On February 5, 2015, the USPTO announced the launch of an Enhanced Patent Quality Initiative and solicited public comments on certain proposals aimed at improving patent quality, which are due by May 5, 2015. With a few weeks left in the comment period, the Office of Inspector General of the U.S. Department of Commerce issued a report on its review of the USPTO’s quality assurance program. The report is eye-opening and underscores the problems the USPTO faces in measuring and improving patent quality.
USPTO Patent Quality Pillars and Initiatives
In the February 5 Federal Register Notice, the USPTO identified three patent quality pillars and six new patent quality initiatives [...]
John Richards (Ladas & Parry LLP, New York) identifies the problem that filing a patent involves a prior art search which is probably not as focussed as searched that occur in litigation and therefore the patent might require later amendment. The Patent Trial and Appeal Board (PTAB) takes a very strict approach to amendment in the USA. Most jurisdictions do not allow broadening of scope after grant except for the USA and Canada in specific circumstances and under strict time limit.
Penny Gilbert from Powell Gilbert LLP explains the position of biosimilars in the pharmaceutical industry. Biosimilars are essentially generic versions of biologics. Traditional generic compounds are chemical reproductions of the patented compound which makes regulatory approval more straightforward. Biological compounds (proteins or antibodies which are produced from genes) are not identical with one another and have higher hurdles in terms of achieving regulatory approval. The cost of bringing it to market is significant. Doctors may be less willing to prescribe biosimilars as compared to generic chemical compounds when considering the alternatives to the originator’s product. Undertakin [...]
Dimitrios T Drivas (White & Case) gave the speedy run down on the following points and cases, which some might find useful for following up on points of interest:
The decision that in exceptional cases reasonable attorney’s fees may be paid to the prevailing party (an exception to the rule that each party bears its own costs in the USA). The exception was interpreted to mean some sort of ‘bad faith’ by the Federal Circuit overturning the District Court decision. The Supreme Court found that the District Court’s decision should be given due deference.
‘Indefiniteness’ has gone from ‘insoluble ambiguity’ to ‘fails to inform with reasonable certainty’.
Induced infringement (Limel [...]
I am happy to announce the release of my book US Patent Law for European Patent Professionals.
An understanding of US patent law within the context of the US legal system has become increasingly important for patent professionals in Europe in recent decades. Europe and the US are closely linked economic zones, and many inventions for which protection is sought in Contracting States of the EPC are also manufactured and/or brought to market in the United States. As a result, European patent professionals are increasingly confronted with questions from multi-national clients on how best to protect and leverage their inventions within the US. The protection of intellectual property rights in t [...]
Under U.S. patent laws, the 20-year term of a patent can be extended if the USPTO fails to meet certain timeliness benchmarks during the patent examination process. The statute provides for Patent Term Adjustment (PTA) equal to the number of days of USPTO delay, less the number of days of applicant delay. The statute defines taking more than three months to respond as one type of applicant delay, and delegates authority to the USPTO to define other circumstances that amount to applicant delay, which the USPTO has done in 37 CFR § 1.704. While many of the USPTO’s circumstances are not surprising, one category in particular can result in PTA deductions for actions made to advance prosecution. [...]