• Cipla wins battle over F.HOFFMANN-LA ROCHE LTD

• Nicholas Piramal Gets Injunction in Trademark Case

• Novartis vs. IVAX (Court of Appeal for England and Wales; [2007] EWCA Civ 971)

• CIAS Inc. vs. Alliance Gaming Corp. and Bally Gaming, Inc.
• Daiichi Sankyo Co., Ltd. vs. Apotex, Inc. and Apotex Corp (collectively Apotex)
  

• Pfizer Inc. vs. Pifer Pharmaceuticals Pvt. Ltd.
• Microsoft Corp. vs. AT&T Corp.
  
  
• Novartis Patent Case and The Indian Patent Law
• Nokia vs. Qualcomm Patent Drama

CIPLA WINS PATENT BATTLE OVER F. HOFFMANN-LA ROCHE LTD
Facts: - F.HOFFMANN-LA ROCHE LTD (Plaintiff) jointly owns a patent with Pfizer Products Inc. in respect of a drug medically termed as a "Human Epidermal Growth Factor Type- 1/Epidermal Growth Factor Receptor" (HER/EGFR) inhibitor, popularly known as Erlotinib and sold as Tarceva for the treatment of cancer. The defendant Cipla Limited had announced its plan to launch a generic version of Tarceva in India. The plaintiffs state that such an announcement of Cipla would infringe and violate the plaintiffs' rights and that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva and that such action, as announced by it, would deliberately violate the legal rights of the plaintiff. The plaintiff filed an appeal against the judgment passed by the Delhi Court declining the order for grant of an interim injunction to restrain the Defendant/Respondent Cipla Limited from manufacturing, offering for sale, selling and exporting the drug Erlotinib.

Analysis: - The case is in respect of Erlotinib Hydrchloride Polymorphs A+B which is an unstable form and cannot be administered as such. The x-ray diffraction pattern of the tablet Tarceva showed that it corresponded to Polymorph B for which the patent is yet to granted. Tarceva corresponded to polymorphs A and B and so there was no need for the plaintiffs to have applied for a separate patent in respect of polymorph B. Polymorph B could not be granted a patent since it was not patentable under Section 3 (d) and further the plaintiffs failed to demonstrate any enhanced efficacy over the known closest prior art polymorphs A and B.

Judgment: - The appeal was dismissed by the Delhi High Court (full Bench) with costs quantified at Rs.5 lakhs which will be paid by the appellants/plaintiffs to the defendant within a period of four weeks.

NICHOLAS PIRAMAL GETS INJUNCTION IN TRADEMARK CASE
Facts: - Piramal Healthcare Ltd. is one of India's largest Pharma companies, has filed trademark infringement suit against Indore-based Endolabs pharma marketing group in Bombay High Court. The defendants have infringed the products by name Agepyrine, Zypyrine, Elgipyrin and Easipyrin respectively which are the trademark of Parimal.

Analysis: - Piramal is a registered proprietor of mark "ESGIPYRIN' and the trade mark has been registered on January 22, 1974. The defendant is engaged in a deliberate, dishonest and fraudulent act of, counterfeiting and is passing of their products as that of the plaintiff. In case of Laxmikant V. Patel Vs. Chetanbhai Shah reported in (2002) 3 SCC page 65 in paragraph 14 it was specifically held that "it is the usual practice to grant ad-interim relief in the nature of injunction once a case of infringement of trade mark is made out".

Judgment: - The Mumbai High Court has ordered an ex parte injunction against the defendant for infringing Plaintiff's trade mark for arthritic pain reliever Esgipyrin

Novartis vs IVAX (Court of Appeal for England and Wales; [2007] EWCA Civ 971)

A Court of Appeal for England and Wales on October 18, 2007 dismissed appeal in Re. Novartis vs IVAX in a suit relating to Novartis cyclosporine formulation. Novartis had sued IVAX alleging infringement of its two UK patents No. 2,222,770 (the '770 patent) and 2,380,674 (the '674 patent). Both the patents related to a formulation of cyclosporin. The '770 patent was directed towards a pharmaceutical composition comprising a cyclosporin as active ingredient in the form of a "microemulsion pre-concentrate". Typically, a formulation according to the '770 patent comprised a hydrophilic phase; a lipophilic phase, and a surfactant. The '674 patent provided a composition in form of an emulsion or micro-emulsion pre-concentrate for oral administration comprising a cyclosporine or macrolide, and a carrier medium comprising a second component, a lipophilic component and a surfactant. Novartis, claimed to have overcome the existing problems due to use of alcohol based formulation such as bioavailability issues, by developing formulation as described in the '770 and the '674 patents.

