All about Patents

The Glivec Decision

2013-04-12T05:51:00.002-07:00

“…A statute is best interpreted when we know why it was enacted. … If a statute is looked at, in the context of its enactment, with the glasses of the statute-maker, provided by such context, its scheme, the sections, clauses, phrases and words may take color and appear different than when the statute is looked at without the glasses provided by the context…” - Justice Chinnappa Reddy in Reserve Bank of India v. Peerless General Finance and Investment Co. Ltd. and others

Introduction

The recent compulsory licensing judgments have done their bit in bringing concepts such as “Public Interest” and “Public Morality” in to the limelight in the Intellectual Property arena. An increasing number of people are now talking about “Role of Patents in Facilitating Affordable Drugs” and mechanisms through which one can maintain the balance between “Patent Rights” and “Public Rights”.

Thus, it was, but expected that the recent decision by Supreme Court of India in the Glivec patent case would trigger another round of heated discussions on India’s stance on drug patents. The Glivec decision has left the multinationals apprehensive and unsure about their strategies in India. Industry pundits are speculating that the Glivec decision will drive the pharmaceutical multinationals away from India to regions which they believe would provide more fertile grounds for their R&D as well as generate better returns on their IP.

There are also sections in the Industry who believe that India has stuck the right chord and the Glivec decision will ensure that essential drugs can now be made available more easily to those in need as well as the judgment can act as precedent to similar patent cases all over the world, especially in the developing countries.

Background

Following is a snapshot of some of the key points as well as summarization of circumstances surrounding the Glivec decision.

CGP 571481 in free base form (International Nonproprietary Name ‘Imatinib’), was one of the derivatives of N-phenyl-2- pyrimidineamine (formula I) invented by Jürg Zimmermann. The free base form and other derivatives displayed valuable anti-tumoral properties. These properties allow them to be used in anti-tumoral drugs and in drugs for treating atherosclerosis.

A patent application was filed on April 28, 1994 by Novartis in the United States for the N-phenyl-2-pyrimidine-amine derivatives, including Imatinib and the application was granted as US Patent No. 5,521,184 on May 28, 1996.

In their submission, Novartis stated that starting from Imatinib free base one could reach to the beta crystal form of Imatinib Mesylate in two ways. The two ways are specified below:

1. By digesting another crystal form (Alpha crystal form) or an amorphous starting material of the methane sulfonic acid addition salt of compound of formula I. In this process, one would first arrive at Imatinib Mesylate in amorphous form, as the intermediate stage, and thereafter, following further processes, reach the beta crystal form of Imatinib Mesylate.

2. By dissolving another crystal form (Alpha crystal form) or an amorphous starting material of the methane sulfonic acid addition salt of compound of formula I. In this process one would reach the beta crystal form of Imatinib Mesylate directly thereby skipping the intermediate stage of the amorphous form.

In their submission, Novartis also stated that the best way to produce the beta form is by directly proceeding from the free base form to the beta form by introducing a specified amount of the beta crystals at a specified step during the processing.

The beta crystal form of Imatinib Mesylate, according to Novartis, had the following benefits over the alpha crystal form of Imatinib Mesylate:

· Better flow properties

· Better thermodynamic stability

· Lower hygroscopicity

Based on the above benefits, a patent application was filed in India claiming the beta crystal form as a “new” and “superior” invention. However, an important point to be noted is that no claim of superiority of the beta crystal form of Imatinib Mesylate in regard to the beneficial properties over the starting material Imatinib, or even over Imatinib Mesylate in amorphous form or any form other than the alpha crystal form was made.

The patent application was filed on July 17, 1998 at the Chennai Patent Office bearing application number 1602/MAS/1998. The priority date for the application was July 18, 1997, the date on which the patent application was filed in Switzerland. An important thing to point here is that Switzerland was not a convention country as defined under section 2 (1)(d) read with section 133 of the Act and it was notified as a convention country only on November 30, 1998.

Stage 1: Patent Office

As India’s patent laws on product (Drugs) patent were still evolving in 1990s, the Indian patent application was kept in the “mailbox” and was taken out of the “mailbox” only after January 1, 2005 when India started recognizing product patents (facilitated by deletion of Section 5 of the Act).

However, before the application was taken out of the mailbox, some interesting events had already happened. Novartis had received a grant of exclusive marketing rights (EMR) on the subject matter of the patent application on March 27, 2002. Also, the patent application had received five pre-grant oppositions.

The Assistant Controller at the Indian Patent Office heard all the parties of pre-grant opposition on December 15, 2005 and rejected the Indian patent application (1602/MAS/1998). The main reasons for the rejection were:

1. The Indian patent application was anticipated by US Patent 5,521,184 (Novartis own patent on N-phenyl-2-pyrimidine-amine derivatives, including Imatinib).

