Post-Amgen Claiming Techniques in Focus

Last year’s landmark decision in Amgen V. Sanofi emphasized that “the more a party claims, the broader the monopoly it demands, the more it must enable.” That is, particularly when claiming a broad genus of antibodies, the specification cannot be a research assignment to engage in trial and error as to the recited claim scope.

Since that time and perhaps dealing with inadequate specifications filed prior to Amgen, prosecutors have considered whether fallback claiming techniques such as Jepson format claiming or mean-plus-function formatted claims can at least secure some protection in the case where broader claims fail.

The USPTO is now committed to providing clarity on these topics in In re Xencor.Continue Reading USPTO Appeals Panel to Clarify Antibody Claiming in MPF & Jepson Format

Latent OTDP Issues & Litigation

The Federal Circuit’s decision in In re Cellect clarified that patenting obvious variants of the same invention across multiple patents—Obvious-Type Double Patenting (OTDP)—can result in the elimination/reduction of Patent Term Adjustment (PTA). OTDP was fatal to the challenged Cellect patents given the expiration of the reference patent. This was because a terminal disclaimer to remedy OTDP is not possible after expiration. Earlier this year I explained ways to proactively insulate a patent portfolio from potential Cellect vulnerabilities.

For patent owners facing newly invigorated OTDP attacks in litigation, and where a terminal disclaimer can still be filed, the potential loss of significant PTA creates a strategic quandary.

A terminal disclaimer cannot be withdrawn once filed. So, if a patent owner simply files a terminal disclaimer to moot the OTDP challenge, years of additional patent term (PTA) may be unnecessarily surrendered where the patent owner might have won. But, if the patent owner loses on OTDP without a terminal disclaimer on file, the patent is invalidated.

Recently a patent owner attempted to resolve this quandary with a contingent terminal disclaimer.Continue Reading Contingent Terminal Disclaimers?

Claim Overlap Can be a Landmine for the Uninformed

Earlier this week the Federal Circuit decided In re Cellect, LLC, affirming the PTAB’s cancellation of claims for obviousness-type double patenting (ODP) over reference claims from earlier expiring patents in the same family in which differences in expiration dates were due solely to patent term adjustment (PTA).

For those in the SEP and Bio/pharma spaces, this is a call to action.Continue Reading Building Patent Portfolios – Post Cellect

Word Count Fees, Inflationary Bump, & Director Review

As I discussed earlier this week, the USPTO has released a laundry list of proposed practice changes for consideration — some, good, some bad, some ugly. One of the better ideas is allowing petitioners, for a commensurate expanded word count fee, to exceed the standard word count limit for a single petition such that larger claim sets can be addressed in a single filing. This avoids the current practice of splitting a single patent challenge across multiple petition filings.

The fees for the above proposal will be considered at a hearing next month, and are targeted to become effective for FY 2025. Additionally, existing PTAB filing fees are proposed to increase by 25%, justification for which is explained as a reaction to inflation and additional work resulting from Arthrex. And, finally, there is a new fee proposed for seeking Director Review.

Here’s the breakdown of the proposed increases and newly added fees:Continue Reading Increased PTAB Fees & Newly Proposed Costs

Examination Quality vs Speed

The USPTO has had an accelerated examination program known as “Track-1” since 2011. The program allows patent applicants to advance a patent application out-of-turn such that a determination can be made within 12 moths of filing. That is, like a Lightning Lane of sorts (for you Disney fans) to skip the typical wait times for patent examination. In this way the program is said to be designed to foster “faster innovation.”

In theory, it is a great idea. If you are a start-up, for example, and need to get your claims allowed quickly for business reasons. Paying a fee for the expedited attention, agreeing not to extend filing dates of responses, and limiting the number of claims, is a fair compromise.

But, if patent examiners are rushed to judgement to meet internal deadlines, and do so without the most relevant information, the USPTO is doing the public a disservice. Recent trends also suggest that examiners may be moving these cases to allowance to get time-sensitive work off of their dockets.Continue Reading The PTO Has a Track-One Filing Problem

Long Battle Ahead for Patentable Subject Matter Clarity

Remember the good ole days when every bar meeting had that Alice panel that said the same thing over and over? (i.e., “your guess is as good as mine”) And by good ole days, I mean the days when you skipped that panel and caught up on your emails back in your room. 🙂

Well, here we go again.

With American Axle failing to tempt the SCOTUS, the message has become clear….”Congress, this is your mess to fix.” So, we now embark on yet another adventure on sorting out the patent world’s biggest hairball – and that’s saying something!Continue Reading Tillis Bill’s Shot Across the Bow on 101

Next Week’s CLE Agenda

For those seeking CLE this month, a number of great programs to consider in the coming weeks.

First up, the freebie 🙂

Next Tuesday, March 15th @ 1pm(EST) Gardella Grace presents the free one-hour webinar entitled In Possession of an Invention? Litigation Insights for Life Sciences Patent Drafting.  Presenters include