LSIPR Newsletter 12:14


PATENTING STRATEGIES


Terefore, declarations should be avoided if possible, and, if they cannot be avoided, meticulous care should be taken regarding the accuracy and fairness of the statements made.


Tip 5: Duty to disclose—keep it simple


Another reason a court might find a patent unenforceable is if the applicant deliberately withheld material information (such as relevant prior art)


from the USPTO during


examination. In order to minimise this threat, all potentially material documents known to the applicant should be submitted to the USPTO before the patent is issued. Tis may sound straightforward, but the difficulties in complying with the duty of disclosure are numerous, and grow exponentially when there are a number of related, co-pending applications. Oſten there are several related patent applications filed around an important drug product, all pending at the same time.


“The inclusion of narrow claims specifically directed to the expected commercial drug product or its approved uses is essential to a strong patent position.”


deemed essential for obtaining a patent, the applicant must ensure they are presented in the most unbiased way possible, keeping in mind that, when the data are submitted in the form of a declaration, the declarant (usually an inventor or other expert) will almost certainly be the target of a withering attack by the accused infringer during subsequent litigation on the patent. Te challenger will probe the expertise and veracity of the declarant, looking for any possible argument that the latter committed fraud by misrepresenting something in the declaration.


Besides the primary application(s) claiming the drug product itself, including new salt forms or polymorphs, other applications might claim methods of making or using the product, while others may relate to different compounds that share a similar activity or structural element. Because each of these co-pending applications and their progeny relate in some way to the drug product, any reference cited, rejection made, or argument presented in these cases should be reviewed with an eye to whether it might be material to patentability of the claims of any other application in the group, and so should be cited to the examiner handling the other application.


Where there are many co-pending, related applications, this reviewing and cross-citing can be a complex, arduous task requiring substantial resources, and always with a risk that something potentially material will be accidently omitted in a given case. Consideration should therefore be given to minimising the number of related co-pending cases in active prosecution, utilising strategies such as delaying examination of relatively unimportant cases and foreign counterparts, prosecuting


progeny applications


(continuations and divisionals) serially rather than in parallel, and abandoning applications with little commercial or competitive value.


Tip 6: Round up rogue rights


On the face of it an obvious problem to avoid, the uncovering of problems regarding ownership of patents


that protect existing commercial


11


products or products under development is surprisingly common.


Ownership of patent rights initially vests


with the inventor(s), so one should make an accurate inventorship determination before filing an application and then seek assignments from each of the inventors either before or shortly aſter the filing date. Inventors may leave the company and become difficult to locate and/or uncooperative, so delays in obtaining those assignments runs the risk of greatly complicating the process. All employees who are involved with research or other activities that may result in inventing should be required to execute an agreement assigning all future inventions to their employer as a condition of employment.


Likewise, consulting agreements, joint research agreements, and contracts with outside entities such as clinical research organisations


should make it clear that


inventions made under the contract either belong to the company that will be marketing the drug, or will be exclusively licensed to that company.


Te nightmare scenario is where an individual who did not assign and has no obligation to assign to the company is later deemed by a court to be an inventor. If that individual licenses or assigns his/her rights to a competitor, the patent cannot be asserted against the latter. Identifying that individual as a co-inventor early in the process, long before the patent issues and the product is on the market, will allow the company developing the drug to lock in an assignment from the individual before potential competitors wake up to the opportunity.


Te above discussion highlights only a few of the many important factors to consider when building a strong pharma patent. In practice, the process is complex and continuous, requiring periodic and strategic evaluation from draſting to issuance. Only such diligence can position an important patent as close as possible to the bulletproof ideal that will not only help the patent survive future challenges, but also reduce the likelihood it will be challenged in the first place. n


Janis Fraser is a principal at Fish & Richardson. She can be contacted at: fraser@fr.com


Christine Goddard is a principal at Fish & Richardson. She can be contacted at: goddard@fr.com


www.lifesciencesipreview.com


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