Actual - Legal

There was no sustained indigenous intellectual property protection system in Chine for long. The People’s Republic of Chi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

na (PRC) began to establish an intellectual property protection regime based on the Soviet model during the year 1949. In

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

1978, China adopted the open-door policy. The Patent Law of China was first promulgated on March 12, 1984. There are three

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

types of patents: patents for inventions, utility models and designs.

The Article 5 of the Patent Law, no patent ri

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ght shall be granted for any invention-creation that is contrary to the laws of the State or social morality or that is de

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

trimental to public interest. Also, no patent right shall be granted for any of the following:

Scientific disco

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

veries;

Rules and methods for mental activities;

Methods for the diagnosis or for the treatment of d

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

iseases;

Animal and plant varieties;

Substances obtained by means of nuclear transformation

Acc

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ording to article 22 of the Patent laws the basic requirement for grant of a patent is; “Any invention or utility model fo

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

r which patent right[s] may be granted must possess novelty, inventiveness and practical applicability.”

In China th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ere was a pre-grand opposition before 1992. This pre-grant opposition was abolished and replaced by post-grant opposition

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

(or revocation). Thus shortened the time required to grant a patent by six to ten months, depending on the type of patent

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

application.

After the grand of the patent, any person (either an individual or an entity) who believes that the pat

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ent should not have been granted pursuant to the Patent Law can request that the Patent Reexamination Board declare the pa

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

tent invalid. The rule 64(2) of the Implementing Regulations provides a list of grounds on which an invalidation request c

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

an be based on such grounds include issues relating to, inter alia,

Novelty, inventiveness, and practical appli

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

cability;

Enablement and written description;

Amendments that go beyond the scope of the patent appl

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ication’s original disclosure;

Whether the subject matter is patentable;

Double patenting; and

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

Formal matters.

Invalidation proceeding may take up to two years, with three possible outcomes:

The

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

entire patent is declared invalid;

Part of the patent is declared invalid; and

The patent is upheld

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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