Thursday, December 07, 2017

CAFC addresses obviousness, marking, damages in Arctic Cat


In the technical area of thrust steering
systems for personal watercraft (“PWC”) propelled by jet
stream, Arctic Cat sued BRP for infringement.

BRP did not do well before the jury, and sought JNOV:


At trial, the jury found both patents not invalid,
awarded a royalty consistent with Arctic Cat’s model
($102.54 per unit) to begin on October 16, 2008, and found
by clear and convincing evidence that BRP willfully
infringed the asserted claims.

(...)

After post-trial briefing, the district court denied
BRP’s renewed motion for judgment as a matter of law on
all issues. It granted Arctic Cat’s motion for an ongoing
royalty, awarding $205.08 per unit. BRP appeals the
district court’s denial of judgment as a matter of law on
validity, marking, damages, and willfulness, as well as its
grant of an ongoing royalty and decision to treble damages.




Of motivation to combine, the CAFC wrote:


Therefore, a motivation to combine can
be found explicitly or implicitly in the prior art references
themselves, in market forces, in design incentives, or in
“any need or problem known in the field of endeavor at
the time of invention and addressed by the patent.” KSR,
550 U.S. at 420–21; accord Plantronics, Inc. v. Aliph, Inc.,
724 F.3d 1343, 1354 (Fed. Cir. 2013) (“[M]otivation to
combine may be found explicitly or implicitly in market
forces; design incentives; the ‘interrelated teachings of
multiple patents’; ‘any need or problem known in the field
of endeavor at the time of invention and addressed by the
patent’; and the background knowledge, creativity, and
common sense of the person of ordinary skill.” (quoting
Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1328–29 (Fed. Cir. 2009))). “The court should consider a
range of real-world facts to determine ‘whether there was
an apparent reason to combine the known elements in the
fashion claimed by the patent at issue.’” Intercontinental
Great Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336,
1344 (Fed. Cir. 2017) (quoting KSR, 550 U.S. at 418).
Motivation to combine is a factual determination as to
whether there is a known reason a skilled artisan would
have been motivated to combine elements to arrive at a
claimed combination. This is not the ultimate legal
determination of whether the claimed combination would
have been obvious to the ordinary artisan—meaning that
it is possible that a reason or motivation may exist, but
nonetheless the ordinary artisan would not have found
the combination obvious.


When a challenger shows that a “motivation” existed
for a relevant skilled artisan to combine prior
art in the way claimed in the patent at issue,
such a showing commonly supports and leads
readily to the further, ultimate determination
that such an artisan, using ordinary creativity,
would actually have found the claimed invention
obvious. But the latter conclusion does not follow
automatically from the former finding, and additional
evidence may prevent drawing it. . . . Even
with a motivation proved, the record may reveal
reasons that, after all, the court should not conclude
that the combination would have been obvious
. . . .
Intercontinental Great Brands, 869 F.3d at 1346–47.



BRP tried the finite, predictable solution approach from KSR:


BRP argues a skilled artisan would have selected the
Challenger system because it was one of a finite number
of identified, predictable solutions to the problem of offthrottle
steering in PWCs. See KSR, 550 U.S. at 421. The
SAE Interim and Draft Final Reports identified the
Challenger’s throttle reapplication as one of four solutions
to the problem of off-throttle steering, along with rudders,
flaps, and scoops. The National Association of State
Boating Law Administrators also explained that jet boats
and PWCs are similar and off-throttle directional control
is a problem for both. Rheault ’833 disclosed that its
steer-responsive throttle “is applicable to single-engine
personal watercraft,” and Rheault ’938 states the Challenger
jet boat’s thrust steering “is applicable to all types
of watercraft vehicles, including personal watercraft
vehicles.” J.A. 8942 at Abstract; J.A. 8920 at 8:15–17.
For these reasons, BRP argues a reasonable jury could
only have found a skilled artisan would have been motivated
to modify a PWC with Challenger’s off-throttle
thrust reapplication system, which would have combined
known elements to improve the system in the same way
and yield expected results



