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CLINICAL TRIALS


A recent study revealed that biotechnology companies or universities discovered 42 percent of all innovative drugs approved by the US Food and Drug Administration (FDA) between 1998 and 2007. Biotechnology companies, however, are sometimes unprepared for the intellectual property considerations that arise as a promising drug (either their own or one licensed from a university) progresses through clinical trials. Eric Steffe explains.


As companies that have at least one approved product know, numerous issues emerge that go far beyond procuring patent protection for the product and the company’s platform technology. Tese issues include seeking patent protection for downstream discoveries, the renewed importance of process patents, data exclusivity, inventorship disputes, and clearance of third-party patents covering commercial manufacturing methods and patient administration protocols.


Downstream discoveries and corporate publication policies


Creating a strong exclusivity position through patent protection is important for biotechnology companies to raise financing, attract partners and block competitors. However, a patent application claiming a lead product is normally filed shortly aſter the product is made (i.e. before the product enters clinical trials). Such ‘product patents’ oſten have expiration dates that only provide a few years of exclusivity aſter FDA approval. Tus, seeking patent protection for later discoveries that arise during the clinical trials process is a necessity for obtaining additional patent term. Indeed, certain well-known biological drugs are protected by patents encompassing downstream discoveries, which may provide patent terms extending some 12 to 15 years beyond the expiration dates of the lead product patents.


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Following the practice of large pharmaceutical companies in the small molecule arena, established biotechnology companies maximise the possibility of obtaining downstream patents in two ways. First, they rigorously ‘mine’ experimental protocols and data generated during clinical trails for potentially patentable inventions. Such companies flood the US Patent and Trademark Office (USPTO) with applications, out of which at least a subset of the total number filed are granted as patents. Indeed, emerging companies surprised to


are learn about, and have


sometimes rarely


budgeted for, the vast scope of subject matter for which patent protection can be sought. Tese include vectors, dosing schedules, dosage forms, pharmacokinetic data, new indications, adverse events, route of delivery, biomarkers, combination therapies, cell culture conditions and media, host cells, purification methods, purity profile, formulations, drug storage and reconstitution, personalised medicine and scale-up procedures. In sum, established companies view the lead compound as merely the starting point for patent protection.


Second, established companies avoid unnecessarily creating prior art against themselves. Tis can be a difficult balance to achieve for many companies in biotechnology where a publication culture may be deeply imbedded from origins in academia. While


there are compelling business reasons to publish, whether to maintain investor interest, retain scientific talent or attract collaborators, publications should be co-ordinated with patent filings.


Commonly encountered publication policies require delaying publication until aſter an initial patent application is filed. While logical, and indeed suitable in many situations, such a policy is frequently inadequate if the goal is to maximise long-term patent protection. In biotechnology in particular, a more


detailed disclosure is


necessary for the applicant to support a patent claim than is necessary for an examiner to raise an obviousness rejection based on prior art. For example, dose predictions based on preclinical animal model data in the first patent application may be too inaccurate to support a patent claim covering a different dose schedule later deemed in clinical trials to be most suitable for humans. Nonetheless, if the model data has been published by the company, it may be ‘close enough’ for an examiner to support an obviousness rejection when combined with other prior art references.


While it requires living with uncertainty, the best publication policy for companies desiring to maximise long-term patent protection may be to avoid bright-line rules. Preferably working closely together, the company’s patent attorneys and scientists should make judgement


Life Sciences Intellectual Property Review 2011 35


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