Drugs: From Patent to Market is a Long Haul

Recently I was perusing press releases to see if I could find any interesting news items worth reporting. One particular press release did catch my eye. The title was AvidBiotics Granted U.S. Patent for Bactericidal Proteins that Selectively Kill C. Difficile. C. Difficile, or Clostridium difficile…more commonly called C. Diff. for short…. is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. I have known people who have suffered with C. Diff., and it is no joking matter. So a treatment for C. Diff. is interesting enough, but an innovation that would kill only C. Diff., without harming other (good) bacteria, might be a real breakthrough. The problem with many antibacterial drugs is that they kill the good bacteria with the bad, or sometimes kill the good and not the bad, which can lead to a hose of digestive problems.

In any event, AvidBiotics Corp., which is a privately held biotechnology company, recently announced that it obtained US Patent No. 8,673,291, entitled “Diffocin and Methods of Use Thereof,” which claims modified R-type bacteriocins from C. difficile that specifically kill C. difficile bacteria. Also covered are methods of manufacturing such bactericidal proteins.

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03.26.14 | Patent Issues, Pharma | Gene Quinn

What’s the Harm in Allowing Software Patents?

As many of you undoubtedly already know, the United States Supreme Court will soon decide whether software is patent eligible in the United States. The fact that such a question needs to be addressed in the year 2014 would be comically funny if it were not so tragically sad. Software has been patented in the United States since 1968, which means software has been patentable in the United States for the last two generations. Yet the Supreme Court is poised to decide whether software is or should be patent eligible in Alice v. CLS Bank, which will be argued to the Court on March 31, 2014.

What is the harm in allowing software patents?  Saying that software is not patentable subject matter is akin to saying that a car battery is not patentable subject matter. No one could seriously argue that a new and non-obvious car battery would not be patentable subject matter. In fact, that is exactly what many researchers are trying to find right now, albeit not the same type of car battery that we are used to inserting under the hood.

Any car is itself just a bunch of pieces of metal that sit there fastened together to create a tangible shell that has taken on an identifiable structure. The car has lots of potential, but without some kind of fuel it doesn’t even have potential energy. It merely has potential to move from place to place under appropriate conditions. A car without a battery isn’t something that is useful in any real world sense of the word.

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03.17.14 | Patent Issues, software patents | Gene Quinn

IBM Brief: Abstract Idea Jurisprudence Is Unworkable

On March 31, 2014, the United States Supreme Court will hear oral arguments in a case that could determine the fate of software patents in the United States. Recently, IBM filed an amicus brief at the United States Supreme Court in the case of Alice Corporation Pty. Ltd. v. CLS Bank International. While many attorneys contributed to this brief, former Solicitor General of the United States Paul D. Clement is the Counsel of Record on behalf of IBM.

I think it is fair to say that the IBM brief can be summarized as follows: ‘The abstract idea doctrine is unworkable.’ Bravo! If the Supreme Court cannot define the term “abstract idea,” which they have never done,  how can it be at all appropriate for the Court to apply the doctrine as if it has meaning? At least with respect to software, there is also no uniform application of the patent laws, which at least conceptually should raise concerns of disparate treatment of those similarly situated.

Something needs to be done to once and for all acknowledge that software is patent eligible. Even having to say that and hope it is what ultimately happens is truly saddening in the year 2014. Software is all around us and empowers practically everything, and according to a Government Accountability Office (GAO) report from August 2013, somewhere between 50% to 60% of all patent applications filed deal in some way with software. Software is the very backbone of innovation and the fact that we have to wonder whether it is patent eligible more than 46 years after the first software patent issued is really an indictment of the judicial system as it relates to patent law and jurisprudence.

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Jepson Claiming Improvements

According to 37 C.F.R. 1.75(e), improvement patent claims should follow a specific template.  Rule 75(e) states:

(e) Where the nature of the case admits, as in the case of an improvement, any independent claim should contain in the following order:

(1) A preamble comprising a general description of all the elements or steps of the claimed combination which are conventional or known,

(2) A phrase such as “wherein the improvement comprises,” and

(3) Those elements, steps, and/or relationships which constitute that portion of the claimed combination which the applicant considers as the new or improved portion.

(emphasis added).