2. The patent was not allowed under section 3(d) of the Indian Patent Act; and

3. The priority date (July 18, 1997) was wrongly claimed as the priority date for the Indian patent application and was thus also anticipated by the patent application filed in Switzerland.

In response, Novartis filed five writ petitions challenging the orders of the Assistant Controller as well as two writ petitions challenging the constitutionality of Section 3(d) in the Madras High Court. While the five writ petitions were transferred to the IPAB as appeals, the Madras High Court dismissed the two writ petitions on Section 3(d).

Stage 2: IPAB

The IPAB heard the five appeals challenging the decision of the Assistant Controller and pronounced its judgment on June 26, 2009. In the decision, the IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness and said that the Indian patent application fulfilled the tests of novelty and non-obviousness. The IPAB also accorded the priority date of July 18, 1997 to the Indian patent application based on the amended Section 133.

However, the IPAB rejected the application based on Section 3(d) stating that India’s laws on drug patents demanded higher level of inventiveness so that the act was successful in preventing evergreening of patents. The IPAB also weighed in the pricing of Glivec (Rs 1, 20,000 per month) under Section 3(b) and concluded that while a process patent could be given for preparation of Imatinib Mesylate in beta crystal form, a product patent on Glivec would be disastrous to public order and morality and thus Novartis could not be granted a product patent.

Stage 3: Supreme Court

“…Patent systems are not created in the interest of the inventor but in the interest of national economy. The rules and regulations of the patent systems are not governed by civil or common law but by political economy…” - Michel on Principal National Patent Systems

Before dwelling into the merits of the case, the Supreme Court took a look into the history of patent laws in India, specifically; they cited the Justice Ayyangar’s work and recommendations on revamping the patent system of India. The Supreme Court observed that historically, barring USA, the rest of the world did not allow product patents in the field of food, medicines and chemistry.

In addition to Justice Ayyangar’s report, the Supreme Court also cited works of Sudip Chaudhuri in his book “The WTO and India’s Pharmaceuticals Industry” to understand the performance of Indian Pharmaceutical Industry and how it has been impacted time and again with changes in Patent Laws. The Supreme Court also cited letters from various organizations such as HIV/AIDS Director of the WHO, and Director of Advocacy, Communication and Leadership for UNAIDS to the Indian Government expressing their concern on availability of affordable drugs to poor nation and role of Indian pharmaceutical industry in ensuring the continued availability of such drugs.

Coming to Section 3(d), the Supreme Court observed that the section was specifically amended to deal with chemical substances and more particularly to pharmaceutical products. Thus, the Supreme Court viewed Section 3(d) as a second tier of qualifying standards to identify genuine inventions in chemical and pharmaceutical domains and thereby put a check on evergreening of patents.

In an interesting turn of events, the Supreme Court took time to discuss the differences between the concepts of “inventions” and “patentability” during the proceedings. The Supreme Court acknowledged the fact that Section 3(d) represents the concept of “patentability”. However, the Supreme Court also stressed on the fact that when Section 3(d) is isolated from rest of Section 3 and when the legislative history behind the incorporation of Chapter II in the Patents act, 1970 is disregarded, one can observe that it is possible to see Section 3(d) as an extension of the definition of “invention”. Thus, the Supreme Court concluded that the Act sets different standards for qualifying as “inventions” things belonging to different classes.

During the hearing, the following arguments were made by Novartis:

1. The Genesis of beta crystalline form of Imatinib Mesylate (derivative of N-phenyl-2- pyrimidine-amine) was disclosed in example 21 of the US patent number 5,521,184.

2. The beta crystalline form was brought to being by not one but two inventions. The first invention was to select example 21 and the second invention was to choose methane sulfonic acid to produce the methane sulfonic acid addition salt of the free base Imatinib, called Imatinib Mesylate. Novartis claimed that 5,521,184 patent did not teach or suggest to a person skilled in the art to select example 21 in preference to other compounds. Moreover, US patent 5,521,184 did not teach a person to select one particular salt even when example 21 was selected. Thus, Novartis argued that creating Imatinib Mesylate from Imatinib in free base was the result of an invention that involved technical advance as compared to the existing knowledge. Further, Novartis argued that once the salt form of Imatinib was arrived at, further research was required to ensure that that particular salt form of Imatinib is suitable for administration in a solid oral dosage form. As the relevant crystalline form of the salt that was synthesized needed to be invented, Novartis said that arriving at the beta-crystalline comprised two inventions.

The Supreme Court observed the following in response to arguments made by Novartis:

1. The US patent 5,521,184, granted on May 28, 1996 expressly stated that the compounds of N-phenyl-2-pyrimidine-amine derivatives included their respective salts.

“Salt-forming groups in a compound of formula I are groups or radicals having

basic or acidic properties. Compounds having at least one basic group or at

least one basic radical, for example a free amino group, a pyrazinyl radical or a

pyridyl radical, may form acid addition salts, for example with inorganic

acids, such as hydrochloric acid, sulfuric acid or a phosphoric acid, or with

suitable organic carboxylic or sulfonic acids…”

“….any reference to the free compounds should be understood as including the corresponding salts, where appropriate and expedient.”