IVAX planned to introduce a cyclosporin formulation in the UK under the trade name EQUORAL. IVAX's EQUORAL product was a 100mg/ml oral solution and 25mg, 50mg and 100mg soft gelatine capsules. The oral solution was intended for dispersion in a drink, and the capsules to be swallowed. 

Mr. Justice Pumfrey of the Patents Courts considered the issue of infringement and validity of both the patents. The trial court noted that although there were micro-emulsion-sized particles in the EQUORAL dispersion, that dispersion was not a micro-emulsion and therefore could not infringe the Novartis patent. On the validity, the trial court held the ‘770 patent was valid but the ‘674 patent was invalid due to obviousness. Novartis appealed against the decision of non-infringement of the ‘770 patent arguing too narrow claim construction. IVAX argued that if the ‘770 patent covered EQUORAL, the ‘770 patent would be invalid. The Court of Appeal dismissed the appeal noting that EQUORAL was mainly comprised of all that Novartis was actually trying to avoid since at least 86% of the active ingredient was carried by particles that were larger than micro-emulsion size.

CIAS Inc. vs Alliance Gaming Corp. and Bally Gaming, Inc

CIAS, Inc. (formerly Currency Identification & Analysis Systems) sued Alliance Gaming Corporation and its subsidiary Bally Gaming, Inc. (collectively Alliance) alleging infringement of U. S. Patent No. 5,283,422 (the ‘422 patent), entitled "Information Transfer and Use, Particularly with Respect to Counterfeit Detection". Both CIAS and Alliance are in the business of systems for the detection of counterfeit usage. CIAS alleged that the Alliance detection systems for tickets used in casino slot machines (known as the Slot Data System (SDS) and Slot Management System (SMS)) infringed the ‘422 patent, literally or under the doctrine of equivalents. Alliance moved for summary judgment of non-infringement on the ground that the Alliance systems did not infringe any claim of the '422 patent when properly construed. The trial court agreed with Alliance. On appeal, the CAFC concluded that although the District Court erred in its construction of the term "comprised of", that error did not affect the construction of the substantive terms supporting the judgment of non-infringement and therefore affirmed the judgment of the trial court.

One of the key issues in this case was construction of the phrase “comprised of”. The District Court observed that the meaning of "comprised of" was not clearly resolved in patent-specific precedent, and therefore held that the "ordinary and customary meaning" should be used. The District court ruled that "comprised of" does not have the same open-ended meaning as "comprising”, and that "comprised of" should be construed as a closed-end term that excludes the presence of all elements beyond those presented in the "comprised of" clause. Thus the District Court construed "comprised of" as "a limiting description of composition," reasoning that such construction preserved the distinction between “comprised of” and “comprising”.  The CAFC disagreed with the trial court on such construction observing that the term “comprised of” is an open-ended transition phrase. The CAFC further noted that the usual and generally consistent meaning of "comprised of," when it is used as a transition phrase, is, like "comprising," meaning that the ensuing elements or steps are not limiting. The conventional usage of "comprising" generally also applies to "comprised of." Alliance argued that several judicial decisions have used "comprised of" to mean "consists of." However, the CAFC noted that these rare usages did not remove from "comprised of” its conventional meaning when used as a transition term. Distinguishing over the Glaxo Grp. Ltd. v. Apotex, Inc. (376 F.3d 1339, 1343 (Fed. Cir. 2004), the CAFC observed that in the Glaxo case, the usage of "comprised of" was not as a claim transition term, but was the court's description of the defendant's product. Citing several cases, the CAFC concluded that “Correctly construed, comprised of does not of itself exclude the possible presence of additional elements or steps” (Decided September 27, 2007).

Daiichi Sankyo Co., Ltd. vs Apotex, Inc. and Apotex Corp (collectively Apotex)

Daiichi sued Apotex in the U. S. District Court for the District of New Jersey following Apotex’s paragraph IV ANDA for generic Ofloxacin ear drop certifying that Daiichi’s U.S. Patent No. 5,401,741 (the ‘741 patent) was invalid and/or not infringed. Following a Markman hearing and a bench trial, the District Court concluded that the ‘741 patent was not invalid. The court also found that Daiichi did not intend to deceive the Patent and Trademark Office during prosecution of the ‘741 patent. Finally, because Apotex stipulated that the subject matter of its ANDA fell within the scope of the claims of the ‘741 patent, the court found that Apotex infringed the ‘741 patent. Apotex appealed and the CAFC reversed the judgment of the trial court.

