Effect of the Uruguay Round Agreement Amendments Upon Patent Term Extension

April 17, 1996 Advisory

This paper was originally presented on April 17, 1996 at the TWELFTH ANNUAL JOING PATENT SEMIAR hosted by the Connecticut Patent Law Association.

"It ain't over till it's over." Yogi Berra, American League M.V.P. Award
in 1954 and 1955 playing for the N.Y. Yankees Baseball Team.

"It ain't over even after it's over!" Robert E. Rich, Jr., 1994 Vice-Chair,
Board of Directors, Buffalo Sabres Hockey Club.

"It was déjà vu all over again." Attributed to Yogi Berra.

I. BACKGROUND DISCUSSION

An important effect of the Uruguay Round Agreements Act ("URAA") on the life of any patent, be it biotechnological, pharmaceutical, or other, is the new patent term of twenty (20) years from the filing date of the patent application. For commercially valuable patents, the tail end of the patent's life is typically the most economically valuable portion. There has been considerable controversy recently in the published intellectual property law literature about the downside risk associated with long pendencies and regulatory delay in regard to the patent term shortening consequences, as compared to the pre-URAA grant of 17 years from patent issuance.

In response, Congress acted to provide narrowly circumscribed relief in the form of patent term extension for prosecution delays attributable to interferences, secrecy orders, and the appellate review process by the U.S. Patent Office. The length of the term extension obtainable under one or a combination of these bases is five (5) years. In addition, regulatory review provides a separate and distinct basis for up to five (5) years. In addition, regulatory review provides a separate and distinct basis for up to five (5) years of patent term extension, after patent issuance, for certain food additives, drugs, and biotechnological products reviewed by the Food and Drug Administration ("FDA") or the U.S. Department of Agriculture (U.S.D.A.). Taking into account these two sets of bases for term extension, the maximum patent term, based upon a combination of a five year extension attributable to prosecution delay and a five year extension attributable to delay in regulatory approval after patent issuance, is thirty (30) years from filing.

The patent term extension opportunities for clients impose significant burdens on patent practitioners, necessitating a "hurry up and wait" prosecution strategy in order to maximize the patent term extension achievable. This paper provides methodology for aggressively responding to the URAA extension possibilities in light of the guidance afforded by recent writings on this subject, with particular attention to the impact on the biotechnological arts.

II. UNIQUE CONSIDERATIONS FOR BIOTECHNOLOGICAL PATENT APPLICATIONS

Patent applications relating to biotechnology typically have long pendencies in the Patent Office, almost invariably more than three years, and not infrequently between five and ten years. Pre-URAA patent applications, i.e. those that were pending prior to June 8, 1995, are entitled to the benefit of the longer of (a) 17 years from the patent issuance or (b) twenty years from the effective filing date of the patent application.8 Since the vast majority of these so-called "transitional" patent applications have been pending more than 3 years in the biotechnology field, it is advantageous to obtain the patent issuance based upon the pre-URAA patent term rules, rather than some later post-URAA filing, in order to avoid loss of the opportunity to take advantage of the seventeen years from issuance patent option. Accordingly, biotechnology patent appeals will be the option of choice in order to maintain this patent term opportunity, and re-filings causing post-URAA treatment should be undertaken only as a last resort.

The enhanced significance of patent appeals (as opposed to re-filings) for biotechnology, in view of the patent term advantage associated with pre-URAA filings, underscores the value of a conservative strategy for prosecuting these applications with an eye toward maximizing the portion of the prosecution time attributable to Patent Office delays. Suggested approaches are identified in the next section of this paper.

III. PROSECUTION STRATEGIES TO MAXIMIZE TERM EXTENSION FOR PROSECUTION DELAYS

What is a conservative prosecution strategy in view of the amendments brought about by virtue of the URAA? Largely, it is a common sense approach employing foresight by the patent practitioner to minimize total prosecution time, while maximizing the portion of prosecution time that can be attributed directly to Patent Office delays. Note that extensions for successful appellate review will be reduced by the Patent Office for lack of due diligence by the applicant during appellate review. Moreover, the patent term-shortening consequences of undue delay by the practitioner during appellate review could provide a basis for a malpractice claim against the practitioner.

In order to minimize prosecution time overall, consideration should be given to the following. First, conduct a comprehensive pre-filing patentability search to minimize the likelihood that a "road-block" prior art reference is uncovered during prosecution, since the surprise reference invariably adds to both the length and the difficulty of the prosecution. The pre-filing search provides the added benefit of enabling the practitioner to clearly identify and summarize the prior art in the "background" section of the patent application.

Second, consider consistently providing a verbal response to an Examiner's restriction requirement, in order to avoid the necessity of a separate Office Action for a written requirement. After receiving a final restriction, consider simultaneous filing of divisional patent applications in order to effect "parallel path" prosecution for all aspects of the invention(s) attributable to the originally-filed patent application.

Third, consider the use of preliminary amendments to provide a clearer, more focused, recitation of the invention. This strategy is increasingly needed in light of the rapid filing protocols of today's competitive environment, since the preliminary amendment option provides a more leisurely opportunity for a fresh look at the claims and specification after the rush to file has been completed. Care needs to be taken, in drafting the "remarks" section of the preliminary amendment, in order to avoid establishing an unfavorable file wrapper record, and to avoid suggesting rejections to the Examiner that otherwise might not materialize.

