Update: Roche v. Cipla Decision Available on Delhi High Court's Website

The Roche vs. Cipla decision is now available on the Delhi High Court Website. The decision can be accessed from here. A detailed analysis will follow soon.

India Court Rules Against Swiss Drug Maker Roche

Four years back, an injunction plea by Roche against Indian generic drug maker Cipla to prevent Cipla from manufacturing the generic version of Tarceva (Cancer Drug) was rejected by Delhi high court. News has just come in that the Delhi high court has ruled that Cipla's generic drug erlotinib hydrochloride is not infringing the patent held by Roche for Tarceva. The court also ruled that the patent for Tarceva is valid in India.

This ruling comes in just one week before another high profile case where the Supreme court will be hearing a plea by another Swiss giant Novartis over its cancer drug Glivec.

The details of the judgment are awaited.

IPO Provides List of Patent Applications & Pending in the field of Pharmaceuticals and Food

After disclosing the list of patent applications and patents related to traditional knowledge, the Indian Patent Office has now provided the list of patent applications and patents related to the field of Food and Pharmaceutical. The list of granted patents can be accessed from here for Food and from here for Pharmaceutical. The list of pending applications related to Food and Pharmaceuticals are provided below:

Food: Delhi, Kolkatta, Mumbai and Chennai
Pharmaceuticals: Delhi, Kolkatta, Mumbai and Chennai

Source: http://www.ipindia.nic.in/

 

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.

Generic Drugs and Branded Drugs - Details about the FDA Process

Drugs Manufacturers are required by the Food and Drug Administration (FDA) to submit details of the scope of their patents when they submit a New Drug Application (NDA). The details, along with the patent number and expiration date of each patent are published in “Orange Book”. The details, among other things, correspond to information about the drug’s components, clinical data and the intended uses for which the drug will be marketed. This information is called “use codes”. After the submission, FDA may approve the NDA for multiple “methods of use”. The “methods of use” roughly translates into treatment of different conditions or treatment of the same condition in different manners. Thus, the patentee has rights either on the drug compound itself or on a specific method of using the drug.

After an NDA has been approved, a generic company can consult the details of Orange Book and subsequently file an Abbreviated New Drug Application (ANDA), put simply, an application for manufacturing the generic version of the patented drug. The company filing the ANDA needs to show to the FDA that the generic drug will not infringe the patentee’s patent. The FDA evaluates the ANDA application to assess whether the proposed drug would infringe the patent on the basis of the information present in the Orange Book. A unique aspect about the entire cycle is that the FDA does not validate the information (use codes) entered in the orange book and “assumes” the information to be accurate. Thus, the use codes become the deciding factor in the approval or denial of the ANDA application.

In situations where no patents exist in the orange book and where the relevant patents will expire before the ANDA application is approved by the FDA, there is not much cause for concern. In situations where patents exist and are active, the generic company has two options. The first option is to file a “Section viii” statement and the second option is to file a “Paragraph iv” certification. Under the first option, the generic company markets the drug for one or more “methods of use” not covered in the patentee’s patent. This option differentiates the generic company’s intended method of use from the patentee’s (brand company) method of use and allows the generic company to manufacture and market the generic only under the “method of use” approved by the FDA. Under the second option, the generic company, by filing “Paragraph iv” certification, states that a listed patent in the orange book will not be infringed or is invalid. “Paragraph iv” certification provides more options to the generic company as it does not have to differentiate its method of use from the brand company’s method of use and allows the generic to market the drug for all uses. A peculiar thing about “Paragraph iv” filing is that under the statutes, “Paragraph iv” filing is considered as an act of infringement and the patentee has the right to drag the generic to the court of law. The approval of the ANDA in such cases is stalled for 30 months or until the court decides on the validity or infringement of the patent.

Date of Enforcement and Patent Amendments

The Indian Patents Act, 1970 has been amended in the years 1999, 2002, 2005 and 2006 to harmonize the patent laws and to make them more relevant to the new technologies. Some of the major changes have been allowance of product patents in drugs and chemicals, introduction of pre-grant opposition and changes in timeline and fee structure. Every amendment that is made is associated with a date of enforcement that tells us when the old provisions /act cease to exist and new provisions are enforced. 

This post deals with the apparent confusion that prevailed with respect to date of enforcement of patent amendments and interpretation of patent laws when scope of the laws is not easy to decode. The parties in contention are Philips Electronics India Limited (appellant), Asian Electronics Limited (respondent 1) and Controller General of Patents & Designs (respondent 2).  The appellant had filed an appeal in the High Court of Mumbai against the order of respondent 2 for granting of patent number 193436 (Application No. 545/BOM/1999) belonging to respondent 1. The matter was thereafter transferred by the High Court of Mumbai to the IPAB for hearing. 

