Generics Beat the Tax Man

Attorney: Richard D. Kelly
November 27, 2023

Recently Mylan in Mylan, Inc. v. Comm’r of Internal Revenue, 76 F4th 230 (3rd Cir. 2023), beat the tax man. Mylan tried to deduct its ANDA litigation expenses as ordinary and necessary business expenses which are an immediate deduction, while the Internal Revenue Service (IRS) claimed the expenses should be capitalized which is not as valuable. The IRS asserted that the expenses should be capitalized, under 26 U.S.C. § 263 and the associated regulations, similar to money paid to acquire approvals from the Food and Drug Administration (“FDA”).  Mylan at 243. The Court rejected the IRS’ argument observing “ultimate FDA approval is never decided by the outcome of patent litigation under [35 U.S.C.] § 271(e)(2), even if it is delayed by such litigation.” Mylan at 244. The Court concluded “it makes no difference in deciding the question of deductibility whether the patent litigation expenses are incurred by the patentee or the alleged infringer.  Nor does it matter that the deductibility question arises in the context of an ANDA suit.” Mylan at 239-40.<... Read more

Sisvel – PTAB Guidance On A Proposed Amendment In An IPR Is Not Binding On The PTAB

Attorney: Richard D. Kelly
November 20, 2023

In Sisvel Int’l S.A. v. Sierra Wireless, Inc., Appeal nos. 2022-1387 and 2022-1492, (Fed. Cir. 2023) the Court considered this issue of when was a claim broadened in a post grant proceeding. Sisvel’s patent U.S. 7,433,698 (‘698) was involved in two IPRs, IPR 2020-01070 and IPR2020-01071 where it attempted unsuccessfully to amend its claim 10.  Sisvel received preliminary guidance from the PTAB on its original motion to amend claim 10 which then led it to file a revised motion to amend.  Sisvel’s revised motion proposed these amendments:


The amendments to the preamble and the first two limitations result in a more limited claim than original claim 10. However, the PTAB and Federal Circuit held the third limitation “setting the value” to be broader than the original limitation.  The original claim required that the value of at least one parameter be based at least in part on information in the at least one frequency parameter.  The amended claim required the “use of the frequency parameter” which was interpreted as being broader in scope than the “based on” language of the original claim 10.  Using the information was broader in scope than the old language “based at least in part on information in at least one frequency parameter.”  “Using the parameter” was broader than basing it on the parameter.  The Federal Circuit used the example of using a value V and multiplied by X and then dividing by X where the value X was used to calculate V, but the value V is not based on X.  Thus, while proposed claim 36 is narrower overall than claim 10, the last limitation is broader.  It is possible for infringement of claim 36 to exist where none existed for claim 10 since a device only “using the frequency parameter” of claim 36 would not infringe claim 10 but would infringe proposed claim 36.  The amendment process does not permit a patentee to broaden any aspect of a claim even though the overall the claim is narrower, see Hockerson-Halberstadt, 183 F.3d at 1374 see also 37 C.F.R. § 1.175(b) (“A claim is a broadened claim if the claim is broadened in any respect.”)<... Read more

FTC Alleges Misuse of Orange Book Listings: Puts10 Pharma Companies on Notice

Attorney: Richard D. Kelly
November 10, 2023

On Tuesday, the FTC announced that it is cracking down on companies it asserts is improperly or inaccurately placing drugs on the list of FDA-approved products, known as the Orange Book. The challenge may result in removal of products from the Orange Book.<... Read more

FDA Announces Formation of a New Digital Health Advisory Committee

Attorney: Richard D. Kelly
October 19, 2023

On October 11, the FDA announced the formation of a new Digital Health Advisory Committee to assist the FDA in exploring the complex, scientific and technical issues related to digital health technologies (DHTs). The committee’s function is to advise the FDA on issues related to DHTs, help the agency understand the benefits, risks, and clinical outcomes associated with use of DHTs. The FDA notice explained that:<... Read more

The Federal Circuit's First Enablement Decision Since Amgen

Attorney: Richard D. Kelly
September 25, 2023

Federal Circuit applied Amgen v. Sanofi, 598 U.S. 594 (2013)in deciding that claims 1-4, 19 and 20 of Baxalta’s hemophilia patent, U.S. Patent 7,033,590 (‘590), were invalid as lacking an enabling disclosure.<... Read more

In Re Cellect – ODP Defense Does Not Impact The Expiration Date of A Patent With Both PTA and PTE In The Absence of A Terminal Disclaimer

Attorney: Richard D. Kelly
September 15, 2023

The Federal Circuit in In re Cellect, Appeals Nos. 2022-1293, 2022-1294, 2022-1295, 2022-1296 held that the earliest patent to expire in a series of patents subject to obviousness-type double patenting (ODP) controls, i.e., the PTA in the later to expire patents is lost and all patents are invalid for double patenting. In Cellect the relation between the patents is shown below:

<... Read more

American Axle Part 2 – Not an Abstract Idea

Attorney: Richard D. Kelly
August 4, 2023

On July 28, 2023, Judge Williams of the Delaware District unsealed his decision on remand from the Federal Circuit addressing competing summary judgment motions regarding the patent eligibility of remanded claim 1. The Federal Circuit remanded the case to the district court to determine if claim 1 was directed to an abstract idea argued by Neapco on appeal for invalidity.  Claim 1 provided:<... Read more

USPTO Announces Revised Director Review Process

Attorney: Richard D. Kelly
July 26, 2023

On July 24, the USPTO announced a revised Director interim review process. Although the USPTO in July 2022 had requested comments on its director review process and the comment period was closed on October 19, 2022, the USPTO has still not formalized the process or published any proposed rules to implement it.  Instead, it revised its interim review process.<... Read more

Lessons from Amgen v. Sanofi

Attorney: Richard D. Kelly
July 5, 2023

Amgen provides a window on the Supreme Court approach to patent issues - look to history and established policy as our patent law is not code based but rather common law based. The Court noted that the “enablement requirement” is found essentially unchanged in every version of the patent law since 1790. While Amgen concerned the enablement provision, the same approach applies to patent eligibility, the “judicial exceptions,” which have existed in our case law since the early 19th century.  In deciding Amgen the Supreme Court did not consider previous Federal Circuit decisions but looked to history of the enablement provision which involved Court decisions from the 19th and early 20th century.  While Amgen was the Court’s first antibody case, it found analogous cases which provided guidance as to how the enablement requirement had been interpreted.  Since U.S. patent law is based on common law, this is the appropriate approach to provide the needed predictability.  Without understanding the policy behind the exceptions, one will continue to wander aimlessly from one case to the next.<... Read more