Understanding pharmaceutical patents and their intersection with the FDA
About this event.
Insights into the patent process, from filing to issuance, with a focus on the particularities of pharmaceutical patents, for both small molecules and biologics. Learn how to structure your filings for success, and peer into the complex but valuable interaction between your patents and the FDA regulatory procedure.
Q. What are the downsides of making a claim too broad?
There are at least the following two downsides to making a claim too broad.
First, beginning prosecution with claims that are unreasonably broad can waste time (and therefore money). Although you should (usually) try to claim as much space around your technology as possible, starting too far away from the goal (from what you’re due in the eyes of the examiner) can mean wasting your first communications with the patent office working through predictable or silly rejections that are mostly irrelevant to the key features of your invention.
Secondly, too broad of a claim is a liability when it’s unsupported or only tenuously so by the specification. Although patents do have a presumption of validity before a court of law, opposing counsel will find any way to show that your claims are invalid, including the enablement and written description requirements. So even if you were able to convince the examiner that your narrow examples and discussion should support a much broader claim, a judge or jury may disagree. Again, this concern only applies to broad claims that overstep their support. A strongly supported broad claim is a powerful asset to have.
Q. You mentioned a 1-year grace period post-disclosure. Can you describe what constitutes disclosure?
The courts have repeatedly ruled that public accessibility is key to constituting a “disclosure.” So any document or statement you make about your invention that can be retrieved or encountered by members of the public will trigger that 1 year grace period if you haven’t yet filed. The most common items that do this are journal and conference papers, conference presentations, advertising promos, and published financial documents. You can check out our writeup on managing public disclosures for more information on this topic. Note, though, that this discussion gets trickier if we need to consider experimental public use activities and offers for sale (even secret ones).
Finally, remember that any conversation of disclosure must account for the scope of the invention at hand in light of the state of the art of its field. In most cases, exact chemical structures are critical information in the pharmaceutical industry and should be guarded with secrecy until filing; however, statements about broader categories may or may not count as an “invalidating” disclosure that would trigger this bar. For example, if it is common knowledge that a broad category of molecules has general activity towards a certain target, simply stating that you’re working within that category for that target (and keeping your modifications secret) may not count as such a disclosure. Due to this fine line, be sure to speak with your counsel on this topic especially when preparing any of the above mentioned documents.