The "substantial evidence" standard was pivotal:


If such a fact finding is supported by substantial evidence,
we may not reverse it. In briefing and oral argument,
BRP devoted much of its argument to re-litigating its case
and its evidence rather than addressing the evidence that
could have supported the jury’s finding of no motivation to
combine. We do not reweigh the evidence and reach our
own factual determination regarding motivation. The
question for us on appeal is only whether substantial
evidence supports the jury’s presumed finding. See, e.g.,
Apple, 839 F.3d at 1052 (“Our job is not to review whether
Samsung’s losing position was also supported by substantial
evidence or to weigh the relative strength of Samsung’s
evidence against Apple’s evidence. We are limited
to determining whether there was substantial evidence
for the jury’s findings, on the entirety of the record.”). We
conclude that it does.



There was asserted ambiguity on motivation to combine:




This evidence may not rise to the level of teaching
away. Nonetheless, in light of this record, the jury’s
determination that there was no motivation to make this
particular combination is supported by substantial evidence.
Evidence suggesting reasons to combine cannot be
viewed in a vacuum apart from evidence suggesting
reasons not to combine.
In this case, the same reference
suggests a reason to combine, but also suggests reasons
that a skilled artisan would be discouraged from pursuing
such a combination. Under such circumstances, the jury’s
fact finding regarding motivation is supported by substantial
evidence. Coupled with testimony confirming the
potential problems of automatic throttle reapplication and
suggesting an alternative approach might reduce those
same problems, J.A. 2230–32, a jury could find a skilled
artisan would not have been motivated to combine the
Challenger system with a PWC to arrive at the claimed
combination.


Of some interest is the text


An internal BRP “brainstorming” session identified thirtytwo
possible designs directed to off-throttle steering. J.A.
9454. And there is evidence that other potential solutions
to the off-throttle steering problem existed but were not
fully disclosed for confidentiality and other concerns. See,
e.g., J.A. 7532 (noting that some ideas offered in response
to SAE’s inquiry “have typically either not conveyed
sufficient information or have patent, propriety, or litigation
concerns”).



What can happen when does not object:


BRP argues that substantial evidence does not support
the jury’s presumed factual finding that the claimed
invention received industry praise because “praise from a
Coast Guard official in Arctic Cat’s own press release” is a
“hearsay statement [that] cannot overcome persuasive
evidence that the claimed technology described the same
approach as BRP’s system.” Appellant’s Br. 35–36 (citing
J.A. 7828; J.A. 7871; In re Cree, Inc., 818 F.3d 694, 702
(Fed. Cir. 2016)). We disagree for at least two reasons.
First, Arctic Cat contends—and BRP does not contest—
that BRP failed to object to this evidence as hearsay at
trial, so the jury was entitled to credit the statement.
Appellee’s Br. 12. Second, that Captain Holmes’ statements
appear in Arctic Cat’s press release goes to evidentiary
weight. Captain Holmes’ statements and
Mr. Bernier’s testimony constitute substantial evidence to
support the jury’s presumed factual finding that the
claimed invention received praise from the industry. This
evidence of industry recognition of the significance and
value of the claimed invention weighs in favor of nonobviousness.



Of marking, note


We hold an alleged infringer who challenges the patentee’s
compliance with § 287 bears an initial burden of
production to articulate the products it believes are unmarked
“patented articles” subject to § 287. To be clear,
this is a low bar. The alleged infringer need only put the
patentee on notice that he or his authorized licensees sold
specific unmarked products which the alleged infringer
believes practice the patent. The alleged infringer’s
burden is a burden of production, not one of persuasion or
proof.
(...)
We do not here determine the minimum showing
needed to meet the initial burden of production, but we
hold in this case it was satisfied by BRP. At trial BRP
introduced the licensing agreement between Honda and
Arctic Cat showing Honda’s license to practice “Arctic Cat
patents that patently cover Arctic Cat’s Controlled Thrust
Steering methods, systems and developments.” J.A. 7830
§ 1.01. BRP identified fourteen Honda PWCs from three
versions of its Aquatrax series sold between 2002 and
2009. J.A. 3540–41 ¶ II. BRP’s expert testified that he
“review[ed] information regarding those models” and
believed if BRP’s OTAS system practiced the patents, so
did Honda’s throttle reapplication system in the Aquatrax
PWCs. J.A. 2447–49; J.A. 2482. This was sufficient to
satisfy BRP’s initial burden of production.