2. The application also stated that “Acid addition salts can be convened into the free compounds in customary manner, for example by treatment with a suitable basic agent.”

3. The application for beta crystalline form of Imatinib Mesylate was filed in the US on January 18, 2000 and was granted on May 17, 2005 following the order of US Appellate Court dated November 23, 2003.

4. The Drug, Glivec, was however launched much earlier in the market based on US patent 5,521,184 itself.

5. The patent information filed along with the New Drug Application (NDA) filed on February 27, 2001 showed that the active ingredient as Imatinib Mesylate.

6. The description on package of GLEEVEC (Imatinib Mesylate capsules), launched on July 3, 2001stated that the capsules contained Imatinib Mesylate equivalent to 100 mg of Imatinib free base.

Based on the above facts, the Supreme Court concluded that Imatinib Mesylate, marketed under the name Gleevec, was covered by US patent 5,521,184. Moreover, the court also stressed on the fact that how Novartis had used the European counterpart of the US patent 5,521,184 for preventing Natco Pharma to market its drug, VEENAT 100 in UK in order to support its conclusion. The Court also cited the findings of US Board of Patent Appeals in its judgment granting patent for beta crystalline form of Imatinib Mesylate. The court brought to notice that even the US Board of Patent Appeals mentioned in their judgment that though the beta crystal form might not have been covered by US patent 5,521,184, it did have the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm blooded animals suffering from a tumoral disease.

Thus, the Supreme Court held that Imatinib Mesylate as a substance and its pharmacological properties were well known in the art. Having concluded on Imatinib Mesylate, the Supreme Court then focused on beta crystalline form of Imatinib Mesylate. As the beta crystalline form of Imatinib Mesylate is a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it is governed by Section 3(d) of the Act.

The counsel for Novartis argued that in order to attract section 3(d), the subject product must be a new form of a known substance having known efficacy. The counsel also stated that a “conceivable” substance is not a “known substance” within the meaning of the provision. He contended that the word “known” connotes proven and well-established and thus “known efficacy” would imply efficacy established empirically and proven beyond doubt. As neither Imatinib nor Imatinib Mesylate had any known efficacy, he contended that there was no question of showing that the beta crystalline form of Imatinib Mesylate had any enhanced efficacy over Imatinib or Imatinib Mesylate.

However, the Supreme Court rejected the counsel’s arguments as unacceptable both in law and on facts. Consequently, the court concluded that beta crystalline form of Imatinib Mesylate would correspond to a new form of a known substance, i.e., Imatinib Mesylate, of which the efficacy was well known as described in the NDA filed with the US FDA. The court also went on to defined efficacy as “the ability to produce a desired or intended result”. An interesting point over here is that Supreme Court also brought to attention how the patent application for beta form was based on US patent 5,521,184, and how most of sections were directly lifted from the US patent 5,521,184.

In another interesting aspect, the court observed that while the application for grant of patent lay in the “mailbox”, Novartis was granted Exclusive Marketing Rights on November 10, 2003, following which Gleevec was marketed in India as well. The package described the drug as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. However, nowhere on the package is a reference to Imatinib Mesylate in beta crystalline form. This indicates that what were sold as Gleevec were Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate. This leads one to believe that the claim for patent for beta crystalline form of Imatinib Mesylate is nothing but an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible.

Thus, the Supreme Court held that the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act.

Conclusion

This decision has forced the pharmaceutical multinationals to come up with new strategies as well as create a checklist for launching new patented drugs in India. Companies are going to be more apprehensive than ever before to do business in India. Partnerships with local companies may emerge as one of the short term solution but questions are being already raised on its implications in the long run. Till then, it will be interesting to see whether India continues to be the “pharmacy of the world”.

Catch 22 in a Recent Copyright Infringement

2013-02-27T02:44:00.005-08:00

This entry is not about the famous novel by Joseph Heller but is about an alleged copyright infringement in Finland that very nicely summarizes the catch-22 situation that Heller wrote about in his novel.

Most of you would be aware of the famous torrent site “Pirate Bay” that facilitates peer-to-peer sharing of torrent files. "Pirate Bay" has often been the target of various anti-piracy groups and "Pirate Bay" is no stranger when it comes to fighting claims of copyright infringement. However, in early February this year, it was "Pirate Bay" which was doing the suing. What makes the entire situation even more interesting and hilarious is the fact that the one getting sued is "CIAPC", a Finnish "anti-piracy" group.

