10 PATENTING STRATEGIES Tip 1: Know your enemy


Validity challenges are usually based on obviousness or lack of novelty in view of prior art. Knowing what prior art is out there when craſting the original application and claims permits the draſter to anticipate possible grounds for future rejections so that support for overcoming them, or avoiding them in the first place, can be built in.


Although a thorough prior art search at the time of draſting the application adds to the initial expense, it can streamline prosecution and, more importantly, result in claims that stand up to challenge aſter grant, so it’s money well spent.


Even the most thorough search normally cannot turn up so-called secret prior art—ie, a patent application that is on file but not yet published. Avoiding unnecessary delays in filing your patent application will help minimise the likelihood that, before your filing date, someone else has filed a relevant application that was undetected in your prior art search.


Another strategy is to describe numerous embodiments of the invention of varying scope in the application to provide support for amendments that might be needed during examination to carve around the prior art once it becomes known.


Tip 2: Embrace the narrow


Te inclusion of narrow claims specifically directed to the expected commercial drug product or its approved uses is essential to a strong patent position. Many applicants instinctively seek the broadest scope possible to stop competitors from ‘designing around’ the claim by developing slightly different, competing products. While broad claims certainly can be useful in that respect, their breadth makes them more vulnerable to an invalidity challenge. A finding that any compound encompassed by the claim is not patentable will invalidate the whole claim.


Generally speaking, narrow claims specifically directed to the particular molecule that constitutes the drug product or the specific disease indication(s) for which the product will be marketed will present fewer vulnerabilities and result in a stronger patent position.


Of course, one can include both broad and narrow claims, along with claims of intermediate breadth—particularly if the ultimate product has not yet been selected


or if there is a concern that competitors will be able to design around the narrowest claims.


Tip 3: It’s all in the details


When draſting the application, one may be tempted to skim over details of how to make and use the claimed drug product, either to gain a competitive advantage by hiding important details or simply to expedite the application draſting process. Skimping on such details is highly risky.


Te claimed subject matter must meet the statutory ‘enablement’ requirement—ie, the supporting disclosure must teach both how to make the claimed compound and how to use it without the need for ‘undue experimentation’.


For claims covering small molecule drugs, a challenger may attack on ‘how to make’ enablement grounds if, for example, the description of the compound’s synthesis is so thin that it is difficult to reproduce the synthesis, or if it utilises starting materials that are not generally available.


A challenge on ‘how to use’ enablement grounds may occur if there is no reason to believe the claimed drug product actually has biological activity, or if the activity is not convincingly tied to the treatment of disease.


Also, US law still requires the specification to disclose what the applicant considers to be


the “best mode” of practising the invention. Although recent changes in the law have taken the teeth out of that requirement by removing it as a ground for invalidity, it lurks in the US statute, with uncertain consequences for the applicant who ignores it.


Tip 4: Beware the data


Even a well-draſted patent with valid claims will be useless in litigation if the court finds the patent unenforceable because it was obtained as a result of a deliberate misrepresentation by the applicant to the USPTO. Although recent clarifications in the law have made unenforceability more difficult to prove, accused infringers still commonly raise the issue in litigation—if only as an excuse to paint the applicant as unscrupulous.


It is therefore vital to be very careful when presenting data to the USPTO, either in the original specification or during examination. For example, if it appears that the applicant chose to reveal only selected data that supported patentability and suppressed other, contrary data, the court may determine that this constitutes a material misrepresentation that guts the patent.


To minimise this risk, applicants should carefully consider whether presentation of the data is truly necessary or can be dispensed with in favour of other, less risky strategies. Where the data are


LSIPR Newsletter 12:14


www.lifesciencesipreview.com


GRANDEDUC / SHUTTERSTOCK.COM


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