patent litigation in france - véron & associés · patent litigation in france les germany 15...

Patent Litigation in France LES Germany

15 March 2012

Sabine Agé • Véron & Associés 1

Paris Lyon

Patent Litigation in France

Sabine Agé

Licensing executive society Germany Königswinter 15 March 2012

Most of the decisions mentioned can be found at http://www.frenchpatentcaselaw.info/

2

Highlights

Statistics

Case law

Validity

Infringement

Injunctions


15 March 2012


Statistics

3

Patent litigation in France in figures

350 new patents cases filed per year before the tribunal de grande instance of Paris (exclusive jurisdiction)

110 new patent cases in appeal per year (i.e. 30% of the cases are appealed)

80% infringement actions (remaining 20%: nullity, contract, employee inventions, property claims)

Complete survey on patent litigation in France 2000-2009: http://www.veron.com/publications/Colloques/Patent_litigation_France_Stats_2000-2009_Veron_&_Associes.pdf

Statistics

4

European comparison : data from Harhoff report

0

250

500

750

1000

Allemagne * France Italie Royaume-Uni Pays-Bas

* Germany : one case per claim (infringement / nullity) and one case per patent

0

250

500

750

1000

Allemagne * France Italie Royaume-Uni Pays-Bas

Harhoff (raw data)

Harhoff (rectified data)

http://www.veron.com/publications/Colloques/Patent_litigation_France_Stats_2000-2009_Veron_&_Associes.pdf




15 March 2012


Statistics

5 5 5 5

Validity and infringement

Statistics

6 6 6

Validity and infringement European patents


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Statistics

7 7 7 7

Cour d’Appel: judgments affirmed /reversed

CA Paris

2000-2010

Statistics

9 9 9 9

Cour d’Appel: validity and infringement

CA Paris

2000-2010


15 March 2012


Statistics

10 10 10

The damages awarded

(TGI Paris 2000-2010 – costs under Art. 700 not taken into account – advance payments included – settlement agreement included)

Date Part ies Damages (incl. adv.)

09/02/2007 ETHYPHARM v. LABORATOIRES FOURNIER 10 000 000 €

11/02/2009 L'OREAL et al. v. BOURJOIS et al. 8 200 000 €

14/01/2009 WATERS CORPORATION v. HEWLETT-PACKARD, AGILENT TECHNOLOGY DEUTSCHLAND 4 317 180 €

09/10/2009 LEGRAND, LEGRAND SNC v. ALTERNATIVE ELEC 3 301 000 €

25/06/2010 TECHNOGENIA v. MARTEC, ATELIERS JOSEPH MARY 2 735 013 €

17/03/2009 MICSYSTEMES v. FINANCIERE LIBERTEL 16 2 600 000 €

29/06/2004 Technogenia v. Martec, Ateliers Joseph Mary, BMI, Actciale 2 000 000 €

14/09/2007 KONINKLIJKE PHILIPS ELECTRONICS v. MANUFACTURING ADVANCED MEDIA EUROPE 2 000 000 €

07/04/2009 INSTRUMENTATION LABORATORY SPA v. S.A.S DIAGNOSTICA STAGO 2 000 000 €

14/05/2003 DENTSPLY RESEARCH ET DEVELOPMENT CORPORATION v. EMS France 1 256 178 €

29/10/2008 L'AIR LIQUIDE v. YARA France 1 195 050 €

16/09/2009 HAGER SECURITY v. CEDOM, LEROY MERLIN France 1 184 806 €

09/11/2004 Schneider Electric Industries v. Wenzhou Fly-Dragon Electric 1 000 000 €

25/03/2009 NOVARTIS AG v. JOHNSON & JOHNSON VISION CARE 1 000 000 €

12/09/2007 SEB SA, SEB SAS v. DE LONGHI 989 858 €

08/03/2006 CITEC ENVIRONNEMENT v. K.A. FRANCE, SSI SCHAEFFER 693 653 €

26/03/2010 BRANDT INDUSTRIES v. Société WHIRLPOOL France 651 446 €

28/01/2009 S.A. TREVES v. S.A.S. VISTEON SYSTEMES INTERIEURS 530 000 €

10/07/2002 SEDAC-MECOBEL v. J.P. GRUHIER SA, STYLING 517 036 €

06/06/2007 ROTANOTICE v. M.Y. HEALTHCARE France 500 000 €

Statistics

11

Duration of French proceedings Novartis v. Johnson & Johnson


15 March 2012


Statistics

12

Duration of French proceedings Agilent Technologies v. Waters

Statistics

13

French case law

Validity

Infringement

Injunctions

Most of the decisions mentioned can be found at http://www.frenchpatentcaselaw.info/


