Koo Chin Nam & Co.

Patent Invalidation in Malaysia

Introduction

Patent invalidation is a serious issue in the pharmaceutical industry
Patent invalidation is a serious issue in the pharmaceutical industry

In Malaysia, as in many other jurisdictions of the world, there is a procedure known as patent invalidation. What it is, is a procedure to remove the protection of law given to a patent holder, and to declare that the patent in fact is invalid. Hence, the word “invalidation”.

The effect of invalidation is that the patent is no longer valid, and the whole world may then proceed to exploit the invention as disclosed in the (now invalidated) patent.

Zytiga: An Example of Patent Invalidation

Zytiga is a drug relied upon by millions of prostate cancer patients everywhere.

It is effective in stemming against the advance of prostate cancer in patients, even though it doesn’t get rid of the cancer.

In other words, Zytiga works not by ridding prostate cancer from the body, but by stopping its progress.

Unfortunately, Zytiga is also very expensive.

And because of the patent protection, Johnson & Johnson, the company manufacturing Zytiga, could sell it for a premium.

But all that changed in 2018, when the US Courts invalidated the patent claims protecting Zytiga.

Bloomberg noted that a slew of generic drug companies were waiting to produce their own copies of Zytiga.

That’s what happens when a patent is invalidated: Copycats can exploit the patent to create their own versions.

Zytiga, a drug for treating prostate cancer, had its patent invalidated.

Section 59, Patent Act 1983

In Malaysia’s Patent Act 1983, section 59 allows any aggrieved person to apply to the court for invalidation of a patent, on one or more of the following grounds:

Under section 59(3) of the Patent Act, when only a portion of the patent appears to be invalid, only such affected claims will be declared as invalid by the court.

In the recent unreported case of Merck Sharp & Dohme Corp & Anor v Hovid Bhd [2017] MLJU 77, the judge in his dictum stated:

Under the PA, a patent may be invalidated on any one of the following grounds, among others:
(1) the patent does not pertain to an “invention” – please see ss 11 and 12(1) PA read with s 56(2)(a) PA;
(2) the invention falls within any of the paragraphs in s 13(1)(a) to (d) PA read with s 56(2)(a) PA;
(3) the invention is not new – please see ss 11 and 14(1) PA read with s 56(2)(a) PA;
(4) the invention does not involve an inventive step – please see ss 11 and 15 PA read with s 56(2)(a) PA;
(5) the invention is not industrially applicable – please see ss 11 and 16 PA read with s 56(2)(a) PA; and
(6) the description or claim of the patent does not comply with s 23 PA which requires a patent application to comply with PR – please see s 56(2)(b) PA.

Read: Are you drafting your own patent?

Recent Case on Patent Invalidation

In a recent case, SKB Shutters Manufacturing Sdn Bhd v Seng Kong Shutter Industries Sdn Bhd & Anor [2015] 6 MLJ 293 the Federal Court held that in deciding whether a patent lacks novelty or inventive step (ruling 3), the claims of the patent have to be looked at.

A patent can be shown to lack novelty if “the claimed invention had been anticipated in a single document and/or a single prior art”. (ruling 5)

Where the independent claims have been invalidated, the dependent claims (which depend on the invalidated independent claims) are also invalidated, unless the dependent claims are redrafted as independent claims, incorporating all the features claimed in by the independent claims.

Since redrafting is not possible pending litigation (unlike in the UK) the dependent claims in that case would fail. (ruling 1)

The SKB Shutters case was referred in the recent unreported case of Merck Sharp & Dohme Corp & Anor v Hovid Bhd [2017] MLJU 77.

The High Court of Kuala Lumpur considered various issues, surrounding a patent invalidation action, including prior art and whether invalidation of  an independent claim would also invalidate the dependent claims. (There was only one independent claim in the patent.)

The court allowed the Defendant to tender two unpleaded publications as prior art as it was in the interest of justice to consider the publications.

The court was of the opinion that decisions of the EPO’s Board of Appeal (BOA) and EBOA (Enlarged Board of Appeal) are not binding but can be persuasive to the Malaysian courts when the provisions are similar to the Malaysian Patent Act 1983.

POSITA means “person ordinarily skilled in the art”.

Role of POSITA (Person Ordinarily Skilled in the Art)

The role of the “person ordinarily skilled in the art” or “POSITA” was considered by the court. Referring to the SKB Shutters case, the court was of the opinion that a POSITA can provide evidence to the court in the “4 Matters”:

– construction of the patent, especially its claims
– whether the patent has sufficient disclosure
– whether the patent is novel and not anticipated by prior art
– whether the patent involves an inventive step not obvious to a POSITA

While the court is not bound by the POSITA’s evidence, it may choose to accept a part of the POSITA’s evidence (while rejecting the rest).

The court felt that a POSITA is a notional / hypothetical person who is:

– ordinarily skilled in the field of the invention
– having general knowledge about the field of the invention before the priority date
– uninventive and unimaginative
– maybe prejudiced or conservative towards the invention
– able to explain to the court regarding the “4 Matters” with cogent reasons.

However, the court noted that a court can construe a patent even without a POSITA.

Dependent Claims in Patent Invalidation

The court followed the SKB Shutters case and held that where the independent claim had been invalidated, all its dependent claims were also invalidated.

Reversal of Invalidation

In the recent case of Yeohata Machineries Sdn Bhd & Anor v Coil Master Sdn Bhd & Ors [2015] 6 MLJ 810 the Court of Appeal found that:

If You Are Interested in Invalidating a Patent

It is highly recommended that a thorough study be undertaken before you make any decision to start your patent invalidation proceedings.

Of course, if your situation is that of a defendant being sued for infringement of a patent, you certainly do not have the luxury of time. As some people say, offence is the best defence, and your best defence may include invalidation proceedings against the plaintiff.

If the plaintiff’s patent can be invalidated, the cause of action against you or your organization has been neutralized.

That’s a good strategy that had been taken in the two cases cited above: SKB Shutters and Merck Sharp & Dohme Corp. That’s a strategy that had been taken in the “podcasting patent case“.

Incidentally, lack of sufficient disclosure can be a grounds for invalidating a patent.

Thanks for reading!

Koo Chin Nam & Co.
Patent Registration / IP Litigation

Important Notice

This article has been prepared for general information only, and does not constitute legal advice. You should consult with a lawyer before you make any decisions inspired by the text of this blog post.

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