It's time to say goodbye to 2020 & also this blog. As most of the you are aware that "Pharma IP Circle" has moved to new address & this current address would no longer serve. Looking forward to 2021 with new learning & experience.
Here is our new address:
https://www.pharmaipcircle.com/
Wish all the readers very hopeful, healthy & happy new year 2021.
Image source: https://i.ytimg.com/vi/atLLOMcK830/maxresdefault.jpg
On Dec. 21, 2020, Federal Circuit affirmed district court’s
summary judgment that found infringement under Doctrine of Equivalents (DoE).
Eli Lilly owns US 7,772,209 patent which relates to “a
method of administering an antifolate to a mammal in need thereof, comprising
administering an effective amount of said antifolate in combination with a
methylmalonic acid lowering agent”. Independent claims covers administration of
pemetrexed disodium (antifolate) with folic acid & methylmalonic acid
lowering agent (vitamin B12). This patent is listed in Orange Book for the
product ALIMTA®. Eli Lilly markets
ALIMTA in USA for the treatment of mesothelioma and certain types of lung
cancer. Apotex filed NDA with USFDA to
market different salt i.e. pemetrexed dipotassium. Eli Lilly then sued Apotex for infringement. United
States District Court for the Southern District of Indiana issued summary
judgment of infringement in favour of Lilly. It found that Lilly is not
estopped from arguing DoE because there was no Prosecution History Estoppel
(PHE).
Apotex argued that the term “ALIMTA” in the original claims
would have been understood to mean “pemetrexed,” therefore, Lilly’s amendment
to replace “ALIMTA” with “pemetrexed disodium” was a narrowing amendment and
Lilly surrendered all other salt forms of pemetrexed. Federal Circuit, however,
sided with district court & said that this amendment was not narrowing one.
The intrinsic record equates ALIMTA with pemetrexed disodium. The specification
refers to “pemetrexed disodium” twice, both times in association with ALIMTA. Moreover,
the prosecution history confirms that the inventors used “ALIMTA” in the
original claims—and the Examiner understood the term—as Lilly’s trade name for pemetrexed
disodium. Examiner rejected claims related to ALIMTA trademark under 35 U.S.C.
112, second paragraph because it is improper to use trademark in the claims
according to MPEP. In response to the rejection, Lilly canceled its claims
reciting the trade name and pursued claims using the generic name (pemetrexed
disodium), which mooted the rejection.Therefore, nothing in the prosecution
history suggests that Lilly’s amendment narrowed the claims or or that either
Lilly or the Examiner understood “ALIMTA” to mean anything other than
pemetrexed disodium.
Thus, the district court properly concluded that prosecution
history estoppel does not bar Lilly’s infringement claims under the doctrine of
equivalents.
Dear Readers,
Happy to share that "Pharma IP Circle" blog has moved from blogger to full fledged secure website. Please subscribe to the new blog so that you can get the litigation updates. I would be discontinuing this blog from January 01, 2021 & will share update on only new blog thereafter. You can "subscribe" by putting your name & mail id mentioned on the home page.
Here is the new address:🏠
https://www.pharmaipcircle.com
Thanks for your support. Looking forward to much more in 2021. Happy learning to all!😊
Regards,
Mahendra Gunjal
On Dec. 18, 2020, Federal Circuit affirmed (Rule 36
judgment) Delaware court in Uceris® litigation.
Previously,
Plaintiffs Bausch Health Americas, Inc., Salix Pharmaceuticals Ltd., and Cosmo
Technologies Limited (collectively, "Plaintiffs") filed complaint
asserting that Defendants Actavis Laboratories FL., Inc., Actavis Pharma, Inc.,
Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd.
(collectively, "Defendants") infringed and continue to infringe U.S.
Patent Nos. 10,052,286, 10,064,878, 10,105,374, 10,143,698, 10,154,964, and 10,172,799
by filing ANDA for budesonide extended release tablets, 9 mg. On Oct 28, 2019,
Delaware court issued final order & judgment finding of noninfringement in
favor of Defendants.
On Dec. 16, 2020, Federal Circuit affirmed (Rule 36
judgment) PTAB finding method of use patent invalid as obvious.You can find the
IPR details reported “"here"” on this blog.
IPR decision: Dec. 08, 2020
|
AIA Review # |
Filing Date |
Institution Date |
Petitioner |
Patent |
Respondent |
Status |
|
IPR2020-01045 |
06/10/2020 |
09/01/2020 |
Teva |
7,326,708 |
Merck |
Terminated-Settled |
Note: Mylan already filed IPR on US’708 patent on 10/30/2019 and PTAB instituted IPR on 05/12/2020. DRL & Sun also filed IPRs (IPR2020-01060 & IPR2020-01072) which were instituted on 09/01/2020.
US 7,326,708 (Merck & Co.; Exp: 05/24/2027 with
PED):
1. A dihydrogenphosphate salt of
4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine
of structural formula I:##STR## or a hydrate thereof.
On Dec. 04, 2020, UK High Court found second medical use
patent valid & infringed by Mylan.
Neurim holds EP 1,441,702 patent, which is related to use of
melatonin in improving the restorative quality of sleep, in a patient suffering
from primary insomnia. Mylan/Generics UK
plans to bring generic version of drug in the market. The issues before court
concerned the invalidity of patent as Mylan admitted infringement if patent is
found valid. Mylan asserted that claims of patent are invalid under lack of
novelty, lack of inventive step & insufficiency. Claims 1
and 4 were of relevance here:
1.
Use of a prolonged release formulation comprising melatonin in unit dosage form comprising 2 mg of
melatonin, in the manufacture of a medicament for improving the restorative
quality of sleep in a patient aged 55 years or older suffering
from primary insomnia characterized
by non-restorative
sleep, wherein the medicament comprises also at least one pharmaceutically
acceptable diluent, preservative, antioxidant, solubilizer, emulsifiers,
adjuvant or carrier.
4.
A medicament for use in improving the restorative quality of sleep in a
patient aged 55 year or older suffering from primary insomnia characterized by non-restorative
sleep, which comprises a prolonged release formulation comprising melatonin in
unit dosage form, comprising 2 mg of melatonin, and at least one pharmaceutically
acceptable diluent, preservative, antioxidant, solubilizer, emulsifiers,
adjuvant or carrier.
Mylan cited various prior arts among which “Haimov 1995” was closest one. It disclosed effects of melatonin replacement therapy on melatonin-deficient elderly insomniacs by administering 2 mg sustained-release melatonin. With respect to novelty, Court held that Haimov in no way anticipates the patent because study was directed to a completely different matter. The focus was on “melatonin-deficient” individuals, because the aim of the study was to see if the curing of such a deficiency would improve sleep. There was certainly no focus on restorative sleep or quality of sleep in the technical sense as claimed in patent. Court thus concluded that Skilled Person would have learned nothing about the effect of melatonin on Primary Insomnia characterized by non-restorative sleep from Haimov.
