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…
https://www.lifesciencesipreview.com/news/european-parliament-approves-spc-manufacturing-waiver-3473
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…
http://gabionline.net/Generics/News/Stada-launches-generic-Exforge-following-patent-revocation
Should We Abolish Drug Patent?-As well as protecting the pharmaceutical industry's interests, drug patents also provide the public with an important treatment as well. While in an ideal world, the system would be perfectly balanced, benefitting both pharmaceutical corporations and the general population.
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