Considerations, concerns and recommendations in calculating patent expiry dates for United States patents

Considerations, concerns and recommendations in calculating patent expiry dates for United States patents

World Patent Information 37 (2014) 14e18 Contents lists available at ScienceDirect World Patent Information journal homepage: www.elsevier.com/locat...

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World Patent Information 37 (2014) 14e18

Contents lists available at ScienceDirect

World Patent Information journal homepage: www.elsevier.com/locate/worpatin

Considerations, concerns and recommendations in calculating patent expiry dates for United States patents Frazer McLennan* Shelston IP, Level 21, 60 Margaret St, Sydney, NSW 2000, Australia

a b s t r a c t Keywords: USA Patent expiry Earliest effective filing date Benefit claiming Patent term adjustment Terminal disclaimer

Calculating United States patent expiries for continuing applications involves determining the earliest effective filing date, and is by no means straightforward, especially for chains of applications stretching over 20 years. The United States Patent and Trademark Office provides many definitive answers to the factors determining an expiry date, but leaves one as a great unknown, the earliest effective filing date. A summary of the requirements for claiming the benefit of an earlier filed application is provided, along with examples highlighting the difficulty experienced. Ó 2014 Elsevier Ltd. All rights reserved.

1. Introduction Calculating patent expiries for most countries is relatively straightforward. Some countries even calculate it for you and display it in a field in their online databases. In many cases it is a matter of adding 20 years to the filing date of the application. For example, AU 747547 has a filing date of 16 July 1999, and adding 20 years gives an expiry date of 16 July 2019. Why then, is it so difficult to accurately calculate expiry dates for US patents, and be confident in your answer? The commonly held view of how to calculate US patent expiry dates is as follows: (1) For applications filed prior to, and still in force or pending on, 8 June 1995, the expiry date is the later of 17 years from the issue date, and 20 years from the filing date. a. For example, US 5219846 has a filing date of 20 December 1991 and an issue date of 15 June 1993. Adding 20 years to the filing date gives 20 December 2011, and adding 17 years to the issue date gives 15 June 2010. The expiry date is the later date, 20 December 2011. (2) For applications filed on or after 8 June 1995, the expiry date is 20 years from the date of the earliest related application, or where there are no earlier applications, the filing date. a. For example, US 6472448 has a filing date of 27 March 2001. There are no earlier related applications, so adding 20 years to the filing date gives 27 March 2021 as the expiry date.

b. A further example, US 7105503 has a filing date of 15 February 2002, but in this case there are earlier related applications. These are a continuation-in-part, filed on 22 December 2000, of US 6436915, which is a continuationin-part, filed on 7 April 2000, of US 6214813. The earliest related application has a filing date of 7 April 2000, so adding 20 years gives 7 April 2020 as the expiry date, and not 15 February 2022. These examples however conveniently ignore a number of additional factors that may influence the expiry date such as terminal disclaimers or patent term adjustments. These dates can be obtained from a number of expiry date calculators or guides found online, and they also ignore the additional factors as I have done as they require a bit of manual digging around in the USPTO’s PAIR (Patent Application Information Retrieval) [1] to discover what the particular terminal disclaimer is or the size of the patent term adjustment. I can happily say that my expiry date estimates for the three patents above correspond with those provided by two free patent term calculators located online (PatentLens [2] and MaxVal [3]), such is the extent of these commonly held views. Why then am I not confident in my estimations? With simple examples such as these I am confident, but as the number of continuations or continuations-in-part or divisionals grows, my confidence starts to fall. Situations where the continuing applications span more than 20 years are particularly troublesome. 2. The law, MPEP advice, and relevant decisions

* Corresponding author. E-mail address: [email protected]. 0172-2190/$ e see front matter Ó 2014 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.wpi.2014.01.004

Before I provide some specific examples we should consider the requirements for claiming the benefit of an earlier filed application in the United States.