(...)

The district
court erred in placing this burden upon BRP and thus we
vacate and remand on marking.

Because the district court adopted this legal approach
at the summary judgment stage, it made clear to the
parties that it would be BRP’s burden to prove that the
unmarked products fell within the patent claims. Arctic
Cat, therefore, did not have a fair opportunity to develop
its case regarding the Honda PWCs at trial.
Because
Arctic Cat was not on notice regarding its burden, and in
fact labored under the assumption that BRP had the
burden of proof, reversal would be improper. We thus
vacate the district court’s judgment as to marking and
remand so that Arctic Cat has an opportunity to proffer
evidence related to the identified Honda PWCs.2



Of making arguments in footnotes, from footnote 4 of the
CAFC opinion:


BRP states in a footnote that even if this testimony
were admissible, it is irrelevant and thus Arctic Cat
failed to provide sufficient evidence to support the jury’s
award. Appellant’s Br. 46 n.3. This single sentence,
devoid of any analysis, is insufficient for BRP to meet its
burden on appeal, and we nevertheless conclude
Mr. Bratic’s testimony constitutes substantial evidence
supporting the jury’s reasonable royalty award.



Of a decision without briefing:


Finally, the district court did not abuse its discretion
by trebling damages. While the district court initially
trebled damages without much explanation, J.A. 97–98, it
explained its decision in a subsequent thorough and wellreasoned
opinion. See J.A. 99–116 (applying the factors
outlined in Read Corp. v. Portec, Inc., 970 F.2d 816 (Fed.
Cir. 1992)). Although the district court did not allow the
parties to brief the issue, we will not adopt a blanket rule
that a district court abuses its discretion by deciding an
issue without receiving briefing from the parties. That is
especially true where, as here, BRP attacks the district
court’s procedure but does not explain how additional
briefing would have changed the outcome. In short, BRP
has not shown that the district court’s failure to allow
briefing amounts to an abuse of discretion. We affirm the
district court’s denial of judgment as a matter of law on
willfulness and its order trebling damages.

Perry Mason does patents


In "The Case of the Irate Inventor" (first broadcast 28 May 1960), "Perry Mason" brushes with patent law.

Thirty-nine years before Pfaff, the idea of whether or not an invention was "ready for patenting" arose in determining "who owned" rights to an invention. The particular agreement in the case involved partners, and had clauses for involuntary and voluntary sale of inventions. The partners adverse to Perry's client tried to obtain the invention through an involuntary sale, but Perry got a voluntary sale done first.

Thus, Perry outmaneuvered the adverse partners, and Della Street, Perry's loyal secretary, became owner of an invention for an anti-collision device (for airplanes and possibly other vehicles). The trick: if the partnership broke up, an inventor himself owned rights in inventions not ready for patenting at the break-up time.

This is not your typical Perry Mason episode. The perp did NOT confess in court, and invoked Fifth Amendment rights against self-incrimination. Not your usual Mason with a blurting confession at the end. The details of "what happened" were not revealed until the epilog in Perry's office. As to inventors per se, the disgruntled wife of the inventor was feeding details of his invention to her lover who was his competitor. The cheating wife was the decedent in this case, but not by the victimized husband.

Berger (Talman) is in the credits, but this was near the time he was removed from the show (later to come back).

