In the above case, one of the plaintiffs was a Swiss company (1st Plaintiff - the licensee) while the other was incorporated in the United States of America (2nd Plaintiff- joint owner of the patent-in-suit along with Pfizer Products Inc.). The patent-in-suit was in respect of a small drug molecule termed as a “Human Epidermal Growth Factor Type – 1/Epidermal Growth Factor Receptor” (HER/EGFR) inhibitor, popularly known as 'Erlotinib' and the patent was granted by the Controller General of Patents in February 2007. The drug is claimed to be a major breakthrough in the treatment of lung cancer, and is marketed by the plaintiffs in various countries including in India, under the trademark 'Tarceva'. The defendant-company, Cipla Limited (Cipla) had planned to launch a generic version of the drug Erlotinib in India and export it to other countries. On coming to know of the defendant-company's plans, the plaintiffs had filed an injunction application for restraining Cipla from manufacturing, offering for sale, selling and exporting the patented drug Erlotinib. The plaintiffs also filed a suit for permanent injunction restraining the defendant-company from infringing their patent rights in the drug Erlotinib, rendition of accounts and delivery up of the infringing goods. The plaintiffs alleged they being the owners of the patented drug Erlotinib, the defendant's action of offering a generic version of the stated drug was illegal as it violated their legal rights and that the defendant's action could pose serious health risks to the patients. Cipla in its defence filed a counter claim for the revocation of the patent-in-suit stating that the patent was invalid on the grounds of lack of inventive step and absence of proven enhancement in efficacy. Cipla also argued that the patent-in-suit was invalid due to its non-working as the plaintiffs do not manufacture the patented drug in India and because the patent was new (less than six years old), it is thus dis-entitled to exclusive protection. Further Cipla submitted that it had already been granted the drug approval and was marketing its generic version of the patented drug under the trademark 'Erlocip'. While the Plaintiffs' capsule costs Rs. 4,800 per tablet, Cipla's equivalent tablet costs Rs. 1,600. Cipla alleged that in the area of life saving drugs, it was in public interest that medicines are available at cheap and affordable prices. The High Court of Delhi noted that the relief sought by the plaintiffs was only interim in nature, and therefore declined from making any statement that would affect the final outcome. The Court opined that between two competing public interest – in granting injunction to affirm a patent during pendency of an infringement action as opposed to the public interest in accessing life saving drugs at affordable rates, the balance of convenience is tilted in favour of the latter. The Court further held that the damage caused to plaintiffs is capable of assessment in monetary terms and denied the plaintiffs an order for interim injunction. ....Click here for full details >>

Plant Bioscience Ltd., is the proprietor of patent no. EP 1 069 819, concerning methods for producing new Brassica plants with elevated levels of anti-carcinogenic glucosinolates. The claimed method involves selective breeding of double haploid lines of broccoli with wild species. The process would be deemed 'essentially biological' and unpatentable if it consisted entirely of natural phenomena, but this is put in question by the inclusion of certain steps in the method claim that require human intervention. The patent has so far been maintained in an amended form as a result of opposition and appeal proceedings brought by Syngenta and Limagrain. The opponents argue that the patent should be revoked on the basis that the claims refer to an essentially biological process i.e., conventional breeding. The enlarged Board of Appeal of the EPO has been requested to consider the extent to which the exclusion of patentability under Article 53(b) EPC can be escaped. The referral to the Enlarged Board of Appeal is being seen as a test case for the patentability of conventional seeds and breeding methods and the outcome will clarify the degree and nature of human technical intervention which is required to escape the process of exclusion of Article 53(b) EPC. Examination of other applications in this field may be suspended until the Enlarged Board issues its decision. ....Click here for full details >>

On 1st April 2008, the European Patent Office (EPO) has announced an increase of the excess claims fees on European patent applications to Euro 200 per claim from the existing Euro 45 per claim. The number of ‘free claims’ claims have been increased from 10 to 15. The move is directed at reducing the “voluminous” patent applications filed by the parties before the EPO. Applicants who wish to follow the PCT route do not need to pay the claims fees immediately, they are allowed a period of one month for amending the claims following entry into the European phase and payment of the excess claims fees. Claims that are deleted following a preliminary amendment can be reintroduced at a later stage provided that the parties pay the balance in claims fees, if it is found at the time of grant that there are more claims than what was paid for at the time of filing. Un-searched claims must be deleted and can only proceed in a divisional application. A way to avoid penalty on excess number of claims without affecting their scope is by making use of multiple dependencies and by ensuring that the original disclosure contemplates the multiple combinations created by multiple dependencies. Parties can also make use of “consistory clauses” in the specification setting out in claim-like language the ‘preferred’ or ‘optional’ features of the invention. These clauses can be later introduced into the claims during the prosecution or after grant or before the national courts. ....Click here for full details >>

