Trastuzumab - UK

On July 27, 2016, The Court of Appeal (UK) has confirmed that two Genentech patents concerning lyophilised formulations of trastuzumab (the active ingredient in Herceptin) are invalid for obviousness. It also confirmed that a finding of obviousness does not require, in every case, that the skilled person "would" have arrived at the claimed invention without inventive effort.

This is an appeal from the decision of Birss J dated 21 November 2014 in an action by Hospira UK Limited ("Hospira") for revocation of two patents, European patents (UK) Nos. 1 516 628 and 2 275 119. The judge held both patents invalid on the ground of lack of inventive step and added matter. Genentech Inc. ("Genentech"), whose patents these are, appealed to the court.

At first instance, Birss J concluded that the differences between the claimed invention and the prior art ("Carter") "were the result of nothing more than the application of routine screening techniques to common general knowledge excipients" by the motivated skilled team.

During appeal Floyd LJ noted that the judge was well placed to form an impression of the degree of interest in trastuzumab by the time it was known that phase II clinical trials were under way and it was open to him, upon the evidence, to reach the conclusions that he had reached as to the skilled person's motivation to start developing a lyophilised formulation. Thus it was obvious to develop the lyophilised formulation and hence patents are invalid.

Tadalafil - UK

On Aug 10, 2016, The English High Court (Patents Court) has ruled in a patent dispute concerned with the treatment of erectile dysfunction. Actavis and Mylan had commenced "clear the way" litigation by seeking to revoke Eli Lilly's patent in order to launch generic versions of its CIALIS (Tadalafil) medicine upon expiry of the relevant SPC protection (November 2017).

One of Eli Lilly's patents, regarding the dosage regimen of CIALIS (EP(UK) 1,173,181), was found to be valid and infringed. The other patent, regarding microparticulate formulation of the active ingredient (tadalafil) (EP(UK) 1,200,092), was invalid. Both patents are expiring in Apr 2020 and Aug 2020 respectively.

Read the judgement in full at:
http://www.bailii.org/ew/cases/EWHC/Patents/2016/1955.html

Lisdexamfetamine dimesylate - USA

On August 30, 2016, U.S. District Court for the District of New Jersey entered a Final Judgment ending a Hatch-Waxman patent infringement lawsuit and protecting innovator pharmaceutical company Shire's blockbuster drug Vyvanse® (lisdexamfetamine dimesylate), which had net sales of over $1.7 billion in 2015.

The Final Judgment follows one of the few instances in a pharmaceutical case where the Federal Circuit has issued an opinion affirming summary judgment of no invalidity. The Federal Circuit here affirmed the District Court, which also found that the claims are infringed and not invalid for anticipation. The ANDA-filers were Actavis, Amneal, Mylan, Roxane, and Sandoz.

The Final Judgment includes injunctions preventing the ANDA-filers from launching generic versions of Vyvanse® until the full term the patents, which expire in 2023.

Controller can not raise new objection(s) in Hearing without giving intimation or time to respond to Applicant

Pfizer filed patent application No.991/MUMNP/2003 for “CHIRAL SALT RESOLUTION” of “3-{(3R, 4R)-4-Methyl-3-[methyl-(7H-pyrrolo [2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile” on Oct 27, 2003. Subsequently FER was issued on Mar 13, 2008 with objections such as clarity of claims, distinctiveness and section 3(i). Applicant then filed response to FER with amended set of claims. The learned Controller issued official letter on Mar, 14, 2011 regarding intimation about Hearing on Mar 29, 2011 with new objections of section 2(1)(j) on the ground of lacking novelty, inventive step and section 3(d).

Applicant apprised the Controller during hearing about new objections. Controller agreed but he held that objection can not be ignored at this stage. Applicant then submitted written submission and amended claims. Surprisingly the instant application refused u/s 15 of Indian Patent Act under those new grounds section 3(d) and novelty. Applicant then submitted review petition to set aside the order passed by Controller but ultimately that was also denied.