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35 USC 120 states [4] An application for [a] patent for an invention disclosed . in an application previously filed in the United States, which is filed by an inventor or inventors named in the previously filed application shall have the same effect . as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. MPEP 201.11 discusses the requirements of an application that is claiming the benefit of the filing date of an earlier filed application under 35 USC 120. Part III Reference to Prior Applications states in its introduction [5] The third requirement of the statute is that the later-filed application must contain a specific reference to the prior application. This should appear as the first sentence of the specification following the title preferably as a separate paragraph and/or in an application data sheet. Further, in Part III C. Benefit Claims to Multiple Prior Applications, it states Sometimes a pending application is one of a series of applications wherein the pending application is not copending with the first filed application but is copending with an intermediate application entitled to the benefit of the filing date of the first application. If applicant wishes that the pending application have the benefit of the filing date of the first filed application, applicant must, besides making reference to the intermediate application, also make reference to the first application. The reference to the prior applications must identify all of the prior applications and indicate the relationship (i.e., continuation, divisional, or continuation-in-part) between each nonprovisional application in order to establish copendency throughout the entire chain of prior applications. There is no limit to the number of prior applications through which a chain of copendency may be traced to obtain the benefit of the filing date of the earliest of a chain of prior copending applications. In relation to the term of a patent resulting from a benefit claim to an earlier filed application, 35 USC 154(a)(2) states [6] TERM.-Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120 . from the date on which the earliest such application was filed. Particularly in relation to continuing applications, MPEP 2701 Patent Term, in discussing 35 USC 154, further states [7] A patent granted on a continuation, divisional, or continuation-inpart application that was filed on or after June 8, 1995, will have a term which ends twenty years from the filing date of earliest application for which a benefit is claimed under 35 U.S.C. 120 . regardless of whether the application for which a benefit is claimed under 35 U.S.C. 120 . was filed prior to June 8, 1995. The language used to differentiate earlier filed applications is important. 35 USC 120 makes reference to a “previously filed

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application” and an “earlier filed application”, and not to the “first filed application” which appears in MPEP 201.11 Part III C. 35 USC 154 refers to “an earlier filed application” and MPEP 2701 refers to the “earliest application for which a benefit is claimed” rather than the first filed application thus leaving it open to be other than the first filed application. This is discussed in Sticker Indus. Supply Corp. v. Blaw-Knox Co., 405 F.2d 90, 160 USPQ 177 (7th Cir. 1968) [8] Congress may well have thought that Section 120 was necessary to eliminate the burden on the public to engage in long and expensive search of previous applications in order to determine the filing date of a later patent. Indeed, the fact that each application in a long chain grows out of the one immediately preceding it does not necessarily mean that the invention finally described in the last application could properly claim the filing date of the first application even if the cross-references were complete. This also explains why the last clause of Section 120 refers to ‘the earlier filed application’ rather than the ‘first application’. Although Section 120 may not be ideally drafted, it is clear to us that the ’earlier filed application’ means the first application whose filing date is being claimed by the applicant. The inventor is the person best suited to understand the relation of his applications, and it is no hardship to require him to disclose this information. 35 USC 120 further states [4] No application shall be entitled to the benefit of an earlier filed application under this section unless an amendment containing the specific reference to the earlier filed application is submitted at such time during the pendency of the application as required by the Director. The Director may consider the failure to submit such an amendment within that time period as a waiver of any benefit under this section. After The Patent Act of 1952 was enacted, the Examiner-inChief, P J Federico, produced a commentary on the new Act [9], and stated, in relation to the specific reference to an earlier filed application, The third requirement of the statute is that the second application must contain a specific reference to the first application. In view of this requirement the right to rely upon a prior application may be waived or refused by an applicant by refraining from inserting a reference to the prior application in the later case, although it is difficult to imagine a situation in which this right would be deliberately waived. In a Q & A session entitled Questions and Answers Regarding the GATT Uruguay Round and NAFTA Changes to U.S. Patent Law and Practice, published by the USPTO on 23 February 1995, in the subsection “20-year Patent Term”, it was asked [10] 3. Does an applicant have to claim the benefit of an earlier filed application? Can you adjust the start of the period of the 20-year patent term by not claiming the benefit of a parent application? The answer was An applicant has full control over claims to the benefit of an earlier filing date under 35 U.S.C. 120. The 20-year term will be based upon the filing date of the earliest U.S. application that the applicant makes reference to under 35 U.S.C. 120. Whether an applicant is entitled to the benefit of the filing date of an earlier application is something that an applicant should examine before the patent is

