Posts Tagged: "allergan"

Saint Regis Mohawk Tribe Outraged at Senator McCaskill over Sovereign Immunity Bill

McCaskill’s seemingly calculated ploy to get out in front of other Senators, all alone in her demand for a legislative solution that strips Native American Indian Tribes of sovereign immunity, may backfire. The Saint Regis Mohawk Tribe, which acquired the Allergan RESTASIS® patents and then granted back to Allergan an exclusive license, issued a scathing statement.

Senator McCaskill introduces bill to abrogate Native American Sovereign Immunity

Senator McCaskill (D-MO) has introduced a bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review (IPR) proceedings at the United States Patent and Trademark Office. Indeed, the sole purpose of McCaskill’s short, ill-conceived and hastily assembled bill is to make it impossible for Native American Indian Tribes that own patents to assert sovereign immunity when those patents are challenged in proceedings at the Patent Trial and Appeal Board… What this means is McCaskill’s bill cannot and will not remove claims of sovereign immunity from PTAB proceedings. McCaskill’s bill would only discriminate against Native American Indian Tribes.

Allergan’s patent transaction with St. Regis Mohawks could presage more arbitrage patent transactions

News of the St. Regis patent transaction has sparked interest in others pursuing similar arbitrage arrangements that provide revenue streams to Native American tribes outside of gambling and tobacco. According to Shore, there’s a lot of interest in pursuing such deals in sectors outside of pharmaceuticals. White seemed confident that other tribes would soon pursue their own similar IP deals. “There are 500 tribes in the U.S.,” White said. “There is a lot of media surrounding this and there is a lot of money. There will be other tribes.” Small operating companies have plenty of reason to contemplate such a transaction of their own patents themselves, Shore said. “There may be no IPRs filed yet, but they may be looking to do this preemptively so that when they engage in an enforcement campaign, they have removed the risk of IPR.”

Mylan calls Allergan’s patent deal with Indian tribe a “sham” transaction in PTAB hearing on sovereign immunity defense

The tribe is raising a sovereign immunity defense in the case as the tribe is a sovereign entity which is not amenable to a suit unless it consents or Congress abrogates its immunity. Shore argued that the sovereign immunity defense is based on binding Supreme Court precedent. “It would frankly be unprecedented for the board to deny the tribe the right to seek a dismissal before conducting the hearing on the merits,” Shore said… On seven occasions during the call, Torczon called the sale of the patents to the St. Regis tribe a “sham” transaction, arguing that the tribe didn’t purchase the patents but rather were paid to take them. Torczon drew parallels between the patent sale and racketeering cases in the context of lending fraud. “So facially this transaction is a sham.

The only solution for the transgressions of the PTAB is to disband this runaway tribunal

Hiring senior associates to be Administrative Patent Judges was a mistake, hiring so many senior associates from the same firm was an even bigger mistake. Making it clear that their job was to kill patents at all costs was inexcusable. Interpreting the rules at every turn to be disadvantageous to patent owners is un-American, violates fundamental notions of fairness of procedure, and tilts the balance so heavily toward challengers that it has become more feared by patent owners than any government agency or body. In short, the PTAB has destroyed the U.S. patent system and the value of U.S. patents. In my opinion, the only solution for the very serious transgressions of the PTAB is to disband this runaway tribunal.

PTAB institutes Mylan IPR challenges on Allergan patents for RESTASIS

Last week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents owned by Allergan plc, which cover RESTASIS®. Each of the patents is listed in FDA’s Orange Book and are set to expire on August 27, 2024. Each of these patents, with the exception of the ‘191 patent, were previously challenged by Apotex Corporation in IPRs filed on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any decision on institution.

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants for a generic version of Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. by Horizon. Both cases were filed in the U.S. District Court for the District of New Jersey.

FDA approval of Teflaro puts Allergan’s portfolio of anti-infectives into focus

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one for Allergan, which saw its overall revenues increase by 48 percent when compared to 2015’s first quarter; revenue for Allergan’s branded pharmaceutical divisions grew by 71 percent year-over-year. The company’s infectious disease division was not its most profitable and yet it saw the greatest amount of growth compared to the previous year. Teflaro entered the Allergan portfolio thanks to a series of acquisitions in the biopharma realm over the past few years. The pediatric anti-infective was first developed by Forest Laboratories, formerly of New York City, which was acquired by Actavis in February 2014 for a combination of cash and equity which reached a reported $25 billion.

FTC charges Endo Pharmaceuticals with antitrust violations for pay for delay patent settlements

The FTC’s complaint alleges that Endo paid the first generic companies that filed for FDA approval – Impax Laboratories, Inc. and Watson Laboratories, Inc. – to eliminate the risk of competition for Opana ER and Lidoderm, in violation of the Federal Trade Commission Act. The FTC is asking the district court to declare that the defendants’ conduct violates the antitrust laws, and further seeking an order that the companies disgorge their ill-gotten gains. Of course, the FTC asks for a permanent bar to prevent the companies from engaging in similar anticompetitive behavior in the future.

Tech Round-Up: Anonymous Takes on ISIL, Square IPO Beats Estimates and a Freeze Ray

From tech developers trying to take a stand against tech-savvy terrorists to a pair of highly anticipated initial public offerings of stock for tech start-ups, there’s been plenty of news to cover in recent days. We also take a little time to explore research at an American university which has led to the world’s first-ever “freeze ray” laser technology.

Biotech and Pharma Update: January 2014

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes for Ranbaxy *** Inovio Develops DNA-based Immune Booster to Enhance T-cell Responses *** Fish & Richardson Wins Hatch-Waxman Litigation for Allergan *** FDA approves Mekinist with Tafinlar for Advanced Melanoma

Allergan Victory in ALPHAGAN® P Patent Infringemet Suit

The United States District Court for the District of Delaware handed Allergan, Inc. (NYSE:AGN) a victory last week in its patent infringement lawsuit brought against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd., Apotex, Inc. and Apotex Corp. The defendants had been seeking permission to market generic versions of Allergan’s drugs ALPHAGAN® P, which is indicated for the lowering of intraocular…