Then Applicant filed appeal and challenged the order at IPAB by summarizing all above facts. IPAB said that, “objections raised under section 3(d) of the Act was neither contained in the first examination report nor mentioned in the hearing notice and the same was taken for consideration at the time of actual hearing and relied on by the Assistant Controller while passing the impugned orders. In view of this serious lapse on the part of the learned Assistant Controller we are of the considered view that the impugned orders are vitiated on the sole ground of flagrant violation of the principles of natural justice.”

IPAB citing the decision (OA/18/2011/PT/DEL – Telefonaktiebolaget LM Ericsson. vs. The Controller General of Patents, New Delhi) said- “it is better that the notice of hearing indicate what are the prior art that the Controller will be referring to which the inventor has to explain and prove the patentability of the invention.”

Consequently IPAB directed that the Assistant Controller shall reconsider the matter afresh by furnishing the objections well in advance to the appellant enabling the appellant to give their response both in respect of section 3 (d) of the Act and as well as in respect of novelty. It is made clear that some other Assistant Controller other than the Assistant Controller who passed the orders impugned shall reconsider the entire matter afresh by affording reasonable opportunity to the appellant as stated above.

High court of Delhi granted permanent injunction in trademark infringement of pharmaceutical products

In two separate proceeding, Merck KGA successfully brought permanent injunction against LA LIFESCIENCE and EMIL PHARMACEUTICAL for trademark infringement “EXFLAM/EMFLAM” and “COSOME” respectively.

Plaintiff had filed the present suit for permanent injunction restraining infringement of trademark and rendition of accounts, damages and delivery up, etc. against the defendant in the High Court of Delhi. Judge Mr. S.P.GARG handed down these two decisions.

“EXFLAM” and “EMFLAM” are under registration Nos. 471455 & 467598. It is pleaded that the defendant is engaged in the manufacture and sale of pharmaceutical and medicinal preparations and had adopted the trademark “LAFLAM” with respect to its medicinal preparations.

“COSOME” is under trademark registration No. 147029. It is pleaded that the defendant is also engaged in the manufacture and sale of pharmaceutical and medicinal preparations and had adopted the trademark “COZOLE” with respect to its medicinal preparations.

While delivering the decision in theses 2 cases, court considered “whether rival marks are deceptively similar and are likely to cause confusion in the mind of unawary purchasers. The purchasers are not expected to be well-versed with the chemical compositions of the medicinal preparations. It is well settled that while considering whether a mark is likely to deceive or to cause confusion, the question has to be approached from the point of view of a man of average intelligence and imperfect recollection”.

Also court said - citing ‘Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd.’, 2001 (5) SCC 73, the Supreme Court after considering a large number of judgments of Foreign Courts and Indian Courts cautioned that strict measures to prevent confusion and lesser degree of proof is required for a Plaintiff to prove infringement in pharmaceutical cases if the marks are similar.

Finally court concluded that in these instant cases, the defendant’s mark in respect of medical preparations is phonetically and visibly similar to the registered trademark of the plaintiffs. It is, therefore, evident that the defendant has infringed the registered trademark of the plaintiffs’ and has passed of his goods as those of the plaintiffs.

International applications filed to the Indian Patent Office as Receiving Office may be filed electronically using ePCT

On 3 November 2014, the Indian Patent Office, in its capacity as receiving Office, notified the International Bureau, that it is prepared to receive and process international applications in electronic form (e-PCT)with effect from 15 November 2014. Standard fees such as transmittal fees, filing fees, search fees have to be paid (see PCT Applicant’s Guide, Annex C (IN)). But interestingly online payment is not available. One can file – international applications, subsequently filed documents for international applications, to the extent supported by the relevant software. In case of failure of the electronic systems when an international application is filed with it, the Office will use all means available, such as fax or e-mail, to inform the applicant about procedures to follow as alternatives. It’s another good initiative by Indian patent office to streamline the process, albeit many difficulties in online filing system at IPO. Hope for seamless system in future..

Next on target…..Patented Drugs !!!

It seems 2014 would be in very much focus with respect to affordability of medicine as Indian Government is considering bringing the patented drugs under price control. According to news, after sitting on it for years, the government is finally initiating steps to regulate the price of patented medicines and medical devices, a move that may provide relief to patients suffering from life-threatening diseases.

