Patent Baristas

The Board of Patent Appeals and Interferences (BPAI) of the U.S. Patent and Trademark Office has combined three patent interferences into a single interference between Sepracor and Wyeth. The interference was declared to determine the priority of inventorship of claims directed to racemic O-desmethylvenlafaxine (ODMV) succinate.

Wyeth markets racemic ODMV succinate in the U.S. under the brand name Pristiq® for the treatment of major depressive disorder in adults. Sepracor, if it wins the interference, could end up owning the patent rights that would then be infringed by Wyeth’s sale of Pristiq.

The U.S. is — at least for now — a “First to Invent” country, rather than “First to File” as is the case in most other countries. While other countries set up a race to the patent office, inventors in the U.S. can file second but still prevail if they can show proper documentation that they invented first.

An inventor can trace back to the date of conception for the earliest date of invention that you can rely on as long as the inventor works diligently on it (no gap in effort) until either filing a patent application for the invention (constructive reduction to practice) or making it (actual reduction to practice).

The interference is between Wyeth’s U.S. patents 6,673,838 and 7,291,347, the two patents listed in the FDA’s publication entitled Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for Pristiq, and three of Sepracor’s pending U.S. patent applications, 10/720,134, 11/091,518 and 12/011,083.

The earliest application filing date asserted by Sepracor (April 6, 1999) is approximately 22 months earlier than the earliest application filing date asserted by Wyeth for its claims (February 12, 2001). The BPAI has set January 6, 2010 for oral arguments in this interference.

The Board combined the actions and added Count 5 showing an interference between the compound of claim 1 of U.S. Patent 6,673,838 (Hadfield) and claim 60 of application 10/720,134 (Jerussi), both of which read as:

A compound which is O-desmethyl venlafaxine succinate.

Other counts include oral dosage forms comprising O-desmethyl venlafaxine succinate. The Jerussi application was accorded an earlier constructive reduction to practice (i.e., benefit for the purpose of priority) of Application 09/527,442, filed 17 March 2000.

Sepracor filed motions to get the benefit of earlier filed provisional applications 60/167,906 (filed 30 Nov. 1999) and provisional application 60/127,938 (filed 6 Apr. 1999).  In the interference, Wyeth has raised an objection that (at least some) claims by Sepracor are invalid for failing to meet the written description requirement under §112 as well as objecting to the priority claims of the earlier filed Jerussi applications.

An interference occurs when an application claims subject matter that is the “same patentable invention” found in the claims of another application or issued patent. The Board of Patent Appeals and Interferences decides which entity invented the common invention first and that party wins the interference.

As part of the procedural mechanism for resolving interferences, the PTO prepares one or more “counts.” These counts define the scope of the subject matter (invention) in dispute. In general, priority of invention then goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice.

That is, priority goes to the party that has either: (1) the earlier date of conception and the earlier date of reduction to practice or (2) the earlier date of conception, but a later date of reduction to practice, coupled with a reasonably diligent effort to reduce the invention to practice from just before the other party’s date of conception until reduction to practice.

Note, however, that during the course of the proceedings both parties will have an opportunity to knock out or to limit the other party’s claims in the patent or application regardless of who invented first. For example, one party may show that the other party was not entitled to a patent in the first place because its claim or claims were not valid. In various circumstances, patent claims are often limited or thrown out if it is shown that a party did not have grasp of the invention as claimed at the time of filing.

These tactics have to be wielded carefully since an attack on patentability of an opponent’s claims corresponding to the count can also end up being an attack on the patentability of your own claims. In such cases, the parties thus have an opportunity to enact a type of mutually assured destruction by arguing that neither party should have a patent because the invention was already in the public domain.

Unlike the discovery available in federal district courts, the scope of discovery in interferences before the USPTO is fairly narrow. In the trial phase, the parties can present evidence in the form of testimony of various witnesses, which can be with exhibits, consisting of documents of all kinds, including laboratory notebooks, internal reports, publications, etc. Anything relevant to the issues in the interference may be introduced as an exhibit.

Generally, the parties will reach some state in the game where they decide to resolve the conflict through a settlement agreement. In settling, the parties will have to decide who would be entitled to priority under U.S. patent law. Usually, the parties give each other documents showing conception and reduction to practice and then they try to decide whether someone has enough evidence to prove an earlier date of invention.

In settlement, the parties can also try to resolve questions of patentability such as §112 issues. Often, a settlement will include licensing or cross-licensing, which may or may not include payment of royalties.