One of the key issues in this case was determination of who could be the “ordinary person skilled in the art”? The ‘741 patent related to a method for treating bacterial ear infections by topically administering the antibiotic Ofloxacin into the ear. Claim 1 of the ‘741 patent was directed to a method for treating otopathy which comprises the topical otic administration of an amount of Ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy.

The District Court concluded that the ordinary person skilled in the art pertaining to the ‘741 patent “would have a medical degree, experience in treating patients with ear infections, and knowledge of the pharmacology and use of antibiotics. This person would be . . . a pediatrician or general practitioner—those doctors who are often the ‘first line of defense’ in treating ear infections and who, by virtue of their medical training, possess basic pharmacological knowledge.” Apotex disagreed and argued that the District court erred in this determination and that one having ordinary skill in the relevant art could be properly defined as “a person engaged in developing new pharmaceuticals, formulations and treatment methods, or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.”

The CAFC noted that several factors may have to be considered in determining level of ordinary skill in the art such as including: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field. The CAFC observed that the art involved in the ‘741 patent was the creation of a compound to treat ear infections without damaging a patient's hearing. This would have required, and also described in the written description details, the inventors’ testing Ofloxacin on guinea pigs and their findings that ototoxicity did not result from the use of their compound. Such animal testing, the CAFC noted, is traditionally outside the realm of a general practitioner or pediatrician. The CAFC also considered that although a general practitioner or pediatrician could (and would) prescribe the invention of the ‘741 patent to treat ear infections, he would not have the training or knowledge to develop the claimed compound absent some specialty training such as that possessed by inventors of the ‘741 patent. Accordingly, the CAFC concluded that the level of ordinary skill in the art of the ‘741 patent was that of a person engaged in developing pharmaceutical formulations and treatment methods for the ear or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also had training in pharmaceutical formulations. On the issue of obviousness, the CAFC held that the invention of the ‘741 patent would have been obvious to one having ordinary skill in the art at the time of the invention. (Precedential Opinion Issued: September 12, 2007).

Pfizer Inc. vs. Pifer Pharmaceuticals Pvt. Ltd.

Pfizer, the plantiff has filed a passing off case against the defendant company in order to restrain it from using trademark“PIFER, PIFOL or PIFSER” or any other trademark that is deceptively similar to plaintiff’s trademark “PFIZER” with regard to pharmaceutical products. The present application filed by the plaintiff seeking amendment of plaint addressed issues of equity however the Delhi High Court denied the amendment of plaint on the ground that

1. The amendment should not work injustice to other side. If injury to other side can be compensated by costs then it is not treated as injustice.

2. The amendment should be allowed to avoid multiplicity of proceedings as far as possible.

3. The amendments that are impliedly or expressly prohibited by law or deprive other party a valuable right accrued to them should not be allowed.

Microsoft Corp. vs. AT&T Corp.

US patent law says that “No infringement occurs when a patented product is manufactured and sold in a foreign land.” There is an exception to this rule. If components are supplied from US to a foreign country and are assembled outside the US, it does not constitute infringement according to Section 271(f) of the US Patent Act.

Novartis Patent Case and The Indian Patent Law

The Novartis patent case is the first Indian patent litigation that came up after the Indian Patent (Amendment) Act 2005 was given effect. It is drafted in compliance with the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) and considering the flexibilities allowed in TRIPS.

In this case the well known Swiss pharmaceutical company, Novartis has alleged that the amended Indian patent law is not compliant to TRIPS. Novartis holds a patent over the beta crystalline form - Imatinib Mesylate (named Gleevec), a cancer drug used in the treatment of Myeloid Leukemia outside India. It acquired exclusive marketing rights (EMR) in India during the transition period when product patents were still not available in India but Indian generic versions of the drug were also available. With the acquiring of EMR the price of Gleevec increased to Rs. 1,20,000.00 ($ 2500) per patient per month while generic versions are available at about Rs. 8,000.00 ($175) per patient per month on the Indian market.

After the Indian Patent Law was amended, the Gleevec patent application was taken up for examination. A pre-grant Opposition to the patent was filed at the Chennai Patent Office by the Cancer Patients Aid Association on behalf of cancer patients on account of lack of inventive step. The inventive step requirement under the new Patent (Amendment) Act 2005 requires that in pharmaceutical patents, in case where there is a new form of a new substance, there should be ". enhancement of the known efficacy ."

The Novartis patent application was rejected by the Assistant Controller of Patents & Designs, Chennai on the grounds that the application claimed 'only a new form of a known substance' without any enhancement of the known substance. Following this, on 17 May 2006, Novartis filed two sets of cases in the Chennai High Court.

• The first case challenged the order of the Chennai Patent office, which rejected the Gleevec Patent Application of Novartis, following a pre-grant opposition by the Cancer Patients Aid Association.