“Biogen” insufficiency has been an accursed ground of patent insufficiency ever since it had been introduced by Lord Hoffman in the ruling of Biogen v Medeva. The issue was recently revisited in the case of Lundbeck by the Board of Appeal of the EPO. The patent in question concerned an anti-depressant in the class known as selective serotonin re-uptake inhibitors (SSRIs). Citalopram was originally patented by the Danish company H Lundbeck A/S, but the patent expired several years ago. Citalopram is a ‘racemate’ in that it comprises equal quantities of two mirror image isomers also known as stereoisomers or enantiomers. Patents for enantiomers often follow some time after the patents for the underlying formulae and represent very valuable extensions of term of protection for the drug companies. Lundbeck was successful in resolving citalopram into its +ve and –ve enantiomers and discovered that the +ve enantiomer was responsible for the re-uptake inhibitor activity and named it escitalopram. The patent for escitalopram was held to be invalid for insufficiency by the trial judge. The judge applied the principals of the Biogen ruling to arrive at his decision. On appeal, one of the judges Lord Hoffman opined that the trial judge had erred in applying the Biogen decision in the present case as the Biogen decision applied to only product by process claims and cannot be extended to ordinary product claims in which the product is not defined by a class of processes of manufacture. Lord Justice Jacob gave a concurring but separate opinion, stating that Biogen decision would apply to cases where claims relate to the entire class of products but only one member of the class has been enabled but will not apply to the present case where the desirable end is fully enabled. As a result, Lundbeck’s claim being limited to a single product was held to be patentable. ....Click here for full details >>

On 3rd April 2008, Sao Tome and Princepe submitted its request for accession to the Patent Cooperation Treaty at the World Intellectual Property Organisation (WIPO), to become the 139th country to accede to PCT. The PCT will enter into force on 3rd July 2008 in Sao Tome and Princepe. As a result of which, Sao Tome and Princepe will be automatically be designated in PCT applications and in requests for a preliminary international examination. On the other hand, citizens of Sao Tome and Princepe will be able to file international patent applications through the PCT. ....Click here for full details >>

Geron Corporation is the proprietor of patents relating to embryonic stem cells. A California based group alleges that three of Geron’s patents read on prior art and are therefore invalid. The group requested the USPTO to revoke the patents by filing three different requests against each patent. However, Geron circumvented the proceedings by simply amending its patents to avoid prior art. As a result, the USPTO recently issued a series of Actions Closing Prosecution, each of which concluded that prior art has failed to invalidate Geron’s patents. The California Group is contemplating filing appeals against the USPTO’s decision, chances of success of which are considerably low given that Appeals Board rarely reverses the Patent Examiner’s decision in these cases. The California group appears undaunted and is reportedly in possession of evidence which is yet to be submitted in any prior legal proceedings. The US Patent statute clearly protects patent owners from harassments through repeated revocation proceedings and also prohibits patent challengers from re-litigating evidence that could have been introduced in the original proceedings, but was not introduced. It is expected that the California group’s upcoming challenges will give rise to interesting decisions interpreting inter partes re-examination estoppel law in the United States. ....Click here for full details >>

In January 2006, Repligen initiated patent infringement proceedings against Bristol Myers-Squibb for patents that allegedly read on the BMS drug Orencia. The Court had issued a Markman order resolving issues relating to interpretation of the patent claims, resolving a question of infringement, and resolving other issues relating to motions for summary judgment and motions of dismissal. However, before the Court ruled on the stated motions, the rival parties had arrived at a settlement. Pursuant to the settlement, Repligen has received an up-front payment of US$ 5 million and upto US$117 million in future royalties. ....Click here for full details >>

