug discovery. It’s hard to discover new drugs, and it’s expensive. And the results of that show in where the innovative efforts are in this study. So, one of the key questions in my mind is not whether the drug companies are evergreening, but rather whether we are striking the right balance in incentives for brand new drug discovery versus old drug improvement. That, I think, will take a lot more study.Continue Reading ...
In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that it effectively eliminates the written description requirement. Amgen at 15, 16. According to the Court, where a functional genus claim to antibodies to a newly characterized antigen is concerned, the underlying science is not so advanced as to establish that “make and use” is equivalent to the required description of the claimed antibodies. Id….
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The U.S. International Trade Commission (ITC) announced that it was investigating potential patent infringement committed by Cupertino, CA-based consumer tech giant Apple Inc. (NASDAQ:AAPL)… Aqua Connect said that Apple gave the ACTS terminal server product its “full support” when released to industry praise in 2008. To attract enterprise and government customers, Apple worked closely with Aqua Connect on development and sales of its terminal server service. “In early 2011, however,…
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By Michael Borella — Mastermine brought a patent infringement action against Microsoft in the District of Minnesota. At issue were four claims of U.S. Patent No. 7,945,850 and three claims of U.S. Patent No. 8,429,518. After claim construction and ind…Continue Reading ...
(A DEGREE OF)
$$ It should be noted that during this second etch stage, there is a degree of lateral dimension loss of the ridges 20. / 注目すべきことは、第２エッチングの過程で畝20の横寸法が、ある程度減少することである。(USP7598149)
$$ In that case, there must exist in the initially formed member a degree of flexibility/plasticity such that the materials from which the member is formed may be deformed into the forms necessary. / その場合、部材形成材料を変形して必要な形にできるように、最初に形成された部材内にある程度の柔軟性／可塑性が存在しなければならない。(USP6833656)
$$ Moreover, within each region, optical filtration characteristics are spatially graded in an x direction to provide a degree of optical tuneability to each region. / 更に、各領域内では、光学フィルタ特性は、各領域に対してある程度の光学的な同調性を与えるようにｘ方向に空間的に等級付けされる。(USP6788479)
$$ Nevertheless, the motor speed can only be controlled to within a certain tolerance, giving rise to undesired fluctuations in the rotational speed of the disk. / それにもかかわらず、モータの回転速度は、ある程度の許容誤差範囲内でしか制御することができず、ディスクの回転速度について、望ましくない変動が生じることとなる。(USP8120867)
$$ This means specific equipment is, to some degree, limited to certain applications and it is not cost effective to optimise them for other applications. / つまり、特殊な装置はある程度までは特定の用途に限られ、特定の装置を他の用途のために最適化することは費用効果がよくない。(USP8107877)
$$ In an embodiment of the present invention, it is preferred if the agent that reduces the effect of PK1 on a PKR does not prevent PK2 having its effect on a PKR (whether fully or partially). / 本発明の一実施態様では、ＰＫＲに対するＰＫ１の効果を減退させる作用剤がＰＫＲに対する効果を有するＰＫ２を阻害しない（完全またはある程度）ことが好ましい。(USP7615210)
$$ The shutter 522 and its actuating mechanism 524 may be replaced by a liquid crystal shutter configured to operate between clear and partially opaque states; a liquid crystal shutter is a form of spatial light modulator. / シャッタ５２２およびその作動機構５２４は、透明状態とある程度不透明な状態の間で動作するように構成された液晶シャッタで置き換えることもでき、液晶シャッタは空間光変調器を形成する。(USP6414294)
$$ It is advantageous to have some degree of redundancy built into the system to provide more accurate results. / ある程度の冗長度をシステム内に組み込んでより正確な結果を与えるのが有利である。(USP7577260)
$$ A more practical form of device is the two-cavity design which eases the tolerancing of wavelength positioning in relation to laser sources which themselves have some degree of instability. / より実際的な形のデバイスは、２キャビティの構成であり、それは、自体がある程度の不安定性を有するレーザ源に関する波長の位置決めの公差を緩和する。(USP6980362)
$$ The gain and offset for each scan angle will also be temperature dependent to some degree. / 各走査角度に関する利得とオフセットもやはりある程度まで温度依存性であろう。(USP6900756)
$$ FIG. 8 illustrates a system with higher levels of magnetic confinement made by retracting to some degree the inner magnetron magnetic pole as described by the present invention; / 図８は、本発明によって表現される、内部マグネトロン磁極をある程度後退させることによって、磁気閉じ込めのレベルを高めるシステムを示す。(USP6383565)