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issued. . Applicant however should determine whether the claims that are about to issue are entitled to or require the benefit of the earlier filing date. If not, the applicant should consider not claiming the benefit of the earlier filing date to avoid having the 20-year patent term measured from that earlier filing date. It appears that “wishes” in MPEP 201.11 Part III C. is the operative word. If an applicant wants to claim the benefit of an earlier filed application then, assuming all other legalities hold true, they need to amend the specification to include a reference to a chain of earlier filed applications that indicate their benefit claim. There does not appear to be any requirement that they include every application back to the first filed application; only that they include those linking back to the earliest filed application they wish to claim benefit from. In most cases it probably will be the first filed application, but not always. It appears that they are able to waive the right to rely on an earlier filed application by not inserting the relevant reference, or they lose the right by neglecting to insert any or all of the correct reference. Not referencing an earlier filed application can lead to issues of prior publication. Although the rules regarding prior art discuss abandoned applications, including those that are continuations which may take an earlier filing date, the discussion is not specific to later applications that have not referenced all earlier filed applications, although in terms of subject matter an earlier abandoned application would be the most relevant. The subject matter of an unpublished abandoned application or the subject matter removed, either by cancellation or redaction, from a specification prior to publication can find its way into the public domain, either by the file wrapper becoming available in PAIR or by publication of an international application, and thus may be used as prior art against a later filed application that does not claim benefit from an earlier filed application [11]. The usual situation is that an application is published eighteen months after filing, and becomes available as prior art against a later filed application not claiming benefit from it or an earlier filed application. Even if the earlier application later becomes abandoned, its effective filing date is determined in the same manner, by references to earlier filed applications. 3. Examples and discussion For example, US 5965581 includes a reference to a single earlier filed application, US Serial No. 08/965922 as a continuation-in-part, which was filed on 7 November 1997. However, US Serial No. 08/ 965922, issued as US 5972967 on 26 October 1999, is not the earliest filed application. US 5972967 is a divisional of US Serial No. 08/735878, issued as US 5733919, and filed on 23 October 1996. US 5733919 is the first and earliest filed application. The applicant had the opportunity to claim benefit of the first filed application but chose, either actively or by neglect, to claim benefit from the intermediate earlier filed application rather than the first filed application. The expiry date, according to 35 USC 154, is 20 years from the filing date of the referenced earlier filed application, which is 7 November 1997, making the expiry date for US 5965581, 7 November 2017. This is supported by Hovlid v. Asari, 305 F. 2d 747, 134 USPQ 162 (9th Cir. 1962) [12]. The applicant had three applications: 03/ 404688 filed on 18 January 1954 but later abandoned, a continuation of that application, US 2748075 filed on 29 November 1955, and a divisional of the second application, US 2868525 filed on 12 March 1956. The divisional contained a reference to its parent application but not the first filed application. The parent application contained a reference to the first filed application. It was held,

