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Announcement: USPTO COVID-19 Prioritized Examination Program

The United States Patent and Trademark Office (USPTO) has announced a new prioritized examination program to expedite the examination of applications for marks used to identify qualifying COVID-19 medical products and services. Applications that qualify for the program will immediately be assigned to an examining attorney for review, which expedites examination by approximately two months. The USPTO will not charge additional fees for applications that qualify for the program because it considers the COVID-19 outbreak to be an “extraordinary situation” for trademark applicants.

To qualify for prioritized examination, the trademark or service mark application must cover a product that is subject to the United States Food and Drug Administration (FDA) approval for use in the prevention and/or treatment of COVID-19, or a medical service (including medical research) for the prevention and/or treatment of COVID-19.

The USPTO started accepting petitions to advance the initial examination of applications for qualifying COVID-19-related marks beginning June 16, 2020.

Read the full announcement here.




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Fee Shifting Under § 285 Does Not Apply to Conduct Solely Arising in IPR

Considering for the first time whether fee shifting of § 285 applies to exceptional conduct arising solely from an inter partes review (IPR) proceeding, the US Court of Appeals for the Federal Circuit held that § 285 does not authorize an award of fees based on conduct at the United States Patent and Trademark Office (USPTO) during the course of an IPR proceeding. Amneal Pharma. LLC v. Almirall, LLC, Case No. 2020-1106 (Fed. Cir. June 4, 2020) (Dyk, J.).

Almirall owns certain Orange Book-listed patent rights to medication used to treat acne. Its competitor, Amneal, planned to market a generic version of the acne medication. Before seeking approval to do so, Amneal filed an IPR petition challenging the validity of certain claims of Almirall’s patents. Amneal then filed an Abbreviated New Drug Application (ANDA), identifying Almirall’s patents in the Paragraph IV certification. Almirall subsequently filed a district court action against Amneal for infringement. Shortly after the district court action was filed, the parties entered into settlement negotiations, during which Almirall offered Amneal a covenant-not-to-sue, provided that Almirall drop its pending IPR. The parties were unable to reach agreement at that time, and the IPR culminated in the Patent Trial and Appeal Board (PTAB)’s final written decision, finding the challenged claims not unpatentable. Amneal appealed the PTAB’s final determination. Shortly after the appeal was filed, the parties reached an agreement and jointly moved to dismiss the appeal. Almirall also moved for fees under § 285 for Amneal’s allegedly unreasonable conduct in maintaining its IPR, even after Amneal offered it a covenant-not-to-sue.

Comparing IPRs to interference proceedings, the Federal Circuit looked to a decision of its predecessor, the Court of Customs and Patent Appeals, which determined that § 285 did not extend to appeals of administrative proceedings at the USPTO, and IPRs were no different. Stopping short of proclaiming a categorical rule that § 285 applies only to conduct in district court proceedings, the Court explained that at most, § 285 speaks to awarding fees that were incurred during, in close relation to, or as a direct result of district court proceedings. In the circumstance here, where the alleged exceptional conduct was solely before the USPTO and an appeal of the USPTO decision—not a district court’s decision—an award under § 285 was not appropriate. In addition, the Court noted that the USPTO has its own procedures for sanctioning exceptional conduct under 37 C.F.R. § 42.12, where the PTAB may award “compensatory expenses, including attorney’s fees,” among other sanctions.




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Inherency Can Be Used in Obviousness Analysis to Supply Missing Limitation

Finding that inherency can be used to show the presence of a missing claim limitation, the US Court of Appeals for the Federal Circuit affirmed a district court decision that asserted claims in pain management method patents were invalid as obvious. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361 (Fed. Cir., Dec. 27, 2019) (Reyna, J.).

Persion has US Food and Drug Administration (FDA) approval for its extended release hydrocodone product, Zohydro ER, and also owns two patents directed to methods of treating pain with extended release hydrocodone in patients with mild to moderate hepatic impairment. Persion sued Alvogen for infringement of certain claims in these two patents after Alvogen filed an Abbreviated New Drug Application (ANDA) requesting approval from the FDA to market a generic version of Zohydro ER. The asserted claims include: (i) non-adjustment claims directed to administering a dose of hydrocodone to patients with mild to moderate hepatic impairment without adjusting the dose relative to a healthy liver patient, and (ii) pharmacokinetic claims directed to pharmacokinetic parameters achieved after treatment with hydrocodone.

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Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).

EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.

Hospira appealed.

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