<\/p>\n
Cargo Pharmaceuticals International Inc. is a generic pharmaceutical manufacturer. It does not conduct research and development itself into new drugs, but manufactures drugs that have already been invented but are not subject to patent protection.<\/p>\n
Cargo is interested in making a generic version of the anti-ulcer drug “Bontract”. Bontract was developed by Astra Pharmaceuticals Ltd who are an English company based in London. The short chemical name for the active ingredient in Bontract is “Bungodamide”. Bungodamide works by reducing the amount of acid produced by the stomach, which in turn reduces the discomfort associated with stomach ulcers. Astra made a European Patent application for Bungodamide and a patent was granted pursuant to that application in July 2009. They have also obtained regulatory approval for the sale of tablets containing Bungodamide under the name “Bontract” throughout Europe, and the drug has become very popular with prescribing doctors.<\/p>\n
Cargo want to challenge the validity of the Bungodamide patent as they have discovered the following information:<\/p>\n
Bungodamide is a variant of a chemical found naturally in the Bungoo, an arboreal plant found in the rainforests of Northern Queensland, in the North-East of Australia. Local aboriginal people have for many years chewed Bungoo leaves to deal with indigestion.<\/p>\n
They have obtained a sample of “Dr McCarthy’s Stomach Pills”, which were sold in pharmacies throughout Queensland between 1975 and 1982. Among some other herbal ingredients, these contained crushed Bungoo leaves. The quantity of Bungodamide contained in Dr McCarthy’s pills is similar to that found in Bontract pills. The packaging for the pills states that they are useful to ease the symptoms of indigestion and stomach acidity.<\/p>\n
(i) What options are available to Cargo for challenging the validity of Astra’s European patent?<\/p>\n
(ii) What grounds for challenging the patent arise from the matters noted above, and how would you assess and investigate the chances of such challenges being successful?<\/p>\n
Cargo are confident that they can successfully challenge the validity of Astra’s patent, so they proceed to carry out clinical trials in the UK to demonstrate the efficacy of Bungodamide in order to submit an application to the UK regulatory authorities to market their version of it. Astra issue a claim before the Patents Court in London alleging that these trials infringe their patent for Bungodamide. Cargo accept that their product falls within the scope of the claims of Astra’s patent.<\/p>\n
(iii) Have Cargo infringed Astra’s patent?<\/p>\n
(iv) On what basis can Cargo defend the claim?<\/p>\n
The main principle of English law is, to make business for it self . There is no other principle distinctly, certainly, and consistently maintained through all its narrow turnings.<\/p>\n
Charles Dickens<\/p>\n
Necessity is the mother of all inventions.<\/p>\n
Since the evolution of mankind from the apes to Homo sapiens, there have been consistent changes in his attitude. Nevertheless mimicking, imitating others still forms part of his nature. Similar notion can be figured out between the companies manufacturing generic drugs. Who eagerly await, tend to manufacture the generic drugs after the patent protection expires or patent protection is revoked. Consequently often end up on a slippery ground. Finding themselves in someone else\u2019s territory ie. Infringing the right of the Patentee. Whether innocent, or deliberate. That\u2019s a matter of introspection. We have a similar situation at hand. Here lies crux of the problem, on one side we see a company investing millions of dollars in research and development to invent a novel product or process. Try to monopolise it, shouldn\u2019t they? They are ones who have a run for their money. Poor them! are always at daggers drawn with the Generic companies. Which try to capitalize on the pedestal established by them. The real question here is, are the first manufactures really the ones who are the brain behind the invention. What if the product or process was there already? Used since ages. Even though in different part of the globe. (some would argue, so what, doesn\u2019t that form part of their research? )Does that justify their use of monopoly right (Food for thought) of barring other manufactures? Developing a patented drug by a generic company leads to violation of the monopoly right of patentee. Here impends the conflict of interests. We have to rationalize the second hand use of the pharmaceutical products. Determine the Concept of Novelty, its validity. Principle of obviousness & inventive step Let\u2019s draw a route map of the journey to be undertaken by means of this problem. Let\u2019s examine what aspects of law are unravelled in this problem. The legal issues to be examined are whether it was a patentable invention. Analyse concept of novelty. Decide whether the compound in issue was novel. Whether there was any inventive step involved in the manufacturing of the drug. Was it not obviousness? Its argued that whether issue at hand stands the test UK patent law. The applicability of the Swiss test. The concept of second use of medicine compounds. Whether the patent was valid or not. Or it stands to be revoked .<\/p>\n