by the District Court in the first place, and later confirmed by the Court of Appeals, that [the] appellant’s second patent contained no reference whatsoever to appellant’s abandoned application and, therefore, his second patent was invalid under Section 102(b) of the Patent Act of 1952, 35 U.S.C. 102(b) by reason of the public use and sale of the device in March of 1954; i.e., more than one year prior to November 29, 1955. November 29, 1955 (the date appellant filed his application which matured into his first patent) was held by the district court to be the earliest filing date to the benefit of which the application for appellant’s second patent was entitled. The Court of Appeals’ decision further stated It seems clear that if the benefit of the filing date of a prior application is claimed, the subsequent application must contain or be amended to contain a reference in the specification to the prior application identifying it by serial number and filing date and indicating the relationship of the applications. Having failed to state the serial number, filing date and the relationship of the second patent to the abandoned application, there seems to be a complete failure to comply with Rule 78 and Section 120, and consequently, a waiver of the benefits afforded by the latter section. The next example relates to US 7477268. This application contains the following paragraph that references earlier filed applications. This application is a continuation of U.S. patent application Ser. No. 10/776,389, filed on Feb. 10, 2004, now U.S. Pat. No. 7,372,473 which is a divisional application of U.S. patent application Ser. No. 10/082,527, filed on Feb. 22, 2002, now issued as U.S. Pat. No. 6,778,195, which is a continuation application of U.S. patent application Ser. No. 09/551,411, filed Apr. 18, 2000, now issued as U.S. Pat. No. 6,366,303, which is a continuation application of U.S. patent application Ser. No. 08/104,251, filed Aug. 9, 1993, now issued as U.S. Pat. No. 6,061,062, which is a continuation application of U.S. patent application Ser. No. 07/811,830, filed Dec. 20, 1991, now abandoned. US Serial No. 07/811830 is the first filed application, and has a filing date of 20 December 1991. As US 7477268 references all earlier filed applications it would be reasonable to say that it is claiming benefit from the first filed application. This would give it an effective filing date of 20 December 1991 and as such an expiry date of 20 December 2011. Everything is clear up to this point, except when you view the relevant record in PAIR you find that the applicant paid the 4th year maintenance fee on 13 June 2012, which is about 6 months after the “expiry” date. It would appear that the applicant, although having referenced all earlier filed applications in the specification, is not claiming benefit from the first filed application, and there is no indication as to which earlier filed application they are claiming benefit from. The obvious question is, why still maintain a patent if it has expired? Furthermore, US 7477268 is not the latest application. US Serial No. 12/116906, published as US 2008204477, was filed on 7 May 2008. It too references all of the earlier filed applications, including US 7477268, and as such should have expired on 20 December 2011. The Non-Final Rejection sent by the US examiner on 22 February 2012 contains the following objection. This patent application is a child of many parent applications with the ultimate parent . being filed on December 20, 1991 which is

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more than twenty years ago. In view of MPEP 2701 . the term for this patent application has expired. This was not the sole objection. There were other objections relating to priority, fair basis and obviousness so in the examiner’s mind the application was still being prosecuted. Eventually the application was abandoned but whether it was a result of the patent expiry objection or the others we will never know. These examples indicate where my uncertainty comes from. If the rules for determining the expiry date as stated above are followed, then the answer does not reflect reality. What the reality is, I’m not sure. A proposal to alter Rule 78 of the Patent Rules to require the applicant to identify the claims in a continuation-in-part application that were relying upon an earlier filed application, and hence identify the benefit claim of the earlier filing date, was made under former Director of the USPTO, Jon Dudas, but was challenged and subsequently dropped. Any other claims in the application would have been given the filing date of the application. If this had been a requirement under Rule 78 then we may have some reason to say that US 7477268 has a number of claims with a filing date of 28 December 2006, and is therefore entitled to an expiry date of 28 December 2026 for those claims. The problem with that is there must also be a number of claims claiming benefit from an earlier filed application, with an earlier filing date and also an earlier expiry date. A single application with two filing dates and two expiry dates doesn’t make sense, and would probably require some form of legal determination of the true expiry date, although examiners are required to make these decisions when rejecting a claim on the basis of relevant prior art. MPEP 706.02 Rejection on Prior Art VI. DETERMINING THE EFFECTIVE FILING DATE OF THE APPLICATION The effective filing date of a U.S. application may be determined as follows: (A) If the application is a continuation or divisional of one or more earlier U.S. applications or international applications and if the requirements of 35 U.S.C. 120 and 365(c), respectively, have been satisfied, the effective filing date is the same as the earliest filing date in the line of continuation or divisional applications. (B) If the application is a continuation-in-part of an earlier U.S. application or international application, any claims in the new application not supported by the specification and claims of the parent application have an effective filing date equal to the filing date of the new application. Any claims which are fully supported under 35 U.S.C. 112 by the earlier parent application have the effective filing date of that earlier parent application [13]. However, US 7477268, is not a continuation-in-part. The paragraph referencing the earlier applications clearly states that it is a continuation application, which is considered to be one of the three separate types of continuing applications, and its claims therefore take the earlier filing date in their entirety as stated in MPEP 706.02 VI (A) above; we just don’t know what the earlier filing date is. If we have a closer look at other factors influencing the expiry date such as patent term adjustments and terminal disclaimers in an attempt to explain the confusion, we don’t fare any better. 3.1. Patent term adjustment and terminal disclaimers Viewing the record for US 7477268 in PAIR we can see that there was no delay on the part of the USPTO so there is a zero day figure for the patent term adjustment.

