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Pharmaceutical Manufacturing and Packing Sourcer

The Path to Protection

Over the past decade, patent practitioners and inventors alike found that the US Patent and Trademark Office (USPTO) was turning more and more into a black hole in which patent applications were deposited, never to come out on the other side as a granted US patent.Due to many factors, including court decisions and USPTO policy changes that made it more difficult to obtain allowances, the past decade has also seen a growing reluctance on the part of the USPTO to grant broad patents. On the other hand, this has led to reluctance on the part of speciality pharmaceutical and drug delivery companies to spend time and money preparing and filing patent applications, which would cover potential new products.Who could blame pharma companies for cutting back on patent filings in the face of the USPTO rejecting about two-thirds of their applications?

While the situation is changing somewhat, in that the USPTO reports that patent grants were up 35 per cent over 2009, are the patents being granted broad enough to provide useful protection? The answer is a mixed bag. This article addresses some useful ways to tilt the odds in your favour.

Accelerated Examination Programme

One of the major problems facing the industry is the slow pace of examination of patent filings. It is not unusual for the first communication from the examiner to be received two to three years after the application is filed.Moving the case to allowance often takes multiple backand- forth attempts with the USPTO, which typically adds on at least another year or two to the process. In many cases, this timeline is simply too slow to provide the necessary patent protection to encourage investors, or to ward off third party competition.

The USPTO has established procedures under which the examination of a patent application may be accelerated.Under one of these procedures, the USPTO will advance an application out of turn for examination if the applicant files a grantable petition to make special under the accelerated examination programme. According to its statistics, close to 40 per cent of accelerated patent applications are allowed via a first office action, and about 60 per cent are ultimately allowed.

Under the new USPTO accelerated examination programme, applicants must submit a complete patent application along with a petition and requisite fees, a pre-examination search, as well as an accelerated examination support document.The patent application must be submitted electronically via the EFS-Web system. It can have up to three independent claims, but no more than 20 in total.

In order to qualify for accelerated examination, the application must include a pre-examination search provided by the applicant and an accelerated examination support document.The pre-examination search must include a classified search of the US patents and published patent applications in the class and subclass where the claimed invention is most likely to be classified in the current US patent classification.The search is supposed to cover the subject matter of the independent claims using terms recognised in the art given their broadest reasonable interpretation, and should consider individual features by themselves and combinations of features.The USPTO also requires a text search of foreign patent documents.The accelerated examination support document (AESD) must include:

  • An information disclosure statement (IDS) citing each reference deemed most closely related to the subject matter of each of the claims. For each reference cited, the accelerated examination support document must include an identification of all the limitations in the claims that are disclosed by the reference specifying where the limitation is disclosed in the cited reference
  • A detailed explanation of how each of the claims are patentable over the references
  • A concise statement of the utility of the invention as defined in each of the independent claims; and a showing of where each limitation of the claims finds support in the written description of the specification
The AESD must be filed with the application and a petition to make special.

In order to ensure acceptance of the request for accelerated examination, the first step is to obtain a proper preexamination search. Searches typically carried out by pharma companies, or quick searches by patent counsel, will not suffice. Generally, an acceptable search costs around $2,000 to $4,000. The AESD must be carefully crafted to ensure compliance with the USPTO requirements. The AESDs are usually prepared at the author’s patent law firm and cost around $4,000 to $14,000, depending upon the complexity of the invention, the closeness of the prior art uncovered in the search and the complexity of the arguments that must be prepared and submitted, and any miscellaneous prior art surprises that come along the way that need to be dealt with. These costs are exclusive of the costs for preparing the patent application and the set of claims for the accelerated case, and exclusive of prosecuting the patent application once the examiner reviews the case.

In many cases, the goal of the accelerated examination is to obtain a patent with useful, but not necessarily the broadest, claims.The fact that the allowance rate is so high is indicative of the fact that most filers are following this path.The author has found that patent examiners are less reluctant to allow patent claims that have structural limitations (in addition to, or instead of, functional claim limitations) that tailor the coverage toward the exemplified embodiments provided in the patent application.This is particularly true for accelerated examination cases.One useful strategy is to file the accelerated examination application with a set of claims that cover the commercial product in a narrow, but useful, manner, which (hopefully) captures designaround formulations, where there is a clear story as to patentability over the prior art. Such claims are much more likely to result in allowable subject matter.

Does the fact that the accelerated application includes narrower claims mean that one cannot obtain broad patent coverage? No. It is often the strategy that broader claims are also filed in a ‘sister’ patent application either before, concurrently, or after the accelerated case. In fact, it is often the case that multiple cases are filed simultaneously, for example, covering the product narrowly, the (approved) method of treatment using the product, and aspects of the product broadly. In this way, one achieves the best of all worlds.

Appealing the Examiner’s Final Rejection

Sometimes, despite one’s best efforts and continuous contact with the patent examiner, a patent application is finally rejected. This is often misinterpreted to mean that the file is closed, and that a patent will not be forthcoming. That is hardly the case. Typically, the patent applicant has two opportunities to file responses to official actions of the patent examiner rejecting the patent claims. It is common that two responses are not sufficient to convince the examiner that the claims are allowable over the prior art that the examiner has relied upon in rejecting the claims.

When time is not of the essence, or where it appears that a continued dialogue may provide a fruitful result, the applicant may file a request for continued examination (RCE), or a continuation application. This resets the opportunity for back-and-forth discussion with the patent examiner. However, the patent examiner is not required to pick up the RCE or continuation application quickly for review. Therefore, it may take up to a year before the discussion on patentability recommences.