With respect to inventive step, Mylan combined this reference with
another references such as “MELATONEX label
and Zisapel”. MELATONEX is a dietary supplement containing melatonin which is
sold in USA without prescription. MELATONEX supplementation can help to restore
the melatonin for a restful, natural sleep. Zisapel is a review of the
literature in the area of melatonin treatment. It neither reported any original
research nor did it give any meta-analysis of the data reviewed. Court said
that Zisapel goes nowhere close to exploring any relationship
between non-restorative sleep in Primary Insomniacs and melatonin. There is
nothing to render the invention in the patent obvious to the Skilled Person.
With respect to insufficiency also, Court did not convince with Mylan’s argument. Mylan contended that there was no data in the patent which evidenced the claimed effect, namely an improvement in the restorative quality of sleep in a patient suffering from Primary Insomnia characterized by non-restorative sleep. Court focused on Examples 2 and 3 and considered whether they render the patent plausible. Court said that these examples disclose reasonably large clinical study in patients who were Primary Insomniacs at least some of whose sleep was characterized by its non-restorative quality. These studies were conducted on established lines and resulted in a statistically significant outcome in that it enabled the conclusion that melatonin enhanced the restorative value of sleep. Thus Court rejected the contention that the patent is invalid by reason of insufficiency.
On Nov. 30, 2020, Delaware court on remand found Quillivant
XR® patents valid & infringed by ANDA filer in a Hatch-Waxman suit.
Plaintiff (Tris Pharma) filed suit against defendant (Actavis)
for alleged infringement of U.S. Patent Nos. 8,465,765; 8,563,033; 8,778,390;
8,956,649 and 9,040,083. Actavis challenged the validity based on obviousness
and obviousness-type double patenting. After a five-day bench trial, the
original judge (now retired) found all the asserted claims to be invalid for
obviousness under 3 5 U.S. C. § 103. Tris appealed. The Federal Circuit vacated
the judgment because [the judge]'s obviousness decision lacked the requisite
fact-finding, and because the [judge] erred in rejecting Tris's evidence of
objective indicia of non-obviousness." The Federal Circuit thus remanded
the obviousness analysis to the district court for further fact-finding.
All asserted claims basically related to methylphenidate
aqueous extended release oral suspension & its pharmacokinetic (PK) &
pharmacodynamic (PD) aspects. Federal Circuit specifically ordered further
fact-finding to address whether a liquid MPH formulation with a single mean
PK profile, 12-hour duration of effect, 45-minute onset of action,
Tmax range of 4 to 5.25 hours would have been obvious over the prior art.
Prior arts cited were disclosing one or more limitations but not all. Most of
the prior arts were related to ER solid formulations of methylphenidate. Only
one art cited was related to liquid formulation but that disclosed IR
composition. The question on remand was whether Actavis has demonstrated by
clear and convincing evidence that an artisan of ordinary skill would have been
motivated to achieve the combination in question and would have had a
reasonable expectation of success in doing so.
Court said that Actavis bears the burden & their arguments
are confusing and conflicting. Actavis first submitted that POSA would have
been motivated to make a formulation with a single peak profile. Court said
that assuming arguendo that this fact
were established, it would not by itself constitute clear and convincing evidence
that an artisan of ordinary skill would have been motivated to combine a single
peak profile with a liquid MPH formulation that has both a 12-hour duration and
45-minute onset. On the contrary, Actavis next states in the opening line of
its second argument that its own expert, Dr. Staller, established at trial
"that POSA would not have been concerned about the specific shape of the
PK curve-[because] clinical effects [i.e., PD characteristics as opposed to PK
characteristics] are what matter." Court thus said that, so POSA would
have been indifferent (i.e., would have lacked motivation) to use a formulation
that produced a single peak profile. Actavis' last affirmative argument with
respect to motivation to combine a single peak profile, 12-hour duration, and
45-minute onset in a liquid MPH formulation too, lacks merits. Actavis argued that
POSA "would have been motivated to pursue this [combination] because [the
combination had] already appeared in the prior art." Court however said that
only two of the extended release prior art references disclosed formulations
with a single mean peak plasma profile, and neither of those references
achieved an onset within 45 minutes. Court also said that there was no
reasonable expectation of success because prior art taught away from combining
in a liquid MPH formulation a single mean peak, 12-hour duration, and 45-minute
onset. Specifically, prior art taught that multiple peaks, achieved by multiple
pulses of medication, were required to achieve both a 12-hour duration and
45-minute onset. Thus, the prior art taught away from use of a single peak to
achieve that combination of clinical effects.
With respect to secondary consideration, court found unexpected
results and long-felt, unmet need in favor of Tris. Court said that combination
of single peak profile with a 12-hour duration and 45-minute onset was
unexpected as discussed above. Moreover, Tris's evidence of long-felt unmet
need as of July 2010 for a liquid methylphenidate formulation with a 12-hour
duration and 45-minute onset is especially compelling. Because, children, the
primary focus of ADHD treatment, often have difficulty swallowing pills; and it
is much easier for patients generally and children in particular to comply with
a therapy regimen that is accomplished with a single daily dose as opposed to
multiple doses taken throughout the day. The need was long-felt and unmet
because even though methylphenidate had been used to treat ADHD since the mid-1950s,
the only two formulations available as of July 2010 that allowed for a single daily
dose regimen (i.e., 12-hour duration of effect) and an early onset were Concerta®
and Focalin®, and both of those formulations required the swallowing of a pill
or capsule. The only liquid formulation available at the time, Methylin® OS, was
an immediate release product with a duration of effect that lasted only three
to four hours.
Court thus concluded that all asserted claims are not
invalid and defendants infringed each of the asserted claims.
On Nov. 30, 2020, Delaware court found composition patent covering
combination invalid as obvious & not infringing.
Background of the
case:
Plaintiffs (Horizon) owns NDA for DUEXIS® (ibuprofen and
famotidine) tablets, 800 mg / 26.6 mg. It is indicated for the relief of signs
and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the
risk of developing upper gastrointestinal ulcers in patients who are taking
ibuprofen for those indications. Defendant (Alkem) submitted ANDA on March 31,
2018 seeking USFDA approval to market generic version. Horizon sued Alkem in district
of Delaware for infringement of OB listed patents, such as U.S. Patent Nos.
8,309,127, 8,318,202, 8,449,910, 8,501,228 & 8,067,033. By trial the
parties narrowed the case to US’033 patent only.
The asserted patent is directed to stable pharmaceutical
compositions of famotidine and ibuprofen separated by way of barrier layer in a
single dosage form. Independent claim 1
is:
1. A pharmaceutical
composition comprising a first portion
that comprises 800 mg ibuprofen and a second
portion that comprises 26.6 mg famotidine, wherein the surface area of
direct physical contact between ibuprofen and famotidine does not exceed 130
mm2 , wherein no more than about 1% sulfamide is present when the
composition is stored at 40° C. and 75% relative humidity for a period of one
month, wherein the composition is formulated so that release of both the
ibuprofen and the famotidine occurs rapidly at about the same time, wherein
none of the composition, the famotidine, and the ibuprofen is enterically
coated or formulated for sustained or delayed release, and wherein the
composition is for use according to a TID (three times per day) administration
schedule for reducing 4 the risk of developing ibuprofen-induced ulcers in a
human patient requiring ibuprofen for an ibuprofen-responsive condition.