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There are five terminal disclaimers relating to US 7477268. Four of them relate to the chain of referenced earlier filed applications, and the fifth is a member of the same patent family. The earliest filed of the applications in the terminal disclaimers is US 6061062. It was filed prior to 8 June 1995, so its expiry date is the later of 20 years from the earliest filing date it claims benefit of, 20 December 1991, or 17 years from its issue date, 9 May 2000. This makes the expiry date 9 May 2017. It has been suggested [14] that US 7477268 is riding on the coat tails of US 6061062 as a result of the terminal disclaimer; essentially postponing its expiry, in an attempt to explain this anomaly. The relevant rule is Patent Rule 321 [15]. 1.321 Statutory disclaimers, including terminal disclaimers. (a) A patentee owning the whole or any sectional interest in a patent may disclaim any complete claim or claims in a patent. In like manner any patentee may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted. A terminal disclaimer applies to the terminal part of the term, and it relates to an applicant giving away their rights. There is nothing that says a patent term is extended beyond its expected expiry date as a result of relying upon another application to limit the term of another. US 6061062 may have been filed prior to 8 June 1995 but US 7477268 was not, and as such is subject to a maximum twenty year term only, calculated from the earliest referenced filing date. If the filing date of US 6061062 is that earliest referenced date then that is 9 August 1993, which would make the expiry date of US 7477268, 9 August 2013. This could explain why maintenance fees are still being paid on US 7477268; but still doesn’t explain why the first filed (and earliest referenced) application hasn’t been used. The same argument will apply to any of the other earlier filed applications in the chain of continuing applications, each with a different possible expiry date. 4. Concluding remarks There doesn’t appear to be anything in US patent law and the examiner’s manual as quoted above to indicate a requirement to state which earlier filed application the applicant is claiming benefit from other than having to insert a reference to it. If that earliest filed application happens to be part way down a list then that appears to be acceptable. The Leahy-Smith America Invents Act [16] does not address this issue, thus leaving Section 120 and Rule 78 in their current ambiguous state. A cynical approach to take is concluding that a later filed application will contain a complete list of all earlier filed applications, regardless of whether or not benefit is actually claimed from the earliest filed application, merely to avoid potential prior art objections arising from unlinked earlier applications. The example above is not an isolated case. If you can, conduct a search for patent families where there is a filing date in the early 1990s and a publication date after 2010. Such a search reveals hundreds, if not thousands, of similar examples, and that’s only the extreme situation. There will be many more patent families where this issue is only just starting. We are often told not to rely entirely upon patent term expiry calculators or other indications as to a patent’s status or expiry date, but instead to seek legal advice or confirmation from the relevant national register as this will be the most accurate and up to date information. However in the case of the USPTO, unless there is a clear indication that a patent has expired or been abandoned, we have to assume that a patent is still current. There is no calculation of the anticipated expiry date, and no clear way of calculating it ourselves.

