Federal Circuit to Reconsider In re Cellect Carve Out?

Back in August, the Federal Circuit issued its long-awaited decision in Allergan v. MSN Laboratories Private Ltd. That decision distinguished In re Cellect as not generally deciding that a second later expiring patent can always serve as a proper OTDP reference. And more particularly that a first-filed, first issued, later-expiring claim cannot be invalidated by a later filed, later issued, earlier expiring claim (yes, its a mouthful).

Yesterday, that decision was petitioned for en banc review. Continue Reading Allergan OTDP Exception – Rehearing?

CAFC Distinguishes Cellect Based on First-in-Time Patent Term

Today the Federal Circuit issued its long-awaited decision in Allergan v. MSN Laboratories Private Ltd. As expected by many following the case, the Court decided that being “first” matters in double patenting scenarios—at least when the subject and reference patent claim a common priority. (here)

Allergan answers one question, but others remain. Continue Reading Allergan “First” Exception To Cellect OTDP Scenarios

Final Rule Package Expected in Fall

For those patent professionals living under a rock the past few months, the USPTO issued a notice of proposed rulemaking (NPRM) back in May that seeks to add a new stipulation requirement for terminal disclaimers filed to overcome non-statutory double patenting (here). Under the proposal, to overcome an obviousness-type double patenting rejection, the Applicant would need to stipulate that the entire patent subject to the terminal disclaimer will be enforceable only to the extent that the conflicting claims of the reference patent remain valid and enforceable. In other words, if conflicting claims of a reference patent fail, so too would all claims of the subject patent, including any patentably distinct claims.

The NPRM comment period closed yesterday and hundreds of public comments have been collected (here). Now what?Continue Reading Public Comment Period on Controversial Terminal Disclaimer Proposal Now Closed

Proposal to Thwart Rerun Patent Assertions

An inventor may obtain claims in a second U.S. patent that vary in only minor (patentably indistinct) ways from claims the same inventor obtained in a first patent. But the USPTO will typically reject the claims in the second application under the doctrine of “obviousness-type double patenting.” Inventors can overcome such rejections during prosecution to obtain the second patent (and many more thereafter if desired) by filing a terminal disclaimer. The language of the terminal disclaimer prevents the timewise extension of patent term through multiple filings and prevents the indistinct claims from being separately assigned. In this way, terminal disclaimers are designed to strike a balance between incentivizing innovation while providing more certainty and protection to the public.

Over the years, the terminal disclaimer has worked exactly as designed. However, the usual bad actors have driven the USPTO to propose its first change in decades.Continue Reading Terminal Disclaimer Proposal Driven By Rerun Lawsuits

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

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?

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

Term Act Seeks to Add New Bio/Pharma Litigation Hurdle

It was easy to miss last week’s introduction of a new patent reform bill on the House side entitled: “Terminating the Extension of Rights Misappropriated Act of 2019” with so much focus on the Senate’s patent subject matter eligibility hearings.  The “Term Act of 2019” is described as addressing “the rising cost of prescription drugs by significantly limiting the process known as “evergreening,” whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices.”

Under the heading “Prevention of Double Patenting” the bill seeks to add a special presumption for Orange Book patents directed to a same drug/biological product.
Continue Reading Bio/Pharma to Face Second Double Patenting Hurdle?