How can this be possible, one may ask! Well, CIAPC copied the design of Pirate Bay website including the CSS stylesheet for an anti-piracy campaign. Not surprisingly, Pirate Bay’s usage policy prohibits organizations from using any site material without permission. If Pirate Bay is able to successfully assert its claim, the anti-piracy group may just have to pay and in case Pirate Bay loses, there will be at least one precedent that says that copyrights are invalid! A catch-22 situation indeed!

“Divided” on “Divided Infringement”

2013-02-27T02:44:00.001-08:00

“Divided” on “Divided Infringement” - The lessons from Akamai, McKesson and Zoltek

The last quarter of 2012 saw some important decisions delivered in patent lawsuits that led to creation of what some may call as “new standards” on induced or divided infringement. The major point of contention was on the liability of the parties when separate parties perform separate parts of a “method” claimed in a patent.

Traditionally, in cases relating to induced infringement, the patentee (plaintiff) needed to prove that the defendant has induced another party to directly infringe the patent. Thus, under the old school, induced infringement required the proof that a “single party” performed all the steps of the method claim. However, the “single party” requirement was exploited by many to circumvent the claims and avoid costly lawsuits. This was especially true in the field of internet where multiple parties/entities are involved for completing a specific action. The “single party” requirement created problems for the patentee who often found it hard to find one party that performed all the elements of direct infringement. The people drafting the patent application were also forced to write claims keeping in mind the “single party” requirement for providing infringement.

However, the decisions in Akamai vs. Limelight, McKesson vs. Epic Systems and Zoltek vs. United States have put open to interpretation, yet again, the requirements to prove infringement under 35 USC 271. The “new standards” as laid down in Akamai and McKesson, now require the patentee to only prove that (i) the defendant was aware of the patent, (ii) induced the performance of the method claimed and (iii) and those steps were performed. Thus, it is no longer necessary to prove that all steps were performed by a single party. Consequently, the defendant will be held liable even if performs some of the steps and actively induces others to perform the remaining steps of the method claimed.

One can draw parallels with principles of “vicarious liability” and mens rea, which are often used in deciding liability of parties in criminal and contractual cases, in the “new standards” for deciding induced infringement. The knowledge of the patent and active inducement will make the defendant vicariously liable for the acts done by others. It is quite probable that the 6-5 en banc decision will be taken up by the Supreme Court in the near future for providing further clarity on the topic. Till then, the uncertainty on divided infringement is likely to continue.

Case Laws:

1. BMC Resource vs. Paymentech

2. Akamai vs. Limelight

3. McKesson vs. Epic Systems

4. Zoltek Corporation v. United States

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

2012-09-11T21:13:00.002-07:00

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

2012-09-07T11:19:00.003-07:00

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

2012-08-09T20:59:00.001-07:00

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

2012-08-01T11:08:00.000-07:00

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

2012-08-01T04:34:00.000-07:00

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

2012-07-27T19:50:00.002-07:00

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)

2012-07-27T05:54:00.000-07:00

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

2012-07-05T23:35:00.003-07:00

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

2012-06-18T02:41:00.001-07:00

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

2012-06-08T01:58:00.000-07:00

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

2012-05-30T05:08:00.003-07:00

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

2012-05-24T03:08:00.000-07:00

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.

Is lack of communication at patent office hampering your patent application?

2012-05-16T03:10:00.001-07:00

This post deals with a recent application that was filed at the IPAB and highlights the importance of timely communication on all matters at the patent office. The journey of a patent application from filing to its grant is time bound. Every action comes with a deadline and failures to meet the deadlines have their own consequences. This is what happened when a patentee was not informed about the grant of his patent by the patent office and the patentee subsequently filed for amendments in the patent application. Thus, the question that needs to be answered is whether the amendments that were filed by the patentee (without having information on the grant of his patent) correspond to amendments for the pre-grant application or for the post-grant application?

B. Braun Melsungen AG, a German medical and pharmaceutical company, had filed an application (1857/MAS/1998) for a patent titled “AN I. V. CATHETER” on August 18, 1998 at the Indian Patent Office. On May 27, 2005, the agents of the patentee were intimidated that the application was in order to grant but the letters would be issued after the disposal of pre-grant opposition. Form 13 was filed on September 10, 2007 for changing the counsel by the patentee and the counsel was informed on December 19, 2007 that patent has been granted on the application and the grant of patent has been recorded in the Register of Patent Office on December 3, 2007 (Ref: Patent No. 210062 (1857/MAS/1998), dated August 18, 1998 granted on September 17, 2007”).

The situation gets tricky on September 19, 2007 (see image) when the counsel for the patentee filed another Form 13, this time for amending the claims in the patent application. The patentee cancelled all the original 54 claims and replaced the claims with new set of 28 claims. The required payment for form 13 was made on September 21, 2007 because of which the date of filing of form 13 was considered as September 21, 2007. The examiner allowed the amended claims stating that the allowed claims were well within the scope of the claims of the specification before the amendments. What makes matter even more interesting is the fact that the patentee had filed another application under rule 137 and rule 138 for condonation of delay under section 8(1)(b). Section 8(1) (b) deals with the filing date for international application under PCT where India has been designated. Rule 137 and rule 138 deal with specials powers given to the controller on matters where no special provisions are made in the patent act.

