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Posts Tagged: "allergan"

ITC’s Botox Ruling Could Have Public Interest Implications

Korean company Daewoong and its U.S. counterpart Evolus recently found themselves in a dispute with U.S.-Irish company Allergan and its counterpart Medytox over misappropriation of both a bacterial strain and the manufacturing process to make cosmetic injection products from that strain. Daewoong recently received Food and Drug Administration (FDA) approval to market an injection in the United States that competes with Botox, owned by Allergan-Medytox. In order to prevent this entrance into the market, Allergan-Medytox filed a complaint with the International Trade Commission (ITC) to block imports of the new product under Section 337. The only relationship between Allergan and Medytox is an anticompetitive market allocation agreement. Daewoong’s new product posed a threat to the profitability of Allergan’s agreement with Medytox and therefore became the subject of a dispute before the ITC. Importantly, the manufacture of the products occurs in Korea and the injectables are then imported into the United States.

ITC Issues Limited Exclusion Order on Botox Products, Partially Reverses Trade Secret Finding

In September, the International Trade Commission (ITC) decided to review an initial final determination (FID) in the Matter of “Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same,” Investigation No. 337-TA-1145, a complaint filed by Allergan against Botox products made by Daewoong and its partner, Evolus, a “performance beauty company”. On Wednesday, the ITC issued a Final Determination in the case, finding that the sale and importation of the products into the United States violated Section 337 of the U.S. Tariff Act. The Commission issued a Limited Exclusion Order (LEO) prohibiting importation of the products by Daewoong and Evolus for a period of 21 months, as well as a cease and desist order against Evolus preventing the Company from selling, marketing, or promoting the products in the United States for a period of 21 months. However, the Commission reversed the FID’s finding that a trade secret exists with respect to Medytox’s bacterial strain.

ITC Decision to Review Final Initial Determination in Botox Case Could Have Big Implications for Trade Secrets

Last week, the United States International Trade Commission (ITC) issued a notice in the Matter of “Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same,” Investigation No. 337-TA-1145, stating that the ITC has “determined to review in part a final initial determination (FID) of the presiding administrative law judge (ALJ) finding a violation of section 337 of the Tariff Act of 1930.”Last year, Allergan, the U.S. manufacturer of Botox, and Medytox, the Korean manufacturer of a similar product, filed a joint complaint against Daewoong, a Korean drug maker, under Section 337 of the Tariff Act of 1930, alleging that Daewoong had stolen Medytox’s botox strain trade secret in Korea and introduced it to the U.S. market. The FID was issued on July 6, 2020, wherein the ALJ found that certain products sold by the Korean drug maker Daewoong and its partner Evolus, Inc. violated section 337 through their importation and sale in the United States of a botulinum neurotoxin product “by reason of the misappropriation of trade secrets.”

Patent Filings Roundup: Robot Vacuum Wars, PTAB Filings Dip, Pharma Litigation Abounds

This week’s District Court filings were robust, with a dip in Patent Trial and Appeal Board (PTAB) filings–a big chunk of which were related to a dispute over robot vacuum cleaners. A few new (or renewed) assertion campaigns, a few small inter-company disputes, and a number of pharmaceutical disputes led the charge. I say Robot, you say vacuum:  Call it the great robot vacuum wars of 2020: industry leader iRobot sued SharkNinja for infringement of three patents (as well as false advertising)—seeking a preliminary injunction of a competing product right before the lucrative holiday season.  iRobot contended that SharkNinja had “brazenly ripped off” their Roomba robotic vacuum cleaners with their much less expensive IQ Robot competitor product.  That bid failed, and the case continued; now SharkNinja has filed multiple IPRs seeking to invalidate the asserted patents.

Drug Patents and the High Cost of Healthcare: Case of Over-Advocacy for Under-Patentability

The price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to evade PTAB scrutiny of these patents by reliance on Tribal Immunity based on its deal with the St. Regis Mohawk Tribe. The PTAB, unlike the examiner corps, does have the ability to consider rebuttal expert testimony, and is thus not-so handicapped in its capacity to vet drug patents of questionable validity, with aplomb.

Controversy Over Restasis Patents is Misplaced

Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan responded by assigning their patent to the Saint Regis Mohawk Tribe who in turn invoked sovereign immunity at the PTAB, and demanded their rights in a real court with a real judge and jury. Mylan, Teva, the PTAB, Congress, and class action lawyers have formed a mob to gang up on Allergan for defending their intellectual property rights. They filed hundreds of suits accusing Allergan and the Tribe of fraud, conspiracy, and sham transactions stemming from an “invalid” patent. The attackers are mistakenly focusing on the patent as the problem. The problem is not the patent, but rather all of the incentives that reward copying instead of innovating.

If it Looks Like a Kangaroo, Hops Like a Kangaroo…

What’s abundantly clear – and disastrous for both the patent system and the public – is that the PTAB’s Kafkaesque rules for complaining about anything outside of what an expert stated in a submitted declaration, including allegations of judicial misconduct, is undermining the public’s already marginal confidence in the entire IPR process. Even Franz Kafka himself would be bewildered by a process which requires one to seek permission to complain – from the very body about whom a litigant is complaining.

