Contempt Suit Agaisnt Natco filed by Bristol-Myers Squibb

Natco Pharma is in news again in the patent world. A contempt suit has been filed against Natco by Bristol-Myers Squibb for violating a court order that prevented Natco from selling a generic version of Bristol's patented cancer drug - Dasatinib (patent granted in 2006). Natco was ordered by Delhi Court to stick to its undertaking that it will not manufacture or sell a generic version of Dasatinib. Economic times reports that Natco has not only denied the allegations but also filed a contempt suit against Bristol-Myers Squibb for "misinterpreting facts to court".


The generic version sold by Natco costs Rs 9,000 whereas Dasatinib costs Rs 1.5 lakh per month, reports Times of India. The pharma world will keep a close eye on Wednesday on the court proceedings to see how the whole thing unfolds. It will be interesting to see how the court handles this situation - whether the whole matter is seen as an issue of compulsory license or as an issue of contempt of court's order.

Consent from Applicant Required to Provide Search Results to EPO

Starting January 1, 2011, EPO required an applicant to submit search results (without any delay - emphasis added) related to any priority filings (See Amended Rule 141 of EPC).  This requirement was not applicable for priority applications from US, UK and JPO as the EPO electronically received the search results directly from the patent offices of US, UK and JPO. This was made possible because of mutual agreements between the EPO with the patent offices of US, UK and JPO. 

While there is no issue with respect to delivery of search results when a US patent application has been published, the same is not true for delivery of search results for unpublished US patent applications. The issue arises because 35 USC 122 prohibits the USPTO from providing information about an unpublished patent application without the consent of the applicant. 

In order to tackle the above issue, the USPTO recently issued a notice requesting the applicants to file Certification and Authorization form PTO/SB/69 for US applications that will serve as the priority application for their European counterpart. Essentially, this form will act as the applicant’s consent and allow the USPTO to timely provide the search results of an unpublished US patent application to the EPO. Failure to file the form will prevent the USPTO from delivering the search results. The consequence of not receiving the search results on time may lead the EPO to vacate the mutual agreement between the EPO and the USPTO thereby requiring the applicant himself to provide the search results. If the applicant fails to provide the search results on time, the application may be considered as deemed withdrawn. The Certification and Authorization form PTO/SB/69 should be filed before the corresponding European patent application is filed at the EPO.

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.

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.

Source: http://www.ipindia.nic.in/iponew/PublicNotice_PCT_02July2012.pdf

Interpretation of the word "discovers" in 35 USC 101

The differences between an “invention” and “discovery “ are well known in the IP fraternity. Discoveries that fall under the laws of nature, physical phenomena, and abstract ideas have been held not patentable. There have been many famous case laws that discuss the difference between an invention and a discovery (See Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)).  However, none (maybe) that discuss how to interpret the word “discovers” in light of 35 USC 101 or discuss the difference between the words invents and discovers in 35 USC 101. Are they different in meaning or analogous to each other? What was the intention of the congress to include the word discovers in 35 USC 101?

35 USC 101 discloses what can be patented. 35 USC 101 states:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The 101 section clearly specifies the various statutory classes under which an application for a patent can be made. Further, it is very clear that in order to develop a good understanding and correctly interpret each and every word in the law, the complete title (35 USC 101 in the present scenario) needs to be read in its entirety.

As 35 USC 101 uses both the words, invention and discovery, how does one interpret the meaning of discovery in light of 35 USC 101?  Is there a possibility that certain inventions (that are also patentable) may not be covered under 101 if one were to delete the word “discovery” from 35 USC 101? 

In other words, discovering the property of electromagnetism will not lead to the grant of a patent. The application of this discovery may get you a patent for which one will have to come up with an inventive step that falls under the statutory classes. So exactly what does the word “discovers” tell us about 35 USC 101?

Consolidation of Multiple Patent Infringement Lawsuits into a Single Lawsuit

One of the common practices employed by plaintiffs in patent infringement suits to reduce litigation costs is to consolidate multiple defendants in a “single lawsuit” as opposed to filing a “separate lawsuit” against each defendant. This practice of consolidation has been often critiqued by industry observers who have attributed the increase in patent litigation in the recent years to this practice. If you observe the litigation suits filed in the various district courts in the United States, you will observe two parallel, yet completely tangential stories. While some plaintiffs are consolidating multiple defendants in the same lawsuit in some specific district courts, other plaintiffs are filing separate lawsuits for each defendant when the trail is happening in other district courts. Surprisingly enough, I found out that the process of consolidating multiple defendants in a single lawsuit is not straight-forward. 

Traditionally, the consolidation of multiple defendants in a single lawsuit was allowed only when any right to relief is asserted against the defendants jointly, severally or when the infringement of the accused product arises out of the same transaction, occurrence or series of transaction (299 (a)). In addition to the above factors, the consolidation was allowed when questions of fact common to all defendants or counterclaim defendants will arise in the action (299 (b)).

The first clause of section 299 is also known as “same transaction or occurrence” test which was used by courts for deciding on consolidation of defendants. However, it has been observed based on case studies that different courts have different interpretation of the “same transaction or occurrence” test. For example, when multiple defendants are accused of infringing the same patent through different acts of infringement, some courts have allowed for consolidation stating that there is a definite logical or relational dependency in the acts thereby satisfying the test while other courts have refused to allow consolidation stating that different acts of infringement does not satisfy the “same occurrence or transaction” test. The second clause of section 299 is not as twisted as the first clause as courts found out that question over the validity of patent claims were common to all accounts (read: acts) of infringement. With the enactment of the Leahy-Smith America Invents Act (AIA), few amendments were made to Section 299 to bring clarity to the overall process of consolidation. Post AIA, the defendants cannot be consolidated into one suit for trial solely based on allegations that each defendant has infringed the patent(s).  

The AIA act will certainly bring down the number of multi-defendant lawsuits, however, it may result in an increase in the number of lawsuits that would translate into added burden and load on the courts. Moreover, there may be still ways to beat the system and reduce the costs. For example, plaintiffs may file a patent infringement lawsuit covering the same patent in different district courts against different parties thereby forcing the courts themselves to consolidate the lawsuits into one single lawsuit. Even if the lawsuits are filed in the same court, the judges themselves may consolidate the lawsuits during the trial.