Suru International, an Indian company that manufactures syringes, catheter and cannulas, had raised a pre-grant opposition for 1857/MAS/1998 on the grounds that the invention was not novel and that the patentee had not only failed to comply with section 8 (1) (b) but also the fact that the patent office was treating the amendments as pre-grant amendments.

Upon examination of patent records, it was revealed that 1857/MAS/1998 was allotted number 210062 on September 17, 2007. Further, it was revealed that notice of allotment of a patent number to an application under rule 37 of patent rules 2003 is not communicated to the officers at the patent office. Based on the above information, the IPAB has asked the patent office to consider the matter afresh from September 21, 2007. As form 13 was filed after grant of patent, the IPAB has decided that the responses filed after date of grant will be dealt in accordance with provisions on post-grant applications.

The IPAB has gone one step ahead and called for greater transparency and communication at the patent office so that examiners are aware of when Form 13 are filed, when the patent is granted and when the number has been allotted. IPAB also placed importance on the availability of information and requested that once a patent number is allotted, it should be made immediately available on the patent office website so that the patentee’s are well informed about the status of their applications.

Recent IPAB Decision - A hotchpotch of arguments

2012-05-04T03:59:00.002-07:00

What happens when a pre-grant opposition is filed for an Indian patent application and the following happens:

The pre-grant opposition application is withdrawn by the respondent on the grounds that the party (respondent) is no longer interested in pursuing the matter.
The documents cited as prior art in the pre-grant opposition belong to the inventor of the current application and has been abandoned.
The most important cited document is not from the same technology area.
There is no agreement between the experts testifying on the matter of novelty and inventive step.

This is what happened in a recent IPAB decision in which the patent application was not allowed for grant. The patent in suit is 40/2007/PT/MUM, titled “NOVEL AGRICULTURAL COMPOSITION”. The patent application discloses an agricultural composition comprising an effective amount of a sulphur active ingredient and a dispersing agent. According to the appellant (patentee), the novel feature of the invention was the ability to instantly convert sulphur to its sulphate form so that desired quantity of sulphur is made available for assimilation by plants. The composition was in the form of grains (0.1 mm to 2.5 mm) that were soluble in water and ranged from 2 to 12 microns in particle size.

Background: Seven documents were cited in the first examination report, the response to which was filed by the appellant by limiting and modifying the initial set of 15 claims to 13 claims. Thereafter, the pre-grant opposition was filed by the respondent. The most important document from a prior art view disclosed all the elements of the current application. However, the difference lay in the fact that the document was targeted towards fungicides whereas the current application targeted the easy assimilation of sulphur in its sulphate form by plants. Further, the percentage by weight of each ingredient was different in the cited document and the current application. Even though the respondent withdrew their appeal and did not go ahead with the opposition, the board nonetheless stressed on the fact that it was the duty of the board to not allow an application to go forth to the public merely because the opposition is withdrawn.

For deciding the novelty and inventive steps, the board relied on the fact that the process of assimilation of sulphur in sulphate form was known in the art and the main area of contention was with respect to the particle size and the speed at which the sulphur containing composition gets oxidized and becomes sulphate. In order to throw light on the novelty and inventive step, the board agreed with the findings of the controller who had concluded that agricultural composition included both fungicidal composition and nutrients required for the plants. As a result of this, the cited document acted as deciding prior art for the current application. The board stated “The use of sulphur as a nutrient is a known use, the rapid oxidation by change in particle size is known, there are prior arts which feature economic advantage of the composition as also sustained release.” The above argument was also used while considering the testimony of 10 experts in the field of horticulture and sulphur. There was difference of opinions with respect to what the experts thought of the novelty and inventive steps of the invention with one expert going as far as stating in his testimony that the claims (as filed) did not do justice to the invention and only dependent claims 12 and 13 in combination with examples in the specification brought out the novelty of the invention. Further details can be found on the IPAB site.

Declaratory Judgment - A preemptive action!

2012-05-02T23:31:00.001-07:00

In a typical patent infringement lawsuit, the patentee enjoys the convenience of bringing the lawsuit at his/her own will. In other words, when the patentee is made aware of an infringer, the patentee has the liberty of waiting for the “right time” to file a lawsuit against the infringer in order to claim maximum damages. What happens when the so called “alleged infringer” has made an honest mistake and was unaware of patents mentioned in the lawsuit? Are there any provisions or preemptive actions present in the patent laws that can be exploited by people who have invested a substantial amount of capital, efforts and time in manufacturing and launching their products and subsequently feel that they may become targets of potential patent infringement lawsuits?