It was known that Ibuprofen (NSAID) causes ulceration when
used in the treatment. Therefore search was carried out to prevent this side
effects. Famotidine is a gastroprotectant which helps to reduce this side
effect. But both these two active ingredients are not compatible when used
together. Therefore, plaintiff come with the dosage form where these two actives
are separated, such as tablet in tablet dosage form. By doing this the
interaction between these two actives was avoided, thus reducing the impurity
formation & providing stable product with no or less side effects.
Obviousness:
Defendant argued that asserted claims are invalid as obvious
over certain prior arts. These prior arts disclosed claimed limitations such as
combination of actives, their dose, their interaction & formation of
impurity etc. One of them was US
2007/0043096, where dispute arose to determine whether it is a prior art under
102(a). [US’096 discloses unit dosage
form comprising ibuprofen & famotidine, in amounts suitable for three times
per day administration.] The
priority date of the US’033 patent is Nov. 2007. US’096 application was
published in Feb. 2007. Defendant argued that US’096 is “by another” as it
mentioned different inventors than the US’033. Plaintiff argued that it is not “by
another” because the inventive idea was conceived by same inventors mentioned
on both US’033 patent & US’096 application. Court, however disagreed &
said that claimed limitation regarding stability was not conceived by these
same inventors. It was a work from other inventor & therefore it is a prior
art under 102(a). Other prior arts disclosed other claimed limitations such as
impurity level, rapid dissolution, reduction of risk of ulcer etc. Plaintiff argued that there was not motivation
& reasonable expectation of success in combining these prior arts. But, district
court disagreed & said that POSA would have reasonable expectation of success
in doing so because most of things were
known in the art with rational behind that.
Indefiniteness:
Defendant argued that the “no more than about 1% sulfamide”
limitation is indefinite because scope of the invention in not clear to POSA.
Defendant argued that the ’033 patent does not define “sulfamide,” provides no
chemical name, structure or specific method of testing for “sulfamide,” does
not refer to the USP or Famotidine Impurity C, and does not provide any method
for identifying or quantifying “sulfamide” in a composition. Court, however,
disagreed & said that a POSA would understand “sulfamide” in the “no more
than about 1% sulfamide” limitation in all the asserted claims to be USP
Famotidine Impurity C. US’033 patent
explains that “sulfamide” is “a principal degradant of famotidine formed by the
interaction of famotidine and ibuprofen.” Therefore, “a POSA would have
understood that ‘sulfamide’ in the ’033 patent does not refer to the small
molecule sulfamide, but instead means Famotidine Impurity C in the USP because
it is the only known principal degradant that contains a sulfamide functional
group and that is formed as a result of the acid-catalyzed hydrolysis of
famotidine.”
Infringement:
Plaintiff argued that Alkem’s ANDA Product infringes the
asserted claims under DOE. Court’s construed - “a first portion” as reciting
“an ibuprofen compartment that is not a core” and “a second portion” as
reciting “a famotidine compartment that is not a shell”. Plaintiff applied DOE theory
to more than one claim element — “a first portion” and “a second portion” — at
the same time. Court said that Plaintiff was specifically instructed at trial
to provide legal support for this, which seemingly contradicts applying DOE on
an element-by-element basis, not to the invention as a whole. Court found DOE theory
inapplicable here but still proceeded with the analysis.
Alkem’s ANDA Product is a tablet-in-tablet dosage form with
a barrier-coated ibuprofen (800 mg) core portion and a famotidine (26.6 mg)
shell portion; on the other hand, the claimed composition required a famotidine
(26.6 mg) core and an ibuprofen (800 mg) shell, with an optional barrier layer.
Defendant argued the difference in design is not trivial stating that Alkem’s
ANDA Product is substantially different in at least two important ways –
stability and dissolution. In terms of stability, Alkem contended that the
asserted claims rely on the geometry of the small famotidine core to reduce
and/or minimize “the surface area of the core, or of direct physical contact
between the incompatible active pharmaceutical ingredients.” Moreover, a
barrier layer is optional in claimed invention due to the design of the
invention. This is not the case with defendant’s product. Court said that the inventive aspect of the
’033 patent is a stable pharmaceutical composition of famotidine and ibuprofen
in a single unit dosage form comprising a famotidine core, having a reduced or
minimal surface area, surrounded by a layer of ibuprofen. The specification
repeatedly highlights the increased stability provided by the disclosed
geometry. Unlike the pharmaceutical composition of the asserted claims,
Defendant’s ANDA Product must use a barrier layer and cannot rely on the
geometry of a small famotidine core. Therefore, in regard to stability,
Defendant’s ANDA Product is substantially different as geometry contributes
nothing to stability.
In terms of dissolution, Defendant argued that its ANDA
Product is substantially different from the claims. Defendant argued that when
DUEXIS® (commercial embodiment of the ’033 patent) is exposed to the
dissolution medium, the ibuprofen begins to dissolve from the shell immediately
and the famotidine does not begin to significantly dissolve until the
dissolution medium further penetrates into the core (i.e., about five minutes
later). When Alkem’s ANDA Product is exposed to the dissolution medium, the
famotidine begins to dissolve from the shell immediately and the ibuprofen does
not begin to significantly dissolve until the dissolution medium further
penetrates into the core (i.e., about fifteen minutes later). Court said that,
Defendant’s arguments are not as strong. While there is a discernable difference
in the release of the ibuprofen and famotidine in Defendant’s ANDA Product
occurring about fifteen minutes later than in DUEXIS®, the later release still
meets the claim limitation of “release of both the ibuprofen and the famotidine
occurring rapidly at about the same time” when “at about the same time” is
defined as the ‘033 patent specification defines it: “release of one API begins
before release of the second API is completed.”
Under “Function-Way-Result” test, Court agreed with
Defendant & said that the ’033 patent specification teaches the use of
geometry, with the option of a barrier layer. Moreover, using the design of the
present invention, the barrier layer can be omitted without sacrificing
stability. Under this view of the “function-way-result” test, while the
function and the result may be substantially the same, the way is not. The way
does not use geometry at all. As Alkem’s ANDA Product requires a barrier layer
as a consequence of its geometrical design, it does not infringe under the
“function-way-result” test.
On Nov. 19, 2020, Federal Circuit affirmed judgment of infringement
& damages against Glaxo.
Plaintiff (Vectura Ltd) filed suit in 2016 against defendant
(Glaxo) for alleged infringement of US 8,303,991 patent. The ’991 patent
concerns the production of “composite active particles” for use in pulmonary
administration, such as in dry-powder inhalers. The composite active particles described
in the patent consist of additive material (magnesium stearate) that is adhered
to particles of active ingredient. The additive particles promote the
dispersion and delivery of the active ingredient into the lungs when the
inhaler is activated. The specification discloses “milling method” to produce composite
active particles.
In the district court, Vectura alleged infringement by GSK’s
Ellipta-brand inhalers: the Breo, Anoro, and Incruse devices. Each of the
accused inhalers features one or more “blisters,” which are sealed receptacles
containing a single active ingredient, an excipient, and, optionally, additive
material. The blisters use magnesium stearate as the additive material and
lactose as the excipient. GSK uses multi-step mixing process. GSK first mixes
the lactose excipient with magnesium stearate in the absence of the active
ingredient. After a de-lumping step, GSK then mixes the lactose particles with
the active ingredient. In that step, small particles of the active ingredient
are deposited onto the larger lactose particles.
