Interpretation of Patent Claims in UK

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.

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.

Cargo want to challenge the validity of the Bungodamide patent as they have discovered the following information:

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.

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.

(i) What options are available to Cargo for challenging the validity of Astra’s European patent?

(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?

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.

(iii) Have Cargo infringed Astra’s patent?

(iv) On what basis can Cargo defend the claim?

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.

Charles Dickens

Introduction:

Necessity is the mother of all inventions.

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’s territory ie. Infringing the right of the Patentee. Whether innocent, or deliberate. That’s 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’t 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’t 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’s draw a route map of the journey to be undertaken by means of this problem. Let’s 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 .

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’s 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’t form part of the state of art. The entry to the gateway of patents lies in ascertaining new pharmaceutical activity.

Concept of novelty

Concept of obviousness

Inventive step

Legal issues

Patent – Grant – Opposition – Obviousness – Anticipation – Defendant’s patent concerned with manufacture of medicine – Claimant oil exploration company challenging validity of patent – Patent being revoked on grounds of anticipation and obviousness – Defendant appealing revokation – Whether patent valid.

(i) What options are available to Cargo for challenging the validity of Astra’s European patent?

Legal Issue – Whether patent is valid or not – Patents Act 1977, s 72(1)(c)

Claim Is anticipated (s 72(1)(a))

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 ) – (d) Patent act 1977) ]

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.

In genetech’s 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.

It was held in a Chiron vs Murex [1996] RPC 535 (CA) that where the claimed subject matter contains substances

[1996] RPC 535

Validity

Obviousness – section 72(1) of the Patents Act 1977 allows the court to revoke a patent upon the ground that ‘the invention is not a patentable invention’. That section draws the distinction between an invention and a patentable invention. An inventor may make an ‘invention’, but may not be able to obtain a monopoly for it unless he satisfies the conditions set out in section 1(1) of the Act. One of those is that the invention ‘involves an inventive step’. Section 3 states that

‘An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above)’.

Thus a patentable invention is one which inter alia is not obvious. There is no requirement for ‘lateral thought’.

The classic approach to obviousness is that suggested by Oliver LJ in Windsurfing International Inc v Tabus Marine (Great Britain) Ltd [1985] RPC 59, at page 73, line 45:

‘There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally

[1996] RPC 535 at 557

skilled but unimaginative addressee in the art at the priority date and impute to him what was, at that date, common general knowledge in the art in question. The third question is to identify what, if any, differences exist between the matters cited as being ‘known or used’ and the alleged invention. Finally the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.’

Although the first three steps suggested by Oliver LJ require judgment and analysis of the evidence, it is the four step which is normally the most difficult to complete. As pointed out by Oliver LJ the fourth step requires answering the jury question. By that, he meant that the court must make a balanced assessment of the evidence as only in that way can the court decide whether the invention was obvious.

The word ‘obvious’ is an ordinary English word and does not have in patent law any technical meaning. As Diplock LJ pointed out in Johns-Manville Corporation’s Patent [1967] RPC 479, at page 493, line 50:

‘Patent law can too easily be bedevilled by linguistics, and the citation of a plethora of cases about other inventions of different kinds. The correctness of a decision upon an issue of obviousness does not depend upon whether or not the decider has paraphrased the words of the Act in some particular verbal formula.’

[1989] RPC 147 at 155

Obviousness

(23) (per Dillon and Mustill LJJ) The question whether an invention would or would not have been obvious to a person skilled in the art, having regard to matter which had been made available to the public at the relevant date, was a jury question to be considered broadly as a touchstone of the originality of the supposed invention. The judge must form his own mental picture of the art and of the skilled practitioner and see how it measured up against the tasks which the latter was assumed to be tackling (pp 246, 281).

General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd, [1972] RPC 457, and Johns-Manville Corp’s Patent, [1967] RPC 479, referred to by Mustill LJ.

(24) (per Purchas and Mustill LJJ) To assess inventiveness one must look not at individual achievements but at the total work and the result. There was a risk in seizing on a few aspects of the case and drawing too close to them to achieve a proper perspective (pp 222, 285).

British Westinghouse Electric & Manufacturing Co Ltd v Braulik (1910) 27 RPC 209, referred to.

(25) (per Mustill LJ) To fasten on the word “step” in the expression “inventive step” and look at the steps actually taken by the inventor was unsound. The history of the route by which he arrived at the invention was not material to the validity of the patent. The word step must carry the meaning of “activity”, as the other two texts of the European Patent Convention (Article 56) made plain (p 285).

[1989] RPC 147 at 154

(26) A novel idea for a project carried through to a successful conclusion, in a field where the necessary facts could not be discovered by ready reference to an available source, might involve the necessary inventive step to merit patent protection (pp 221, 243, 280).

American Cyanamid Co (Dann’s) Patent [1971] RPC 425, IG Farbenindustrie AG’s Patents (1930) 47 RPC 289, Beecham Group Ltd v Bristol Laboratories Ltd, [1978] RPC 153, Johns-Manville Corp’s Patent, [1967] RPC 479, Olin Mathieson Chemical Corp v Biorex Laboratories Ltd [1970] RPC 157, Tetra Molectric Ltd v Japan Imports Ltd, [1976] RPC 541, and American Cyanamid Co v Ethicon Ltd, [1979] RPC 215, considered.

(27) (per Dillon and Mustill LJJ) Being the first to succeed was not enough; but if no one else had set out to produce the invention this might be evidence that it was not obvious (pp 242, 277).