Declaratory judgment is one such provision that can be used by the “alleged infringer” as a preemptive action to clear any uncertainty about their products. As the name implies, Declaratory Judgment is merely declarative where the court provides its opinion on an issue. Thus, when a patentee sends a Cease and Desist letter to the alleged infringer stating that certain products or services of the alleged infringer are infringing or potentially infringing patents owned by the patentee, the “alleged infringer” can file for a Declaratory Judgment in their own jurisdiction or a “favorable jurisdiction”. Although the patentee has the option to file a motion for transfer of the jurisdiction, the selection of a favorable jurisdiction by the alleged infringer acts as a great tool to control the venue and time of future trials.

The alleged infringer can file for a Declaratory Judgment on the following grounds, namely, non-infringement, invalidity, and unenforceability. Further, while filing for Declaratory Judgment, the alleged infringer has to prove that controversy exists over the patents and the products in order to persuade the court to grant the Declaratory Judgment.

Some advantages of Declaratory Judgment:

A strong pre-emptive action that can be used by alleged infringers
Increases expenses of the patentee by forcing the patentee to continue proceedings in the jurisdiction where the Declaratory Judgment is filed by the alleged infringer
Less expensive as it does not involve a trial and the court provides opinion on the controversy
Get an idea on the likely outcome of a future trial and accordingly take appropriate corrective actions (such as out of court settlements).

The wait is over! - IPAIRS Version 2.0 Launched

2012-04-25T21:08:00.000-07:00

April 24, 2012: The wait is over! The Indian Patent Office has (finally) launched the much awaited IPAIRS Version 2.0 which boasts of a new search interface and search fields for searching patents, published application and patent agents. The new search fields that have been added to expand the functionalities of the database are “Applicant Address”, “Inventor Address”, Journal Number (U/S 43(2)), PCT Application number and International classification.

Similar to the integrated view of Espacenet, IPAIRS Version 2.0 allows one to view not only the complete specification of a specific patent but also valuable information of the patent on eRegister, Prosecution history and controller decision in a single window. This is definitely a great change and will allow users to search more effectively for Indian patent literature.

The Travancore Mats & Matting Co. v. Kollekattu Joseph Scharia et al. at IPAB, Chennai

2012-03-17T03:30:00.001-07:00

This post deals with a revocation application that was filed at the IPAB in Chennai. The applicant, The Travancore Mats & Matting Co. filed a revocation application under section 64 of the Indian Patent Act, 1970 for revocation of patent number 206494, titled “A METHOD OF MAKING COIR TUFTED RUBBER MATS”. The patent was filed on 05/05/2000 and belongs to Kollekattu Joseph Scharia (Respondent). The first independent claim of the patent is reproduced below:

The process of making coir tufted rubber mats in rolls, by tufting perpendicularly the evenly cut coir yarn into a soft flexible sheeted rubber compound obtained through mixing of natural rubber, synthetic rubber, reclaimed rubber, rubber chemicals fillers and process oil, in a kneader machine or in a mixing mill OR by mixing rubber latex, rubber chemicals, fillers and hardener in a planetary moving agitator.

The applicant, who has been in the business of manufacturing mats for several years, through their learned counsel, alleged that the respondent should not be entitled to the patent as the respondent is not the true and first inventor of the invention and obtained the invention wrongly. Further, the applicant also alleged that the invention is very well known to the public of India and was used by the public much before the respondent had filed for a patent for the invention. In addition to the above reasons, the applicant also argued that the patent lacks novel and inventive step and the “process of making coir tufted rubber mats” would have been obvious to a person skilled in the art. The applicant claimed that the respondent has obtained the patent illegally by failing to disclose material facts such as proof of manufacturing, sales of products that are important and relevant for consideration of the respondent’s eligibility to such a patent.

In responding to the applicant’s allegations, the respondent submitted that mats, as disclosed by the patent, were not known to the public or manufactured by anyone. Further, prior to the filing of the patent, the coir mats that were available in the market were mostly PVC tufted coir mats. The respondent claimed that the PVC mats are not eco-friendly and do not posses ant-skid properties. The respondents agreed that there were rubber tufted coir mats that were available in the market; however such rubber tufted coir mats suffered from various deficiencies and lacked effectiveness and the advantages that the mats as described in the patent owned by the respondent described. The respondent stressed that a substantial amount of time, effort, development and testing was invested to invent the mats described in the patent. The mats described in the patent are manufactured by embedding straight and evenly cut coir fiber from the coir yarn to rubber compounded sheets. The uniqueness of the manufacturing method allowed th mats to be cut into any desired shape and size without requiring any type of mould or hydraulic press.

The respondent highlighted the fact that the application for revocation of the patent was filed without any substantial objection or supporting documents, even though the applicant had alleged that the invention was known to the public. Consequently, the onus for establishing invalidity lied with the applicant and the applicant had failed to establish any grounds for proving invalidity by failing to submit any substantial evidence.

