Following up on Rocco's discussion of obviousness-type double patenting (OTDP), I have some thoughts on the PTO's proposed rule changes to OTDP and terminal disclaimer practice.
In May, the patent office proposed a rule in which "to overcome double patenting the patentee would need to agree that the patent with the terminal disclaimer will be enforceable only if the patent is not tied and has never been tied through one or more terminal disclaimers to a patent in which any claim has been finally held unpatentable or invalid over prior art." By now the proposed rule changed to obviousness-type double patenting and the filing of terminal disclaimers has been heavily discussed, and heavily criticized.
As many have discussed, it seems highly unlikely this rule would pass, and questionable whether the patent office even has the authority to pass such a rule in light of a Congressional statute that unequivocally stated "Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims." 35 U.S.C. ยง 282. Nor does it seem particularly fair to patentees to make such a rigid rule in which a single overly broad claim could invalidate an entire patent family.
But the concern of the patent office is quite valid, as practitioners in the ANDA field are quite aware, litigation costs can balloon when patentees seek numerous continuations and create what some call a "patent thicket," or serially bring continuation patents in new litigations. And it does seem materially unfair to Defendants to repeatedly face litigation on claims the patent office deemed materially indistinct from invalidated claims, each time obtaining a fresh presumption of validity, requiring clear and convincing evidence to overcome.
While I admittedly have not exhaustively reviewed the writing on this topic, there seems to me a simple and obvious compromise that I have not seen discussed, that would preserve a patentee's right to continue to assert related claims while protecting Defendants from serially having to prove invalidity by clear and convincing evidence: for any patent which contains a terminal disclaimer over an invalidated patent, shift the burden to the patent owner to prove by a preponderance of the evidence that the claims are patentably distinct and thus valid.
This would seem to be a fair compromise, in that a patentee who essentially acquiesces to a finding that the claims are not patentably distinct in the patent office must bear the burden of proving otherwise in court, while avoiding a rigid rule in which a single invalidated claim knocks out an entire family.
I tend to agree that this change cannot come from the patent office. But given that OTDP is a judge-made doctrine, it seems like the change could come from the judiciary in addition to Congress. Indeed, a panel of the Federal Circuit appeared to come pretty close to this compromise in SimpleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018), but determined it was bound by earlier precedent.
In an opinion authored by Judge Lourie, the panel stated "Although a terminal disclaimer does not conclusively show that a child patent involves the same cause of action as its parent, the terminal disclaimer is still very relevant to that inquiry" and "a terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent." "But as our precedent indicates, that strong clue does not give rise to a presumption that a patent subject to a terminal disclaimer is patentably indistinct from its parent patents." Specifically Judge Lourie wrote, "our cases foreclose the inference that filing a terminal disclaimer functions as an admission regarding the patentability of the resulting claims" and, perhaps suggesting to the defendant that it seek en banc hearing, stated "As a panel, we lack the authority to deviate from this precedent."
Interestingly, Google did file a petition for rehearing en banc, but did not argue for any rebuttable presumption. Rather, it appeared to argue for an absolute rule akin to that proposed by the Patent Office. The Federal Circuit did take the somewhat unusual step of inviting a response, but ultimately denied the petition for en banc hearing without comment or dissent.
I do wonder if at least Judge Lourie might have been interested in taking the case en banc to address a compromise position, such as a rebuttable presumption. Perhaps someone will try this and we'll see what the Federal Circuit's appetite is. That seems more likely to me than Congress intervening, though perhaps the PTO's actions will force Congress to act. But this does seem to be an issue gaining attention, and I expect we'll see some changes sooner rather than later.
I welcome any thoughts or comments anyone has!
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