15 March 2012


Validity

14 14

Validity

1. Dosage regime (patentability exclusion)

2. Insufficiency

3. Novelty

4. Inventive step

5. Procedure

Validity

15 15

1. Dosage regime (patentability exclusion)

Merck patent EP 0 724 444: “Use of finasteride for the preparation of a medicament adapted for oral administration for the treatment of androgenic alopecia in a person wherein the dosage amount is about 0.05 to 1.0 mg [per day]”

G 2/08 of 19/02/2010

Two separate actions for invalidity:

Actavis Group, Paris TGI, 3rd ch., 1st sect., 28/09/2010 (non patentable therapeutic method)

Teva, Paris TGI, 3rd ch., 1st sect., 9/11/2010 (insufficiency)


15 March 2012


Validity

16 16

Actavis v. Merck (1/2)

The Tribunal acknowledges the patentability of a new therapeutic use

It refers to decision G 2/08

But it considers that a dosage regime

is a therapeutic method

and not a new therapeutic use

Actavis v. Merck, Paris TGI, 3rd ch., 1st sect., 28/09/2010

Validity

17 17

Actavis v. Merck (2/2)

Only the doctor has the right to determine the dosage regime

In France, the leaflets inform that the prescribed dosage regimes are merely indicative and that a doctor must be consulted

Actavis v. Merck, Paris TGI, 3rd ch., 1st sect., 28/09/2010


15 March 2012


Validity

18 18

2. Insufficiency

2.1. Particle size measurement

2.2. Enantiomers

Validity

19 19

2.1. Particle size measurement (1/2)

EP 0 937 120

Claim relating to starch in a dispersed phase wherein “the average numeral particle size is from 0.1 to 0.5 m”

Paris TGI, 3rd ch., 2nd sect., 16/04/2010, Novamont v. Biotec


15 March 2012


Validity

20 20

Particle size measurement (2/2)

“Although the patent mentions a measurement made by scanning electron microscope after starch solubilisation with hydrochloric acid (HCl)5M, this indication does not define the conditions under which these measurements must be taken.”

A book and an expert report establish that the duration of the acid attack and the temperature have an influence on the starch dissolution and that these are not mentioned

Therefore, the patent does not provide “the conditions for determining the claimed starch particles”

Paris TGI, 3rd ch., 2nd sect., 16/04/2010, Novamont v. Biotec

Validity

21 21

2.2. Enantiomers

Action for invalidity initiated by Teva against Sepracor

Sepracor’s patent EP 0 663 828 claiming the use of levocetirizine (Xyzall), one of the cetirizine (Zyrtec) enantiomers, for the treatment of allergic rhinitis and asthma

On the same date, Sepracor filed a patent application relating to the use of dextrocetirizine, the other enantiomer for the treatment of allergic disorders

The patent in dispute (levocetirizine) is considered “speculative”

Paris TGI, 3rd ch., 1st sect., 6/10/2009, Teva v. Sepracor


15 March 2012


Validity

22 22

Enantiomers: insufficiency

“The description must contain the pharmacologic properties and one or several therapeutic uses”

The inventor does not have to prove the result but he has to mention that this result was sought and exists

Paris TGI, 3rd ch., 1st sect., 6/10/2009, Teva v. Sepracor

Validity

23 23

3. Novelty

3.1. Purity

3.2. Enantiomer

3.3. Implicit disclosure


15 March 2012


Validity

24 24

3.1. Purity

EP Madaus 0 520 414 relating to diacetylrhein (osteoarthritis)

Claim 14:

“Pharmaceutical preparation containing diacetylrhein having less than 20 ppm of aloe-emodin components together with conventional pharmaceutical carriers and auxiliary supports”

Held invalid for lack of novelty:

“In general, a document disclosing a chemical compound makes this product available, according to the meaning of Article 54 EPC, in all degrees of purity.”