$$ Also, many workpieces have a sufficiently large thermal capacity to tolerate some degree of ripple in the laser beam during processing. / また、多くの加工片は、十分に大きい熱容量を有するので、加工作業の間、レーザービームにはある程度のリップルが許容される。(USP5434880)
$$ This value of A can be determined dynamically according to traffic to some extent. / このＡの値は、ある程度はトラフィックに従って動的に決定できる。(USP8224387)
$$ A collection of manually associated objects may constitute a virtual case file for a project and may be to some extent user-specific. / 手操作で結びつけられたオブジェクトを集めて、プロジェクト用のバーチャルケースファイルを構成し、これはある程度ユーザに特定であってもよい。(USP6424968)
$$ Considerations as to the polymer material and application method adopted narrow the available choice to some extent. / 重合体材料および採用された利用方法に関する考察は、ある程度まで利用可能な選択を狭める。(USP7596989)
$$ This angle may be varied to some extend but is preferably less than 30 degrees and most preferably less than 25 degrees. / この角度は、ある程度の範囲で変更可能であるが、３０度未満、最も好ましくは２５度未満であることが好ましい。(USP8267456)
$$ In response to a user’s query the system must offer images that are similar in some user-defined sense. / ユーザの照会に応えて、前記システムはある程度ユーザが明示した意味で類似する画像を提供しなければならない。(USP7593602)
$$ The particular form of detector 19 shown here, is described in some detail. / ここで示されている特定な形態の検出器１９がある程度詳細に説明される。(USP6458239)
$$ Preferably the membrane wall is itself elastic or elastomeric to provide all or some of the restoring force as it flexes to the displacement position. / この膜状壁部材は、好ましくは、それ自体が弾性を有するか又は変位位置まで撓むにつれて全ての又はある程度の復元力をもたらす弾力性を有するものとされる。(USP6422434)
$$ Whilst this provides some improvement to control of flow resistance, this is still inadequate in some circumstances. / これは、流量抵抗の管理にある程度の改善を与えるが、なお、ある場合にはまだ不適当である。(USP6186974)
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BASF V. JOHNSON MATTHEY: Nov. 20, 2017. Before Lourie, O’Malley, and Taranto. Takeaways: The CAFC held that, with respect to indefiniteness, there is nothing inherent in the Nautilus standard that precludes a relevant skilled artisan from understanding with reasonable certainty what compositions perform a particular function; a “context-specific inquiry” may …
The post Federal Circuit Holds that Nautilus Standard Does Not Preclude a Relevant Skilled Artisan from Understanding with Reasonable Certainty What Compositions Perform a Particular Function appeared first on CAFC Blog .Continue Reading ...
The petitioner in the Oil States v. Greene’s Energy Group case has filed its reply brief. The reply brief is available [here].Continue Reading ...
BASF Corporation owns U.S. Patent No. 8,524,185,
which describes and claims systems for performing catalytic
conversion of nitrogen oxides (NOx) in an exhaust gas
stream. As relevant here, the patent claims a partly-duallayer
arrangement of coatings on a substrate over which
exhaust gas passes—a coat along the full length of the
substrate containing “a material composition B effective
to catalyze selective catalytic reduction (SCR) of NOx”;
and beneath part of that coat, on the outlet end of the gas
passage, a partial-substrate undercoat containing “a
material composition A effective for catalyzing NH3
oxidation” (ammonia oxidation, or AMOx). ’185 patent,
col. 19, lines 40–55 (claim 1); see also id., col. 20, lines 3–5
(dependent claim 5, similar); id., col. 20, lines 42–62
(independent claim 17, similar, but adding restrictions
concerning precious metals). In 2014, BASF sued its
competitor, Johnson Matthey Inc., for infringement of the
’185 patent. The district court held that the “effective for
catalyzing”/“effective to catalyze” language is indefinite
and entered judgment of invalidity of all claims on that
BASF appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1). We reverse the judgment of invalidity for
indefiniteness. We remand for further proceedings in
accordance with this opinion.
Of the law:
We review a determination of indefiniteness de novo.
Id. Determinations about governing legal standards and
about intrinsic evidence are reviewed de novo, and any
factual findings about extrinsic evidence relevant to the
question, such as evidence about knowledge of those
skilled in the art, are reviewed for clear error. Id. at
1377–78, 1382; see Teva Pharm. USA, Inc. v. Sandoz, Inc.,
135 S. Ct. 831, 841–42 (2015); UltimatePointer, L.L.C. v.
Nintendo Co., Ltd., 816 F.3d 816, 826 (Fed. Cir. 2016);
Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335,
1342 (Fed. Cir. 2015).