Background of the case:

The patent application was accepted and notified in the Gazette of India Part III Section 2 dated July 17, 2004 under Patent Application No. 193436. The notice of opposition to the grant of patent under section 25 and Rule 55 was filed by the appellant on December 14, 2004(prior to the coming into force of the Patents (Amendment) Act, 2005). The opposition was filed on the grounds of non-compliance of section 8 by respondent 1. According to the appellant, respondent 1 has failed to disclose information about the status of foreign filing of the same application to the controller and as a result has failed to fulfill the statutory obligations. Failure to disclose the information about foreign filing has therefore established the grounds of section 25(1) and thus the patent application should not be granted.

The controller heard the matter on June 28, 2006 and ordered the grant of patent on July 24, 2006. The controller based his decision on section 15 of the Patents Act, 1970 as amended by the Patent Amendment Act 2002 (emphasis added), (hereinafter, “Old Act") rather than section 25. Aggrieved by the actions of the controller, the appellant alleged that the controller erred in construing that he could decide an opposition (that was filed under Section 25(1)) under Section 15 of the Patents Act. 

The counsel for the appellant argued that as the opposition was filed under section 25(1) of the Old Act, the decision on opposition should have been taken under the Old Act and not based on Patents Act 1970, as amended by Patent Amendment Act 2005 (emphasis added)(hereinafter, “Current Act”). According to the counsel, section 15 of the Current Act has no application in opposition proceedings and by considering section 15 rather than section 25, the appellant has been denied a statutory remedy by the controller thereby negatively affecting the outcome of the proceedings. 

The counsel based his reasoning on section 162(5) of the Current Act, the General Clauses Act and paragraph 7 of the Circular dated 14th March 2005 of the Controller General of Patents & Designs. Section 162(5) reads:

Notwithstanding anything contained in this Act, any suit for infringement of a patent or any proceeding for revocation of a patent, pending in any court at the commencement of this Act, may be continued and disposed of, as if this Act had not been passed.

In response to the allegations from the counsel of the appellant, the counsel for respondent 1 submitted that the provisions for continuing proceedings as described in section 162(5) cannot be extended and made applicable to all pending proceedings and were only applicable to specific pending proceedings. 

Decision of the IPAB Board:

After hearing the arguments of both the parties, the board observed that the opposition was filed on December 14, 2004 under the then existing section 25(1) and the matter was heard by respondent 2 on September 18, 2006. The board pointed out that before the matter was heard by respondent 2, the Patents (Amendment) Ordinance, 2004 had come into force amending the Patents Act, 1970 with effect from January 1, 2005 which was later replaced by the patents (Amendment) Act, 2005. The board brought to the attention of the parties the instructions given by the Controller General through office instruction dated January 14, 2005 on how to deal with the pending oppositions under section 25(1). 

The instruction read:

“The cases which have been accepted and notified in the Gazette for inviting opposition u/s 25(1) of the Act, before this Patents (Amendment) Ordinance, 2004 came into force, the opposition if any will be dealt with as per the old Act and rules and if no opposition is filed, the application shall directly proceed to grant.”

Further, sub-section 2 of section 1 of the Ordinance number 4 of 2004 stated:

“Sub-clause (ii) of clause (a), and clause (b), of section 37, sections 41, 42, 47, 58 to 62 (both inclusive) and 73 shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint; and the remaining provisions shall come into force on the 1st day of January, 2005.”

Moreover, the board specified that the appellant has got a right to go for appeal before the Honorable High Court as per the provisions available under section 116 (2) of the principal Act that were operative and in force when the impugned order was passed.

Section 116(2) reads:

“116 (2) Save as otherwise expressly provided in sub-section (1), an appeal shall lie to a High Court from any decision, order or direction of the Controller under any of the following provisions, that is to say, section 15, section 16, section 17, section 18, section 19, section 20, section 25, section 27, section 28, section 51, section 54, section 57, section 60, section 61, section 63, sub-section (3) of section 69, section 78, section 84, section 86, section 88 (3), section 89, section 93, section 96 and section 97.”

 The board concluded that the respondent 2 wrongly applied section 15 and ignored the Office instruction 1/2005 dated January 14, 2005 because of which respondent 2 failed to notice the date of enforcement of the amendments. Consequently, the decision of the respondent 2 is erroneous as instead of referring to section 25, the respondent 2 has referred to section 15 to decide the proceedings. The board has directed the order to be amended and asked the controller to base his decision under section 8 and section 25 of the old act as applicable on the date of filing of the opposition and not on section 15.  For further information, please refer to the IPAB site.