Posts Tagged: "Mylan"

The U.S. Court of Appeals for the Federal Circuit today denied rehearing and rehearing en banc to Biogen International, which had petitioned the court following a November decision  affirming a district court ruling that Biogen’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Three judges split from the majority, with Judges Lourie, Moore and Newman dissenting on the denial of en banc rehearing. Judge O’Malley had dissented from the November panel decision, but she retired on March 11, 2022, and only participated in the decision on panel rehearing.

On March 12, the U.S. Court of Appeals for the Federal Circuit (CAFC) granted Janssen Pharmaceuticals’ motion to dismiss Mylan Laboratories’ appeal and denied Mylan Laboratories’ request for mandamus relief, holding that the court lacked jurisdiction to hear Mylan’s appeal and that Mylan had failed to qualify for mandamus relief. In 2019, Janssen Pharmaceuticals sued Mylan Laboratories in district court for infringing U.S. Patent No. 9,439,906 (the ‘906 patent). In response, Mylan Laboratories petitioned the Patent Trial and Appeal Board (Board) for inter partes review (IPR) of the ‘906 patent, raising four grounds for the unpatentability of certain claims, all based on 35 U.S.C. §103. In opposition to the institution of the IPR, Janssen Pharmaceuticals argued that the IPR “would be an inefficient use of Board resources,” due to two co-pending district court cases: the suit against Mylan Laboratories and another against Teva Pharmaceuticals, arguing “that both actions would likely reach final judgment before any IPR final written decision.”

The Federal Circuit issued an Order staying further proceedings at the PTAB relating to the RESTASIS patents now owned by the Saint Regis Mohawk Tribe. The stay will remain in place until at least one day after the oral argument scheduled for June 2018. The Court will consider whether the stay shall remain in effect or be lifted based on the merits of the case.

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.

As Sherkow’s Twitter critique notes, however, this hesitation to extend sovereign immunity to tribes in proceedings at the PTAB without precedent for doing so presumes that such an immunity defense would be denied by default, a presumption Sherkow called “painfully, absolutely wrong.” The abrogation of tribal sovereign immunity can be legislated by Congress, (which, as has been noted, was already attempted by Sen. Claire McCaskill [D-MO]) but without Congressional action specific to this abrogation, the default presumption would be that tribes have sovereign immunity to assert. “Hesitancy extending the immunity where immunity is unclearly presented is one thing,” Sherkow wrote. “But upending the Constitutional scheme on Kiowa’s dicta is another.”

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.”

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.

Ruschke noted that his authority to expand the panels for PTAB trials doesn’t require him to notify the parties in the trial that the decision to expand the panel has been made. In response to questions on panel expansion, Ruschke noted that when the decision to expand the panel has been made, “the parties will find out in the decision when it issues at that point.” So decisions to expand panels are made in secret and parties in the trial only find out about panel expansion after a decision is reached… Interestingly, petitioner General Plastic requested a rehearing with an expanded panel but the expanded panel in that case found that PTAB’s governing statutes do not permit parties to request, or panels to authorize, expanded panels; panel expansion only lies within the Chief Judge’s discretion.

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).

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.

Mylan had to show by clear and convincing evidence that the idea for the ’445 patent claim was conceived by someone at the FDA and communicated to Mr. Pavliv, the named inventor. The Court agreed with the district court that Mylan did not carry the burden of showing that someone other than Mr. Pavliv had conceived a “definite and permanent idea” of an EDTA-free Acetadote formulation. Mylan argued that Mr. Pavliv’s prior communications with the FDA, including the FDA’s request for justification of the inclusion of EDTA, required Cumberland to undertake research that would have inevitably led to the invention. However, this was not the same as a suggestion to remove EDTA. Derivation is not proved by showing conception and communication of an idea different from the claimed invention, even if that idea would make the claimed idea obvious.

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

EpiPen’s eruptive timing was important. Had Congress been in town, lawmakers would have filled the front pages with populist blather. Had Mylan been less forthcoming about the retail drug supply chain, the press would have been less likely to look into its composition. Had Mylan’s CEO not been a sitting Senator’s daughter, gossipy Hill reporters would have been bored. If health insurer withdrawals from ACA exchanges had not led to higher consumer costs and rates to match, and most important, if anaphylaxis did not simultaneously threaten the lives so many children and bust the back-to-school budgets of more than 15 million middle American families, the multi component drug pricing issues might have been buried on news papers’ back pages. EpiPen pulled these issues out of hiding into the light of public concern where oversimplified self-serving solutions tend to wilt. The fact is we have been treated to a highly publicized health pricing tutorial using a live case study to learn about the many drivers of retail drug pricing.

The problem is that the government is standing in the way of these competitive autoinjectors getting into the hands of the patients who need them. For example, Teva Pharmaceutical Industries has a competitive autoinjector. However, in March, the U.S. Food and Drug Administration (FDA) rejected Teva’s application to bring its competitive autoinjector to patients… While Mylan, like most large pharmaceutical manufacturers, has spent millions of dollars on lobbyists and political campaign contributions, there is no evidence of any illegal quid pro quo. Mylan is simply acting in the interests of its shareholders. It is the system itself, not Mylan, that is corrupt.