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I understand that many factors come into play here. There are some factors that the USPTO has definitive answers for; factors such as the filing date of the application, patent term adjustments, patent term extensions, terminal disclaimers and statutory disclaimers. Then there appears to be a factor for which the USPTO has an answer but one which is not clearly defined; and that is benefit claims. If a clear indication could be made as to the benefit claim, then the rest is easy, and an expiry date calculated. Once we can confidently predict an expiry date then viewing the maintenance fee records in PAIR will make it clear if a patent is still current. Editor’s note The following publications relating to the patent term and expiry dates of US patents may also be of interest to readers: - Tridico Ph.D., Anthony C. You May Be Entitled to Additional Patent Term: Recent Developments in U.S. Patent Term Adjustment. CIPA Journal, March 2013. - Anne Marie Clark, Heidi Berven. The face of the patent is not the “Whole Story”: determining effective life of a pharmaceutical patent in the United States. World Patent Information, 26(4), 2004, 283e295. - Richard E. Caves, Michael D. Whinston, Mark A. Hurwitz, Ariel Pakes and Peter Temin. Patent Expiration, Entry, and Competition in the U.S. Pharmaceutical Industry. - Brookings Papers on Economic Activity. Microeconomics. 1991, (1991), 1e66. References [1] USPTO Patent Application Information Retrieval (PAIR), . [2] PatentLens, 2012, Cambia, Australia, http://www.patentlens.net/, [accessed 13.09.12]. [3] MaxVal, 2012, MaxVal Group, California, http://www.maxval-ip.com/, [accessed 13.09.12]. [4] 35 U.S.C. 120 Benefit of earlier filing date in the United States. Patent Laws, , [accessed 12.09.12].

[5] MPEP 201.11 Claiming the Benefit of an Earlier Filing Date Under 35 U.S.C. 120 and 119(e) e 200 Types, Cross-Noting, and Status of Application, , [accessed 13.09.12]. [6] 35 U.S.C. 154 Contents and term of patent; provisional rights. Patent Laws, , [accessed 12.09.12]. [7] MPEP 2701 Patent Term e 2700 Patent Terms and Extensions, , [accessed 12.09.12]. [8] Sticker Indus. Supply Corp. v. Blaw-Knox Co., 405 F.2d 90, 160 USPQ 177 (7th Cir. 1968), , [accessed 21.09.12]. [9] Commentary on the New Patent Act, Federico P J, 1952, , [accessed 20.09.12]. [10] Questions and Answers Regarding the GATT Uruguay Round and NAFTA Changes to U.S. Patent Law and Practice, , [accessed 12.09.12]. [11] MPEP 901 Prior Art, , [accessed 29.07.13]. [12] Hovlid v. Asari, 305 F. 2d 747, 134 USPQ 162 (9th Cir. 1962), , [accessed 21.09.12]. [13] MPEP 706.02 Rejection of Claims, , [accessed 21.09.12]. [14] Question about the patent term, , [accessed 12.09.12]. [15] MPEP e Patent Rules, , [accessed 21.09.12]. [16] Leahy Smith America Invents Act, 2011, , [accessed 25.09.12].

Frazer McLennan has extensive knowledge of patent searching with almost 20 years experience. After working for 7 years as a Patent Examiner at the Intellectual Property Office of New Zealand, Frazer spent over five years in industry at GenericsWeb e 4 years as a senior searcher and a further year as their Information Manager. He has been with Shelston IP since 2008, providing patent information support across all teams, with a particular emphasis on chemical and pharmaceutical subject matter. Frazer’s undergraduate work in relation to the preparation of new Indium (III) compounds has been published and cited in the academic literature.