Watch Your Mouth - Therasense, Inc. v. Becton, Dickinson & Co.,

The US federal circuit has now issued an en banc decision on inequitable conduct in the case Therasense, Inc. v. Becton, Dickinson & Co.,.

The case was related to a patent (US 5,820,551) on an electrochemical sensor for testing whole blood (i.e. blood with all its natural ingredients) comprising an electrode. The new thing was that the electrode was not covered by a membrane, whereas there the prior art allegedly relied on the technical prejudice that covering the electrode with a membrane is necessary to prevent some ingredients of the blood from sticking to the surface of the electrode. The inventors have apparently found a way to circumvent the necissity of that membrane.

The closest prior art US 4,545,382 ("the '382 patent") discloses that "Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.”

In order to support the argument that the latter passage did not clearly teach a device without a protective membrane, the applicant's director for R&D, Dr. Sanghera submitted a declaration to USPTO stating:
"[O]ne skilled in the art would have felt that an active electrode comprising an enzyme and a mediator would require a protective membrane if it were to be used with a whole blood sample. . . . [O]ne skilled in the art would not read lines 63 to 65 of column 4 of U.S. Patent No. 4,545,382 to teach that the use of a protective membrane with a whole blood sample is optionally or merely preferred."

Now, the problem starts with the fact that the prior art '382 was held by the applicant of the case under dispute and that the applicant's declarations in this older application were in contrast with Dr. Shanghera's declaration mentioned above.

However, in the EP counterpart of the '382 (the prior art of the case at issue), the applicant's EP representative had argued as followed:
"It is submitted that this disclosure is unequivo-cally clear. The protective membrane is optional, however, it is preferred when used on live blood in order to prevent the larger constituents of the blood, in particular erythrocytes from interfering with the electrode sensor. Furthermore it is said, that said protective membrane should not prevent the glucose molecules from penetration, the membrane is “permeable” to glucose molecules. This teaches the skilled artisan that, whereas the [D1 membrane] must . . . control the permeability of the glucose . . . the purpose of the protective membrane in the patent in suit is not to control the permeation of the glucose molecules. For this very reason the sensor electrode as claimed does not have (and must not have) a semipermeable membrane in the sense of D1." (D1 is another piece of prior art)

This discrepancy (i.e. a discrepancy between declarations given in different procedures relating to different patent applications) and the fact that the submissions of the EP representatives in the EP counterpart of the '382 patent had not been disclosed to the USPTO led to a judgement of a california district court holding the patent unenforceable for inequitable conduct, which was upheld by the Federal Circuit in 2010.

Although the Federal Circuit has finaly vacated the district court's finding of inequitable conduct and has remanded by further proceeding, this case appears to have a big impact on our practice as EP representatives because not only it is clear that our comments on the construction of prior art documents could be used against our clients in the US if the same prior art document is cited in a co-pending or completely unrelated application but also that there may be a duty to disclose these comments as soon as the same documents is cited again. This is a difficult task because, in priciple, it requires keeping track of all the citations of the entire patent portfolio and disclosing all the comments on that document as soon as the document is cited again in another applicaion.

Does offering at a trade fair imply a risk of first infringement? - BGH Pralinenform II

The fact that exhibiting a product on a trade fair implies the risk of a first infringement used to be undisputed in the good old days.

In April 2010, the Federal Supreme Court (BGH) has overturned this case-law and issued a ruling (Pralinenform II - I ZR 17/05 according to which the mere fact of exhibiting a product on a trade fair in Germany does not imply the statutory presumption that the exhibitor intends to sell the product in Germany.

The ruling related to trademarks and the generalization to other intellectual property rights is under dispute.

A recently published decision of the Frankfurt Upper District Court has apparetnly disregarded the BGH decision under 6 U 157/09 in a case relating to the well-known Stabilo-pens by putting the burden of proof for the intention not to sell the product in Germany to the alleged infringer.

The Mannheim District Court (29.10.2010, 7 O 214/10) was apparently a little more up to date by ruling that the mere fact of exhibiting a product infringing a patent was not sufficient to prove the alleged infringer's intention to sell the product in Germany with a degree of certainty sufficient to grant a preliminary injunction.

For the practice, it is higly advisable to provide evidence not only for the exhibition of an infringing product but also for the alleged infringer's intention to sell the product on the German market.

AstraZeneca/Omperazol and the technical effects in the mechanical arts

Upon reading the ECJ decistion in re Astra Zeneca, I suddenly got a bad feeling about the creative ways a good patent attorney in the field of mechanical arts often works.

When arguing on the advantages of the invention, arguments on the technical effects of the distinguishing features need to be provided. These arguments have to be plausible to an extend that the Examiner believes that the technical effect is achieved indeed. This assesment has to be made "on the balance of probabilities".

When trying to argue on the inventive step, the patent attorney has to formulate an "objective technical problem" solved by the feature in question by referring to the technical effects thereof. If the specific advantages of a particular feature (e.g. taken from the specification) are not explicitly mentioned in the specification and the inventors are not available (e.g. during oral proceedings), both the patent attorney and the examiner usually rely on their technical expertise and sometimes "predict" the technical effects in a way which may sometimes be speculative.

This is usually not considered problematic in the mechanical arts where the technical effects of well-defined measures are usually predictable such that the examiner may well assess the plausibility of the attorney's arguments using his technical knowledge. However, the practice shows that a "good story" which is plausible and supported by convincing technical arguments provided by the attorney is often decisive in this regard.

In the field of chemistry or pharmacy where the effects of features may be less predictable, the EPO often requires the provision of comparative studies, which may be handed in later provided that the effects in question had been asserted already in the original disclosure. This is very rare in mechanics.

Now what happens if your client is an undertaking dominating the market and the "story" provided by the attorney in the mechanical arts turns out to be wrong in the end?

The AstraZeneca ruling by the ECJ (which related to information needed to obtain a supplementary protection and not ton inventiveness) contains a passage which may be transferred to the above case immediately:

"In the present case, the Court observes that the submission to the public authorities of misleading information liable to lead them into error and there-fore to make possible the grant of an exclusive right to which an undertaking is not entitled, or to which it is entitled for a shorter period, constitutes a practice falling outside the scope of competition on the merits which may be particularly restrictive of competition. Such conduct is not in keeping with the special responsibility of an undertaking in a dominant position not to impair, by conduct falling out-side the scope of competition on the merits, genuine undistorted competition in the common market"

What to learn from this? Be prudent with speculations on technical effects. Astra Zeneca was sentenced to pay a fine of 52,5 million EUR......