Weekly Patent Litigation Roundup

Weekly Patent Litigation Roundup

U.S. Supreme Court declines to hear Mohawk drug patent case

HOGANSBURG — The U.S. Supreme Court declined Monday to hear a case over a now-invalidated patent held by the Saint Regis Mohawk Tribe for the best-selling dry eye drug Restasis. The drug’s developer, Allergan Inc., announced in September 2017 it had transferred its patents on Restasis to the tribe to protect the drug from a patent dispute. Under the deal, Allergan agreed to pay the tribe $13.75 million. In exchange, the tribe claimed sovereign immunity as grounds to dismiss a patent challenge through a unit of the U.S. Patent and Trademark Office. The agreement called for the tribe to lease the patents back to Allergan, and receive $15 million in annual royalties as long as they are valid…
United Therapeutics Fires Back After Sandoz Files Anti-Competitive Lawsuit Over PAH Drug

United Therapeutics is taking on accusations that it is unfairly blocking competitors from launching generic versions of the company’s top-selling pulmonary arterial hypertension (PAH) drug, Remodulin. Sandoz filed a lawsuit that claimed Maryland-based United Therapeutics and Smiths Medical ASD conspired to block the Novartis subsidiary from launching a generic product. After the lawsuit was filed in federal district court in New Jersey, United Therapeutics called the legal claims made “meritless.” In a statement released earlier this week, United Therapeutics said the lawsuit stems from Sandoz’s own failure to bring its generic version to market, despite having eight years to do so. The lawsuit filed by Sandoz and its development partner RareGen claim that United Therapeutics and Smiths have stymied attempts for its generic of Remodulin (treprostinil) from gaining hold in pharmacies across the country. Less than a month ago, Sandoz launched its generic treprostinil in the United States. In the lawsuit, Sandoz claimed in the lawsuit that United “placed artificial restrictions on Smiths’ cartridges to ensure they can only be used to administer injections of the brand-name treprostinil drug supplied by United Therapeutics….”

Discovery Rulings in Abbvie v. BI Adalimumab Litigation

In an opinion issued on April 11, 2019, the court granted BI’s motion to compel production of pre-litigation “patent dance” disclosures from the AbbVie v. Amgen suit, and settlement agreements between AbbVie and other biosimilar applicants.  The AbbVie v. Amgen litigation involved seven of the eight patents asserted against BI. During the litigation, Amgen and Abbvie engaged in disclosures pursuant to BPCIA including Amgen producing confidential information about its proposed biosimilar under § 262 (l)(1)(B)(i), (l)(2), and disclosures regarding the parties invalidity and infringement assertions (“3B” and “3C” disclosures).  Amgen and AbbVie later settled…
Court Confirms “Unique” Pleading Requirements In Hatch-Waxman Actions

In a March 31, 2019 opinion in Belcher Pharmaceuticals LLC v. International Mediation Systems, Limited, Judge Stark of the Delaware District Court held that complaints in Hatch-Waxman actions can satisfy the requirements imposed by Ashcroft v. Iqbal, 556 U.S. 662 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), “as applied to the unique context of a Hatch-Waxman claim for patent infringement.” C.A. No. 19-960-LPS-CJB, D.I. 30 at 9 (D. Del.). There, the defendant filed an application under 21 U.S.C. § 355(b)(2), often called a “paper NDA,” and sent a Paragraph IV Notice to plaintiff.[1] The parties subsequently negotiated an offer of confidential access, and the defendant provided its entire 4,000 page NDA to plaintiff about three weeks prior to the 45-day deadline for filing suit…
European Parliament approves SPC manufacturing waiver

The European Parliament has voted to approve the supplementary protection certificate (SPC) manufacturing waiver, which will allow the stockpiling of generic versions of patented drugs. SPCs extend exclusivity on a drug after the expiration of its patent, for a period of up to five years. Under the proposed waiver, however, EU-based companies will be make generics and biosimilars of patent-protected drugs during the last two years of their SPC-protected drugs, as long as they are intended for export to a market outside of the EU. Companies will also be able to stockpile generics and biosimilars during the last six months of an SPC’s protection period ahead of entry onto the EU market…
Stada launches generic Exforge following patent revocation

German generics producer Stada Arzneimittel announced on 20 March 2019 that it is set to launch a generic version of the antihypertensive Exforge (amlodipine/valsartan combination), following the revocation of a Novartis European patent. This will be Stada’s second attempt at launching the generic combination product. Following the initial launch, Stada and its subsidiaries were forced to withdraw the product from the market one year later in December 2017 as Novartis had obtained an interim injunction before the Düsseldorf Higher Regional Court for patent litigation, confirming the Exforge patent until July 2019. However, on 11 March 2019, Novartis’s European patent was revoked following a successful opposition filing by Stada and its subsidiaries, who claimed that the patent, which had previously been upheld by the Objection Division of the European Patent Office, would not stand in an appeal before the Board of Appeal of the European Patent Office…


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