Genetic
Technologies Limited v. Merial L.L.C., et al., Nos. 15-1202;-1203 (Fed. Cir.,
Apr. 8, 2016).
The
following claim to a method for detection of at least one coding region allele was held to be drawn to non-patent eligible
subject matter under Section 101 since the correlation between variations in
the non-coding regions and allele presence in the coding regions are a
consequence of the naturally occurring linkages in the DNA sequence:
1.
A method for detection of at least one coding region allele of a multi-allelic
genetic locus comprising:
a)
amplifying genomic DNA with a primer pair that spans a non-coding region
sequence, said primer pair defining a DNA sequence which is in genetic linkage
with said genetic locus and contains a sufficient number of non-coding region
sequence nucleotides to produce an amplified DNA sequence characteristic of said
allele; and
b)
analyzing the amplified DNA sequence to detect the allele.
The
claim also did not pass step two of the Mayo/Alice analysis since
it performed no more than well-understood, routine, conventional activity, i.e., “amplifying genomic DNA with a
primer pair” and “analyzing the amplified DNA sequence to detect the allele.”
The
Federal Circuit also emphasized that is has “repeatedly recognized that in many
cases it is possible and proper to determine patent eligibility under 35 U.S.C.
§ 101 on a Rule 12(b)(6) motion. . . . In many cases, too, evaluation of a
patent claim’s subject matter eligibility under §101 can proceed even before a
formal claim construction.”
Intendis
GmbH v. Glenmark Pharmaceuticals Inc., USA, No. 2015-1902 (Fed. Cir. May 16,
2016).
To
avoid infringement of the following claim, Glenmark changed its formulation by
substituting isopropyl myristate for lecithin and triglyceride:
1.
A composition that comprises:
(i)
azelaic acid as a therapeutically active
ingredient
in a concentration of 5 to 20%
by
weight,
(iii)
at least one [triglyceride]
in a concentration
of
0.5 to 5% by weight,
(iv)
propylene glycol, and
(v)
at least one polysorbate, in an aqueous
phase
that further comprises water and
salts,
and the composition further comprises
(ii)
at least one polyacrylic acid, and
(vi) lecithin, wherein the composition is in
the form of a hydrogel.
Glenmark then stated in its
filing to the FDA that “[i]sopropyl myristate was selected as [a] penetration
enhancer instead of lecithin and medium chain triglyceride” under the heading
“Selection of penetration enhancer.”
Glenmark’s statement to the FDA was used to find that Glenmark infringed
the claims of the patent under the doctrine of equivalents.
To
determine whether the scope of equivalents covered the prior art (which is impremissble),
the district court constructed a hypothetical claim that literally covered
Glenmark’s formulation. The district
court determined that a proper hypothetical claim included the claimed excipients
and Glenmark’s excipient, namely, the hypothetical claim includes isopropyl
myristate as an alternative to the claimed triglyceride and lecithin. Glenmark argued that a proper hypothetical
claim should have included any penetration enhancer. The Federal Circuit disagreed with Glenmark,
stating that the district court “correctly rejected as too broad Glenmark’s
proposed hypothetical claim which would cover all penetration enhancers. The district
court’s infringement finding was that the excipient in Glenmark’s product
(isopropyl myristate) was equivalent to the claimed excipients (lecithin and
triglycerides); it was not a finding that any penetration enhancer would be
equivalent to the claimed excipients.”
The
Federal Circuit also held that an amendment to the claims during prosecution did
not result in prosecution history estoppel.
During prosecution, the examiner noted that two dependent claims, which recited
a lecithin “concentration of up to 1%” and “concentration of up to 3%,”
respectively, could include zero lecithin. Applicant amended the two dependent
claims to recite a lecithin “concentration of from more than 0 to 1%” and “concentration
of from more than 0 to 3%,” respectively, noting that they were “amended to
expressly state what has already been made clear on the record.” The Federal
Circuit agreed with the district court that the amendments were for
clarification purposes, and “not to disclaim formulations with zero lecithin.”
