iIndia’s leading generic maker Sun Pharmaceutical will license certain patent applications related to the anti- depression drug escitalopram (Lexapro) following settlements of lawsuit.
Sun Parma and its US subsidiary Caraco Pharmaceutical Laboratories have entered into agreements with Forest Laboratories and H. Lundbeck A/S to settle the legal proceedings related to escitalopram oxalate (Lexapro) tablets out of court.
As per the new settlement Sun Pharma will license to Lundbeck on a worldwide basis certain patent applications related to the synthesis of escitalopram and citalopram in exchange for an upfront payment and, if the technology is used, royalties on sales, the companies stated in a press release.
Caraco filed an Abbreviated New Drug Application (ANDA No. 78-219) with the FDA seeking generic approval for 5, 10, and 20 mg tablets of escitalopram oxalate in March 2006.
Forest laboratories and Lundbeck initiated legal action against Caraco on July 10, 2006 by filing a patent infringement lawsuit at United States District Court Eastern District Of Michigan Southern Division alleging that Caraco’s ANDA products would infringe their ‘712 patent.
Forest and Lundbeck, who listed the ‘712, ‘941, and ‘069 patents in the Orange Book, alleged that an infringement suit could reasonably be asserted against any generic ANDA applicant, including Caraco, that attempts to seek approval for, and market, a generic version of Lexapro before the expiration of the ‘712, ‘941, and ‘069 patents.
On February 20, 2007, Caraco filed a declaratory judgment action against Forest and Lundbeck seeking a declaration that Caraco’s ANDA Products will not infringe the ‘941 patent.
In 2008, the Federal Circuit held that Caraco, as an ANDA applicant, alleged a judicially cognizable injury-in-fact sufficient to bring a declaratory action for infringement despite a covenant not to sue given by Forest and Lundbeck.
Again, Caraco argued in its declaratory judgment that Caraco is entitled to a declaration that the manufacture, use, or sale of its ANDA Products would not infringe the claims of the ‘069 patent.
The ‘069 patent, the patent issued on September 2, 2008 for H. Lundbeck A/S titled “Crystalline Composition Containing Escitalopram.” The ‘069 patent is scheduled to expire on August 12, 2022, with pediatric exclusivity extending protection until February 12, 2023.
H. Lundbeck A/S is the owner of the ‘069 Upon information and belief, Forest Laboratories Holdings, Ltd. is the exclusive licensee of the ‘069 patent and Forest Laboratories, Inc. holds New Drug Application (NDA) No. 21323 on Lexapro (escitalopram oxalate) tablet products.
The companies resolved the dispute after reaching an agreement out of court last week. Apart from licencing escitalopram rights to Forest and Lundbeck, the settlements require Forest provide licenses to Caraco for any patents related to Lexapro and with respect to the marketing of Caraco’s generic version of the product as of the date that any third party generic that has received final approval from the FDA enters the market other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.
Caraco will take over the commercialization and sale of several products from Forest’s Inwood business. Caraco will pay Forest an undisclosed advance against royalties and royalties on net sales of these products.
Forest will reimburse Caraco for a portion of their costs related to this litigation.
These agreements will be subject to review by the US Federal Trade Commission, the release said.
Generic versions of brand-name prescription drugs that typically
contain the same active ingredients, were allowed to be marketed in US following the Congress enacting the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Amendments to the the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1984.
Congress passed the Hatch-Waxman Amendments, which simplified the
procedure for obtaining approval of generic drugs, for the purpose of decreasing the cost of pharmaceuticals through increased competition and to expedite the marketing of lower-priced generic drug products.
Under the Hatch-Waxman Amendments, a generic manufacturer submits what is called an Abbreviated New Drug Application (ANDA). To receive approval of its ANDA, an applicant must show, inter alia, that its generic drug is “bioequivalent” to the listed reference drug.
An ANDA also must contain a “certification” to each patent that the NDA
holder has submitted to FDA for listing in the Orange Book in connection with the listed reference drug.
A so-called “paragraph IV” certification asserts that the listed patent is invalid, unenforceable, and/or will not be infringed and, on that basis, seeks FDA approval of the generic product prior to patent expiration.
The submission of a paragraph IV certification has two important consequences.
First, a generic applicant that is first to submit an ANDA containing a
paragraph IV certification for a listed patent is entitled to 180 days of generic market exclusivity during which no other competing generic drug products may be marketed. This statutory benefit to the first filer is commonly known as “180-day exclusivity.”
In particular, the statutory provision of the FFDCA applicable here provides that “[i]f the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this section [containing] such a certification, the application shall be made effective not earlier than one hundred and eighty days after” the earlier of: (a) the first commercial marketing of that ANDA applicant’s proposed drug; or, (b) a court decision—whether it involves the first applicant or not—that the particular patent that is the subject of the paragraph IV certification is invalid or not infringed.
Thus, unless a subsequent generic applicant can obtain a court decision of noninfringement and/or invalidity as Congress intended, the approval of its ANDA can be delayed indefinitely by the purported exclusivity of the first.
Second, the submission of a paragraph IV certification for a listed patent provides grounds for a claim of an artificial act of infringement that creates the necessary case or controversy and subject matter jurisdiction to enable an NDA-holder/patent owner to file, and a district court to resolve, an action for patent infringement—before the generic drug is actually made, used, or sold—to determine whether the generic drug, if marketed and sold in accordance with the ANDA, would infringe the relevant patent.
The submission of a paragraph IV certification likewise creates the necessary case or controversy and subject matter jurisdiction for an ANDA applicant to file a declaratory judgment action against the NDA-holder/patent owner if the ANDA applicant is not sued on the listed patent within the applicable 45-day period.
An applicant submitting an ANDA containing a paragraph IV certification
must notify both the NDA holder and patent owner of its paragraph IV certification.
After receiving notice of the paragraph IV certification, the NDA holder/patent owner has 45 days in which to file an infringement suit against the generic manufacturer.
The NDA holder/patent owner’s filing of a lawsuit prior to the expiration
of 45 days prevents FDA from issuing final approval of the generic maker’s ANDA for a period of 30 months, absent certain exceptions.
On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was signed into law. Title XI of the MMA, labeled “Access to Affordable Pharmaceuticals,” amended provisions of the FFDCA and, in particular, the Hatch-Waxman Amendments.
Under the MMA, an ANDA applicant who has filed a paragraph IV certification is statutorily entitled to institute and maintain an action for declaratory judgment against an NDA-holder/patent owner if: (1) the 45-day period has passed since notice of the paragraph IV certification was received; (2) neither the patent owner nor the NDA-holder/patent owner brought an action for infringement of the patent within the 45-day period; and, (3) the notice of paragraph IV certification contains an Offer of Confidential Access to the ANDA.