PTAB Overturns Rejection for Overlapping Ranges

Attorney: Derek Lightner, Ph.D.
November 11, 2022

On October 19, 2022, the Patent Trial and Appeal Board (PTAB) overturned the obviousness rejection of a claim to an aqueous dispersion. Claim 1 of the application in question, USSN 16/083,182 (the 182 Application), recited<... Read more

A Class of 957 Predicted Salts Is Insufficient To Meet the ‘At Once Envisage' Standard

Attorney: Marina I. Miller, Ph.D.
October 26, 2022

Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more

USPTO Extends Cancer Immunotherapy Pilot Program

Attorney: Marina I. Miller, Ph.D.
October 24, 2022

To accelerate innovation in the health and medical fields, the USPTO published a Federal Register Notice announcing a fifth extension of its Cancer Immunotherapy Pilot Program. Petitions requesting participation in the pilot program that are compliant with the program’s requirements and are filed on or before January 31, 2023, will be accepted. The extension will also allow the USPTO to continue the program while it evaluates potential expansion opportunities. The USPTO first implemented the Cancer Immunotherapy Pilot Program in June 2016, in support of the White House’s National Cancer Moonshot initiative, which sought to accelerate cancer research. It permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier. The extension reflects the continued effectiveness of the pilot program. All parameters will remain the same as in the original pilot through the January 31, 2023, extension.<... Read more

Applications For Patent Term Extension (PTE) Now Easily Searchable at USPTO

Attorney: Richard D. Kelly
September 8, 2022

As part of the USPTO’s effort to make drugs more affordable it is now publishing a list of PTE applications filed within the last five years by filing date as well as a listing all granted PTEs. This is the first time the USPTO has published a compilation of filed but not yet granted PTE applications.  Previously the USPTO published a list of granted PTEs only.  Previously the only way to discover if a PTE had been filed for a patent was to review the patent file history. This required that one first review the FDA Orange Book for patents listed for a newly approved drug and then search the USPTO application file records to determine if a PTE had been filed on one or more of the listed patents. The new list includes the drug name, patent number and PTE filing date; it also links directly to the application making review easy. Since a PTE application must be filed within 60 days of a drug’s approval the new listing will allow generic drug companies to determine the patent exclusivities quickly and easily for the new drug. A link to the PTE extension page is here.  The page has two lists, one for PTEs filed in the last five years and one for all granted PTEs.<... Read more

Federal Circuit Revisits Assignor Estoppel

Attorney: Richard D. Kelly
August 18, 2022

On August 11, 2022, the Federal Circuit issued its opinion in the remand of Hologic, Inc. v Minerva Surgical, Inc. from the Supreme Court’s decision limiting the application of assignor estoppel to where the assignor is taking in litigation a position inconsistent with his prior representations in assigning the patent. In this case the issue was whether the issued claims are materially broader than the claims in the assigned application, Minerva Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298, 2302, 2309 (2021). The Supreme Court in Minerva refused to discard the concept of assignor estoppel but instead held that the concept comes with limits and “reaches only as far as the equitable principle long understood to lie at its core.” The Supreme Court held that assignor estoppel “applies only when an inventor says one thing (explicitly or implicitly) in assigning a patent and the opposite in litigating against the patent’s owner.” Id. at 2304. Stated differently, where the assignor has not any explicit or implicit representations which conflict with an invalidity defense.<... Read more

Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorneys: Richard D. Kelly and Elissa Sanford
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

Federal Circuit Reverses Novartis Gilyena Negative Limitation Decision

Attorney: Richard D. Kelly
June 22, 2022

On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more

The PTAB Weighs in on Obviousness-Type Double Patenting and PTA

Attorney: Richard D. Kelly
May 16, 2022

Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period.  Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue.  The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and MitsubishiMagna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more

XML Format Effective July 1, 2022 For PCT Sequence Listings

Attorney: Richard D. Kelly
May 16, 2022

WIPO has announced that as of July 1, 2022, all sequence listings must be submitted in XML format. Information on the standard and a tool for complying is found at https://www.wipo.int/standards/en/sequence/.<... Read more

Markush Language Distinguishes over Multi-Component Solvent

Attorney: Derek Lightner, Ph.D.
January 31, 2022

The Patent Trial and Appeal Board (PTAB) overturned the examiner’s obviousness finding in Ex parte PETER KAPITAN and ALEXANDER SAJTOS (Appeal 2021-001272; USSN 14/409,522) substantially on the basis of a recitation of “… the solvent … is an alkane selected from a group consisting of pentane and hexane” distinguishing over the prior art description of the optional use of petroleum ether, with evidence that petroleum ether is not simply pentane or hexane.<... Read more