Warner
Chilcott Co., LLC v. Teva Pharms. USA, Inc., 2015-1588, 2016 U.S. App. LEXIS
4945 (Fed. Cir. March 18, 2016)
The patent in this case claimed a risedronate
dosage form having EDTA (which binds
calcium ions, thus blocking
calcium–risedronate complex) to sufficiently reduce
or negate the food effect (fed/fasted absorption rates):
An
oral dosage form having pharmaceutically
effective
absorption comprising:
(a)
[about 35 mg] of risedronate sodium;
(b)
[about 100 mg] of disodium EDTA; and
(c)
an enteric coating [that is a methacrylic
acid
copolymer] which provides for release
of
the risedronate sodium and the
disodium
EDTA in the lower gastrointestinal
tract of a mammal.
The Federal Circuit held that it
would be obvious “to use a chelating agent to bind calcium
ions to mitigate the food effect for risedronate and thereby achieve similar
fed/fasted absorption.” The Federal
Circuit also stated that the specific claimed dosage for EDTA did not make the
claim non-obvious: “In view of the broad disclosures in the specification
providing embodiments with varying amounts of EDTA, and nothing in the asserted
claims teaching one of skill in the art that or how only the specific 100 mg
amount produces pharmaceutically effective absorption, Warner Chilcott failed to
show the criticality of the claimed amount [of EDTA].”
Merck
& Cie v. Watson Laboratories, Inc., Nos. 15-2063, -2064
(Fed. Cir. May 13, 2016)
The
Federal Circuit held that the following fax from Merck to a buyer in response
to a buyer’s request qualifies as an offer for sale, and invalidates Merck’s
patent to a folate [MTHF] based on the on-sale bar:
[W]e
would like to handle your purchase of [MTHF] very simpl[y]. Therefore please
send the order to my attention and I will arrange everything. In addition we need
the exact delivery address/person. The price is 25,000 US$ per kg [of MTHF]
free delivered to your R&D center in the U.S. Payment terms are 60 days
net. With Rick Blair and Richard Bizzaro we discussed a purchase of 2 kg [of MTHF].
If you need more, we have no problem for an immediate[] delivery. After
receiving your order you will get the official confirmation of the order.
The fax qualified as a commercial
offer to sell MTHF notwithstanding the fact that it did not invite the buyer to
accept that offer by signing the fax and returning it to Merck.
Merck
failed to establish that any “industry standard” terms were missing from the
fax, such as safety and apportionment of liability provisions. Merck did not contend that it offered to
supply the buyer with MTHF for experimental purposes, which would have precluded
a finding of on-sale bar. Lastly, the
on-sale bar was not precluded by the confidentiality agreement between the
parties since “[n]othing in the Confidentiality Agreement suggests that an offer
is valid only if it is signed by both parties. “
Amgen
Inc. v. Apotex Inc.,
No. 2016-1308 (Fed. Cir. July 5, 2016).
The
Federal Circuit held that a biosimilar “applicant must provide a reference
product sponsor with 180 days post-licensure notice before commercial marketing
begins, regardless of whether the applicant provided the (2)(A) notice of FDA
review.” The Section (2)(A) notice,
which does not satisfy the post-licensure notice, refers to the notice under
Section (2)(A) that “within 20 days after the FDA notifies the applicant that its
application has been accepted for review, the applicant is to give notice to
the reference product sponsor by providing the application as well as
information describing the manufacturing process. § 262(l)(2)(A).”
Purdue Pharma
L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir.
Feb. 1, 2016)
The
following claim to a dosage form was found to be a product-by-process claim
that was not limited by the process
recitation since “[t]he structure of the 14-hydroxy that is generated from 8α
is the same structure that is generated from 8β:”
An
oral dosage form comprising . . . oxycodone hydrochloride active pharmaceutical
ingredient having less than 25 ppm 14-hydroxy[], wherein at least a
portion of the 14-hydroxy[] is derived from 8α[] during conversion
of oxycodone free base to oxycodone hydrochloride[.]
The broadly construed claim with
no process limitations was then found to be obvious in view of the prior
art. Purdue’s alleged secondary considerations did not demonstrate non-obviousness since “Purdue
invested in [its subsidiary] not because of the
low-ABUK [dangerous compounds
known as alpha, beta unsaturated
ketonesfeatures] oxycodone API, but because it could get oxycodone API at a
lower cost from its subsidiary than it could from an unaffiliated manufacturer
during times of high demand.” Furthermore,
Purdue’s subsidiary “was not successful at marketing its low-ABUK oxycodone API
to any significant customer other than Purdue, which is its corporate
affiliate.”
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