While much has been said about the need for a regular Competitor Patent Monitoring exercise in every major industry, the importance of the patent monitoring process in the Pharmaceutical industry cannot be stressed enough.

Most pharma companies have well set up in-house patent watch processes or an outsourced patent monitoring service. These processes usually give end-user updates on events like:

• Publication of a new patent application filed by a competitor
• PAIR Watch: In this updates regarding changes at US PAIR during prosecution are given
• Grant of competitor’s existing application
• Orange book entries related to the patent/ API

Where Do Existing Patent Monitoring Services Lack?

Based on our study of the patent monitoring reports available in the market, we found that most of them were not concentrating on one vital aspect – none of them report alerts in an insightful manner that would allow an end-user to make a business decision.

Most of the patent watch services present raw data to an end-user, leaving it up to them to put the pieces together and derive insights. Remember that end users of these alerts are researchers or patent attorneys in pharmaceutical companies. They are knee-deep in their daily roles. Hence, information that is not in the form of targeted insights would most often fail to hit the spot.

If critical insights are missed in this manner, it could potentially lead to large threats/ opportunities going under the radar.

The question now is –

How to Conduct an Effective Patent Monitoring Exercise?

Since the Pharmaceutical industry is governed by numerous intricacies involving Patent term extensions, Exclusivities, SPCs, Para I, II, III, IV filings, FDA rulings, Orange Book listing, etc., a simple patent monitoring process – where just the prosecution status of various patent applications are being watched, will not suffice.

In industries like Pharma and especially Generic Pharma, timing is everything.

In such industries, a regular and comprehensive patent watch needs to be performed in a manner that can collect data/events from various sources like the USPTO Public PAIR, Orange Book, PTAB, and other news sources (Drug Watch, Medscape, Reuters) on happenings in the industry. 

Not only such a patent watch collects data but it also has to co-relate them to derive actionable insights based on which decisive decisions on business opportunities/threats can be made in time.

Let us show you a few examples of what type of insights can be derived by correlating data from various sources.

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We have prepared a template of Patent Monitoring Report in an Excel Sheet for you here:

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1. Prosecution Related Insights

While watching prosecution events of a patent application, instead of just letting a user know of changes during the prosecution, using data from Examiner Behavior tools (like GreyB Examiner Analytics) would allow the patent monitoring service provider to provide actionable insights to the end client.

For instance, for a given patent still in the prosecution stage, the following questions could be answered:

• Based on the past behavior of the examiner, what are the probable ways this prosecution could proceed?
• What are the chances of rejection from this examiner? How does this application hold up against rejections faced by applications on similar technology? (done by co-relating rejections from past monitoring data)
• How long could it be before this application gets granted?

A person monitoring the prosecution of US20150376106 could say that there is high chance the application would get granted quickly. This is because Examiner Valenrod Yevgeny has a high grant rate and usually grants applications after two rejections.

2. Understanding Patenting Activity in a Domain

While the prime reason for setting up a USPTO Public PAIR monitoring process is to detect possible freedom to operate concerns the end-client may face, a deeper reading of the prosecution process would allow a service provider also to provide the end-client with additional information like-

• Is the applicant going to file a divisional application? (Claims restricted by the examiner)
• Is the applicant going to file more Process / Product / Composition / Use patents to set up a Patent Fence? (based on analysis of application specifications)
• Which features have been left unclaimed by the applicant – Alternative areas or Improvements/Variations?

For Example – Someone monitoring the patent filings of Actelion in 2004 would have come across publication US20040077670 claiming the API of Macitentan. By reading the application document, a researcher can figure out that Actelion will start building a patent fence of Process/Use patents.

The researcher’s estimate could be proved true by glancing at patenting activity in the Macitentan domain. The table below clearly portrays that Actelion had been active in filing patents for every category of Macitentan in an attempt to build a patent fence.

3. Reveals Strength of Competitor’s Patents

An added benefit of pursuing a regular patent monitoring service is that it would allow you to judge the strength of your competitor’s patents.

This, in turn, could help you decide whether or not to jump in at the sign of a possible opportunity, using insights like

• Can the competitor’s application be challenged as well based on the evidence presented in the ongoing Inter Partes Review/ Post Grant Review against another granted patent related to the same Drug/ API
• Is a competitor trying to develop generics for the drug, in spite of the patent being in effect? (Competitor may have evidence for filing a Para IV challenge)

Of course, all these insights can be derived by the user themselves based on the analysis of the data presented by the alerts.

The reason a pharmaceutical company sets up an independent patent watch process is to save its researchers time and effort.

We have found that the best way to add value to the patent monitoring service is by providing end-users with concise and targeted information, which is enough for the user to make quick decisions, without having to spend their time analyzing the information you provide.

Authored by: Lindce Sabi Varghese, Senior Associate, IP Solutions.

If you any queries about patent monitoring service, feel free to reach us out.

Related Article: How A Patent Monitoring Report Can Help In Holistic Competitor Intelligence?