The issue here is claim construction of two disputed terms:
1) “composite active particles” and 2) “promotes the dispersion of the
composite active particles”.
With respect to first claim construction, GSK’s proposed
construction of that term included a process limitation requiring that the
composite active particles be “formed by milling . . .But district court
rejected that argument & construed the term to mean “[a] single particulate entit[y/ies] made up of a particle of active
material to which one or more particles of additive material are fixed such
that the active and additive particles do not separate in the airstream.” During appeal Glaxo challenged the said
construction & said that the court should have construed that term to
require that the composite particles be produced by the “high energy milling”
process referred to in the specification. GKS argued this based on support in
the specification & based on prosecution history. During prosecution
Vectura said that wet-mixing processes disclosed in prior art were different
from the “aggressive milling procedure” recited in the application. For this
reason, GSK argued, the applicants clearly disclaimed mixing processes other
than high-energy milling, confirming that the term “composite active particles”
should be construed to include a process limitation.
Federal Circuit, however, denied the arguments & said
that although the ’991 patent contains a few statements suggesting that its
high-energy milling is required, those statements are outweighed by the
numerous statements indicating that high-energy milling is merely a
preferred process. Moreover, the fact that the ’991 patent criticizes other
methods is not dispositive. Therefore, the specification of the ’991 patent
does not make its milling method an essential part of apparatus claim 1. With
respect to prosecution response, Federal Circuit said that the statement did
not purport to add a process limitation to the apparatus claim. Instead, that
statement merely sought to demonstrate that Prior art’s coated particles were
necessarily different from the applicants’ coated particles because it used a
process that could not possibly produce “particulate additive matter on the
surface of [a] particle of active material,” as required by the applicants’
claim. Applicant distinguished prior art based on the unique structure of the
claimed composite particles, not the disclosed milling method.
With respect to second claim construction, Parties agreed
that Vectura needed to prove that the use of magnesium stearate in the accused
inhalers improves the dispersion of the active ingredient compared to identical
products in which only the lactose excipient is coated with magnesium stearate.
GSK argued that there was no substantial evidence of infringement as to that
limitation because Vectura staked its case on a defective scientific test (referred
to as “Study 2). Federal Circuit, however, said that the principal flaw in
GSK’s argument is that Vectura did not rely solely on Study 2 to prove that the
accused inhalers satisfy the dispersion limitation. Vectura introduced other
evidence on dispersion as well. Vectura’s witnesses testified that coating
active ingredient particles with magnesium stearate helps overcome the tendency
of the particles to stick together and therefore increases the dispersion of
the particles in the lungs. Evidence of tests conducted on coated and uncoated
active-ingredient particles showed that coating the active particles
substantially increased the dispersion of the active-ingredient particles and
thus the amount of the active ingredient that could be delivered deep into the
lungs. Tests run on GSK’s products showed that the particles of vilanterol and
umeclidinium were consistently associated with magnesium stearate.
Federal Circuit thus affirmed the infringement & also
damages awarded by the Jury.
On Nov. 23, 2020, Federal Circuit affirmed district court & held that Hospira’s ANDA infringes composition limitations.
Background of the
case:
The plaintiffs (Par) own US 9,119,876 and US 9,295,657,
which claim particular compositions containing epinephrine. These patents cover
Par’s marketed product, Adrenalin®. Hospira filed ANDA seeking permission to
manufacture and market a generic version of Par’s Adrenalin®, 1 mg/mL, product.
Par sued Hospira for patent infringement based on ’876 and ’657 patents. District
court found in favor of Par & held Hospira’s ANDA infringing certain
limitations of asserted claims.
The ’876 and ’657 patents share same specification. Claim 1
of the ’876 patent is representative:
1. A composition comprising:
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or
salts thereof, in the range of about 6 to 8 mg/mL of a tonicity regulating
agent, in the range of about 2.8 to 3.8 mg/mL of a pH raising agent, in
the range of about 0.1 to 1.1 mg/mL of an antioxidant, in the range of about
0.001 to 0.010 mL/mL of a pH lowering agent, and in the range of about
0.01 to 0.4 mg/mL of a transition metal complexing agent, wherein the
antioxidant comprises sodium bisulfite and/or sodium metabisulfite.
Relevant here, the issues related to limitations of tonicity
agent, pH lowering agent & transition metal complexing agent.
Federal Circuit
analysis:
With respect to “about 6 to 8 mg/mL of a tonicity
regulating agent” limitation, Hospira argued that its ANDA contains concentration
of 9 mg/mL of sodium chloride & thus not falling into the claim limitation.
However, during claim construction parties agreed in the district court that
the term “about” had its “plain and ordinary meaning; i.e., approximately.” Hospira
did not propose any further narrowing construction. Federal Circuit said that the evidence
supported a finding that “about 8” encompasses 9, considering the purpose of
the upper limit. The court credited Dr. Elder’s testimony on this point, which
focused on the technological facts, the importance of the purpose of the
limitation, and the limitation’s noncriticality. Dr. Elder explained the
purpose of both ends of the claim range—to avoid hypertonicity of the solution
(which would lead to cell shrinkage) and to avoid hypotonicity of the solution
(which would lead to cell swelling) and thereby achieve isotonicity, which is
the stated goal of Hospira’s inclusion of sodium chloride. And he explained why
it was clear that a “physiologically acceptable” concentration would include
concentrations as high as 9 mg/mL, there being nothing critical to the exact
numbers in the claimed range given the purposes of the upper and lower limits.
Thus, Federal Circuit find no clear error with the district court’s finding on
this matter.
With respect to “about 0.01 to 0.4 mg/mL of a transition
metal complexing agent” limitation, Hospira argued that district court’s analysis
should have focused entirely on the characteristics of the composition that
Hospira was likely to sell, not on what compositions the ANDA, if approved,
would allow Hospira to market. Federal Circuit disagreed & said that the
district court did not commit clear error in finding that citric acid acts as a
transition metal complexing agent in Hospira’s ANDA product. Hospira
represented to the FDA that its citric acid buffer has a “chelating effect”
allowing it to complex with transition metals. Moreover, Hospira’s experts
acknowledged at trial that citric acid has “chelating properties” and therefore
could bind with elemental impurities in its product. As it is a Hatch-Waxman suit, statements made
in the ANDA to gain approval can be used to find infringement. And if ANDA is
silent on those statements then it is the product that the generic company is
likely to sell that guides the infringement analysis. But, here, Hospira made
these statements & thus it is the ANDA that governs infringement analysis
& not the product which would likely to sell.