Tuesday, December 05, 2017

PTAB reversed in Hulu matter: To bar Hulu from pressing an argument it raised in a ground the Board found “redundant” and that it expressly incorporated into other proposed grounds of unpatentability on which the Board instituted would not only unfairly prejudice Hulu, ...


The decision was a mixture:


Today we decide three appeals in companion cases
from final written decisions of the United States Patent
and Trademark Office (“PTO”) Patent Trial and Appeal
Board’s (“Board”) inter partes reviews (“IPRs”) of U.S.
Patent No. 7,191,233 (“the ’233 patent”), owned by CRFD
Research, Inc. (“CRFD”). Iron Dome LLC v. CRFD Research,
Inc., No. IPR2015-00055, 2016 Pat. App. LEXIS
6855 (P.T.A.B. Apr. 22, 2016) (hereinafter “Iron Dome
Final Written Decision,” Appeal No. 16-2198); DISH
Network Corp. v. CRFD Research, Inc., No. IPR2015-
00627, 2016 Pat. App. LEXIS 7567 (P.T.A.B. June 1,
2016) (hereinafter “DISH Final Written Decision,” Appeal
No. 16-2298); Hulu, LLC v. CRFD Research, Inc., No.
IPR2015-00259, 2016 Pat. App. LEXIS 4340 (P.T.A.B.
June 1, 2016) (hereinafter “Hulu Final Written Decision,”
Appeal No. 16-2437). For the reasons stated below, we
affirm the Iron Dome and DISH Final Written Decisions,

but we reverse the Board’s determination on obviousness
in the Hulu Final Written Decision.



As to review:


We review the Board’s factual findings for substantial
evidence and its legal conclusions de novo. In re Gartside,
203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “Substantial
evidence is something less than the weight of the evidence
but more than a mere scintilla of evidence.” In re Mouttet,
686 F.3d 1322, 1331 (Fed. Cir. 2012) (citing Gartside, 203
F.3d at 1312). It is “such relevant evidence as a reasonable
mind might accept as adequate to support a conclusion.”
In re Applied Materials, Inc., 692 F.3d 1289, 1294
(Fed. Cir. 2012) (quoting Consol. Edison Co. of N.Y. v.
NLRB, 305 U.S. 197, 229 (1938)). We have jurisdiction
over these appeals under 28 U.S.C. § 1295(a)(4).



Of Hulu:


Hulu appeals the Board’s determination in the Hulu
Final Written Decision that (1) claims 1–3, 23, and 24 are
not anticipated by Bates, (2) claims 1–6, 8–11, 23–25, and
29–31 would not have been obvious over Bates and Chan;
(3) claims 13, 14, 34, and 35 would not have been obvious
over Bates and Zou; and (4) claims 15, 17–20, 36, and 38–
41 would not have been obvious over Bates, Zou, and
Chan. For the reasons stated below, we reverse the
Board’s determinations of nonobviousness, ...

Hulu challenges the Board’s determination that various
claims of the ’233 patent would not have been obvious
on the grounds on which the Board instituted review. On
appeal, the only claim limitation in dispute for these
grounds is “transmitting a session history of said first
device from said first device to a session transfer module
after said session is discontinued on said first device.”
’233 patent, col. 9, ll. 35–37 (emphasis added). We conclude
that the Board erred, both in how it performed its
obviousness analysis and in the merits of its determination
of nonobviousness.
Hulu first contends the Board failed to conduct a separate
analysis on obviousness as to each of the instituted
grounds. Instead, according to Hulu, the Board improperly
relied on its finding that Bates did not anticipate
various asserted claims of the ’233 patent to support its
finding of nonobviousness without considering whether
Bates suggests transmission of session history after
discontinuation.
We agree that the Board legally erred in its treatment
of Hulu’s obviousness challenge. Although Hulu raised
separate arguments as to the obviousness of certain
claims, the Board performed limited fact-finding in its
obviousness inquiry, only examining the level of ordinary
skill in the art and then relying primarily on its determination
that Bates did not anticipate the challenged
claims. Hulu Final Written Decision, at *28–31. But
“[t]he tests for anticipation and obviousness are different.”
Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364
(Fed. Cir. 2008). As noted, anticipation is a question of
fact, while obviousness is a question of law based on
underlying factual findings. Kennametal, Inc. v. Ingersoll
Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015).