A committee comprising representatives from the health ministry, pharmaceuticals department, the drug price regulator and department of industrial policy and promotion is scheduled to meet early next month to discuss at least three options, said an official familiar with the development. While negotiated price mechanism, that was recommended by an earlier panel and junked, is one of the options, the inter-ministerial committee will also explore the possibility of reference pricing and differential pricing.

Under a system of reference pricing, the domestic price is linked to those in comparable markets. In case of differential pricing, the government can fix separate prices for its procurement programme and for purchase by others, including individual buyers.

Various countries, including developed ones, use various tools to regulate prices, India controls prices of only a handful of medicines and patented ones are not covered, often resulting in complaints of over-pricing. During the period of a patent, only one company, which has invented the medicine has rights to manufacture it and uses its monopoly rights to fix the price.

Although a proposal to regulate the price of patented medicines was floated several years ago, the government has refused to move forward. In fact, an internal committee of the department of pharmaceuticals had recommended a negotiated price mechanism for government purchases and for use by insurance companies. The proposal was to link the domestic rate with those at which governments in the UK, France, Canada, Australia and New Zealand purchase drugs from the company that holds the patent. The actual price was to be linked to the purchasing power in India.

But, this mechanism was only going to apply to 23% of the market, leaving a vast majority outside the proposed regime and opening the proposal to criticism.

 

indian patent office considering disclosure of inn in pharma patent applications

According to the news published in economic times indian patent office is considering mandatory disclosure of inn (international non proprietary names) in patent application for pharmaceuticals.

This is another first of its kind provision patent office wants to include as nobody in the world even considered. The motive behind this consideration is to help examiners, generic industry and public as large as well. They said it would bring more clarity in identifying the pharmaceutical substance in the claimed product. Also it would help to weed out frivolous inventions by filing opposition to the same.

But on the other side body represntating the multinationals has opposed this move. According to them it is another burden  to innovator companies to comply with as they already dealing with section 8 and section 3d requirements. Another point of contention was that it is not always possible to innovator to disclose inn of exact compound, for example at the time of filing basic substance patent. Because hundreds of compounds are disclosed and claimed in patent when these compounds are in pre clinical or even in earlier phase. So it is not possible to exact disclose which one would be the active substance or pharmaceutical product.

The consultation was held on oct 9, where all four patent office and some law firms discused this issue. Patent office has also asked for the submissions regarding the same. Lets wait and watch what would be the next course of action by indian patent office against multinational companies, as ipo is already under pressure by these companies for not complying TRIPS.

Indian patent office starts functioning as ISA and IPEA

Indian patent office (IPO) has now started functioning as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA) under the PCT from 15th October 2013. IPO will search and examine patents filed under the Patent Classification Treaty (PCT). This is a major development and in itself is a huge responsibility for the Indian Patent Office.

The PCT, which currently has 17 nations acting as ISAs and IPEAs, enables inventions to be protected in each of the 148 contracting states. Indian Patent Office has certain advantages like reasonably low official fees charged for different categories as compared to other nations which are designated as ISA and IPEA. Also being the only English speaking nation in the Asian region to be recognized as an ISA/IPEA would mean that several international applications received by WIPO under the Patents Cooperation Treaty would be sent to the Indian Patent Offices for search and preliminary examination purposes.

Fees and Charges to be charged by IPO while functioning as ISA and IPEA:-

Kind of fee or charge Amount (Indian rupees)

Search fee (Rule 16.1(a))                                             10000 (2500)1

Additional fee (Rule 40.2(a))                                       10000 (2500)1

Protest fee (Rule 40.2(e) and 68.3(e))                          4000 (1000)1

Late furnishing fee (Rule 13ter.1(c) and 13ter.2)        4000 (1000)1

Preliminary examination fee (Rule 58.1(b)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Late payment fee for preliminary examination [amount as set out in Rule 58bis2]

Additional fee (Rule 68.3(a)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Cost of copies (Rules 44.3(b), 71.2(b) and 94.2)/page   4   
1 - individual entity

But this major leap forward comes with daunting challenge of dealing with the backlog of applications. Already IPO is running very much behind its schedule, it is interesting to see the developments and efforts that would be taken by IPO to deal with the situation. 