With respect to “about 0.001 to 0.010 mL/mL of a pH
lowering agent” limitation, Hospira argued that the trial court improperly
accepted Par’s counting not just hydrochloric acid but also citric acid as a pH
lowering agent. Hospira contends that citric acid—specifically, the citric acid
that remains after subtracting the amount that serves as a transition metal
complexing agent—cannot be a pH lowering agent because it is already included
in the buffer system that counts toward meeting the claim limitation requiring
a certain amount of pH raising agent. Federal Circuit however said that Hospira
has not made and preserved a claim-construction argument that, an acid, i.e., a
pH lowering agent, cannot also be part of an agent that overall serves to raise
pH. Indeed, the passages of the specification of the ’876 and ’657 patents that
discuss a “buffer system” made up of an acid and a base, at least strongly
suggest the opposite. Federal circuit thus rejected Hospira’s argument that
citric acid molecules must be allocated between the pH raising agent limitation
and the pH lower agent limitation.
On Nov. 05, 2020 Federal Circuit affirmed-in-part district court’s interpretation of proper venue in Hatch-Waxman cases.
Mylan (Mylan Pharmaceuticals Inc. (MPI)/ Mylan Laboratories
Ltd.(MLL)/ Mylan Inc.) in Jun.2018 filed ANDA with USFDA to market generic version of Jublia®. Plaintiff
(Valeant pharma / Dow pharma) on Sep 26, 2018 filed suit in New Jersey district
court. The next day, Valeant filed an essentially identical protective suit
against Mylan in the Northern District of West Virginia. In Jan. 2019, Mylan
moved to dismiss Valeant’s New Jersey District Court complaint against MPI and
Mylan Inc. for improper venue pursuant to Federal Rule of Civil Procedure
12(b)(3). Mylan argued that
venue was improper under § 1400(b) because no Mylan defendant resides in New
Jersey, the only alleged act of infringement—submission of the ANDA—did not
occur in New Jersey, and the Mylan defendants do not have regular and
established places of business in New Jersey. In response, Valeant argued that
it is unduly narrow to limit “an act of infringement” under § 1400(b) to the
act of submitting the ANDA. Valeant contended that “the Court must consider
Mylan’s planned, future acts.” In August 2019, the district court granted
Mylan’s motion to dismiss the complaint against all defendants based on
improper venue. Valeant appealed.
Federal
Circuit said that under Hatch-Waxman cases, it is an act of infringement
to submit an ANDA (artificial infringement). Federal Circuit further said that the
question in this appeal, therefore, is whether the act of infringement
identified in § 1400(b) occurs only when and where an ANDA-filer submits its
ANDA to the FDA or occurs wherever future distribution of the generic is
contemplated. Court said that they are bound by the decision of Supreme Court in
“TC Heartland”. Court said that both parties agreed that § 1400(b) requires a
past act of infringement. Specifically,
“has committed acts of infringement,” a present perfect phrase, counsels
that the acts accused of infringement must have already occurred. However, in Hatch-Waxman cases no actual infringement
occurs. Therefore, it is the submission of the ANDA, and only the submission,
that constitutes an act of infringement in this context. Since, MPI has not submitted ANDA from New
Jersey, it not a proper venue for this case. Proper venue would be West
Virginia from where MPI submitted an ANDA, as district court correctly found.
Distribution of product in future has no relevance here. Therefore, it does not
matter if future sell would occur in New Jersey. Venue is proper only in those
districts that are sufficiently related to the ANDA submission—in those
districts where acts occurred that would suffice to categorize those taking
them as a “submitter” under § 271(e).
Federal Circuit reversed with respect to the entity, MLL. Court
said that as this is a foreign entity, it is subject to venue in any judicial
district, including the District of New Jersey. Whether MLL can be held
answerable to claims of infringement in this case turns on whether MLL’s
involvement in the submission of the ANDA is sufficient for it to be considered
a “submitter,” and thus, amenable to suit. The district court’s conclusion
dismissing the complaint as to all defendants after only evaluating Mylan’s
venue argument is, therefore, incongruous. Federal Circuit, thus, reversed the
district court’s venue-based dismissal of MLL and remanded for further
consideration.
Brief background of the case is like this. Plaintiff, Astrazeneca filed suit against number of generic companies for launching generic dapagliflozin (DAPA) product in India. Two patents-in-suit are IN 205147 (Genus patent - expired on Oct 02, 2020) & IN 235625 (specific patent – expires on May 15, 2023). Defendants filed counterclaim alleging invalidity of IN’625 patent based on IN’147 patent. Astrazeneca then asked for interim injunction. Both Plaintiff & Defendants (Alkem & Intas) filed their respective briefs.
Court said that the issue at this stage of preliminary
injunction is whether defendants have raised a credible challenge to IN 625? Actual
validity issued would be tried at trial stage. The challenge to the species
patent i.e. IN 625 is, broadly, laid on the grounds such as lack of novelty in
view of prior claiming, lack of novelty due to
prior publication, lack of inventive step, failure of the plaintiffs to make
full and fair disclosure as required under Section 8 of the Act. Court said
that the fact that both in the pleadings and in the documents, there is a
definitive assertion that DAPA is covered in the genus patents granted in India.
Plaintiff said that DAPA is covered but it is not disclosed in genus patent. Plaintiff
further argued that coverage does not necessarily include disclosure which is
founded on the Markush claim/group. But court said that the fact that the
plaintiffs have taken out an infringement action both for IN 147 and IN 625 is
a sufficient clue, at least at this juncture, that DAPA is claimed in both suit
patents. Therefore, the defendants submission
that IN 625 should be revoked on account of prior claiming under the provisions
of Section 64(1)(a) of the Act has substance, at least at this stage.
With respect to anticipated by what was published or
publicly known, court said that while counsel for the defendants, based on the
affidavit of Mr. Martin, did try to convey that a person skilled in the art
could iterate the claims and arrive at 8 molecules based on prior publication
and not hindsight, this is an aspect which would be required to be tested in a
trial. Therefore, on this score, the defendants' defence, at this stage, in my
opinion, does not inject vulnerability.
With respect to inventive step, court said that there is no
clue in IN 625 of an unknown technical effect on its priority date. Plaintiff tried to persuade the court with post filing
evidences. But court said that post priority date evidence can only be taken
into account to confirm the existence of technical effect which is found
embedded in the specification of IN 625 and is capable of being understood by a
skilled person having common general knowledge and not to rely upon the same to
establish its effect for the first time. The plaintiffs have not been able to
demonstrate, at least at this stage, the existence of such technical effect in
the specifications.
With respect to Section 8 requirement, court said that in
the instant actions, specific details were sought by the Indian Patent Office
concerning search and examination report. What was submitted by the plaintiffs
to the Indian Patent Office via the letter dated 10.01.2005 were the corresponding
US patents and not the examination reports. It is also not denied by the plaintiffs
that their response of 19.08.2002, whereby, the validity period of US 117 was
voluntarily aligned with the US genus patent i.e. US 126 was not placed before
the Indian Patent Office. The submission advanced on behalf of the plaintiffs
that the terminal disclaimer is an obviation and not an admission of
obviousness is not an answer to the provisions of Section 8(2) of the Act which
is mandatory.
With respect to other injunctive factors such as balance of
convenience, irreparable harm & public interest, court found these in favor
of defendants. Court thus denied injunction but asked defendants to place on record
the details, quantum, and value of drug manufactured and sold. The defendants
via their affidavits will also undertake to pay damages as and when called upon
to do so by the Court.