Paris TGI, 3rd ch., 3rd sect., 31/03/2010, Negma v. Biogaran

affirmed by Paris CA, division 5, ch. 1, 30/06/2010

Validity

25 25

3.2. Enantiomer

Lundbeck patent EP 0 347 066 covering enantiomer (+) of citalopram

Novelty of the enantiomer with regard to the racemic mixture

The examples describing the racemic mixture taught neither the existence of the enantiomer nor the possibility to isolate it

Same conclusion as Bundesgerichsthof, 10/09/2009 Xa ZR 130/07

Ratiopharm v. Lundbeck, Paris TGI, 3rd ch., 4th sect., 30/09/2010


15 March 2012


Validity

26

3.3. Implicit disclosure

“In light of the absence of any indication in the Lai/Valint I patent application of how to prepare the macromer IDS3H, Dr Vanderlaan carried out, over more than two years, a number of tests using various ingredients and experienced a number of failures before succeeding in producing a high proportion of lenses free of any material defect;

such work, contrary to the appellants’ assertions, exceeds the routine work of the skilled person;

the implementation of example 4 of the Lai/Valint I patent therefore imposes a number of ingredient combinations, some of which could undoubtedly lead to a result in accordance with claim 1 of the patent in dispute, but a great number of which do not meet this claim, so that it is unfounded to assert implicit disclosure through the obtention of an inevitable result, and consequently the allegation of destruction of novelty was rightly dismissed by the court in first instance.”

Novartis v. Johnson & Johnson, Paris Court of appeal, division 5, ch. 1, 27/10/2010

Validity

27 27

4. Inventive step:

4.1. Group of people as “skilled person”

4.2. Problem / solution approach


15 March 2012


Validity

28

4.1. Group of people as “skilled person”

“ …definition of the skilled person as given in the judgment, specifically, a team consisting of a polymer chemist, with the objective of developing suitable materials, of a physicist responsible for determining the physical properties of the ophthalmic lenses and of an ophthalmologist specialised in contact lenses”

Novartis v. Johnson & Johnson, Paris CA, division 5, ch. 1, 27/10/2010

Validity

29 29

4.2. Problem/solution approach (1/2)

Dismissal of a nullity action brought by Sandoz against EP 0 577 303 covering a new process to manufacture gemcitabine (treatment of cancer)

Application of the could/would approach by the court of appeal of Paris

Sandoz v. Eli Lilly, Paris CA, division 5, ch. 2, 13/01/2012


15 March 2012


Validity

30 30

Problem / solution approach (2/2)

“As it results from the constant case law of the Boards of Appeal of the European Patent Office, the issue is not one of knowing whether the person skilled in the art would have been able to carry out the invention by modifying the state of the art, but rather whether he would have acted in the hopes of achieving the advantages that were actually obtained considering the technical problem that was posed because the state of the art contained suggestions along this line (see: Case Law of the Boards of Appeal of the European Patent Office, 6th edition 2010, page 201 I.D.5, “could-would approach” and ex post facto analysis).”

Sandoz v. Eli Lilly, Paris CA, division 5, ch. 2, 13/01/2012

Procedure

31

5. Procedure

5.1. Admissibility of an action for invalidity

5.2. Limitation procedure

5.3. Impact of the EPO decisions

5.4. Impact of the foreign decisions


15 March 2012


Procedure

32 32

5.1. Admissibility of an action for invalidity

Inadmissibility of a request for invalidity filed by a straw man:

“Omnipharm, far from proving to be a current or even simply a potential competitor to Merial, in reality acts on behalf of third companies, which do not want to appear in this dispute, and that it is a shell company hiding other companies”

“Omnipharm does not prove to be in a position to develop, manufacture or sell itself in France a product for veterinary use, in compliance with Merial’s patents in dispute, and in particular to have the required means (infrastructure, staff and installations) to develop such business”

Omnipharm v. Merial, Paris TGI, 3rd ch., 4th sect., 12/05/2011

Affirmed by Paris CA, division 5, ch. 2, 17/02/2012

Procedure

33 33

5.2. Limitation procedure

Limitation possible in France since 1st January 2009

Usually court stays the proceedings pending the decision of the EPO (stay unnecessary pending limitation before French Intellectual Property Institute (INPI), because takes approx. one month)

First decisions on validity of limited claims in 2011: in 3 cases over 4, patent as limited was upheld


15 March 2012


Procedure

34 34

5.3. Impact of the EPO decisions

“The French courts are not bound by the decisions of the EPO which is not a court (as opposed to the European Union courts’ decisions which are binding to national courts)

so that these decisions even issued by the Enlarged Board of Appeal are merely indications of the analysis made by the EPO to grant European patents”