Another route being used more and more is the appeal of a final rejection to the USPTO Board of Patent Appeals and Interferences (BPAI). Every applicant whose claims have been rejected twice may appeal the examiner’s decision to the BPAI. To do so, the applicant first files a notice of appeal accompanied by the appropriate fee, and thereafter must file an appeal brief that points out all of the alleged errors made by the examiner. Although the wait for an actual oral hearing before the BPAI may take years, it is often the situation that the appeal brief results in the case being shifted back to the examiner for further consideration in view of arguments or actions taken post-final rejection which obviate the examiner’s position. This may happen in a matter of one to two months and can result in a fast-tracking of the application at the back-end.

There are other ways to fast-track the review of a finally rejected patent application. For example, there is a new Pre-Appeal Brief Conference Pilot Program at the USPTO, which offers applicants an avenue to request that a panel of examiners formally review the legal and factual basis of the rejections in their application prior to the filing of an appeal brief. This is an optional procedure, but is useful if the applicant feels that the rejections of record are clearly not proper and are without basis. Upon receipt of the request, a Technology Center Art Unit supervisor will designate a panel of examiners experienced in the field of technology (including at least one supervisory examiner and the examiner of record) to review the applicant’s remarks and the examiner’s rejections. A decision should be mailed within 45 days of receipt of the request.

Yet another avenue is the Patent Ombudsman Pilot Program, which is set to run at least until 6 April 2011. This may be a useful avenue where examination has stalled and the applicants’ efforts to move their applications forward through normal channels have not been effective. The ombudsman may be contacted for an application-processing issue that the applicant has been unable to resolve using the USPTO’s existing processes (for example, the examiner does not appear to address a new argument or amendment, and the applicant cannot reach the examiner and supervisory patent examiner after a reasonable period of time). While this programme cannot be used to circumvent the normal examination process, it may be used to help ensure that the application proceeds through the established process in a timely fashion.

The New Obviousness Guidelines

The applicant who ventures down the patent prosecution highway often finds there are bumps in the road. These are typically issues concerning prior art that the examiner uncovers and cites against the pending patent claims. There are basically two types of prior art: the first is anticipatory prior art, for example, a single reference (such as a publication) that describes each and every feature of the patent claim(s); and the second is prior art that makes the patent claim obvious (either alone or in combination with other prior art references).

Dealing with anticipatory prior art is typically straightforward – the claims must differentiate from what was taught in that single reference. If the claim does not differentiate, it must be amended to do so. Dealing with obviousness is more nuanced; the test is based on factual inquiries (1). In making a determination of obviousness, the examiner must consider the scope and content of the prior art, differences between the claimed invention and the prior art; and secondary indicia of non-obviousness (such as commercial success, where available). The USPTO has issued an update to its obviousness guidelines for use by its personnel when applying the law of obviousness, as of 1 September 2010 (2).

While the new guidelines are too detailed and voluminous to be summarised in this article, it is useful to consider these guidelines when dealing with an examiner’s rejection of patent claims. The undercurrent running through the new guidelines is unmistakable – while many basic approaches previously used to demonstrate non-obviousness continue to apply, the examiner has more tools today to reject a patent claim than in the past.When combining prior art references, the examiner no longer has to rely on some basis in one of the references that suggests that it could be combined with the other reference (known as the teaching/suggestion/ motivation or TSM test), and the examiner can rely on an ‘obvious to try’ rationale where the problem is known and the options are limited, for example. It is becoming increasingly clear that reliance on unexpected results is the best bet for overcoming an obviousness rejection. Beware: there should be some nexus between the unexpected results and the invention as claimed.While arguments centering around a lack of a reasonable expectation of success to achieve the claimed invention, or a lack of motivation to arrive at the claimed invention, may be used to overcome an obviousness rejection, those arguments have a more arduous road.

Conclusion

While taking the patent prosecution highway through the USPTO can be a daunting experience, there are ways to, at the very least,move the process along at a quicker pace. A patent application which has been written with the patent prosecution process in mind is invaluable for overcoming the objections and rejections which are likely to flow from the patent examiner. Accelerated review, petitions to make special (that is, based on factors such as manufacture, infringement, environmental quality, energy, recombinant DNA, superconductivity materials, HIV/AIDS and cancer, countering terrorism and biotechnology applications filed by small entities) are useful alternatives to the typical slow-churn of the USPTO in reviewing pharma patent filings. Consideration of the obviousness guidelines can help to develop useful strategies that overcome prior art rejections. On the back-end, using the appeal process to focus the issues and move an application forward is coming into vogue.

References

1. Graham versus John Deere, 383 US 1, 1966
2. Federal Register, Volume 75(169): pp53,643-53,660, Wednesday, 1 September 2010


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Clifford M Davidson is a founding partner at Davidson, Davidson & Kappel LLC, an intellectual property law firm with offices in New York. He counsels pharmaceutical clients in patentrelated matters, including patent prosecution, freedom to operate and infringement opinions, due diligence and techtransfer, and litigation (including ex parte and inter partes proceedings worldwide). Clifford received his BSc in Pharmacy and his JD from Rutgers University, and is a member of the New York and New Jersey Intellectual Property Law Associations, the American Association of Pharmaceutical Scientists and the Controlled Release Society (Pharmaceuticals).
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