Fourth, consider providing a rapid response to an outstanding Office Action immediately upon receipt of the Office Action from the Patent Office. This is a recommendation that is easier said than done, but such a rapid response does help shorten the prosecution time. Never (say never) file petitions for extensions of time for responding to an outstanding Office Action. Such petitions create a record that might adversely impact a later petition for patent term extension due to prosecution delay by the Patent Office.

Fifth, consider programming the practitioner's docketing system to require a "status request" letter after a fixed interval of time has elapsed from the practitioner's last response. Such a protocol can help to move prosecution through the Patent Office, and can also help earmark misplaced or lost Patent Office files.

Sixth, avoid filing terminal disclaimers wherever possible, since a patent subject to a terminal disclaimer is not eligible for a patent term extension based upon a Section 154(b) prosecution delay.

Most importantly, in order maximize the portion of prosecution time that can be attributed directly to Patent Office delays (supporting a petition for a patent term extension under Section 154(b)9), consider filing a Notice of Appeal on the same day that a Final Rejection or second (non-final) Office Action is received from the Patent Office. The reason for this tactic is that the clock for patent term extension under Section 154(b) starts running on the date of the filing of the Notice of Appeal pursuant to Section 134.10

Other opportunities for obtaining effective patent term extension are provided using the vehicle of the provisional patent application discussed in the next section of this paper.

IV. PUSHING THE PATENT TERM ENVELOPE VIA PROVISIONAL APPLICATIONS

The provisional application for a patent is tantamount to a domestic priority document that does not start the twenty year clock running, but does provide the benefit of a priority date for purposes of Sections 102(e) and 102(g). Use of the provisional application route enables a term extension of up to one year, to provide an extended term of twenty-one years from the filing date of the provisional application.

Since more than one "regular" patent application can be filed off of a provisional, consider the possibility of using a "stack and roll" filing protocol.11 Following this methodology, several inventions are "stacked" into a single "combined" provisional application. The "inventive entity" for the combined provisional would be the sum total of all of the inventors for the individual inventions in the stack. Before the expiration of one year from the filing date of the provisional, a separate regular patent application would be considered for each individual invention within the stack.

As another alternative, consider the following strategy to achieve both term extension afforded by the provisional filing, and a shortened total prosecution time. First, file the original application as a Section 111(a) regular application. Next, convert the Section 111(a) regular application into a Section 111(b) provisional (having the benefit of the filing date of the regular application) by filing the required petition and fee within twelve months of the filing date of the regular application. Second, convert the Section 111(b) provisional application back to Section 111(a) regular application, to enable continued prosecution of the application, and to start the clock running on the "normal" twenty year term.12 Using this procedure, it is possible to get up to one year of prosecution of the first regular application without having that one year count toward the twenty year patent term.13

V. IMPACT OF THE URAA ON TERM EXTENSION VIA REGULATORY REVIEW

When drafting the amendments resulting from URAA, Congress recognized that extending patent terms might adversely impact competitors having made significant investments in third party-patented technology on the expectation that of entering the market upon the original expiration date of the subject patent. In light of this scenario, Congress created a "safe harbor" to govern actions by competitors during the safe harbor period between the original and extended patent expiration dates, commonly referred to as the Delta period.14 The Court of Appeals for the Federal Circuit has recently spoken with respect to the relief available for infringements that take place during the Delta period, holding that infringing acts during this period do not become non-infringing by virtue of the safe harbor.15 Rather, the remedy under these circumstances is based upon equitable relief requiring equitable remuneration to the patentee. Patent practitioners must be aware of this relief provided in Section 154(c)(3) of the Patent Statutes when providing counsel to biotechnological and pharmaceutical clients.

VI. CONCLUSION

The changes brought about by virtue of the amendments to the URAA are radically changing the way the prosecution attorneys do business. Knowledge of the changes and a pro-active strategy by the patent practitioner to minimize total prosecution time, while maximizing the portion of prosecution time attributable directly to Patent Office delays, are essential components of good practice for the post-URAA days ahead.

Endnotes

  1. The research assistance of Robert Scott Hauser, an Associate at Wiggin & Dana, is gratefully acknowledged.
  2. See 35 U.S.C. 154c(1).
  3. 35 U.S.C. 154(b).
  4. 35 U.S.C. 134.
  5. See generally Bulletin of the American Intellectual Property Law Association, October-November-December 1996, page 55.
  6. See Charles E. VanHorn, "Practicalities and Potential Pitfalls When Using Provisional Patent Applications", AIPLA Quarterly Journal, Volume 22, Numbers 3 & 4, page 295 (Summer/Fall 1994).
  7. When first filing or later filing a provisional application, it is important to insure that the 35 U.S.C. 112 disclosure requirements are met, including best mode. See generally, Dale L. Carlson, "The Best Mode Requirement in Patent Practice", New England Law Review, Volume 13, Number 2, pages 247-262 (1977); and Dale L. Carlson, "The Best Mode Requirement in Patent Practice Revisited - Unique Considerations Relating to Biotechnology", Sixth Annual Joint Patent Seminar, pages v23-v29 (Penta Hotel, May 1, 1990).
  8. See Dupont Merck Pharmaceutical Co. v. Bristol-Myers Squibb Co., 35 U.S.P.Q. 1718 (C.A.F.C., Aug 8., 1995).
  9. Bristol-Myers Squibb Co. v. Royce Laboratories Inc., 36 U.S.P.Q. 2d 1641 (Nov. 1, 1995), cert. denied 95-737 (64 LW 3467 Jan 9, 1996).