AND



We agree with Hulu that the Board erred on this
point, as Hulu expressly incorporated this argument as
part of other grounds of unpatentability on which the
Board instituted trial.7 Hulu relies solely on the teachings
of Bates to satisfy the transmitting limitation as to
all asserted claims. The Board, in its discretion, elected
to not institute review on Bates alone for redundancy
reasons, but instituted review on obviousness grounds
that include the only reference—Bates—cited in that
ground. To bar Hulu from pressing an argument it raised
in a ground the Board found “redundant” and that it
expressly incorporated into other proposed grounds of
unpatentability on which the Board instituted would not
only unfairly prejudice Hulu, but would also raise questions
about the propriety of the Board’s redundancy
decision. As the parties agree, our obviousness analysis
on this limitation is controlled by the teachings and
suggestions of Bates, and the Board’s decision to not
review the obviousness ground of Bates alone for redundancy
reasons cannot control the breadth of the obviousness
inquiry it took below, and that we must review here.

Monday, December 04, 2017

Microsoft v. Parallel Networks: anticipation and obviousness determinations vacated


Microsoft and IBM appealed the Board’s decisions, arguing
that the Board erred in construing the claim term
“request” and in rejecting the arguments for unpatentability.

On the construction point, Microsoft and IBM lost. But the decision of the Board
on anticipation and obviousness was vacated.

A problem was that the Board failed to address an argument, and the CAFC
found this to be error.

In re Antor, 689 F.3d 1282, was cited for presumed enablement of prior art publications.
The obviousness finding was rejected for insufficient explanation.

Thursday, November 30, 2017

The MS drug ALKS 8700



There has been some recent buzz in the multiple sclerosis community over ALKS 8700 :





ALKS 8700 is currently in Phase 3 development for MS. Alkermes plans to seek approval of ALKS 8700 under the 505(b)(2) regulatory pathway referencing Biogen’s TECFIDERA® (dimethyl fumarate). The registration package for ALKS 8700 will include pharmacokinetic bridging studies that establish bioequivalence to TECFIDERA and data from a two-year safety study known as EVOLVE-MS-1. Initial safety data from EVOLVE-MS-1 were recently presented at MSParis2017, the 7th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in October



link:
http://www.businesswire.com/news/home/20171127005271/en/Biogen-Alkermes-Announce-License-Collaboration-Agreement-Develop

The compound is related to Tecfidera:


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).



link: https://multiplesclerosisnewstoday.com/alks-8700-multiple-sclerosis/


From US 9505776 (first inventor Zeidan; Prior Publication 20140275048, September 18, 2014 ):


[0005]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.

(...)

[0015]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.



The first claim is to a compound:


A compound of Formula (Ia), or a pharmaceutically acceptable salt thereof: (...)


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.

**As to possible patent issues:


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."



from FTC v. Abbvie, 107 F. Supp. 3d 428



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).



from Takeda, 78 F. Supp. 3d 65 (D DC 2015)

AND


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.



from Ethypharm, 707 F.3d 223 (CA3 )

***Of prodrug cases:

From 2016 U.S. Dist. LEXIS 8757


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.




From 2015 U.S. Dist. LEXIS 110099
:


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).



See Amy Kapczynski et al., Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of "Secondary" Pharmaceutical Patents, 7 PLoS One e49470 (2012)
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0049470.

See ANDREW W. TORRANCE, NEUROBIOLOGY AND PATENTING THOUGHT, 50 IDEA 27 (2009) :


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.