Justice Prabha Sridevan, who was hearing the case, dismissed the application for revocation of the patents with costs on the ground that the onus for establishing the invalidity was with the applicant who had failed miserably by not submitting any material evidence.

Image Source: http://4.bp.blogspot.com/-74VPFPl5tRs/TgshAzoe3WI/AAAAAAAABTU/SMJONGd7qfc/s400/doormat.jpg

Protection for Sexually Reproduced Plants

2012-03-15T02:55:00.002-07:00

Many countries provide protection to inventions in the field of agriculture/horticulture either through patents or by an effective sui generis system (such as the Plant Variety Act of India, 2001), or both. Under the Indian Patent Act, sections 3(h) and 3 (j) disclose what can be construed as “patentable” for inventions related to plants.

The recently filed opposition to Monsanto patent on Indian melons at the European Patent Office triggered another debate on whether living organisms and their products are patentable. In the Monsanto patent, the process for melon breeding has been excluded from the scope of the patent; however, the patent office granted protection to the “plant” per se as well as plant products such as seeds, fruits etc. The process of breeding has been excluded because European Union do not provided patent protection for conventional breeding.

The history sheet of protection for living beings, including plant varieties and their products, is far from being clean. There have been many interesting cases where the courts have tried to understand the intent of the congress as well as interpret the sections in patent laws targeted towards the protection of living beings as inventions. Diamond v. Chakrabarty (In the Supreme court of United States) proved to be a landmark case that went on to be cited in many subsequent patent litigation cases. Another interesting patent litigation case was contested between Farm Advantage v. Pioneer Hi-Bred in the year 2001.

Farm Advantage v. Pioneer Hi-Bred: The main areas of contention in the case were patentability of sexually reproduced seeds by breeding under 35 USC 101 as well as determining the intent of the congress in providing dual protection for the same plant products under plant varieties protection act and utility patents.

Background: This was the first case that addressed the issue of whether patent protection could be sought for sexually reproduced plants. Pioneer was granted 17 utility patents relating to inbred and hybrid corn seed products. The seeds were sold under a limited license that allowed the purchaser to use the seeds for production of single crop (emphasis added) and denied the purchaser from using the seeds for propagation or seed multiplication or for the production or development of a hybrid or different seed variety. However, Farm Advantage sold the seeds to certain farmers, who in turn planted the seeds in their fields. When Pioneer filed a lawsuit alleging infringement of its utility patents, Farm Advantage filed a counter-claim arguing that sexually reproducing plants are not patentable and the 17 patents were invalid.

Outcome: The supreme court ruled in favor of Pioneer clearing certain bit of smoke that hovered on whether sexually reproduced plants obtained through breeding were patentable or not.

Natco granted India's first compulsory license for the Patented Drug Nexavar

2012-03-12T04:47:00.002-07:00

Natco has been granted a compulsory license from the Indian Patent office for the patented drug Nexavar. The patent for Nexavar is owned by Bayer. I had blogged in the past on the application for compulsory license by Natco for producing a generic version of the patented drug Nexavar here.

The patent office gave the compulsory license to Natco and stated that Bayer had not met the requirements of the market because of which the life saving drug was not available to the common man at affordable prices. This is the first instance of patent office granting a compulsory license. To read more about compulsory licensing in India and the corresponding sections in the patents act, 1970, please click on the following link:
http://patentsind.blogspot.in/2011/08/natco-pharma-applies-for-indias-first.html

For further read: http://www.moneycontrol.com/news/business/natco-wins-compulsory-licensebayer-for-cancer-drug_679152.html

Image Source: http://blog.timesunion.com/healthcare/files/2011/10/Pill-box-and-upset-man-300x300.jpg

RTI and the Patent Office

2012-03-11T21:50:00.002-07:00

The RTI has been a major weapon in the common man’s armory in his fight against the rampant corruption present in the government offices. It is no surprise that this post deals with the usage of RTI as a tool to tackle the ineffectiveness of the Indian Patent Office.

Bharat Kumar, the appellant, had filed an RTI application on 25.4.2011 seeking information on why the patent office has failed to provide necessary information that explains the delay in grant of his patent application 2254/Del/2005, titled “Titanic Audio”. On receipt of the RTI application, the respondent, Ashok Kumar, CPIO informed that appellant that a request was made to B.P. Singh, group leader of electrical division to furnish the necessary information.

To the dismay of the appellant, B.P. Singh replied that the appellant should seek the information from the section where the file is presently located. To make matters worse, B.P. Singh then went on leave without informing the CPIO. Consequently, the CPIO made a request to the appellant seeking additional time till June, 2011. Upon the return of B.P Singh to the office, the RTI file was again sent on 3.6.2011 seeking the required information. However, B.P. Singh has not provided information to the appellant till date. (A delay of more than 100 days!)

