Written Description is Not Always Your Friend

Attorney: Richard D. Kelly
November 21, 2022

While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more

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

Is the Supreme Court Poised to Consider the Federal Circuit's "Possession of the Invention" Definition of Written Description?

Attorney: Richard D. Kelly
October 5, 2022

The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more

Failure to Identify the Invention and to Explain How you Do It May Lead to Invalidity under Section 101

Attorney: Marina I. Miller, Ph.D.
October 5, 2022

Integrated Technology Solutions, LLC (“ITS”) alleged that products manufactured and distributed by iRacing.com Motorsport Simulations, LLC ("iRacing") infringed on U.S. Patent 10,046,241. iRacing moved to dismiss, arguing that the ‘241 patent was invalid under 35 U.S.C Section 101, as construed by Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 573 U.S. 208 (2014), and its progeny, because the asserted claims were directed to an abstract idea and were patent-ineligible. The U.S. District Court, D. Massachusetts (“the Court”) found that the claims at issue were directed at patent-ineligible concepts, and that the elements of each claim did not transform the claim into patent-eligible application, and granted the motion to dismiss. <... Read more

Federal Circuit Trumped By Supreme Court On Stay Of Mandate In Gilenya

Attorney: Richard D. Kelly
October 3, 2022

Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.<... 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

Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... 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