SPCs and orphan drugs-- is the double layer getting messy or is it just a matter of timing? A new ruling of the District Court in the Hague to shed some light?
The ruling of the District Court in the Hague in the case C/09/595262 KG ZA 20-605 concerns the pharmaceutical Exjade (generic substance deferasirox), protected both by a patent and subsequently a Supplementary Protection Certificate as well by an Orphan Drug Designation. Novartis sued Mylan for infringement of the SPC (under the term of its Paediatric Extension) on Exjade; Mylan countersued alleging the invalidity of the Paediatric Extension. The specific ruling concerns preliminary relief proceedings...
https://ipkitten.blogspot.com/2020/10/spcs-and-orphan-drugs-is-double-layer.html
Menzis Zorgverzekeraar N.V. and AnderZorg N.V. v. AstraZeneca B.V. and AstraZeneca AB, District Court The Hague 14 October 2020, Case no. C/09/541261 / HA-ZA 17-1084
On the 14th of October 2020 the Dutch District Court of The Hague has issued a noteworthy and ground breaking interlocutory judgment in the case of health insurance company Menzis against the pharmaceutical company AstraZeneca. Menzis is set to be rewarded compensatory damages due to the unjust enrichment of AstraZeneca and their role in the lack of price competition for their medicine Seroquel XR...
http://eplaw.org/nl-menzis-et-al-v-astrazeneca-et-al/
Vaccine formulation patent invalid for obviousness and not infringed (Patents Court)
In Merck Sharp & Dohme Ltd v Wyeth LLC [2020] EWHC 2636 (Pat), the Patents Court has held that a patent for a formulation of vaccines which avoided aggregation caused by silicone in the container material was invalid for obviousness...
Central government publishes The Patents (Amendment) Rules, 2020.
In exercise of the powers conferred by section 159 of the Patents Act, 1970, the Central Government has further revised the Patents Rules, 2003 and these rules would be called the Patents (Amendment) Rules, 2020. The Rules have been amended particularly with regard to the requirements relating to working statements/ form-27. Some important changes are as follows:-
Only ‘Disclosed’ if ‘Identified’: IPAB Quashes Ceritinib Patent Revocation
An IPAB bench consisting of Chairman Manmohan Singh J. and the new technical member for Patents Dr. B.P. Singh has quashed the Controller of Patent’s decision that revoked Novartis’s patent on the anti-cancer drug Ceritinib. It held that while the compound was contained in a broader genus patent, it was not ‘disclosed’ therein, as it hadn’t been specifically identified. The 104-page order examines several issues regarding novelty and obviousness, the extent of coverage and disclosure, and timelines for filing of evidence..
China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with regard to pharmaceuticals in the world’s fastest growing consumer market. As we reported here, the most significant change for life science companies is adoption of Hatch-Waxman-like incentives to encourage companies to develop and seek approval in China of new, innovative drug products, and to encourage generic companies to challenge reference product patents…
Claim Construction (District of Delaware): Oct. 20, 2020
Civil Action No.:
19-cv-78 -RGA
Plaintiff: Genentech,
Inc. et al.
Defendants: Aurobindo
Pharma Limited, et al.
Court issued claim construction of a single term in US 7,566,729,
US 7,635,707 and US 8,592,462. The Court heard oral argument on September 23,
2020. Plaintiffs Genentech and InterMune brought cases against Defendants, alleging
Hatch-Waxman Act patent infringement. The cases have been consolidated.
Defendants argued that the term “Grade 2 abnormality in one or more biomarkers
of liver function” as recited in various asserted claims of the three patents
should be construed as indefinite.
CONSTRUCTION OF TERM:
“Grade 2
abnormality in one or more biomarkers of liver function”
Plaintiffs’ proposed
construction: A value obtained from a blood chemistry test of abnormal
liver function that meets the grading criteria for a ‘Grade 2 adverse effect’
set forth in the Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
published Aug. 9, 2006 by the National Cancer Institute, as also presented in
Table 1 of each of the ’729, ’707, and ’462 patents, and incorporated by
reference therein.
Defendants’ proposed
construction: The term is indefinite.
Court’s construction:
The term is not indefinite. Plaintiffs’ proposed construction is adopted.
Plaintiffs argued that “one or more biomarkers of liver
function” is defined in the specification as the five biomarkers alanine
transaminase (ALT), aspartate transaminase (AST), bilirubin, alkaline
phosphatase (ALP), and gamma-glutamyltransferase (GGT). Plaintiffs contended
that the specification consistently identifies “Grade 2 abnormalities” with
respect only to these five biomarkers, which are listed in Table 1. Defendants
contended that a person of ordinary skill in the art (POSITA) would be unable
to determine which liver function tests are in fact “biomarkers of liver
function.” Defendants pointed to several instances in the specification where,
they argued, “biomarkers of liver function” is not clearly defined. For
example, defendants note an instance in the specification which states,
“Examples of biomarkers of liver function include, but are not limited to” ALT,
AST, bilirubin, ALP, and GGT. Defendants have also identified other tests that
can be used to assess liver function, but which are not mentioned in the
specification.
Court, however, agreed with Plaintiff and said that the
disputed claim term can be construed with reasonable certainty. Court said that
the specifications of all three patents use the term “biomarkers of liver
function” to refer to the five tests—ALT, AST, bilirubin, ALP, and GGT—on a basis
sufficient to inform a POSITA as to the scope of the term. All three patents contain two tables which
only list the toxicity criteria for the five tests, ALT, AST, bilirubin, ALP,
and GGT. The patent claims require a “Grade 2 abnormality” and only the five
tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of the requisite
elevation levels that would constitute such a “Grade 2 abnormality.” Consequently,
a POSITA seeking to understand the term “Grade 2 abnormality in one or more
biomarkers of liver function” would look to the specification and find that
only the five tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of a
“Grade 2 abnormality.” As a result, a POSITA would be able to determine with
“reasonable certainty” which tests constitute “biomarkers of liver function.”
IPR decision: Oct. 05, 2020
|
AIA Review # |
Filing Date |
Institution Date |
Petitioner |
Patent |
Respondent |
Final Written
Decision |
|
IPR2016-01479 |
07/22/2016 |
02/15/2017 |
Par Pharmaceutical,
Inc*. |
9,006,224 |
Novartis AG |
Challenged claims patentable |
*This proceeding as
initially filed named Par Pharmaceutical, Inc. as the sole Petitioner. Argentum
Pharmaceutical LLC was joined as a party to this proceeding via a Motion for
Joinder in IPR2017-01063; West-Ward Pharmaceuticals International Limited was joined
as a party via a Motion for Joinder in IPR2017-01078. Subsequently, Par and
West-Ward separately requested termination of their participation in the
proceeding pursuant to settlement. Argentum Pharmaceutical LLC is the sole
remaining Petitioner.
US 9,006,224 (Novartis AG; Exp: 07/01/2028)
1. A method for treating pancreatic neuroendocrine tumors,
comprising administering to a human subject in need thereof a therapeutically
effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein
the tumors are advanced tumors after failure of cytotoxic chemotherapy.
On Oct 02, 2020, Federal Circuit vacated district court’s
grant of JMOL and reinstated the jury verdicts of infringement and damages.