The CAFC found no reasoning in the district court opinion
Under Nautilus, the question presented here is this:
would the “composition . . . effective to catalyze” language,
understood in light of the rest of the patent and the
knowledge of the ordinary skilled artisan, have given a
person of ordinary skill in the art a reasonably certain
understanding of what compositions are covered? The
district court’s reasoning supplies no basis to answer that
question in Johnson’s favor.
Indeed, the district court did not treat the mere observation
about information not “recited” as itself answering
the question. The court immediately went on to
declare that “[w]ithout such information, a person of
ordinary skill in the art could not determine which materials
are within the ‘material composition A’ or ‘material
composition B’ limitation, and which are not.” J.A. 5.
That sentence is the crucial sentence in the district court’s
The problem with that sentence, however, is that it is
entirely unsupported, whether by reference to the specification
or other intrinsic evidence or by reference to extrinsic
evidence. Such support was central to our
determination that indefiniteness of certain physicalproperty
claims was proved in cases such as Dow Chemical
Co. v. Nova Chemicals Corp. (Canada), 803 F.3d 620,
633–35 (Fed. Cir.), rehr’g denied, 809 F.3d 1223 (Fed. Cir.
2015); Teva, 789 F.3d at 1342–45; Halliburton Energy
Services, Inc. v. M-I LLC, 514 F.3d 1244, 1252–54 (Fed.
Cir. 2008); and Honeywell International, Inc. v. International
Trade Commission, 341 F.3d 1332, 1340–42 (Fed.
Cir. 2003). The district court’s analysis in the present
case lacks such support for its conclusion about what a
relevant skilled artisan could determine without more
information than the patent here provides.
The district court’s analysis does not consider that the
specification makes clear that it is the arrangement of the
SCR and AMOx catalysts, rather than the selection of
particular catalysts, that purportedly renders the inventions
claimed in the ’185 patent a patentable advance over
the prior art. As a result, the claims and specification let
the public know that any known SCR and AMOx catalysts
can be used as long as they play their claimed role in the
claimed architecture. The district court’s analysis also
does not address the significance of the facts that both the
claims and specification provide exemplary material
compositions that are “effective” to catalyze the SCR of
NOx and the oxidation of ammonia, disclose the chemical
reactions that define the “SCR function” and “NH3 oxidation
function,” ’185 patent, col. 5, lines 33–49, and illustrate
through figures, tables, and accompanying
descriptions how the purportedly novel arrangement of
the catalysts results in improved percent conversion of
ammonia and improved nitrogen selectivity, see id., cols.
Dr. Epling’s declaration describes his own work with
“SCR catalysts,” speaks of “ammonia oxidation catalysts,”
gives examples of materials that can catalyze under
which conditions, and identifies materials that would “to
some measurable extent catalyze the oxidation of ammonia
if used to treat diesel engine emissions.” J.A. 951,
953. In those ways, Dr. Epling’s declaration implicitly
confirms that the terms at issue are ones whose scope is
understood with reasonable certainty by relevant skilled
artisans. Dr. Epling’s declaration also states: “In my
experience, scientists and engineers in th[e] field do not
consider materials that display only a minimal level of
SCR or ammonia oxidation function to be a material
effective to reduce NOx or to oxidize ammonia.” J.A.
1410. That assertion does not contradict the position of
BASF and its expert, which was that relevant skilled
artisans would reasonably understand what level (under
what conditions) qualify a composition as a claimed
catalyst. In fact, Dr. Epling’s assertion tends to confirm
the existence of just that understanding.
This record, we conclude, does not contain intrinsic orContinue Reading ...
extrinsic evidence that would support a judgment of
Arguing against Micron’s motion to dismiss, Harvard contended that TC Heartland only affirmed a previous precedent set by SCOTUS and that the improper venue challenge was available to Micron back when it filed its first motion in August 2016… The Federal Circuit concluded that the TC Heartland decision “changed controlling law in the relevant sense” and thus the Supreme Court’s interpretation of the patent venue statute was not available to Micron at the time of its August 2016 motion to…
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The World Intellectual Property Organization program on intellectual property and environmental technology is looking for consultants to catalyze green tech transactions in the Asia-Pacific region.Continue Reading ...
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