With reference to the core principle of absolute novelty, it is reckoned unfeasible to patent an already known compound like is the case at hand. But it\u2019s not all heavens. The principle has a stark diversity as well. The principle has another facet as well. Which we cannot deny even though the compound is known, the paradox of the principle lies in the chemical activity of the same known compound. The mere knowledge of the same cannot contain it from being treated as new if it doesn\u2019t form part of the state of art. The entry to the gateway of patents lies in ascertaining new pharmaceutical activity.<\/p>\n
Concept of novelty<\/p>\n
Concept of obviousness<\/p>\n
Inventive step<\/p>\n
Patent \u2013 Grant \u2013 Opposition \u2013 Obviousness \u2013 Anticipation \u2013 Defendant’s patent concerned with manufacture of medicine \u2013 Claimant oil exploration company challenging validity of patent \u2013 Patent being revoked on grounds of anticipation and obviousness \u2013 Defendant appealing revokation \u2013 Whether patent valid.<\/p>\n
(i) What options are available to Cargo for challenging the validity of Astra’s European patent?<\/p>\n
Legal Issue \u2013 Whether patent is valid or not \u2013 Patents Act 1977, s 72(1)(c)<\/p>\n
Claim Is anticipated (s 72(1)(a))<\/p>\n
Before divining in deeper waters, it must be first examined whether the four requisites for patentability1, involving patentable inventions are met or not. [sec 1(1)(a ) \u2013 (d) Patent act 1977) ]<\/p>\n
For the purpose of validty, the word invention appears to mean, what is encompassed by the words of the claim, and if any thing falls within the claim which does not meet the criteria for a patentable invention, then that claim is regarded as invalid until amended.<\/p>\n
In genetech\u2019s patent [1989]RPC 147 (CA) and biogen v Medeva [1995] RPC 25 (CA) it was held that invention must be something more than mere discovery.<\/p>\n
It was held in a Chiron vs Murex [1996] RPC 535 (CA) that where the claimed subject matter contains substances<\/p>\n
[1996] RPC 535<\/p>\n
[1989] RPC 147 at 155<\/p>\n
The question to be examined is, whether the seed of conflict, existence of Bungodamide was a valid invention or merely discovered its novel chemical activity of reducing acid in the stomach. Now there\u2019s a catch 22 situation at hand. Since Bungodamide is a variant of a chemical found naturally in the Bungoo, an arboreal plant found in the rainforests of Northern Queensland, in the North-East of Australia. Local aboriginal people have for many years chewed Bungoo leaves to deal with indigestion.(para 1) So is it novel indeed ? or merely a second hand use of the already existing, known and used compound. Also examining that the<\/p>\n
“Dr McCarthy’s Stomach Pills”, were already sold in pharmacies throughout Queensland between 1975 and 1982. Among some other herbal ingredients, these contained crushed Bungoo leaves. The quantity of Bungodamide contained in Dr McCarthy’s pills is similar to that found in Bontract pills. The packaging for the pills states that they are useful to ease the symptoms of indigestion and stomach acidity.(para 2)<\/p>\n
(ii) What grounds for challenging the patent arise from the matters noted above, and how would you assess and investigate the chances of such challenges being successful?<\/p>\n
I turn to the Patents Act 1977. One of the conditions which must be satisfied before a patent may be granted for an invention is that the invention is new (section 1). Section 2 defines novelty for this purpose. Section 2(1) provides that an invention shall be taken as new if it does not form part of `the state of the art’. Section 2(2) defines this expression. This definition is central to this case, because the case turns on the proper interpretation of this definition and its application to the facts of this case. Section 2(2) reads:<\/p>\n
\u201cThe state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way”.<\/p>\n
Legal issue _ Whether invention made available to public.<\/p>\n
Use of the compound by the aborigninals of Australia in form of bongo leaf.<\/p>\n