Background of the
case:
Glaxo owns US 5,760,069 patent which claims treatment with a
combination of carvedilol and one or more of an angiotensin-converting enzyme
(“ACE”) inhibitor, a diuretic, and digoxin. GSK on Nov. 25, 2003 filed reissue
application for ’069 patent, which ultimately issued as US RE40,000 on Jan. 8,
2008. This patent expired on June 7, 2015. Glaxo own another patent, US 4,503,067
which claims carvedilol and related compounds. This patent expired on March 5,
2007. Both these patents were listed in Orange Book (OB) for drug, Coreg®.
USFDA initially approved carvedilol in Sep 1995. In May 1997, the FDA approved
carvedilol for the additional treatment of congestive heart failure. In March
2002, Teva filed ANDA with PIII certification to US’067 patent & P-IV
certification to US’069 patent. Glaxo did not sue Teva based on any of OB
listed patents. Teva received FDA “tentative approval” for its ANDA in 2004. Teva,
on June 9, 2004, issued a press release to this effect mentioning among other
things that its product is “AB rated” to Coreg®. On expiration of the ’067
patent in 2007, Teva launched its generic carvedilol tablet. Teva’s label dated
“8/2007” mentioned 2 indications:
1. Left Ventricular Dysfunction following Myocardial
Infarction(MILVD)…
2. Hypertension…
Before this final approval, Teva carved out third indication
ie. Congestive Heart Failure. Thus, in September 2007, when the FDA finally
approved Teva’s ANDA as an AB-rated version of GSK’s Coreg®, Teva’s skinny
label was only indicated for hypertension and post-MI LVD—neither of which was
covered by any patent.
Both Teva and the FDA announced the approval of generic
carvedilol with a press release. Teva also announced that it would immediately
begin shipping its product but did not suggest that its product should be used
to treat CHF. In 2011 the FDA required Teva to amend its carvedilol label to include
CHF indication. Teva, thus, amended its label to include the indication for
treatment of heart failure, as required by the FDA. On July 3, 2014, GSK filed
suit for induced infringement of the RE’000 patent. Jury trial was initiated. Teva
presented the defenses of patent invalidity and non-infringement. Teva argued
that since it had omitted (“carved out”) CHF indication from its initial 2007
label till Apr. 2011 (Skinny period) Teva could not be
found to induce prescribing physicians to infringe the ’000 patent. Teva also argued
that it could not be found to induce prescribing physicians to infringe the
’000 patent between May 2011 (when it amended label to include CHF) to June
2015 when patent expired (full label period).
The jury found that Teva induced infringement of claims 1–3
during the period starting January 8, 2008 to April 30, 2011 (Skinny period); and that Teva induced
infringement of claims 1–3 and 6–9 during the amended label period starting May
1, 2011 and ending June 7, 2015 (full
label period). The jury assessed damages based on a combination of lost
profits and royalty, and found that the infringement was willful. The district
court granted Teva’s motion for JMOL (judgment as matter of law), stating
that the verdict of induced infringement was not supported by substantial
evidence because “GSK failed to prove by a preponderance of the evidence
that ‘Teva’s alleged inducement. The district court explained that: “Without
proof of causation, which is an essential element of GSK’s action, a finding of
inducement cannot stand.” The court stated that “even in Sep. 2007, when
generic companies (including Teva) began selling carvedilol, doctors relied on
guidelines and research, as well as their own experience, in addition to GSK
marketing.” Therefore, a reasonable fact-finder could only have found that these
alternative, non-Teva factors were what caused the doctors to prescribe generic
carvedilol for an infringing use & not Teva. GSK appealed.
Federal Circuit
analysis:
Glaxo argued that Teva’s marketing of carvedilol with
knowledge and intent of its infringing use, and promotion of its generic
product as the same as Coreg®, meet the legal requirements of active inducement
of infringement. Teva responds that the
district court correctly ruled that Teva could not be liable for inducing
infringement, because cardiologists already knew of carvedilol and its uses,
and Teva did not directly “cause” them to infringe. Federal Circuit said that there
was substantial evidence to support the jury’s verdict of inducement to
infringe the ’000 patent. The jury received evidence that Teva’s promotional
materials referred to Teva’s carvedilol tablets as “AB rated” equivalents of
the Coreg® tablets. This means Teva’s product can be substituted for Coreg®
& since, Coreg is approved for CHF indication, Teva’s label would induce
physician to prescribe for CHF indication. GSK’s witness, Dr. McCullough,
testified that doctors are “completely reliant” on information provided by the
generic producers, and that doctors receive Teva’s product catalogs, visit its
website, and read its product guides. Dr. McCullough told the jury that the
press release of Teva “indicates that we should be able to prescribe generic
carvedilol for heart failure”. Dr. McCullough testified that Teva’s Spring 2008
catalog lists Teva’s carvedilol tablets next to Coreg® tablets and uses the
phrase “AB rating,” and that this would lead a doctor to believe that “they’re
therapeutically interchangeable.”
There was ample record evidence of promotional materials,
press releases, product catalogs, the FDA labels, and testimony of witnesses
from both sides, to support the jury verdict of inducement to infringe the
designated claims for the period of the ’000 reissue patent. The district
court, thus, applied an incorrect legal standard for granting JMOL to Teva.
Federal Circuit, therefore, reversed the grant of JMOL & remanded for entry
of judgment on the verdict.
Dissent form Chief Judge
Prost:
Judge Prost said that this case is about whether Teva
induced infringement of GSK’s reissue patent, RE40,000, by marketing its
generic carvedilol of for unpatented uses through a “skinny label” & “full
label” period.
With respect to skinny label, Judge Prost said that Congress
provided for skinny labels for exactly these circumstances, such that the lone
method covered in the ’000 patent would not foreclose access to more affordable
carvedilol. Here, the Majority undermines Congress’s provision for skinny
labels by substantially nullifying section viii. Teva in this acted exactly as
Congress intended. Teva waited until GSK’s patent covering the carvedilol
compound expired to launch its product covering two unpatented
indications—hypertension and post-MI LVD. So, when GSK’s ’000 reissue patent
later issued—reciting a narrow method of treating a third indication,
CHF—Teva’s skinny label did not even suggest using its product according to the
patented method. In marketing its generic carvedilol, Teva never stated that it
was approved, or could be used, to treat CHF. Moreover, the parties agreed that
when Teva launched, its skinny label did not instruct doctors to prescribe
generic carvedilol to treat CHF. Also, GSK failed to present evidence showing
that doctors relied on the label in making prescribing decisions. District
court was right when it granted JMOL in favour of Teva a because “neither
sufficient nor substantial evidence supports the jury’s finding of inducement.”
With respect to full label, Judge Prost said that at the
FDA’s direction, Teva amended its label years later to include the patented
method, but there was still no inducement via the full label. Nothing changed
in the market, and doctors’ prescribing decisions were not affected. GSK failed
to prove causation during the full label period. No evidence suggests that any
affirmative act by Teva actually caused doctors to directly infringe the
patented method. Specifically, no evidence suggests that doctors relied on
Teva’s full label in making their prescribing decisions. The record also
demonstrated that many generic carvedilol sales occurred without the doctors’
knowledge at all. In sum, to the extent the doctors prescribed generic
carvedilol to treat patients according to the claimed method, no evidence shows
that they did so because of any action taken by Teva. The district court’s JMOL
of noninfringement during the full label period should therefore be affirmed.