From 45 IDEA 165



There remains one question to ponder when evaluating the amount of evergreen (i.e., improvement) patenting that might be expected in the post-reform Hatch-Waxman universe, namely, the impact that the Schering Corporation v. Geneva Pharmaceuticals n286 decision might have on such practices of innovative pharmaceutical companies. This is a particularly interesting issue to consider in the context of FDA's new listing regulations preventing the listing of patents directed to metabolites, intermediates and packaging. In Schering, the Federal Circuit affirmed the District Court's decision finding that a patent to a prodrug, namely to the drug that is actually administered to a patient, inherently anticipates a patent to the metabolite that is produced from the prodrug in the body. n287 Judge Rader reasoned as follows:
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.
This court sees no reason to modify the general rule for inherent anticipation in a case where inherency supplies the entire anticipatory [*221] subject matter. n288


Tuesday, November 28, 2017

Rembrandt loses appeal at CAFC


From Rembrandt v. Apple


We apply the law of the regional circuit when reviewing
a district court’s grant of summary judgment. Classen
Immunotherapies, Inc. v. Elan Pharm., Inc., 786 F.3d 892,
896 (Fed. Cir. 2015). The Ninth Circuit reviews a grant of
summary judgment de novo. Ariz. Dream Act Coalition v.
Brewer, 818 F.3d 901, 908 (9th Cir. 2016). A “judge’s
function at summary judgment is not to weigh the evidence
and determine the truth of the matter but to determine
whether there is a genuine issue for trial.” Tolan
v. Cotton, 134 S. Ct. 1861, 1866 (2014) (internal quotation
marks and citation omitted). The evidence, and inferences
drawn therefrom, must be viewed in the light most
favorable to the opposing party. Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574, 587–88 (1986)



The word "parrot" arises:


We have also explained that “the concept of equivalency
cannot embrace a structure that is specifically
excluded from the scope of the claims.” Dolly, Inc. v.
Spalding & Evenflo Cos., 16 F.3d 394, 400 (Fed. Cir.
1994). An argument under the doctrine of equivalents
fails if it “renders a claim limitation inconsequential or
ineffective.” Akzo Nobel Coatings, Inc. v. Dow Chem. Co.,
811 F.3d 1334, 1342 (Fed. Cir. 2016). As the Supreme
Court instructed, “if a theory of equivalence would entirely
vitiate a particular claim element, partial or complete
judgment should be rendered by the court, as there would
be no further material issue for the jury to resolve.”
Warner-Jenkinson, 520 U.S. at 39 n.8.

Rembrandt largely parrots arguments supplied by its
expert, Dr. Tygar, in arguing infringement under the
doctrine of equivalents.



Of doctrine of equivalents:

(“[E]ven if the testimony were of
proper scope, it is conclusory, stating only that the product
would ‘operate the same,’ ‘perform [the functions
described in the patent] in essentially the same way,’ and
‘would [produce] the same result.’ It offers no explanation
beyond these conclusory statements.” (citation omitted)).
As in Augme, conclusory testimony from Dr. Tygar on the
“way” prong is insufficient to create a genuine issue of
material fact for trial regarding infringement by equivalents.
Cf. Perkin–Elmer Corp. v. Westinghouse Elec.
Corp., 822 F.2d 1528, 1532 n.6 (Fed. Cir. 1987) (“That a
claimed invention and an accused device may perform
substantially the same function and may achieve the
same result will not make the latter an infringement
under the doctrine of equivalents where it performs the
function and achieves the result in a substantially different
way.”).

