J&J Seeks Ridiculously Broad Patent on Method of Treating Pain

Perhaps you have noticed, but over the past several months we have been trying to increasingly focus coverage on the patent activities of some of the more innovative and interesting companies in the technology sector. This started with our coverage of Apple Patent Activity and buoyed by the interest that was generated we have recently started following Google Patents Activity, IBM Patent Activity and will soon add Microsoft Patent Activity. Stay tuned for other companies to be added to our list of periodic updates.

In any event, I was searching to see what companies we might be able to periodically follow outside the “tech sector” and took a look at a fairly recent list of top patenting companies. I saw Johnson & Johnson on the list so I figured I would take a look. With all the Johnson & Johnson companies there has to be some interesting patent activity, right?

It didn’t take long to find a patent application being pursued by Johnson & Johnson that made me scratch my head. On March 21, 2013, U.S. Patent Application No. 2013/0072575 was published. The title is Method and Composition for Treating Pain. Knowing that so many suffer from chronic pain I was immediately intrigued and had to take a look. Rather than finding something that looks like a potentially exciting innovation I found a bunch of claims that should have absolutely no chance of ever being patented.

The Claim: Apply Cold Topical Analgesic

First, although the title of the application suggests that the patent seeks coverage for a composition, all of the published claims relate to a method. Claim 1 is illustrative of the method and seeks to cover the following:

1. A method of treating pain by topical application of an analgesic composition to the skin of a patient comprising a) placing an analgesic composition in an environment with a temperature of less than 10° Centigrade, b) keeping said analgesic composition in said environment for a period of time sufficient to reduce the temperature of said composition c) removing said composition from said environment, and d) applying said composition topically to the region of pain.

So, essentially you take a topical analgesic, cool it, remove it from the cooling environment and then apply. If this claim gets patented it will be extraordinarily embarrassing for the USPTO. But what exactly was Johnson & Johnson thinking when they tried to obtain coverage with this ridiculously broad claim? It is a violation of USPTO rules to seek a claim that you know you are not entitled to receive. Is there anyone that could possibly rationalize in any intellectually honest way seeking a claim that covers applying a cooled, unspecified analgesic to the region of pain?

For crying out loud, analgesic is defined as a “[d]rug that relieves pain without blocking nerve impulse conduction or markedly altering sensory function.” Topical analgesic compounds are not new, and the claim Johnson & Johnson is seeking is not based on any particular new or improved analgesic. Isn’t it fairly well known already that the application of a topical composition known to relieve pain would, in fact, relieve pain?

Isn’t if also fairly well known that placing something cold on an area that is irritated will reduce swelling, which in turn will reduce pain? YES! Of course it is well known.

Thus, in a post-KSR era where so much is obvious wouldn’t it be the epitome of obvious to cool a topical analgesic before application? Is cooling an analgesic before application an innovation? I am at a total loss as to how there could be any potential hope to obtain a patent on a claim this broad. If the USPTO ever does issue a patent on these claims they will have a lot of explaining to do!

Concern Over Specious Claims in Patent Litigation

Earlier this month Philip Johnson, who is Senior Vice President and Chief Intellectual Property Counsel at Johnson & Johnson, testified before the House Subcommittee on Courts, Intellectual Property, and the Internet regarding the need for legislation to address patent assertion entities. In his prepared statement he explained:

To enhance the objective of maximizing R&D investment and its attendant creation of jobs, it is incumbent on the courts to effectively enforce meritorious patents against those who are infringing them, while weeding out specious claims that act as drags on the system.

I agree with that statement, and I agree with much of Johnson’s testimony, which in my opinion was thoughtful and balanced. He understands the need to offer protections for those innovators who are not manufacturing, but recognizes the truth that there are bad actors in the patent system that are holding up companies with specious claims of patent infringement.

At a time when Johnson & Johnson is seeking legislative help to deal with patent shakedowns, should they be filing patent applications themselves that seek claims that are on their face absurd? How is it at all reasonable to be complaining about “specious claims that act as drags on the system,” while at the same time be seeking specious claims? In all likelihood the USPTO will never issue claims that are so ridiculously broad, but doesn’t asking for such claims simply waste precious Patent Office resources? Of course it does.

What can be Learned?

Aside from poking fun at this obviously ridiculous set of patent claims, pointing out that USPTO resources will be wasted during the examination and a bit of irony over the concern relating to specious patent claims, I’d like to try and turn this into a teaching moment of a substantive nature. As with virtually any patent application or issued patent, there are things worth learning from the drafting of this patent application even if the “innovation” is dubious. So allow me a moment to focus on a teaching point that deals with ranges and the definiteness of the term “about.”

The Manual of Patent Examining Procedure (MPEP) explains that with respect to numerical range limitations, analysis must take into account the ranges one skilled in the art would consider supported by the specification. See MPEP 2163.05. Thus, filing an application that has support for a variety of ranges is important.

Here is what this particular Johnson & Johnson patent application discloses in terms of ranges:

• “The analgesic composition may be stored in an environment with temperatures of less than about 10° C., or less than about 0° C., or less than about ?10° C., or less than about ?20° C. or in a range from less than about 10° C. to less than about ?20° C.”
• “The temperature of the composition should be lowered to about 15 ° C. to about ?30 ° C. or from about 10° C. to about ?10 ° C. or from about 5° C. to about ?5 or about 0° C.”
• “The time period between removal of the analgesic composition and the topical application of it to the region of pain is less than about 10 minutes, or less than about 5 minutes, or less than about 1 minute, or less than about 30 seconds, or less than about 10 seconds, or less than about 5 seconds, or less than about 2 seconds or from less than about 2 seconds to less than about 10 minutes.”

The term “about” has a specific meaning in the patent laws. The term “about” is considered definite if the context of the term as it is used in the specification is clear. See MPEP 2173.05(b). The term “about” also provides additional coverage beyond the specific range identified. For example, the Federal Circuit in the case of In re Woodruff explained that prior art that disclosed a range of “about 1-5” covered a little more than 5. See also MPEP 2144.05. Of course, the term “about” is relative and has to be driven by the technology, although the Supreme Court in their infinite wisdom has found that a PH of 5 may be equivalent to a PH of 6, see Warner Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), and they have also stated that manganese is equivalent to magnesium, See Graver Tank & Mfg. Co. v. Linde Air Products, Co., 339 U.S. 605 (1950), which has to make you wonder about their technical, scientific prowess.