Bungodamide is a variant of a chemical found naturally in the Bungoo, an arboreal plant found in the rainforests of Northern Queensland, in the North-East of Australia. Local aboriginal people have for many years chewed Bungoo leaves to deal with indigestion.<\/p>\n
The compound in question was already used by the aboriginals of Australia. Although in different form. The primary source of the chemical compound \u201cbongo leaf”<\/p>\n
Use in Doctor McCarthy\u2019s pills for indigestion and acidity.<\/p>\n
They have obtained a sample of “Dr McCarthy’s Stomach Pills”, which were sold in pharmacies throughout Queensland between 1975 and 1982. Among some other herbal ingredients, these contained crushed Bungoo leaves. The quantity of Bungodamide contained in Dr McCarthy’s pills is similar to that found in Bontract pills. The packaging for the pills states that they are useful to ease the symptoms of indigestion and stomach acidity.<\/p>\n
(iii) Have Cargo infringed Astra’s patent?<\/p>\n
Yes they have. But they can have the defence that the product was obvious. And invalid to have been given the patent. although it was already granted patent by the EPO. Still it does not pass the novelty test. Cargo<\/p>\n
did it in good faith to expedite the disclosure that it was not novel and formed part of state of art before the prior art disclosure. To revoke the patent right.<\/p>\n
Defence of infringement \u2013 validity us 63<\/p>\n
Prior use<\/p>\n
(iv) On what basis can Cargo defend the claim?<\/p>\n
Invalidity<\/p>\n
The patent right which Astra claim\u2019s to have been infringed by cargo was in fact never valid. (May be valid to dr. macarty or the tribes of queensland who used it prior to Astra) Since Astra\u2019s patent was clearly based on the compound already known and used. Hence be classified as the second use of the compound. We can put up following questions<\/p>\n
Was the product Novel \u2013 no it wasn\u2019t<\/p>\n
Was there any Inventive step \u2013 no inventive step was involved<\/p>\n
Was the product Obvious \u2013 yes, it already existed. There was the know how of the same product. Although in different form but does that matter so far it produces same results.<\/p>\n
Not followed by<\/p>\n
Inhale Therapeutic Systems Inc v Quadrant Healthcare Plc<\/p>\n
[2002] R.P.C. 21; (2001) 24(11) I.P.D. 24075; Official Transcript; Ch D (Patents Ct)<\/p>\n
Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc and Napro Biotherapeutics Inc [1999] RPC 253 (HC)<\/p>\n
[2001] EWCA Civ 414 (CA)<\/p>\n
SmithKline Beecham plc v Generics UK Limited [2002] 25(1) I.P.D. 25005<\/p>\n
SmithKline Beecham plc v Apotex Europe Limited [2003] WL 933395 (HC) [2003] WL 1202563 (CA)<\/p>\n
BASF v SmithKline Beecham Plc [2003] EWCA Civ 872<\/p>\n
Cipla Limited ors v Glaxo Group Limited [2004] EWHC 819(Pat)<\/p>\n
Novelty \u2013 1(1) (a)<\/p>\n
Novelty test \u2013 2(1)<\/p>\n
Evans medical ltd\u2019s patent 1998<\/p>\n
General tire 1972<\/p>\n
State of Art \u2013 2(2) , 2(3)<\/p>\n
Bhular vs satake 1997<\/p>\n
Windsurfing vs tabor marine 1985<\/p>\n
2(4)(a)(b) , 2(4)(c)<\/p>\n
Novel new uses \u2013 2(6) first medical use<\/p>\n
Second medical use EISAI \/ second medical indication 1985<\/p>\n
(here comes in Swiss form claim) Bristol Myer Squibb v baker Norton pharmaceuticals 2001<\/p>\n
MOBIL case 1990 \/VS\/ Merrill Dow vs Norton<\/p>\n
Inventive step \u2013 3<\/p>\n
Skilled man \u2013 technograph printed circuits vs mills 1972<\/p>\n
Genetech inc\u2019s patent 1989<\/p>\n
Plg research vs ardon international 1995<\/p>\n
Windsurfer test \u2013 Test of Inventive step (is the case windsurfer proof)<\/p>\n
applied in windsurfer case 1985 and modified in Ardon international case 1995<\/p>\n
EPO \u2013 problem solution approach<\/p>\n
UK Windsurfer test \/vs\/ EPO problem solution approach<\/p>\n
Claims: what claim does is, it defines the right. Claimed by the patentee to clearly demarks the line of distinction. so that others don\u2019t infringe into his territory and there by infringing the rights of the holder.<\/p>\n
Revocation \u2013<\/p>\n
Grounds \u2013 the grant of patent doesn\u2019t guarantee the validity of the patent. A patent may be revoked on a number of grounds.<\/p>\n
Invention claimed forms part of prior art.<\/p>\n
Infringement:<\/p>\n
Purposive construction : seven reasons why catanic is wrong 1999 EIPR 531 \/<\/p>\n
(2000 EIPR 242 defences )<\/p>\n
Article 69: patent claim interpretation 1991 54 MLR 499 Vol. 54, No. 4 (Jul., 1991), pp. 499-510<\/p>\n
2001 [RPC] 133, 142 (CA) LJ Adlous (kiren amgen)<\/p>\n
2002[RPC] 187, 194-5 J Nuberger<\/p>\n
2003 EIPR 342<\/p>\n
2003 EIPR 342<\/p>\n
2003 EIPR 237<\/p>\n
2008 IPQ 133<\/p>\n
1981 12 IIC 447<\/p>\n
1990 EIPR 165<\/p>\n
1991 EIPR 139<\/p>\n
1999 IPQ 1,30<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
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