“The fact that the regulatory process, which had an explicit grace period, was not complete at the time Reynolds filed the complaint meant that domestic industrial products were, as Philip Morris argued, ‘illegal’. not something to do.”
On March 31, the United States Court of Appeals for the Federal Circuit ruled that Philip Morris Products SA v. International Trade Commission Confirms the US International Trade Commission’s (ITC) Section 337 ruling blocking the importation and sale of electronic vape tobacco products that infringe a patent owned by RJ Reynolds Vapor Company. While many of the precedent decisions dealt with Philip Morris’ procedural and agency challenges to the ITC’s rulings, the Federal Circuit held that several patentability findings submitted by the ITC were not supported by substantial evidence. He also rejected the allegation that it was unsubstantiated.
The current appeal goes back to the ITC complaint filed by RJ Reynolds in April 2020, seeking a Section 337 investigation into Philip Morris’ IQOS line of heated tobacco e-cigarette products. His two patents claimed by RJ Reynolds are US Patent No. 9901123. Smoking Articles Containing Tobaccoand U.S. Patent No. 9930915, Smoking articles and their use to produce inhalantsAn Administrative Law Judge (ALJ) found after a year-long investigation that the accused IQOS products infringed the claims of both patents, and that RJ Reynolds had established a domestic industry presence on both patents, and the public It concluded that profits did not prevent entry. Limited Exclusion Order (LEO).
After reviewing the ALJ’s final initial determination, the ITC confirmed its findings that the ‘123 patent was not invalid for obviousness and that RJ Reynolds met domestic industry requirements. His ALJ conducting a Section 337 investigation had recommended not to issue a cease and desist order (CDO), but the ITC entered such an order against Philip Morris and his LEO.
It takes more than a ‘vague proposal’ to trigger a statutory duty to consult HHS
Chief among Philip Morris’s challenges to the ITC’s Section 337 investigation is the ITC’s failure to comply with its statutory duty to consult with the US Department of Health and Human Services (HHS). Codified in 19 USC § 1337(b)(2), this provision allows the ITC to “consult and seek advice and information” from her HHS and other executive branch agencies during the course of Section 337 investigations. instructing. Philip Morris said that he could not obtain information from the ITC about the FDA’s decision on the public health benefits of IQOS heat-not-burn tobacco products because the ITC did not consult with HHS, and more specifically with the U.S. Food and Drug Administration. claimed it wasn’t.
First, the Court of Appeals for the Federal Circuit held that Philip Morris’ allegation that the ITC failed to meet its statutory duty of consultation was dismissed because it failed to properly raise the issue with the ITC. The ITC itself held that Philip Morris had raised a hearing duty for the first time on a motion to withhold relief from his CDO and LEO, and the Federal Circuit ruled that Philip Morris had several opportunities to raise the issue. I agreed that I didn’t, even though there was. This failure stems from the fact that his ALJ conducting a Section 337 investigation sought views from both parties on his ALJ’s authority to consult with his HHS under Section 1337(b)(2). nevertheless occurred. Philip Morris’ reply brief informed the ITC that:[t]The Federal Circuit agreed with the ITC’s opinion that this “vague suggestion” is not the type of specific demand required to raise or sustain its claim.
Even without considering the forfeiture, the Federal Circuit determined that the ITC had fulfilled its statutory duty to consult with HHS. The court noted that the ITC served notice of the Section 337 investigation on her HHS employee designated to monitor Section 337 proceedings. The Federal Circuit ruled that even under Philip Morris’ statutory interpretation requiring the ITC to take “joint action” with his HHS and participate in an “exchange of information,” the ITC had practically no contact with the FDA on matters of public interest. ruled that he had fulfilled this duty by consulting with Of Section 337 proceedings initiated by RJ Reynolds. The Federal Circuit also accused Philip Morris of failing to clarify what was necessary to comply with the ITC’s statutory obligations under Section 1337(b)(2). Philip Morris could have done by asking the ITC for a briefing from the FDA.
RJ Reynolds Files Section 337 Complaint During PMTA Grace Period
Moreover, the Federal Circuit did not preclude the ITC’s Section 337 findings on public interest and domestic industry factors. Philip Morris cited public health FDA mandates to mitigate the risks posed by IQOS thermal burn protection products, but the Federal Circuit agreed with the ITC that tobacco-free treatments were effective, Public health benefits were not severely affected. Also, based on the Commission’s reasonable review of the evidence, the FDA’s order was not equated with FDA’s approval.
On domestic industry issues, the Federal Circuit agreed that the ITC was right to reject Philip Morris’ argument that RJ Reynolds had not demonstrated economic viability through the sale of his VUSE Vibe and Solo products. bottom. RJ Reynolds had filed a Premarket Tobacco Products Application (PMTA) for his VUSE products as required by the Family Smoking Prevention and Tobacco Control Act by the time he filed his Section 337 complaint in April 2020. did not. However, RJ Reynolds filed Section 337. He filed a complaint with the ITC about a month before the grace period for such filings expired in May 2020. Manufactured goods were “illegal,” as Philip Morris argues,” wrote the Federal Circuit.
The CAFC affirms the ITC’s non-obviousness, infringement and support rulings.
The Federal Circuit also upheld three patentability decisions made by the ITC on appeal from Philip Morris. The ITC’s finding that Philip Morris failed to prove claims 27-30 of the ‘123 patent as more obvious than U.S. Pat. Regarding the federal government, the Circuit found that the ITC was not mistaken in finding that Morgan did not actually teach the use of central heaters in electronic smoking systems. Furthermore, the ITC was right in finding that Philip Morris’ expert testimony did not establish the limited number of design options available to skilled craftsmen. Based in part on the lack of evidence provided by Philip Morris to establish the possible existence of only three of his heater positions, the Federal Circuit ruled that ‘123’s contested claims were of obviousness. Upheld the ITC certification that it is not invalid.
As to infringement of the ‘915 patent, the Federal Circuit challenges claim construction on appeal because Philip Morris did not contest construction of the claim term “receiver” during ITC section 337 proceedings. I recognized that I couldn’t. The claim construction proposed by Philip Morris requires that the claimed “source of electrical energy” be wholly contained in the “receiving end,” rather than partially contained, as argued by RJ Reynolds. had. The Federal Circuit appears to have attempted to challenge Philip Morris’ claim construction argument on the factual question of whether the asserted claims of the asserted ‘915 patent are read by the accused IQOS device. and determined that the “recipient” was not a specific component. can refer to any part of an electrical smoking device that receives a disposable smoking article and has a source of electrical energy.
Finally, the Federal Circuit affirmed the ITC’s finding that expert testimony from Philip Morris was not sufficiently supported to establish an invalid public use of the invention claimed in the ‘915 patent. bottom. Philip Morris provides testimony from his former product management team leader of a heated combustion device exhibited by Philip Morris at a consumer research event based in Miami, Florida, prior to the effective date of RJ Reynolds’ ‘915 patent. Did. While such testimony may establish that Philip Morris was in official use of certain heated combustion devices prior to the effective filing date, the Federal Circuit found that Philip Morris , a technical document embodying the invention of the ‘915 patent. In addition to certain inconsistencies in the witness testimony provided by Philip Morris, the Court of Appeals for the Federal Circuit found that none of Philip Morris’ technical documents were used by the witnesses to identify the heated combustion device. He pointed out that he did not use the same “Accord K” name as
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Author: Trikona