Actavis v. Merck Paris TGI, 3rd ch., 1st sect., 28/09/2010

Procedure

35 35

5.4. Impact of the foreign decisions

“The same is true of the decisions of the courts of the European Union Member States which contribute to the legal debate by explaining the reasoning of each national court on the point of law referred to them, but which are not binding on national case law”

Actavis v. Merck Paris TGI, 3rd ch., 1st sect., 28/09/2010


15 March 2012


Procedure

36 36

Impact of the foreign decisions

The foreign decisions are “legal matters that can be brought to the judge’s knowledge”; ”they are part of the discussion but are subjected, like any other legal matter, to the assessment of the court to which they are submitted”;

“It is not for the French judge to comment on the decisions thus rendered, the latter being only allowed to examine not just the result thereof, but above all their reasoning, so as to be able to assess whether the legal foundations are those set out in the pleadings he was submitted and whether the facts submitted to the other courts are similar.”

Aventis and Sepracor v. Teva, Paris TGI, order in preliminary proceedings, 12 January 2010

Infringement

37 37

Infringement

1. File wrapper estoppel

2. Infringement of standard essential patents


15 March 2012


Infringement

38 38

1. File wrapper estoppel?

Institut Pasteur holds a patent relating to “Cloned DNA sequences, hybridizable with genomic RNA of lymphadenopathy-associated virus (LAV).”

the claims were amended during the grant and opposition procedures to be differentiated from the prior art

Defendant alleged that they should be strictly interpreted or, alternatively, if broadly construed, invalid

Institut Pasteur v. Siemens Healthcare Diagnostics, Paris TGI, 3rd chamber, 2nd section, 28/05/ 2010

Infringement

39 39

The court held that the amended claims must be strictly interpreted to ensure legal certainty for third parties:

“It follows that the amendments made to the claims by Institut Pasteur during the examination and opposition proceedings - which must be taken into account failing which legal certainty for third parties would be violated - resulted in limiting the scope of the invention, which was voluntarily limited in order to obtain the grant then the maintenance of the patent at issue.”

Institut Pasteur v. Siemens Healthcare Diagnostics, Paris TGI, 3rd chamber, 2nd section, 28/05/2010

File wrapper estoppel?


15 March 2012


Infringement

40 40

2. Infringement of standard essential patents

Order of the presiding judge of the tribunal de grande instance of Paris in the framework of the worldwide battle between Samsung and Apple

Samsung sought a preliminary injunction against Apple, arguing that Apple’s iPhones 4S contain chips infringing EP No. 1 188 269 and 1 097 516, declared essential to the UMTS standard within the framework of ETSI (European Telecommunication Standard Institute)

Apple submitted that (i) Samsung’s rights with respect to the chips contained in the telephones are exhausted, (ii) it was granted a FRAND license in accordance with article 6-1 of the ETSI IPR Policy or, at least, Samsung’s FRAND undertaking is an irrevocable offer which Samsung did not withdraw, (iii) the patents at issue are invalid, (iv) Samsung would abuse of a dominant position if an injunction were granted

Samsung v. Appel, Paris TGI (Ord. in preliminary proceedings), 8/12/2011

Infringement

41 41

Dismissal of Samsung’s claim for a preliminary injunction based on Apple’s first argument, i.e. exhaustion of Samsung’s patent rights on the chips integrated in the iPhones 4S

Decision not based on the undertaking provided by Samsung to the ETSI when declaring that the two patents asserted against Apple were essential to the UMTS standard, but the judge states:

ETSI does not check whether the patents which are declared essential are valid and indeed essential to the standard, such that these issues may be submitted to courts

ETSI IPR policy according which the granted licence shall be irrevocable and the royalty rate shall be FRAND are provided to prevent the holder of essential patents from abusing a dominant position

the preliminary injunction sought by Samsung against Apple is disproportionate

Infringement of standard essential patents

Samsung v. Appel, Paris TGI (Ord. in preliminary proceedings), 8/12/2011


15 March 2012


Injunctions

42 42

Injunctions

1. Interim injunctions in preliminary proceedings

2. Ex parte interim injunctions

3. Injunction granted on the merits of the case

4. Enforcement at the risk of the plaintiff

Injunctions

43 43

1. Interim injunctions: legal ground

Art. L. 615-3 of the French Intellectual Property Code (as modified by the 29 October 2007 Act):

“ (…) The court, in preliminary proceedings or ex parte, may order the requested measures only if evidence, reasonably accessible to the claimant, make it likely that its rights are infringed or that such infringement is about to be committed. (…)”


15 March 2012


Injunctions

44 44

Interim injunctions: likelihood of infringement (no)

“The judge ruling in preliminary proceedings has to

decide on the objections brought before him to

challenge the plaintiff’s claims and these objections

may relate to the validity of the patent itself; it is

then for him to assess the seriousness of the

objections, which then deprive the alleged

infringement of any obviousness.”

