Bio/Pharma

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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

OTDP

Avoiding Cellect

The Federal Circuit’s In re Cellect ruling has significant implications for patent portfolios, emphasizing the need for careful planning to avoid obviousness-type double patenting (OTDP) that could compromise statutory term and patent validity. Particularly, patents with patent term extension (PTE) may face increased risk, as reference patents in the same family might have…

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Leveraging Written Description Vulnerabilities in IPR

Bio/pharma patents are rarely targeted in IPR proceedings because their technical vulnerabilities often relate to written description and/or enablement. IPR, of course, is restricted in scope to only grounds of unpatentability that are based on patents and printed publications. And claims in the unpredictable arts, even when challenged in IPR, can be relatively tougher to invalidate as compared to patents in the predictable arts.

That is not to say that 112 issues cannot be litigated in an IPR—only that 112 cannot be a stand-alone trial ground. For example, where a subject patent claims priority to one or more prior filings, the 112 support of those filings is properly litigated in IPR if the claims of the subject patent are argued as lacking support in the earlier filings. The distinction is that 112 is not being assessed as a stand-alone challenge, but rather, as part of the priority assessment to determine the applicability of intervening prior art under 102/103.

The above IPR strategy is not new. However, it might be significantly more valuable to Bio/Pharma patent challengers as a mechanism to force an Amgen analysis on older patent portfolios via IPR.Continue Reading Amgen Analysis: An Emerging PTAB Threat For Bio/Pharma

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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

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Empirical Studies Refute Oft Repeated Fallacies

The PTAB released two studies on historical petition filing practices this month. One directed to the frequency of so-called serial/parallel petition filings, and the other pertaining to Orange Book/Biologics patents. As with the agency’s earlier studies on these same topics (2021), the refreshed data again demonstrates that Orange Book patents are very rarely subject to AIA trial proceedings, and that abusive, serial petition filings have been effectively outlawed for years now.

Of course anyone that actually practices before the PTAB is well-aware of these realities. So, these empirical studies are primarily directed to the oft repeated criticisms of moneyed lobbyists and disingenuous critics at a time when both Congress and the agency grapple with wildly conflicting narratives.Continue Reading PTAB Data Belies Outdated Criticisms

October Webinar to Debrief on Leahy Bill

Senator Patrick Leahy (D) VT and Senator John Cornyn (R) TX have jointly drafted a new bill entitled the “Restoring the America Invents Act.” The Bill proposes to roll-back recent directives and policies of former USPTO Director Iancu, most notably discretionary denials of AIA trial proceedings in view…

Same Questions, Different Rubric?

Senator Patrick Leahy has now proposed draft legislation to add Obviousness-Type Double Patenting (OTDP) to IPR jurisdiction. The argument for adding this potential ground is that it is an important control to combat improperly extended drug monopolies (the justification underlying much of the legislative proposal).  Whether this provision makes it to law is far from clear given the likely push back from Bio/Pharma.

In the meantime, a Pharma dispute recently argued that OTDP is basically the same PTAB obviousness analysis under a different rubric.  An awkward argument given the coming storm.
Continue Reading PTAB Estoppel & Double Patenting?

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Photo Boards, Unsplash
Bill Released – Iancu Era Rebuked

Well, the wait was not that long after all.  Senator Leahy -VT (D) (with co-sponsor Senator Cornyn – Tx (R)) has today released the draft bill entitled “Restoring the America Invents Act.”  The bill includes most of what I expected, with a handful of additional tweaks.

Below is a brief overview of all of the proposed changes.
Continue Reading Restoring the America Invents Act – What You Need to Know

Study Shows Bio/Pharma Patents Fare Better at PTAB

A few years back, the Patent Trial & Appeal Board (PTAB) released a study showing the outcome of proceedings directed to so-called “Orange Book” patents. That study demonstrated that Orange book/Biologic patents were more likely to survive PTAB proceedings relative to other patents. Last week, the 2018 study was updated.

The update shows the performance of Orange Book/Biologic patents at the PTAB since 2012.
Continue Reading Bio/Pharma Patents Fare Best at PTAB

Director Memo Decides Against Standard of In Re Packard

Back in 2018 I noted the current PTO administration had backed away from a dispute on the appropriate 112 standard to apply in AIA trials (after intervention by the previous PTO administration). That is, the initial intervention sought to support the application of the standard enunciated by In re Packard to AIA trial proceedings.  After Director Iancu came on board, that Intervenor Brief was withdrawn.

Today, the PTO formally announced (via memorandum) that the Nautilus standard applies to AIA trials – settling an open question….at least for the time being.Continue Reading PTAB Applies Nautilus 112 Standard to AIA Trials…For Now