double patenting

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PTAB-legislation
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

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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A terminal disclaimer cannot be withdrawn once filed.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?

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?

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?