Judge Post further said…”Teva did everything right—using a
skinny label, taking care not to encourage infringing uses—and yet, given
today’s result, it was ultimately more costly for Teva to sell an unpatented
drug for unpatented uses than it would have been to stay out of the market
altogether: Teva only sold $74 million worth of carvedilol during the allegedly
infringing period (mostly for unpatented uses) but now owes $234 million in
damages for sales made for a single indication. This irony reflects the fact
that Teva’s product was dramatically less expensive—costing less than 4 cents
per pill as compared with Coreg®’s price of at least $1.50 per pill. Teva
should not be liable for inducement”.
On Sep 29, 2020, Intellectual Property Appellate Board
(IPAB) set aside the order of Learned Controller finding compound patent
invalid.
Brief background of the case is like this. Appellant, Novartis
filed patent application - IN 3951/DELNP/2009 on Jun. 16, 2009. This
application claims compound, Ceritinib as tyrosine kinase receptor inhibitor.
This application was granted as IN 276062 on Sep 28, 2016. Post grant
opposition was filed by Natco Ltd. on Sep 26, 2017. Patentee & opponent
then filed their respective written submissions. Hearing was rescheduled few times &
finally it was held on Apr. 09-10, 2019. During this period additional documents
were also filed after the announcement of date of hearing. Parties filed post
hearing submissions & on Aug. 16, 2019, the Learned Controller by its order
revoked the patent under lack of novelty, inventive step, section 3(d) &
lack of sufficiency.
Appellant filed appeal to IPAB on violation of principle of
natural justice. IPAB came heavily on the reasoning of Learned Controller &
found that Learned Controller did not follow the proper procedure of law. IPAB said
that the Learned Controller disregarded the recommendation of the Opposition
Board which found patent valid. Second, the Learned Controller considered the
evidence filed by the Opponent in relation to patent term extension and orange
book listing but has disregarded the rebuttal evidence filed by the Appellant.
Third, the Learned Controller has failed to consider the arguments on novelty
given by the Appellant and has also failed to rely upon the expert affidavit
submitted along with it.
With respect to novelty, IPAB said that the entire finding
of invalidity is based without any prior art cited which discloses or
exemplifies Ceritinib, the compound subject matter of IN 276026. The Controller
has engaged in prohibited act of “cherry picking” of the constituents,
substituents, their arrangement, their positioning, their linkage and interplay
from the subject patent IN 276026 and tried to locate them in the vast pool of
possible substituents contained in markush claims of prior art citations. It is
also settled practice that in order to demonstrate lack of novelty, the
anticipatory disclosure must be entirely contained within a single document. However,
if a cited document refers to a disclosure in another document in such a way as
to indicate that, that disclosure is intended to be included in that of the
cited document, then the two are read together as though they were a single
document. Here, Learned Controller took help of two cited prior arts to attack
“novelty’ of the subject patent by picking suitable equivalent substitutions,
keeping inventive structure of the subject patent IN’026 in sight.
IPAB also said that the opposition was filed by M/s Natco
Pharma Limited on 26/09/2017. At the time of filing of opposition, opponent
paid fees as a natural person. So, filing the opposition by a legal entity and
paying the prescribed fee of filing opposition with the fee which is applicable
to natural person (INR 2400) is not justifiable. If the balance fee of (INR
9600) was paid on 08/11/2017 – a date much later than the last date of filing
opposition, the opposition was not maintainable as per the provisions of the
Patents Act and the Rules made there under. The post-grant opposition was not
maintainable ab initio for lack of filing
proper prescribed fee.
IPAB finally found that the impugned order is void of merit & thus set aside the order.
On Sep 29, 2020, Intellectual Property Appellate Board (IPAB) set aside the order of Learned Controller finding compound patent invalid.
Brief background of the case is like this. Appellant,
Pharmacyclics Inc. filed patent application - IN 1642/DELNP/2009 on Mar. 12,
2009. This application claims compound, Ibrutinib as Bruton Tyrosine Kinase
inhibitor. This application was granted as IN 262968 on Oct 03, 2014. Post
grant opposition was filed by Laurus labs on Sep. 24, 2015. Patentee &
opponent then filed their respective written submissions. Hearing was rescheduled few times &
finally it was held on Nov 22, 2019. During this period additional documents were also filed after the announcement
of date of hearing. Parties filed post hearing submissions & on Mar 04,
2020, the Learned Controller by its order revoked the patent under lack of
inventive step.
Appellant filed appeal to IPAB on many grounds under
procedural & technical aspects. IPAB come heavily on these two aspects
& found that Learned Controller did not follow the proper procedure of law.
IPAB citing the judgment of High Court (W.P.(C) No. 12105/2019; decided on 20/11/2019)
provided important pointers while dealing with the post grant opposition.
Let’s see the IPAB findings in summary:
Technical aspects (Inventive step)
1. The prior arts should be analogus to the claimed invention.
[The prior art relied upon by the opponent pertains to LCK inhibitors, whereas, the invention pertains to BTK inhibitors.]
2. Reasoning of substitution of one group by another group should be justified properly.
[Here, IPAB said that Learned Controller made not only legal error but also scientific errors when deciding the issue of inventive step which is neither based on the arguments of the Appellant/Respondent, written submissions or the evidence filed by their experts.]
3. There should be proper motivation to combine the references.
[IPAB said that Motivation to attach a Michael acceptor from prior art to hypothetical compound has not even referred in the impugned order.]
4. There should not be any hindsight analysis in inventive step inquiry.
[IPAB said that the substitutions are somehow
trying to trace back to the invention by keeping the invention in forefront and
it amounts to “hindsight analysis”.]
Procedural aspects:
1. Trend of filing additional evidences under Rule 60 after the hearing being fixed by the Controller or place documents having evidentiary value in guise of “publication” under Rule 62(4).
[IPAB said that these actions do not find proper basis in the Rules and need to be addressed so as to smoothen the process of post–grant oppositions and reduced the timelines being consumed unduly. It should be ensured that the provisions of Rules 60 and 62 should be followed strictly.]
2. Learned Controller should provide reasons for his findings.
[IPAB said that it is well within his powers as provided in the law to disagree with the opinion of the opposition Board, but while he disagreed on this ground should have annotated the reasons thereof properly.]
3. Inventive step is mixed question of law & facts.
[Here, Learned Controller ignored the legal aspects from the determination of the “inventive step” & focused only on factual aspects.]
4. There is no concept of “ordinary” person skilled in the art in the Indian Patent Act, 1970.
[IPAB said that the determination of
“inventive step” as envisaged in the Patents Act under section 2(1)(ja) clearly
stipulates “person skilled in the art” & not “ordinary” person skilled in
the art. Therefore, inquiry should be made in view of the person skilled in the
art when dealing with inventive step attack.]
IPAB, therefore, set aside the impugned order of the Learned Controller.