Aventis v. Teva, Paris TGI (Ord. in preliminary proceedings), 12/01/2010, (fexofenadine)

Injunctions

45 45

Interim injunctions: likelihood of infringement (no)

“It does not appear likely enough that Cipla’s manufacturing process infringes claim 3 of AstraZeneca’s patent EP 940.”

Paris TGI (Ord. in preliminary proceedings), 10/06/2011, AstraZeneca v. Ethypharm, Mylan (esomeprazole, gastric

antisecretory and antiulcer substance, patent related to a manufacturing processs)

“No imminent infringement of Novartis’ rights being found, the conditions of Article L. 615-3 of the French Intellectual Property Code are not met...”

Paris TGI (Ord. in preliminar proceedings), 05/04/2011, Novartis v. EG Labo (valsartan + hydrochlorotiazide, antihypertensive)


15 March 2012


Injunctions

46 46

Interim injunctions: likelihood of infringement (conflicting decisions)

Validity of the basic patent and imminent infringement not disputed

Only the scope of the SPC (active ingredient alone or in combination with another) was disputed

Interim injunction granted Paris TGI (Ord. in preliminary proceedings), 12/02/2010, EI DuPont de Nemours v. Mylan (losartan + hydrochlorotiazide, anti-hypertensive), affirmed by the Paris CA, division 1, ch. 3, 15/03/2011

Interim injunction denied Paris TGI (Ord. in preliminary proceedings), 28/01/2011, Novartis v. Actavis (valsartan + hydrochlorotiazide, anti-hypertensive), reversed by the Paris CA, division 1, ch. 4, 16/09/2011

Injunctions

47 47

2. Ex parte interim injunctions: only in urgent matters or when existing decision on the same patent or SPC

Interim injunction granted ex parte

Paris TGI (Ord. in preliminary proceedings), 27/10/2011, Novartis v. Sanofi Aventis (losartan +

hydrochlorotiazide, anti-hypertensive)

Request for withdrawal of this order dismissed

Reasons:

Scope of SPC considered in previous cases

Expiry of the patent and expected launch of generic product very close

Paris TGI (Ord. in preliminary proceedings), 31/10/2011, Novartis v. Sanofi Aventis


15 March 2012


Injunctions

48 48

3. Injunctions granted on the merits: stopping the provisional enforcement exceptional

A judgment granting an injunction on the merits of the case is generally provisionally enforceable “under a penalty of € X per recorded infraction after a x-day period following the service of the decision”

Provisional enforcement stopped by the president of the Cour d’Appel if it “"it may have manifestly severe consequences” for the party subjected to it (with regard to its situation, that of the party benefiting from the injunction or that of third parties)

But stopping provisional enforcement remains an exception

Paris CA, division 1, ch. 5, Laboratoires Asepta v. Millet Innovation, 15/12/2010

Paris CA, division 1, ch. 5, Novartis v. Johnson & Johnson, 6/07/2009

Injunctions

49 49

4. Enforcement of the injunction at the risk of the plaintiff

If it enforces a preliminary injunction and the patent claim on the basis of which the injunction had been granted is afterwards declared invalid on the merits, the plaintiff is liable for the harmful consequences of this injunction without needing to demonstrate a fault

Paris TGI, 3rd ch. 2nd sect., 27/01/2012, Medidom & Negma v. Biogaran

But the revocation of a patent does not force the patentee to pay back the damages he has collected from an infringer as a result of a judgment which became final before the revocation of the patent

Cour de cassation, en banc, 17/02/2012, Reginald Wehrkamp-richter v. Louis Paul Guitay, Lpg Systems


15 March 2012


50 50

Thank you for your attention

Sabine Agé

1, rue Volney 75002 Paris Tel. +33 (0)1 47 03 62 62 Fax +33 (0)1 47 03 62 69 53, avenue Maréchal Foch 69006 Lyon Tel. +33 (0)4 72 69 39 39 Fax +33 (0)4 72 69 39 49 [email protected] www.veron.com

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