 

Claims Involving the Skills of the Physician Fall under Method of Treatment Claims and therefore Unpatentable Subject Matter

In most of the Jurisdictions, claims related to method of treatment and allied human surgical processes are not patentable including Europe, Canada, India etc. Lots of debate is going on what actually the scope of these treatments, what areas come under treatment scope and how claims should be drafted to avoid objection of unpatentable subject matter.

Last month, Federal court-Canada handed down interesting decision in Novartis Vs Cobalt case. Federal court rejected the obviousness ground but dismissed the patent on basis of unpatentable subject matter asserted by Cobalt. This particular case is related to Zoledronic acid and product covered therein. Cobalt seeks approval by way of a Notice of Compliance from the Minister of Health to market a generic version of Novartis ACLASTA drug in Canada. Novartis brought an application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company for its drug containing zoledronic acid until the expiry of Canadian Patent No. 2,410,201.

As to validity, Cobalt asserted mainly two grounds for the revocation of patent:

1. Obviousness; and

2. Is the subject matter ineligible for patent protection – is it a method of medical treatment?

I would summarize mainly on later part as court rejected the cobalt’s former allegation as to obviousness.

THE CLAIMS OF THE '201 PATENT 

The claims at issue - claims 1 to 36 - can be considered as being in different groups; each with a general claim, followed by more specific claims.

There are 5 types of claims in the Patent:

a. Claims 1-9 are Swiss-type claims, in that they relate to the use of ZA in the manufacture of a medicament;

b. Claims 10-18 are use claims, in that they relate to the use of ZA;

c. Claims 19-27 are claims to a compound (i.e. ZA);

d. Claims 28-36 are claims to a pharmaceutical composition containing ZA; and

e. Claims 37-39 are claims to a kit containing ZA.

Claim construction related to the claims 10 to 18 particularly, together with a rewritten claim 16 are considered to determine whether they fall under medical treatment claims or not?

Claim features were –

      Claim 10: -use of zoledronic acid

-to treat abnormal bone turnover

-intermittent administration of about at least one year

Claim 11: - administration about one year

Claim 12: - intravenous administration

Claim 13: - dosage from about 2 mg to about 10 mg

Claim 14: - dosage of about 5 mg

Claim 15: - condition is osteoporosis

Claim 16 - once-a-year administration intravenously, 5 mg dose, for osteoporosis

Main arguments were whether such claims were directed to a method of medical treatment or for a vendible product having real economic value. According to the previous case laws vendible product claims are patentable subject matter if they are directed to product having economic value.

But federal court rejected Novartis argument regarding vendible product claims and said these claims are actually directed to method of medical treatment because patent claiming a dosage range within which the physician is to exercise skill and judgment was not a vendible product; and thus, not patentable. Claims where actual involvement of physician comes are directed to treatment claims as it is the physician who has to apply his skills to decide the dose, dosage frequency, route of administration depending on the condition of patient.

The '201 patent specifically states that the mode of administration and dosage “may be selected by the attending physician taking into account the particulars of the patient, especially age, weight, life style, activity level, hormonal status (e.g. postmenopausal) and bone mineral density as appropriate”. (page 11, emphasis added)

Further at page 11, the '201 patent states that the “dose mentioned above is typically administered intermittently, with a period of at least 6 months between doses. The period between bisphosphonate administrations may be longer, e.g. conveniently once per year, once per 18 months, or once every 2 years, or even longer, or any period in between.”

Page 12 of the '201 patent describes dosages that depend on the potency of the bisphosphonates and that dosages may be administered in a divided manner, such as 4 mg one day, and a further 1 mg a few days later.

Finally court held that it is in reality, however contrived the wording of the claim may be, a method of medical treatment under Canadian law, unpatentable.

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company et al., 2013 FC 985