Monthly Archives: December 2010

Sun Pharmaceuticals v. Eli Lilly: Doctrine of Obviousness-Type Double Patenting

A remarkable latest change in the Patentability has risen from the decision of the Federal Circuit in the case Sun Pharmaceuticals v. Eli Lilly, over the later’s patent that claimed the use of gemcitabine (GEMZAR), a drug to treat cancer. Sun Pharma moved to lower court to invalidate this patent on the grounds of obviousness-type double patenting. It stated that Lilly had already got patent rights for the drug and its antiviral usage (expiry date 15 May, 2010), and thus can not file for separate set of patent rights for the same drug as anticancer treatment. The new patent had given Lilly an extended monopoly for 2.5 yrs over gemcitabine. After BIO’s amicus brief, Lilly has requested the Federal Circuit for en banc reconsideration.

Story Behind the case:

A Lilly scientist invented a method to synthesize a genus of chemical compounds including gemcitabine and showed its antiviral activites in 1980s, for which the company got patent rights till May 15, 2010. Shortly after this, they also discovered anticancer activities of the same compound, and a second application was filed, but this one did not claim priority to the first application. All was smooth until the next decision taken by Lilly, of filing a CIP of the first application in order to add onto the definition of the disclosed genus of compounds. What must have been done in good faith, ended up in loss to Eli Lilly, as Sun put forward the disclosure of anticancer activity added to the first patent through the CIP application as the basis to invalidate the second patent on grounds of obviousness type double patenting.

The expansions of obviousness type double patenting:

A two-step process has been established by the Federal Circuit to analyze obviousness type double patenting. Step1- the court interprets the claims of original patent and those of the second patent. Step2- to determine if those differences make the claim’s patentably distinct.

Now, analysis for obviousness under section 103 becomes distinct from obviousness type double patenting in a way that in the later only the claims of the two patents are to be considered. (General Foods v. Studiengesellschaft Kohle, 1992). However, ten years later in 2002 Geneva v. GSK, Federal Circuit started using the description of the original patent to invalidate the second patent, thus marking the expansion of the doctrine of obviousness type double patenting.  The same was repeated yet again in 2007 in Pfizer v. Teva.

In the current Sun v. Lilly decision, the later went into trouble of obviousness type double patenting, due to its CIP filing for the original patent. The decision against Lilly has come opposite to the amended patent statute, 35 USC 103(c), which was brought about to encourage innovations and intra-company growth. The amendment stated that an invention by the company can not become a prior art to any of its own continued innovation made later on, thus giving protection to the company.

What should companies take note of in future:

The inventors should be clear on the repercussions of adding disclosure to a patent application, the details to be added in the disclosure, and the suitable time to invest in follow-on research. The best way would be to include only the minimum disclosure of methods to use the compounds so that it satisfies the utility requirement.

Author – Ms. Ritika Kishore,

Patent Consultant, IIPRD.

The Author of the Blog can be reached: iiprd@iiprd.com.

Advertisements

INTERNATIONAL PATENT PROTECTION IN ELECTRONICS & IT (SIP-EIT) SCHEME BY DIT

It is enriching to hear and read so much of focus going these days into Innovation at Grass Root and Startup level. With initiatives being taken at all levels by Stakeholders including FICCI, MSME, DIT, and NASSCOM, the next wave of the so called Start-up innovation can really be envisioned. As has correctly been stated by the article of Vivek Wadhwa of 14’th December ‘2010, a new breed of Indian Start-ups now is developing high-value products based on Intellectual Property. Having out-licensed some of such out-of-box telecom and network security products, I couldn’t have agreed more.

This article essentially relates to about a 2 year old but not so actively participated scheme that DIT has for Indian Information and Communication Technologies (ICT) based Start-ups and SME’s. Having worked with many Indian Start ups in the domain of Software and Electronic technologies, I have regularly seen unfunded Corporates turning down potential IP’s which could have had significant valuations when put across to the Investors. This is more so the case when the Applicants avoid filing the PCT and National Phase Applications outside India knowing full well that the real valuation of an IP at the present moment is only considered as a value proposition if its protected in US and EP.

The proposed scheme is called the SIP-EIT (Support International Patent Protection in Electronics and IT), wherein the scheme reimburses the costs incurred by SMEs and Technology Start-Up units in filing International Patent Applications (in the field of Electronics & ICT) for their indigenous inventions.

The highlights are as follows:

1. Registered MSME, DSIR Certified companies, and Technology Incubation enterprises are eligible to apply for the scheme.

2. The funds are given as a grant – i.e., no refunds expected.

3. The Applicants are free to hire any Attorneys whose fees are included in the schedume and would be refunded subject to the below mentioned maximum limit.

4. 50% of all expenses, including lawyers fees, is reimbursed by the DIT. However, this “50%” must not exceed Rs. 15 Lakhs

5. Along with the registration and financial details, the Applicant needs to provide a prior art search report indicating the chance of patentability of  the invention, product brochure, and Official copy of Indian Patent Application Filing.

6. The Start-up/SME need not be an ICT company, it can be a Pharmaceutical or any othr company having an ICT product, apparatus and/or process.

The details of the scheme are available here. We believe this to be an excellent support that if utilized properly can yield effective Licensing and Product Commercialization opportunities for the company.

The only caveat in my perspective, at the moment, would be the appropriateness in grant of ICT based Patents in India and their enforceability in the Court of Law keeping the Section 3(k) in mind. We have already seen examples of Computer implemented patents being granted in India of whose corresponding Patents have been rejected by the EPO and other geographies which have tests based on technical effect and tangible results. Therefore, keeping in consideration the inconsistency of patents being granted based on the technical effect bar of the Indian Patent Office, probably its high time that objective tests be set to ensure reliability in the outcome of the patentability to produce defendable and enforceable ICT patents.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.