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

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

The USPTO Strikes Again: More First Action Final Rejections = More Money + Diminished Quality

September 17, 2020

While looking at a first action final rejection after an RCE that I received this week from an Examiner that I respect, I was asking myself why I had received what appeared to be such a shockingly improper action. The answer was provided to me during part of the on-going IPO annual meeting.... Read more

RCE/National Stage Kerfuffle: PTO Creates a Nightmare Scenario

August 6, 2020

Much has been written lately about the USPTO's recent enforcement of its controversial interpretation of filing Requests for Continued Examination (RCE) in National Stage applications (i.e., applications under 35 U.S.C. §371) where the oath/declaration was not filed prior to filing the RCE. This post will not address the legal merits of the USPTO's position.... Read more

Final Rules on PTA Calculations in View of Supernus

June 24, 2020

Although long overdue, the U.S. Patent and Trademark Office (USPTO) released its Final Rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu (85 Fed. Reg. 36335-36342, June 16, 2020). Unfortunately, the Final Rule does not fully address Supernus.<... Read more

Update & Reminder: Patent Term Adjustment Related to IDS Safe Harbor

July 5, 2019

On November 9, 2018, I wrote about the USPTO's release of interim procedures for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (https://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972).... Read more

USPTO's Patent Term Adjustment Policies Reigned in Yet Again

January 28, 2019

Since the Federal Circuit’s decision in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008), which held that the USPTO was improperly reducing patent term adjustment (PTA) by improperly calculating “overlapping” days of agency delay under 35 U.S.C. §154, the courts have been asked on numerous occasions to look at how the USPTO is calculating PTA. Not every case has been decided in favor of the challenger, but a fair amount has. In addition, the USPTO has identified several internal errors including not accounting for the IDS safe harbor under 37 C.F.R. §1.704(d). As such, patentees should be very mindful of this evolving and important provision of law.<... Read more

USPTO Releases Interim Procedure for Requesting Recalculation of Patent Term Adjustment Related to the IDS Safe Harbor

November 9, 2018

On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf).  The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.<... Read more

Is Real and Positive Change Coming for Patent Owners?

June 11, 2018

New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more