The Year in Patents: The Top 10 Patent Stories from 2017

It is that time once again when we look back on the previous year in preparation to close the final chapter of 2017 in order move fresh into the year ahead. 2017 was a busy year in the patent world, although change was not as cataclysmic as it had been in past years, such as 2012 when the PTAB and post grant challenges began, in 2013 when AIA first to file rules went into effect, or in 2014 when the Supreme Court decided Alice v. CLS Bank. It was, nevertheless, still an interesting year… To come up with the list below I’ve reviewed all of our patent articles, and have come up with these top 10 patent stories for 2017. They appear in chronological order as they happened throughout the year.

Three Outstanding IP Deals of 2017

These IP deals were not necessarily selected for their size, but for their indicative nature of a set of circumstances that exist in current markets that made these deals not only possible, but essential… The three trends highlighted by these patent deals: acquisitions by foreign buyers, Unicorns and other well-funded startups looking for assets, and various strategies to avoid the burden imposed by the PTAB, are likely to continue well into 2018. None of these deals would have been entered into if the parties involved did not deem U.S. patents valuable and critical for their relative business, and that is one positive message that all of us involved in the IP marketplace can take with us into the new year.

The PTAB lacks authority to decide the applicability of tribal sovereign immunity

Native American tribes possess and exercise inherent sovereign immunity. It is also undisputable that such power may be abrogated, limited or qualified only by the express and unequivocal action of Congress. In Kiowa Tribe of Oklahoma v Manufacturing Technologies, Inc., the U.S. Supreme Court explicitly affirmed that no court or administrative agency may interfere with that power absent Congressional legislation… The Court again in Bay Mills reiterated that absent congressional limitations, tribes exercise unqualified immunity. The Court even went so far as to note that “a fundamental commitment of Indian law is judicial respect for Congress’s primary role in defining the contours of tribal sovereignty.”

Laurence Tribe, Erwin Chemerinsky say PTAB should recognize Tribal Sovereign Immunity

Tribal sovereignty is not a “sham” or a “contrivance,” even when it produces results Petitioners do not like. There is no dispute that the St. Regis Mohawk Tribe is what the Supreme Court has termed a “domestic dependent nation[]” entitled to tribal sovereign immunity and that its agreement with Allergan is a legitimate contract… Moreover, Petitioners’ objections are being raised in the wrong forum. Congress – rather than the Board, the Article II executive, or even the Article III courts – controls the availability of tribal sovereign immunity.

Double jeopardy at the PTAB forces Allergan and others to seek sovereign immunity defenses

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review process under the Drug Price Competition and Patent Term Restoration Act, colloquially known as Hatch-Waxman. This law creates a regime by which a generic drugmaker can file an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA). The branded pharmaceutical listed in the Orange Book will be covered by patents but the generic drugmaker can include a Paragraph IV certification in the ANDA, a declaration that the patents covering the Orange Book-listed drug are unenforceable and invalid. When a company like Allergan has to face Hatch-Waxman validity trials in federal district court and serial IPRs at the PTAB, it turns Allergan’s Restasis patents into piñatas taking hit after hit at multiple forums before being finally ripped asunder at some point.

Allergan’s RESTASIS® patents declared invalid by Eastern District of Texas

Judge William C. Bryson of the United States Federal District Court for the Eastern District of Texas found that Allergan’s RESTASIS® patents were infringed by Teva Pharmaceuticals USA, but that Teva had demonstrated invalidity of those patents by clear and convincing evidence… In a separate Order dealing with the issue of whether the Saint Regis Mohawk Tribe should be joined as co-plaintiff, Judge Bryson acknowledged that “the sovereign immunity issue is not presented in this case,” but nevertheless went to great lengths in dicta to express his opinion on the matter anyway.

St. Regis Mohawks, BIO send letters to Senate Judiciary slamming the unfair playing field of IPRs at PTAB

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on that committee of various issues in play regarding the recent patent deal between multinational pharmaceutical firm Allergan and the sovereign St. Regis Mohawk Tribe. The two groups sending the letters represent stakeholders in the U.S. patent system coming from very different backgrounds who realize that there are fundamental flaws in the system created by inter partes review (IPR) proceedings which are carried out at the Patent Trial and Appeal Board (PTAB).

Efficient infringer lobby achieves bipartisan effort to abrogate Native American tribal sovereignty

The patent deal with the St. Regis tribe doesn’t shield the patents from validity challenges coming from a Hatch-Waxman trial recently concluded in Texas federal court. “To be clear, if the District Court ruling is adverse to Allergan’s patent position, and there is an FDA approval of a generic version of RESTASIS®, that product could enter the market many years in advance of the listed patent expiry dates,” Allergan’s note reads. The drugmaker further argues that the IPR process in force at the PTAB undermines the 33-year-old Hatch-Waxman statutory regime regarding validity challenges to pharmaceutical patents, is subject to changes to validity proceedings implemented within the executive branch which are not impartial, and creates an unfair burden on innovators by opening patents to challenge proceedings which are often inconsistent before both the PTAB and the Court of Appeals for the Federal Circuit, the court to which PTAB decisions can be appealed.