Friday, 27 July 2012

Patent Office lists Patent Applications Disclosing Traditional Knowledge

The Indian Patent office has provided a list of patent applications that disclose traditional knowledge. The list shows that there are approximately 780 patent applications filed with the Indian Patent Office that belong to the domain of traditional knowledge. The list of granted patent is currently empty as the list is going to be populated by patents that have been granted after July 1, 2012 onwards. 

"Presumption of Validity" - Whether it Changes or Not (Sciele Vs Lupin)

The recently decided CAFC case, Sciele Pharma Inc. v. Lupin Ltd, has a rather very “interesting” fact pattern and throws new light on the discussion on “presumption of validity” under US patent laws. [Section 35 U.S.C. 282 discusses the concept of “presumption of validity”.  Link: Here]

Background: Lupin wanted to introduce a generic version of a drug for which Sciele held a patent (6,866,866) and filed for an ANDA with the FDA. In response to Lupin’s application for marketing the generic, Sciele decides to sue them for patent infringement. Sciele files a lawsuit and is able to delay the FDA’s decision on the generic for 30 months. However, the 30 month period expires during the litigation and Lupin goes ahead with the introduction of the generic in the market only to receive a preliminary injunction from the District Court. Lupin appeals the decision of the district court and the case comes to CAFC. 

The “interesting” fact pattern of US 6,866,866:

1.       Sciele receives office action from the examiner stating that certain claims are not allowable. The file wrapper is not available so I am not able to cite the exact claim numbers.
2.      In response to the office action, Sciele cancels the claims marked as “not allowable” and rewrites other claims in “allowable” form as independent claims.
3.      A notice of allowance is mailed. However, the notice of allowance includes the new claims and the cancelled claims.
4.      Sciele notifies the USPTO and the USPTO issues a supplemental notice of allowance for only the new claims.
5.      However, when the patent is issued, the patent still includes the new claims and the cancelled claims.

If the above sequence of actions did not raise questions in your mind, then what followed certainly will. Sciele files a patent litigation suit against Lupin asserting the cancelled (and invalid?) claims.  In defense, Lupin argues on the patentability of claims by citing references that were already used by the examiner during prosecution for destroying the novelty of the cancelled claims.

While Lupin argues that “presumption of validity” should not apply as the cancelled claims were issued accidently, Sciele argues that a “stronger” presumption should be applied as the patents presented by Lupin have already been considered by the examiner. 

So what does CAFC decide? 

CAFC says that both parties assertion is WRONG. Confused? The explanation that CAFC gave was that a patent is presumed valid (which can be rebutted) and the burden of proof is always the same – clear and convincing evidence irrespective of the fact that the references have already been considered by the examiner. (See: Microsoft vs. i4i). 

Outcome: The CAFC has vacated the preliminary injunction and sent the case back to district court for further processing.

Thursday, 5 July 2012

WIPO and Indian Patent Office Come Together to Simplify the Process of Filing PCT Applications in India

July 6, 2012: Good news for applicants who are looking to file their PCT national phase applications in India! The Indian Patent Office (IPO) has coordinated with the International Bureau (IB) of WIPO to share resources that will eliminate the redundant process that currently exist to submit a PCT national phase application in India. The IPO will now have access to the PCT International applications and the related documents that are available at the IB.

From July 6, 2012, an applicant will no longer be required to file multiple copies of documents that have already been submitted by the applicant at the IB. The IPO will itself electronically acquire the necessary documents required for the PCT national phase applications from the IB.

The IPO has issued instructions for the applicants to make them aware of the changes in the process.  Some of the important changes are that an applicant needs to fill only columns 1, 2, and 3 in Form 2. Additionally, the last page of claims (first page, if claims comprise of only one page) with date and signature also needs to be submitted. Needless to say, all other documents that are applicable will still need to be filed. The complete set of instruction can be accessed here.

An important point to be highlighted is that the changes will be applicable to only those PCT national phase applications entering India which do not claim priority of any PCT national phase application filed previously in India.