Tuesday, September 6, 2016

HIGHLIGHTS OF 2016 FEDERAL CIRCUIT PHARMACEUTICAL AND BIOTECHNOLOGY CASES

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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