Competition law promotes free markets whereas Intellectual Property Law grants exclusive market positions. Two recent cases are helpful in identifying the interface between the two legal concepts. The first case is Ethypharm SA v Abott Laboratories which concerns a novel theory of Sham Litigation. Abott is the proprietor of a patent that increases the bio-availability of Fenofibrate which otherwise has low bio-availability. The patent involves micronizing the API. Ethypharm is a manufacturer of Antara micronized Fenofibrate and supplies it to a US distributor. Several years ago, the US distributor had contested the validity of the micronized Fenofibrate patents and lost, and consequently agreed to pay Abott a 7% royalty on its Antara micronized Fenofribrate. In the present suit, Ethypharm complains that the earlier suit was a sham litigation, in the sense that had the US distributor litigated differently, the Abott patents would have been found invalid. Sham litigation requires that the lawsuit be objectively baseless in the sense that no reasonable litigant could be realistically expecting success on merits. Ethypharm’s argument is novel as it alleges that the prior litigation was in fact a Sham litigation even though the suit succeeded on merits and Abott had prevailed. The second suit is State of Florida et al v Abott Laboratories et al, where 18 State Attorneys General had sued Abott. This complaint rests on a revolutionary legal theory that is in conflict with the existing state policies and legal provisions of US. The States allege that micronized Fenofibrate is more bio-available which makes the older non-micronized generic products less desirable and commercially unprofitable. Scientific innovation has thus reduced the demand for inferior and obsolescent products, which is exactly what Intellectual Property laws promotes. However, according to the States this has created a monopoly position for Abott in the market. The State Attorneys further allege that the State policies prohibit generic substitution for Abott’s Fenofibrate product, which has aggravated Abott’s monopoly in the Fenofibrate market. Interestingly, Abott’s actions are completely compliant to the laws and state policies of the US. However, it is the State Attorneys General’s complaint which is thought provoking, as the States wish to end a monopoly situation, that has been created with their active help and support. ....Click here for full details >>

Google has changed its Adword policy in UK and Ireland and has brought its policy for trademarks in line with that of US and Canada. Pursuant to the new Adword policy, Google has unblocked keywords that were previously restricted due to complaints from trademark proprietors in UK and Ireland. Brand owners must now compete with other firms to position their ads beside the natural search results when a user types their trademark into the Google search engine. However, advertisers are still not allowed to use a trade marked term in the actual advert itself. The bidding process potentially will increase the costs of advertising a trade marked brand through Google’s Adwords programme, with some experts predicting large increases in ad spend beyond previous levels. The change in policy seems to be the inevitable consequence of a series of court decisions in UK, latest being the “Mr. Spicy” decision which seems to suggest that the use of a registered trademark as an keyword trigger could not constitute trademark infringement, unless the registered trademark appeared in the visible text of the sponsored link or on the website linked to the advert. Although, Google’s new Adwords policy only applied to UK and Ireland, interestingly Google’s former policy of blocking registered trademarks as keywords still remain in the rest of the European countries. Recently a French decision concerning the trademark Louis Vuitton has been referred to the European Court of Justice for guidance. If the decision in this case does not favour Google, it could have important ramifications for the new keyword policy in the UK and Ireland. ....Click here for full details >>

The French Cosmetic company Helena Rubinstein filed an opposition against an application for registration of the mark HR HELENA R for “clothing, ties, belts, hats, gloves, etc.” in class 25. The Examining Authority and the Board of Appeal of the Taiwan Intellectual Property Office (TIPO) acknowledged that the rival marks were similar, but rejected the opposition on the ground that documentary evidence provided by the opponent originated from foreign countries and therefore failed to prove use of the opponent’s mark in Taiwan. As a result, the opponent’s claim of its marks to be famous in Taiwan were held to be invalid. The Taipei High Administrative Court concurred with the TIPO’s decision. The matter reached the Supreme Administrative Court in Taiwan by virtue of an appeal by the French company. The Court held that the opponent’s marks were similar to the applied mark and that the evidences submitted to establish fame of a mark should not be rejected only because they pertain to foreign countries and the mark lacked domestic use. According to the Court, the identification of a well known mark should be whether the mark is recognized among the related businesses or consumers instead of whether the consumers had direct contact with the opponent’s mark. The Court further stated that decisive factor in an opposition should be whether opponent’s marks were already famous prior to the application of the infringing mark. ....Click here for full details >>

The European Union annual budget for funded research was increased to EU 5.3 billion when the 7th Framework Program (FP7) was launched in 2006. FP7 has allocated EU 32.4 billion to the ‘Cooperation Programme’ which supports all types of research activities carried out by different research bodies in trans-national cooperation and aims to gain or consolidate leadership in key scientific and technology areas. The budget is devoted to supporting cooperation between universities, industry, research centers and public authorities throughout Europe and beyond. ....Click here for full details >>