• The other case challenged the constitutionality of section 3(d) of the Indian Patents Act, claiming that the section is not in compliance with the TRIPS Agreement and Article 14 of the Indian Constitution ("The State shall not deny to any person equality before the law or the equal protection of the laws within the territory of India.") hence should be declared unconstitutional. It was alleged that Section 3(d) of the Indian Patent Act does not permit innovative medicinal patents with therapeutically relevant safety advantages.

Novartis argued that patents are necessary to recover investments in research and development and thus help in introducing innovative medicines. The Gleevec patent would not hinder the supply of essential medicines to poor countries because of the safeguards to the TRIPS Agreement. It highlighted that the patent was already granted in nearly 40 countries where it reached 22,000 patients. Further it also cited the Mashelkar Committee Report (now withdrawn) to support its claim that the Indian patent law was not TRIPS compliant.

The Indian Patent Office contested the allegations and stated that Section 3 (d) of the Indian Patent Law was an important public health safeguard. Its main aim was to restrict pharmaceutical patents on a strict inventive step requirement and thus bar trivial improvements or new medical uses of known molecules from being patented. It was also pointed out that the TRIPS Agreement does not define an invention and Article 1 of the Agreement allows member countries to implement the TRIPS Agreement in a manner that they find appropriate. In support of Section 3 (d) it was also argued that it followed the Doha declaration to provide access to medicines for all.

The case is of utmost importance in India not only because it raked the issue of TRIPS compliance but also it was the first time that the Intellectual Property Appellate Board (IPAB) became operative. The Chennai High Court stated that the Constitutional issue will be decided by the High Court but the technical issue is to be taken up by the IPAB. There is no doubt that TRIPS does not specifically define invention or inventive step and so it might be claimed that there is no TRIPS violation. However it can also be claimed that there should be provision to patent any type of inventions, subject to certain exceptions (this particular issue would not fall under the exceptions). But it needs to be seen whether an Indian court can decide on TRIPS compliance or whether it is the exclusive discretion of the Dispute Settlement Body of the World Trade Organization.

In the other part of the hemisphere the US Supreme Court has come out with a recent judgment ( KSR v Teleflex and others, on 30th April 2007) on a patent dispute involving a claim over certain features of an electronic automobile accelerator pedal. The patent claim involved is certainly different from the Novartis matter but what is worth noting is that the US Supreme Court had moved from the strict test of obviousness as a rare instance. The court stated, "Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior intentions of their value or utility".

Nokia vs. Qualcomm Patent Drama

Wireless technology giant, Qualcomm known for its strong patent portfolios on wireless technology (including micro-chips) has taken on the world's biggest handset vendor, Nokia. Qualcomm holds a number of crucial third generation (3G) patents on mobile phones that are keys to internet and video reception on mobile phones and has become mobile phone standards. Some of these patents owned by Qualcomm cover both code-division multiple access 2000 (CDMA 2000) and also wideband code-division multiple access (WCDMA), technologies. The WCDMA is a GSM based technology preferred by GSM based mobile set manufacturers over CDMA sets.

Qualcomm licenses these patents that are essential to manufacture sets compatible to use GSM, GPRS and EDGE standards and obtains considerable royalty from most of the major mobile phone manufacturers in the world. The technologies are licensed and shared but the licensees complain that they are charged exorbitantly. They claim that this is an abuse of the patent monopoly because if the royalty payments exceed 5% per set then it would not be commercially viable to be in the business. To address this issue, six companies (Broadcomm, Ericsson, Nokia, NEC Corporation, Panasonic Mobile Communications and Texas Instruments) lodged a complaint with the European telecommunication regulators that the patent licensing practice of Qualcomm is anti-competitive. While the complaint is being investigated, Qualcomm has initiated proceedings against Nokia alleging infringement of 11 of its patents and another patent owned by its subsidiary SnapTrack.

Qualcomm had a technology sharing agreement with Nokia on the CDMA patent that expired on 9th April 2007. The agreement had a provision that allowed it to be extended to 2008 and this extension clause is the contention between the two parties. Qualcomm claims that since Nokia continues to pay for Qualcomm patents and agrees to pay for them this should constitute extension of the agreement, but Nokia contradicts such view and is of the opinion that the discretion to extend the agreement is with Nokia. It is true that Nokia will have to pay not only for the WCDMA patents that it holds but also some others which will expire shortly. Further, with the expiry of the license agreement Nokia can assert its claims for some CDMA products as a strategy (which would not be possible during the duration of the license agreement). Qualcomm has asked the American Arbitration Association to decide in this issue but it is believed that there is some understanding between the parties.