Mar 262011

Today I made it up to Concord NH for the IP Cafe, sponsored by the Patent Law Forum and IIPO student organizations. I hadn’t been back at UNH School of Law since December so memories flooded back to me as I walked the halls and sat in classrooms. I also noted the new addition to the school, which will soon be known as the Franklin Pierce Center for Intellectual Property.

It was really good to start off my Saturday in Concord NH at an IP-dedicated symposium with like-minded individuals.

Mary Wong started things off by explaining what the Franklin Pierce Center for Intellectual Property is or will be. The gist of the center will be to maintain global IP prominence.

Mark Solomon and Deirdre Sanders, from Hamilton Brook Smith Reynolds gave the first talk entitled, Top 10 Issues in Patent Law. Their remarks were basic, for the most part, I think because they were addressing a very diverse audience and they didn’t want to overwhelm anyone! But there were some interesting topics that were raised. Here are the issues they addressed, including my thoughts.
1. What forms of IP can build assets?
Trade Secrets
… and more

Three simple questions that a practitioner can ask an inventor to find out what the invention is all about.
What is the problem you’re solving?
How are others solving it?
How are you solving it?

The 3.5 year first installment is due after the 3.5 years for cases that are before the examiner for longer than 3.5 years.

2. How do you document your idea?
A. Notebooks. This section of the talk was interesting because the company I am currently working for is really big into notebooks. Dierdre used her litigation experience to discuss how notebooks can be more credible if they are initialed by someone else. But an interesting question raised was if this really adds to the credibility of the notebook because this witness, who is supposedly removed somewhat from the inventor, may not really understand and appreciate all the notes the researcher is including in his notebook. This is especially the case if there are lots of lab notes and lots of notebooks.
B. Internal invention disclosure form – One question that you may have with regards to these disclosure forms is, “How far upstream do they encourage invention disclosure forms be filled out?” The answer is at conception.

3. How do you determine ownership?
This topic was interesting to me. Some questions the speaker posed was, Who owns patent rights at the time of bankruptcy? What about when the company goes through a merger or acquisition and the inventor says that he didn’t assign the patent to the company? These questions made me think of the upcoming Stanford v. Roche case.
Another question talked about in the assignment portion of this bullet was, What is the value of recording the assignment at the PTO? An assignment doesn’t have to be recorded at the PTO to be a legitimate assignment. But there are benefits. The recordation tells bona fide purchasers that they should be on notice that you have the rights to it.

4. How do you know when to file?
The United States has a one-year period to file your patent. Australia and Canada also have 1 year. Certain European countries have an absolute bar of novelty, meaning that you have to file it before it becomes public. Certain Asian countries are 6 months.
“Disclosure” may be different from one country to another so even if a form of publication has issued, this may not automatically bar you from filing a patent in another country, depending on how they interpret disclosure.

5. How do you assess where to file?
This involves analysis of multiple factors including:
License agreements that may require certain filings
Potential investors
Potential licensees

6. How do you claim the invention?
Sometimes it is best to split up a patent into two to license the technologies to two separate entities: methods on one patent, compositions on the other. But these are business decisions as well, as they may add on additional maintenance fees.

7. How do you describe the invention?
US requirements include enablement, written description, and best mode. Other countries may be different.
Sometimes your parent application can obviate a continuation-in-part. If the parent mentions, but does not enable, blood, for instance, then the continuation in part will be obvious in light of the parent application, but it would not be enabled so you’re “screwed both ways.”

8. How do you navigate the process?
Remarks made on the record can estopp you. You can live with your description for the rest of your patent. If you make assertions to the foreign office too. But it was pointed out that recently the CAFC said that prosecution in other countries is not relevant for estoppel purposes in this country. I don’t know which case the audience member was referring to, but litigators will argue that this should be narrowly construed. Even if you can mention it at all will cause serious problems.
The way that Dierdre described Markman hearings really got me excited to see one in action. I believe Markman hearings are open to the public to sit in on, but I was not sure. I’ll have to look into this because I got excited about seeing one.
Then they talked about duty to disclose. For instance, who is under the duty? CFR 1.56. The lesson learned from McKesson is that you have to cite to the examiner the same case that they have allowed previous. You can’t assume that they know anything. But you always are assumed to know about previous references being the reasonable practitioner.
Try to disclose everything

9. How do you keep your options open?
You can file one patent that is very big or multiple patents with multiple maintenance fees

10. How do you use an issued patent?

Overall, it was a very interesting event. Tom Field was in the back asking questions and laughing as I remember him best. There was also this pretty sharp audience member who had a Russian accent and who every once in a while corrected the speaker.

 Posted by at 10:59 am
Jan 212011

In Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., the defendant failed to disclose that a 2-hour data point was not part of a test protocol and that a correction factor had not been applied to that p-value. This data point was the only one to produce a p-value of less than .05. The invention, however, went on to say that there was statistical support for synergy. In fact, Sturis said in a declaration to the examiner that the evidence “strongly suggests” synergy. However, he did not disclose statements that by his own standards, neither the rat study nor the Moses study established synergy in humans.

The court held that there was clear and convincing evidence that the opinions Sturis offered regarding synergy was material to the patentability of the claim at issue. This, because they refuted or were inconsistent with the opinions expressed in his Declaration in support of patentability. 37 C.F.R. §1.56(b)(2). The examiner would have wanted to know about this negative view on synergism, as this view was inconsistent with a later “strongly suggests synergy” declaration which the examiner most likely relied on to overcome obviousness.

The take-home message here is that you need to disclose what a reasonable examiner would have wanted to consider, be it qualifications or reservations held by the scientists concerning the conclusions he expressed in his Declaration.

Additionally, the Bork statement was also an example of inequitable conduct. After Sturis’ declaration, Bork represented this to the examiner:

Applicant therefore submits that the data presented in the application, in combination with the data presented in the Declaration of Dr. Sturis, provides clear evidence of synergy for the use of the claimed combination of repaglinide and metformin in the treatment of type II diabetes.

The court held that Bork’s representations to the examiners, to get around the final rejection, went beyond aggressive advocacy, in light of what he knew. Sturis’ “strongly suggests” was much more than Bork’s “clear evidence” of synergy.

Bork then got an email from Sturis containing explicit contrary information. The court noted that the duty to disclose to the examiner lasts until the issuance of the patent. 37 C.F.R. §1.56(a).

The take-home message from Bork is a message I learned while in the class Professional Responsibility: you have to stay within the reasonable limit of aggressive advocacy. Even though you may want something very badly for your client, it should never take precedence over the code of ethics that you have agreed to abide by.

In conclusion, Sturis and Bork both had an intent to deceive the Patent Office. Sturis, by withholding his opinions; Bork, by misstating key conclusions by his exaggerations. This inequitable conduct made the patent at issue unenforceable. Basically, this patent was invalidated on two fronts today. Rest in peace ‘358 patent, rest in peace.

 Posted by at 7:22 am