Claiming done as Rule 75(e) suggests is known as writing a claim in Jepson format, or simply a Jepson claim.  A Jepson claim is one where the preamble makes some kind of statement that relates to the state of the prior art, and then claims an improvement over the prior art. Jepson format allows the patentee to use the preamble to recite elements or steps of the claimed invention which are conventional or known. A Jepson claim is not something that you must employ and it comes with significant disadvantages with only the most nuanced of advantages in very rare circumstances, such as in responding to a double patenting rejection.

When using the format of Rule 75(e), the preamble is considered to positively and clearly include all the elements or steps recited therein as a part of the claimed combination. Therefore, the elements or steps recited in the preamble become a part of the claim and do in fact act as limitations. For more information on patent claiming generally and those claims dealing with Jepson format specifically, see Faber on the Mechanics of Patent Claim Drafting and Advanced Patent Prosecution Workshop: Claim Drafting and Amendment Writing.

Below is an example of a claim in Jepson format, which is taken from claim 6 of US Patent No. 4,892,244:

In a staple cartridge insertable within a surgical stapler and containing staples and comprising an elongated body including one or more longitudinal slots for slidably receiving one or more longitudinal pusher bars comprising a firing mechanism of said surgical stapler, and a plurality of drivers engageable by said pusher bars for ejecting the staples from the cartridge, said staple cartridge releasably fastened to a said surgical stapler, the improvement comprising a lockout mechanism connected to said longitudinal slots for preventing said pusher bars from passing more than one time through said longitudinal slots.

(emphasis added).

The Jepson preamble in claim 6 of the ‘244 patent (above) is all that comes prior to “the improvement comprising.” That which comes before “the improvement comprising” is describing what is already known in the prior art, a very dangerous thing to do without knowing what prior art the Patent Examiner will use against you.

Here is another example of a Jepson claim, take from claim 9 of US Patent No. 4,007,960:

In a reclining chair having a frame, a back portion, a seat portion, recliner actuator means including means forswinging said back portion between an upright and a reclined position, the improvement comprising elevator means for raising said seat and also tilting said seat forwardly to assist exit from said chair, and power actuated drive means common to both the recliner actuator means and the elevator means for sequentially actuating both the recliner actuator means and the elevator means and being operable sequentially in a first mode of operation to drive the recliner actuator means and operable in a second mode of operation to drive the elevator means, said power-operated drive means comprising an extensible ram which extends in one range during said first mode of operation and in another range in said second mode of operation.

(emphasis added). Jepson claim meets means plus function claiming! Yikes!

The relevant case law on Jepson claims suggests that the preamble elements in a Jepson-type claim are admitted to be prior art. In fact, according to MPEP 2129: “Drafting a claim in Jepson format is taken as an implied admission that the subject matter of the preamble is the prior art work of another.”

Overcoming the admission implicitly created by a Jepson claim is not an easy task and, therefore, Jepson claims should be avoided in all but rare circumstances. Of course, as with all general rules, there are exceptions and circumstances where Jepson format may be useful. One such situation is when the patentee is attempting to overcome, or prevent, a double patenting rejection. For example, when the applicant explains that the Jepson format is being used to avoid a double patenting rejection over the applicant’s own copending application, the implication that the preamble is admitted prior art is overcome. See Reading & Bates Construction Co. v. Baker Energy Resources Corp., 748 F.2d 645, 650, 223 USPQ 1168, 1172 (Fed. Cir. 1984).

02.28.14 | Patent Drafting, Patent Issues | Gene Quinn

Understanding Post-Grant Review

Last week, I published an article about inter partes review on IPWatchdog.com. Patent Office statistics for FY 2013 and FY 2014 show that there have been a total of 361 decisions on IPR petitions, with 288 trials instituted. There have been 11 cases that have been joined and only 62 petitions denied, which corresponds with an 82.8% IPR petition grant rate. Having said this, the IPR grant rate during FY 2013 was 87.2%, while so far during FY 2014, the IPR grate rate has been 77.2%.

But what about post-grant review?

Both inter partes review and post-grant review became a reality when “Phase 2″ of the America Invents Act (AIA) became effective on September 16, 2012. But you haven’t seen any post-grant reviews yet, aside from the quasi-post-grant review known as covered business method (CBM) review. That is because the post-grant review provisions apply only to patents issued from applications that have an effective filing date on or after March 16, 2013.  Said another way, post-grant review proceedings are only available to patents issuing from applications subject to first-inventor-to-file provisions of the AIA.

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