CAFC affirms Board: MAGNESITA is generic for refractory products



From within In re Magnesita:


MRC contends that this court should reconsider our
allocation of the burden of proof on the applicant to show
acquired distinctiveness in view of the Supreme Court’s
decision in B & B Hardware, Inc. v. Hargis Industries,
Inc., 135 S. Ct. 1293 (2015). In B & B Hardware, the
Supreme Court held that district courts should give
preclusive effect to Trademark Trial and Appeal Board
decisions in inter partes proceedings if the elements of
issue preclusion are met. 135 S. Ct. at 1299. B & B
Hardware is inapplicable. MRC makes no issue preclusion
argument, but rather attempts to import regulations
governing the evidentiary burdens that apply to adversarial
parties into this ex parte appeal. B & B Hardware
does not address the evidentiary burdens involved in ex
parte proceedings. Indeed, the regulations setting forth
the content requirements for a trademark application
obligate an applicant to submit proof supporting any
claim of acquired distinctiveness. 37 C.F.R. § 2.41; see La.
Fish Fry, 797 F.3d at 1336; In re Steelbuilding.com, 415
F.3d 1293, 1297 (Fed. Cir. 2005). Accordingly, we do not
read B & B Hardware as disrupting our well-settled law.



Note


To establish that a term has acquired
distinctiveness, a trademark applicant must show
that “the primary significance of term in the minds of the
consuming public is not the product but the producer.”
Kellogg Co. v. Nat’l Biscuit Co., 305 U.S. 111, 118 (1938);
Coach Servs., Inc. v. Triumph Learning LLC, 668 F.3d
1356, 1379 (Fed. Cir. 2012). If a term is highly descriptive,
the applicant faces an elevated burden to show
acquired distinctiveness. La. Fish Fry, 797 F.3d at 1336.
To meet its elevated burden, an applicant can submit
advertising expenditures and sales success, as well as
length of exclusivity of use. Id. at 1336–37. But the
precise amount and character of evidence necessary
varies on case-specific facts and the nature of the mark.
See Roux Labs, Inc. v. Clairol, Inc., 427 F.2d 823, 829
(C.C.P.A. 1970).
As an initial matter, an applicant’s claim asserting a
term has acquired distinctiveness acts as an admission
that the term is merely descriptive. Yamaha Int’l Corp. v.
Hoshino Gakki Co., 840 F.2d 1572 (Fed. Cir. 1988); see
Two Pesos, Inc. v. Taco Cabana, Inc., 505 U.S. 763, 772
(1992) (recognizing that § 2 of the Lanham Act “requires
secondary meaning only as a condition to registering
descriptive marks”). By claiming that MAGNESITA has
acquired distinctiveness for Class 37 services, MRC
concedes that MAGNESITA is merely descriptive for
those services. Thus, absent a showing of acquired distinctiveness,
MRC cannot register MAGNESITA as a
trademark.




Sunday, November 26, 2017

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.

See also

Columbo: 5 things you may have missed watching “Mind Over Mayhem”

****
Separately, from the Cornell Daily Sun :


In January, three scholars published a paper — titled “Statistical Heartburn: An Attempt to Digest Four Pizza Publications from the Cornell Food and Brand Lab” — investigating four papers Wansink co-authored on pizza-eating habits and listed 151 claims of data inconsistencies involving incorrectly calculated statistics, sample sizes and standard deviations.

Wansink responded directly to the “Statistical Heartburn” paper, issuing a 16-page response to each of the authors’ 151 claims.

More recently, JAMA Pediatrics retracted a similar study co-authored by Wansink, which reported that children are more likely to choose an apple over a cookie if the apple included an Elmo sticker, but contained numerous statistical errors.

The same day the JAMA publication was retracted, Wansink and his co-authors published a replacement version, which still contained flaws, as both the original and the replacement claimed that the study included 208 students ranging from eight to eleven years old at seven schools in upstate New York. But in fact, the data collected observed kids from three to five years old, Wansink told Buzzfeed News.



link: http://cornellsun.com/2017/11/28/cornell-food-researcher-retracts-fourth-study-due-to-no-empirical-support/







Saturday, November 25, 2017

History can be reversed?


Arizona State University reverses history in the Rose matter:


"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."




link: http://www.businessinsider.com/charlie-rose-loses-walter-cronkite-journalism-awardsexual-harassment-allegations-2017-11

**Separately, in the "alternate history" vein, recall MacKinlay Kantor's If the South Had Won the Civil War.