A show cause notice is going to be issued in the matter and the Information Commissioner, Sushma Singh has ordered B.P. Singh and Ashok Kumar to present themselves for the hearing of the show cause notice. Further, an order has been issued directing that the required information to the appellant be provided within 10 days of the receipt of the order.

When I looked up the patent application 2254/Del/2005 on Indian Patent Office, the status of the application reads “Abandoned under Section 9(1)”. Further, I found a letter from the appellant dated 4.1.2008 requesting for information on the status of his patent application. The letter is available here.

One thing that is clear from the above case is that, henceforth, the patent office ought to be more diligent in handling its daily matters so that such situations can be avoided in future. The common man is now more aware of his rights than ever before. The nexus between the RTI and the common man is becoming stronger and stronger.

Image source: http://www.bigislandchronicle.com/wp-content/uploads/2010/11/Expect-Delays-sign.jpg

Extraterritorial Patent Infringement

2012-03-07T00:29:00.000-08:00

It is well known that patent rights are inherently territorial and cannot provide protection to patent owners in a foreign land if the patent owner has not applied for patent in the foreign land. 35 USC 271 (a) is related to Infringement of a patent and states that “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.” Thus, for an infringement to occur, all the infringing acts have to occur in the territory in which the patent protection is provided.

So what happens when all the infringing acts are not performed within the country? For example, the manufacturing of some (or all) components of a patented machine occurs in the country where patent protection is present and the manufacturing of other components and assembly of all the components to make the machine happens in a foreign country? Do the patent laws address these kinds of situations where rights of patent owners may be wrongly exploited by third parties? Consider the case of Deepsouth Vs Laitram (sometime in 19^th century) where the Supreme Court ruled that shipping of unassembled parts outside United States did not constitute patent infringement.

The patent laws have been amended several times to address such situation and there have been many famous case laws that specifically address the question of “Extraterritorial Patent Infringement”. Section 271 (f) (1) and 271 (f) (2) were enacted in 1984 to address the loopholes in the patent system. These sections imposed liability on exporters of components if they actively induced in assembling the components outside United States to make the patented article or when the exported components did not have any other use except when they infringe the patented article. In 1988, section 271 (g) was added which imposed liability on people who imported into United States unpatented components made by process covered by a US patent.

Some of the case laws for building an in depth understanding of extraterritorial patent infringement are provided below. The “doctrine” of Extraterritorial Patent infringement becomes even more unique with the advent of software patents. A lot of software inventions involve processes/methods that can (and currently are) being performed in more than one country. When patent protection is not present in all such countries, the situation becomes even more interesting. Same is the case with import and export of intangible information. In the era of globalization and increased focus on harmonization of patent laws across the globe, extraterritorial patent infringement will continue to receive its fair share of attention.

Famous case laws on Extraterritorial Patent Infringement:

1. NTP Vs. RIM

2. AT&T Vs. Microsoft

3. Eolas Technologies Vs. Microsoft

4. Bayer Vs. Housey

Auto-rickshaw Meters Stuck in a Patent Row

2012-03-01T17:23:00.002-08:00

Image Source: http://chrisgoestoindia.wordpress.com/2010/10/page/2/

Mumbai Mirror reports that the implementation of the new tamper proof electronic meters used in taxis and auto-rickshaws is likely to face patent hurdles. A Pune based electronic meter manufacturing company, Standard Meter Manufacturing Company has filed a petition in the Bombay High Court on Wednesday, February 29, 2012. In a statement made by Rajendra Pillay, the owner of Standard Meter Manufacturing Company, he has alleged that the the installation of electronic meters is unwarranted and unconstitutional.

The auto union has complained that the implementation of tamper proof seal - a stainless steel mechanism and a plastic cover with a unique numbering series, will give the manufacturing company complete monopoly on the electronic meters market. Moreover, a new seal has to be brought every time the electronic meter is open, which will give the manufacturing company unfair advantage and increase the burden on the taxi and auto-rickshaw owners.

The patent application at issue - 1184/MUM/2003, titled "CLASSIC METER" was filed on 2003-11-14 and was published on 2007-03-16. The Abstract of the patent states:

"The Classic Meter is of Height 12.3 cms, Width 16.9 cms, Length 16.9. The total weight of the taximeter without accessories is 1.5 kgs. (b) Total number of display windows-4 Nos. (c) There is a digital display of fare based on the distance covered and time taken. The LED indicators show the status of 'Hired', 'Stopped' and 'For Hire'. (d) This product adheres to the constructional requirements of Bureau of Indian of Standards. The performance required for IS:2747 has been confirmed to and the approval has been received from the authorities. (e) The option of providing roof lamp for the above mentioned indication is also available."

No information is present in the abstract that discloses the mechanism of the tamper proof seal. However, one thing is for sure, the number of IP cases in India is definitely increasing and more and more number of people and company have started using their IP to exercise their rights in the market.