(28) (per Dillon and Mustill LJJ: Purchas LJ contra) Laborious and costly effort did not necessarily involve an inventive step even if amounting to more than the exercise of proficiency (pp 214, 221, 242, 280).

American Cyanamid Co (Dann’s) Patent, [1971] RPC 425, considered, Valensi v British Radio Corp, [1973] RPC 337, also referred to by Purchas LJ.

(29) (per Dillon LJ) An idea was obvious if at the relevant date a man skilled in the art would have thought the idea well worth trying out to see whether it would have beneficial results; or a research group would have been directly led to try the idea in the expectation that it might well produce a useful result; or the material in question were “lying in the road” and ready for the research worker to use (p 242).

Johns-Manville Corp’s Patent, [1967] RPC 479, Olin Mathieson Chemical Corp v Biorex Laboratories Ltd, [1970] RPC 157, and Philips (Bosgra’s) Application, [1974] RPC 241, applied.

(30) (per Mustill LJ) Section 3 required the court:-

(a) to imagine the hypothetical skilled man, up to date with the prior art, looking toward the goal (whether or not precisely identifiable in advance) which would become the claimed invention if and when realised;

(b) to ask by what routes it would have been possible to proceed to the goal from the starting point;

(c) to see what obstacles he would have faced on those routes and to enquire how he could have overcome them; and

(d) to ask whether they could have been overcome by no more than pertinacity, sound technique or trial and error, or whether a spark of imagination would have been required beyond the imagination properly attributable to him as a man skilled in the art.

The requirement of section 1(1)(b) were fulfilled only if the final question was answered in the latter sense (p 275).

(31) (per Mustill LJ obiter: Dillon LJ contra) A patentable invention was not reached by the mere process of pursuing obvious lines of enquiry by trial and error

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’s 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

“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)

“Case law on these aspects left to be inserted – on validity”

Sec 61,72,74

(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?

Grounds:-

The statutory provisions

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:

“The 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”.

Legal issue _ Whether invention made available to public.

“Made available to the public”

The contrary arguments:

the Mobil case

The General Tire case

Use of the compound by the aborigninals of Australia in form of bongo leaf.

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.

The compound in question was already used by the aboriginals of Australia. Although in different form. The primary source of the chemical compound “bongo leaf”

Use in Doctor McCarthy’s pills for indigestion and acidity.

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.

(iii) Have Cargo infringed Astra’s patent?

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

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.

Defence of infringement – validity us 63

Prior use

(iv) On what basis can Cargo defend the claim?

Invalidity

The patent right which Astra claim’s 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’s 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

Was the product Novel – no it wasn’t

Was there any Inventive step – no inventive step was involved

Was the product Obvious – 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.

Evans Medical Ltd’s Patent Also known as: Chiron Corp v Evans Medical Supplies Ltd

Not followed by

Inhale Therapeutic Systems Inc v Quadrant Healthcare Plc

[2002] R.P.C. 21; (2001) 24(11) I.P.D. 24075; Official Transcript; Ch D (Patents Ct)

Case references

Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc and Napro Biotherapeutics Inc [1999] RPC 253 (HC)

[2001] EWCA Civ 414 (CA)

SmithKline Beecham plc v Generics UK Limited [2002] 25(1) I.P.D. 25005

SmithKline Beecham plc v Apotex Europe Limited [2003] WL 933395 (HC) [2003] WL 1202563 (CA)

BASF v SmithKline Beecham Plc [2003] EWCA Civ 872

Cipla Limited ors v Glaxo Group Limited [2004] EWHC 819(Pat)

Important Sections

Novelty – 1(1) (a)

Novelty test – 2(1)

Evans medical ltd’s patent 1998

General tire 1972

State of Art – 2(2) , 2(3)

Bhular vs satake 1997

Windsurfing vs tabor marine 1985

2(4)(a)(b) , 2(4)(c)

Novel new uses – 2(6) first medical use

Second medical use EISAI / second medical indication 1985

(here comes in Swiss form claim) Bristol Myer Squibb v baker Norton pharmaceuticals 2001

MOBIL case 1990 /VS/ Merrill Dow vs Norton

Inventive step – 3

Skilled man – technograph printed circuits vs mills 1972

Genetech inc’s patent 1989

Plg research vs ardon international 1995

Windsurfer test – Test of Inventive step (is the case windsurfer proof)

applied in windsurfer case 1985 and modified in Ardon international case 1995

EPO – problem solution approach

UK Windsurfer test /vs/ EPO problem solution approach

Claims: what claim does is, it defines the right. Claimed by the patentee to clearly demarks the line of distinction. so that others don’t infringe into his territory and there by infringing the rights of the holder.

Revocation –

Grounds – the grant of patent doesn’t guarantee the validity of the patent. A patent may be revoked on a number of grounds.

Invention claimed forms part of prior art.

Infringement:

Purposive construction : seven reasons why catanic is wrong 1999 EIPR 531 /

(2000 EIPR 242 defences )

Article 69: patent claim interpretation 1991 54 MLR 499 Vol. 54, No. 4 (Jul., 1991), pp. 499-510

2001 [RPC] 133, 142 (CA) LJ Adlous (kiren amgen)

2002[RPC] 187, 194-5 J Nuberger

2003 EIPR 342

2003 EIPR 342

2003 EIPR 237

2008 IPQ 133

1981 12 IIC 447

1990 EIPR 165

1991 EIPR 139

1999 IPQ 1,30