Is There Any Hope For Antibody Patents in the United States?

Attorney: Vincent K. Shier, Ph.D.
January 25, 2022

Conclusion

Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more

Supplementing Element 1 with Element 2 Lacking the Claimed Function is not Obvious

Attorney: Derek Lightner, Ph.D.
December 27, 2021

In Ex parte FRANÇOIS ROY, JONATHAN CLOUTIER, and VINCENT TANGUAY (Appeal 2021-000050; USSN 13/966,396), the Patent Trial and Appeals Board (PTAB) recently reversed an examiner’s finding of obviousness in a rather involved rejection based upon four references, which hinged upon the presence of “thermofusable glue droplets providing a mechanical retention force to retain the wood strips in an interconnected spaced-apart relationship.”<... Read more

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

Attorney: Elissa Sanford
December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

Biogen v. Mylan Written Description - What Does The Federal Circuit's Decision Really Mean?

Attorney: Jeffrey B. McIntyre
December 8, 2021

Following up on my post last week (Dec 1.), I have read commentary about how the Federal Circuit’s decision in Biogen v. Mylan was incorrect. Is it really the case that the decision was wrong and that the Federal Circuit needs to address it en banc (or that the Supreme Court needs to address it)? <... Read more

Biogen v. Mylan: Make Sure Your Patent Applications Cover Your Current R&D

Attorney: Jeffrey B. McIntyre
December 1, 2021

Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.<... Read more

Another Example of Invalid Claims For Lack of Written Description and Enablement

Attorney: Marina I. Miller, Ph.D.
October 18, 2021

In its recent decision, the PTAB (“the Board”) determined that all challenged claims of U.S. Patent No. 10,301,638 B2 were unpatentable under 35 U.S.C. § 328(a) for lack of written description and lack of enablement.<... Read more

Traversing Obviousness Rejections

Attorney: Richard D. Kelly
October 18, 2021

In Chemours Co. FC LC v. Daikin Industries Ltd. et al., 4 F.4th 1370 (Fed. Cir. 2021) reversed a PTAB decision finding the following claim to be unpatentable as obvious:<... Read more

Increased Burden in Drafting "Surviving" and "Useful" Utility Patents in the Life Sciences Industry Extends to Design Patents

Attorney: Grace Kim
October 15, 2021

Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular. There is an increasing burden on patent applicants and patentees to provide complex, lengthy, thoroughly written disclosures to satisfy the rising standards for written description and enablement, as well as the added pressure to draft multiple claims of varying scope.<... Read more

THE RECENT HHS' PLAN FOR GREATER FDA – USPTO COLLABORATION TO LOWER DRUG PRICES: WHY PHARMA PATENT COUNSEL NEEDS TO REVIEW FDA SUBMISSIONS

Attorney: J. Derek Mason, Ph.D., CLP
September 22, 2021

In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.<... Read more

PTAB ADOPTS IDENDEX IN FINDING MARKUSH GROUP NOT ENABLED

Attorney: Richard D. Kelly
September 7, 2021

     In Post Grant Reviews (PGR) the Patent Trial and Appeal Board (PTAB) may consider all statutory challenges to patent claims including those under 35 U.S.C. § 112. One such challenge was brought in Syngenta Crop Protection v. FMC Corp in PGR2020-00028 (Syngenta), decided August 31, 2021, against U.S.P. 10,294,202 (‘202 patent). The PTAB found all challenged claims, 1-3, 9-13, and 21-30, unpatentable as lacking an enabling disclosure commensurate in scope with the claims and a subset, claims 9 – 13, as lacking written description, 35 U.S.C. § 112(a).<... Read more